Patent Docs

CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) -- Chief Judge Rader's Concurrence-in-part and Dissent-in-part

By Michael Borella --

A previous post presented the background of this case, as well as Judge Lourie's plurality concurrence.  As noted in that post, Alice's claimed inventions involved the reduction of settlement risk using a third-party intermediary.  Despite the claims being of various statutory classes, including process, article of manufacture, and machine, Judge Lourie found that they were all directed to patent-ineligible abstract ideas, and thus they failed to meet the requirements of 35 U.S.C. § 101.

This post continues the story of Alice by discussing Chief Judge Rader's concurrence-in-part and dissent-in-part.

Chief Judge Rader, joined by Judges Linn, Moore, and O'Malley, presented the lengthiest opinion in opposition to Judge Lourie.  Chief Judge Rader and Judge Moore would have affirmed the patent-ineligibility of Alice's method and computer-readable medium (CRM) claims, but came to this conclusion based on different reasoning than Judge Lourie.  On the other hand, Chief Judge Rader and Judge Moore believed that the system claims passed the § 101 bar.  Judges Linn and O'Malley would have held that all claims were patent-eligible.  Based on the style with which this opinion was drafted, it may have been in competition with Judge Lourie's concurrence for a majority of the en banc panel.

Throughout, Chief Judge Rader expounded the broad language of § 101, as well as for the separation of the §§ 101, 102, and 103 patentability analyses, which he accused Judge Lourie of conflating.  In doing so, he provided an overview of the legislative history, from the 1952 Patent Act, of the modern interpretation of § 101.  He further pointed to both statements of the authors of the 1952 Act, as well as subsequent case law and commentaries, that indicate that the § 101 analysis is not an "inventiveness" analysis, and that such an analysis instead falls within the ambit of § 103.  In a rebuttal of Judge Lourie's "discovery vs. invention" dichotomy, Chief Judge Rader pointed to the language of 35 U.S.C. § 100(a), which states that "[t]he term 'invention' means invention or discovery."

Regarding laws of nature, natural phenomena, and abstract ideas, he advocated restraint when applying these judicial exceptions so that they do not swallow the statutory language of § 101.  He also emphasized that claims pass the § 101 bar if they recite the application of such an exception, such as a practical use of an abstract idea.  As opposed to Judge Lourie's piecemeal approach, Chief Judge Rader advocated that determining whether this is the case for a given claim requires consideration of the claim as a whole.

Citing support in Diehr and Prometheus, he wrote:

Any claim can be stripped down, simplified, generalized, or paraphrased to remove all of its concrete limitations, until at its core, something that could be characterized as an abstract idea is revealed . . . .  A court cannot go hunting for abstractions by ignoring the concrete, palpable, tangible limitations of the invention the patentee actually claims.

Indeed, he strongly implied that Judge Lourie's approach could be used to render virtually any claim abstract.

He then stated that "[t]he relevant inquiry must be whether a claim includes meaningful limitations restricting it to an application, rather than merely an abstract idea," and proposed six factors to consider when undertaking this analysis:

•  First, "a claim is not meaningfully limited if it merely describes an abstract idea or simply adds 'apply it.' "

•  Second, "if a claim covers all practical applications of an abstract idea, it is not meaningfully limited."

•  Third, "if a claim does not wholly pre-empt an abstract idea, it still will not be limited meaningfully if it contains only insignificant or token pre- or post-solution activity -- such as identifying a relevant audience, a category of use, field of use, or technological environment."

•  Fourth, "a claim is not meaningfully limited if its purported limitations provide no real direction, cover all possible ways to achieve the provided result, or are overly-generalized."

•  Fifth, "a claim is meaningfully limited if it requires a particular machine implementing a process or a particular transformation of matter."

•  Sixth, "[a] claim also will be limited meaningfully when, in addition to the abstract idea, the claim recites added limitations" that are "central to the solution itself."

Remarkably, these factors overlap to a large degree with the four factors of Judge Lourie's "inventive analysis."  The main difference between the two is that Judge Lourie suggested considering whether the human contribution to the claim amounts "to more than well-understood, routine, conventional activity previously engaged in by researchers in the field."  Chief Judge Rader would eschew separate consideration of such a human contribution, and instead consider each claim as a whole.  However, the inclusion of the Chief Judge's sixth factor may make this consideration more difficult to achieve in practice.

His factors also reject the notion that there is an inventiveness or ingenuity requirement component in the § 101 analysis.  Instead, he stated that "[t]he eligibility inquiry is not an inquiry into obviousness, novelty, enablement, or any other patent law concept . . . [e]ach section plays a different role and no one section is more important than any other."  Unlike Judge Lourie, Chief Judge Rader would read the "inventive concept" language of Prometheus as:

[S]horthand for its inquiry into whether implementing the abstract idea in the context of the claimed invention inherently requires the recited steps.  Thus, in Prometheus, the Supreme Court recognized that the additional steps were those that anyone wanting to use the natural law would necessarily use.  If, to implement the abstract concept, one must perform the additional step, then the step merely separately restates an element of the abstract idea, and thus does not further limit the abstract concept to a practical application.  (Internal citation omitted.)

He went on to discuss how computer-specific limitations should be considered in light of these factors.  Invoking shades of the Bilski machine or transformation test, he wrote:

The key to this inquiry is whether the claims tie the otherwise abstract idea to a specific way of doing something with a computer, or a specific computer for doing something; if so, they likely will be patent eligible, unlike claims directed to nothing more than the idea of doing that thing on a computer.  While no particular type of limitation is necessary, meaningful limitations may include the computer being part of the solution, being integral to the performance of the method, or containing an improvement in computer technology.  (Emphasis in original.)

While Judge Lourie seemed to believe that adding general purpose computer components (e.g., a processor, data storage, a transceiver, etc.) to a claim failed to provide meaningful limitations, Chief Judge Rader disagreed.  In fact, he quoted the language of In re Alappat, stating that "a general purpose computer in effect becomes a special purpose computer once it is programmed to perform particular functions pursuant to instructions from program software."

Applying his reasoning to the system claims, the Chief Judge found all of them patent-eligible under § 101.  Acknowledging that issue before the Federal Circuit was whether to grant CLS's motion for summary judgment, he found that there was a lack of clear and convincing evidence that the claims were directed to an abstract idea.  Instead, relying on the reasoning of Bilski, he posited that "[i]f tying a method to a machine can be an important indication of patent-eligibility, it would seem that a claim embodying the machine itself, with all its structural and functional limitations, would rarely, if ever, be an abstract idea."  He also noted claiming an invention to include "circuitry, transistors, capacitors, and other tangible electronic components," or "electronically programmable machines that can fit in the palm of your hand," makes no difference on the abstractness of the claim.

Specifically, the representative system claim included "at least four separate structural components:  a computer, a first party device, a data storage unit, and a communications controller coupled via machine components to the computer and the first party device."  Chief Judge Rader found that, given this recited structure as well as further structural limitations of the invention's configuration, labeling the claim as abstract would defy the meaning of that term.  Particularly, he noted that "someone can use an escrow arrangement in many other applications, without computer systems, and even with computers but in other ways without infringing the claims," and that the recited structure was not inherent in the steps of performing a third-party escrow transaction.

With respect to the method and CRM claims, he considered these together because Alice had conceded that the CRM claims rise or fall with the method claims, despite the CRM claims having a different statutory category.  He framed the issue for the Court as "whether the recited steps are inherent in an escrow and claimed at a high level of generality, such that in fact the claim is not to a practical application of the concept of an escrow, but in effect claims the abstract concept of an escrow."

Nonetheless, in applying his analysis, he broke (or, at least, severely bent) his own rules on not conflating the analyses of § 101 and § 103, and considering the claim as a whole.  Particularly, in determining that the concept of an escrow is abstract, he cited to a prior art accounting reference.  He also performed a step-by-step analysis of the claim and found that each step "recites merely a general step inherent within the concept of an escrow, using a third party intermediary in this fashion."

Finally, Chief Judge Rader indicated that that method claims recited no computer structure.  He found that the stipulation of the method merely being performed by computer was insufficient to meet § 101 requirements due to its lack of specificity about how the computer implementation is arranged.  Chief Judge Rader's reasoning echoes that of the panel in Dealertrack v. Huber, which found a computer-aided method unpatentable because "[t]he claims are silent as to how a  computer aids the method, to what extent a computer aids the method, and the significance of a computer performance of the method.

Additional discussion of the open questions coming out of this decision will be the subject of future posts.

CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc)
Opinion for the court per curiam; concurring opinion by Circuit Judge Lourie, joined by Circuit Judges Dyk, Prost, Reyna, and Wallach; concurring-in-part and dissenting-in-part opinion by Chief Judge Rader, joined by Circuit Judge Moore, and by Circuit Judges Linn and O'Malley as to all but part VI of that opinion; dissenting-in-part opinion by Circuit Judge Moore, joined by Chief Judge Rader and Circuit Judges Linn and O'Malley; concurring-in-part and dissenting-in-part opinion by Circuit Judge Newman; dissenting opinion by Circuit Judges Linn and O'Malley; additional reflections by Chief Judge Rader.

CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc) -- Judge Lourie's Concurrence

By Michael Borella --

On May 10, the Federal Circuit handed down a much anticipated en banc ruling regarding the patent eligibility of computer-implemented inventions under 35 U.S.C. § 101.  In a per curiam opinion that is perhaps the most important § 101 jurisprudence since the Supreme Court's Bilski v. Kappos and Mayo v. Prometheus decisions, a plurality of judges set forth procedures for determining whether claims that recite an abstract idea or a law of nature meet the requirements of this section.  While the overall effect of this case remains to be seen and is likely to be a subject of heated debate, this decision has the potential to impact both patent litigation and prosecution.

In 2007, CLS Bank filed a declaratory judgment action against Alice Corp., contending that, among other things, Alice's U.S. Patents Nos. 5,970,479, 6,912,510, and 7,149,720 were invalid under § 101.  Alice filed counterclaims alleging infringement of these three patents.  Later, Alice's U.S. Patent No. 7,725,375 was added to the mix, and the parties respectively asserted invalidity and infringement contentions for this patent as well.

All four patents are from the same family and "share substantially the same specification."  The plurality described the claimed subject matter as:

[A] computerized trading platform used for conducting financial transactions in which a third party settles obligations between a first and a second party so as to eliminate "counterparty" or "settlement" risk . . . .  Settlement risk refers to the risk to each party in an exchange that only one of the two parties will actually pay its obligation, leaving the paying party without its principal or the benefit of the counterparty's performance.  Alice's patents address that risk by relying on a trusted third party to ensure the exchange of either both parties' obligations or neither obligation.

Between the four patents, method, computer-readable medium (CRM), and system claims were asserted.  The parties stipulated that all claims, including the method claims, require "a computer including at least a processor and memory" and electronic implementation, even though the representative method claim analyzed by the Federal Circuit did not literally recite such a requirement.

The District Court held that all asserted claims failed to meet the requirements of § 101, and thus were invalid.  Particularly, the District Court concluded that the method claims were directed to an unpatentable abstract idea, and that the CRM and system claims would similarly preempt all practical applications of this idea, despite those claims falling under a different statutory category.

On appeal, a Federal Circuit panel reversed the District Court on all counts, holding that all claims, including the method claims, were patent eligible under § 101.  CLS petitioned the full Federal Circuit for review, which was granted.  Sitting en banc, seven of the ten judges overruled the panel and affirmed the District Court's ruling regarding the method and CRM claims.  However, this majority did not agree on the rationale for their conclusion.  Further, five of the judges found that the system claims were unpatentable, while the other five concluded that these claims passed muster under § 101.  Additionally, eight of the judges indicated that the method, CRM, and system claims must rise or fall together.  Consequently, the precedential value of his decision, especially with respect to the system claims, may be limited.

Below, Judge Lourie's plurality concurrence is discussed.  Joining him were Judges Dyk, Prost, Reyna, and Wallach.  The other concurrences and dissents will be examined in subsequent posts.

Judge Lourie admitted the difficulty of analyzing patentability under § 101, and acknowledged the need for a more practical approach to this analysis:

While simple enough to state, the patent-eligibility test has proven quite difficult to apply.  The difficulty lies in consistently and predictably differentiating between, on the one hand, claims that would tie up laws of nature, natural phenomena, or abstract ideas, and, on the other, claims that merely embody, use, reflect, rest upon, or apply those fundamental tools.  For example, deciding whether or not a particular claim is abstract can feel subjective and unsystematic, and the debate often trends toward the metaphysical, littered with unhelpful analogies and generalizations.  What is needed is a consistent, cohesive, and accessible approach to the § 101 analysis -- a framework that will provide guidance and predictability for patent applicants and examiners, litigants, and the courts.  (Citation omitted.)

Judge Lourie then turned to the inevitable overview of Supreme Court decisions impacting § 101 as guideposts for this analysis.  In an example of judicial foreshadowing, he viewed Benson, Flook, Deihr, and Bilski through the lens of Prometheus.  In particular, he focused on the judicial exception to patentable subject matter when the claims at issue incorporate abstract ideas or laws of nature.  Then, he applied Prometheus's approach for analyzing such claims, with special concern for whether a claimed invention would effectively preempt other uses of any potentially abstract idea recited therein.

Particularly, Judge Lourie set forth a four-step analysis for patent eligibility under § 101 based heavily on Prometheus.  These steps are as follows:

1)  Determine "whether the claimed invention fits within one of the four statutory classes set out in § 101."  In other words, is the invention directed to a process, machine, manufacture, or composition of matter?

2)  Determine whether "the claim pose[s] any risk of preempting an abstract idea."  Or, does the claim incorporate an abstract idea?

3)  If an abstract idea is implicated by the claim, then "identify and define whatever fundamental concept appears wrapped up in the claim so that the subsequent analytical steps can proceed on a consistent footing."  Judge Lourie indicates that carrying out claim construction activities prior to this step may be helpful, but is not required.

4)  Finally, "[w]ith the pertinent abstract idea identified, the balance of the claim can be evaluated to determine whether it contains additional substantive limitations that narrow, confine, or otherwise tie down the claim so that, in practical terms, it does not cover the full abstract idea itself."

Judge Lourie refers to this final step as "inventive concept" analysis.  He explicitly states that this "balance of the claim" -- the human contribution -- need not require inventiveness in the same sense that claims must be novel and non-obvious under sections 102 and 103, respectively.  However, he does not clearly differentiate how this inventive concept analysis would differ in practice from, say, an obviousness analysis.  Instead he asserts that:

An "inventive concept" in the § 101 context refers to a genuine human contribution to the claimed subject matter . . . .  [A] person cannot truly "invent" an abstract idea or scientific truth.  He or she can discover it, but not invent it.  Accordingly, an "inventive concept" under § 101 -- in contrast to whatever fundamental concept is also represented in the claim -- must be a product of human ingenuity.

Compared to novelty and non-obviousness analyses "which consider whether particular steps or physical components together constitute a new or nonobvious invention," Judge Lourie states that the inventive concept analysis "considers whether steps combined with a natural law or abstract idea are so insignificant, conventional, or routine as to yield a claim that effectively covers the natural law or abstract idea itself."  But, in practice, this distinction may easily become blurred, and seems to advocate that claims be considered piecemeal under § 101 rather than as a whole.

Furthermore, at first blush, Judge Lourie's differentiation between discovery and invention seems like an aesthetically pleasing dichotomy -- after all, one could say that Pythagoras didn't invent the Pythagorean Theorem, but he did discover it.  However, Judge Lourie went on to point to four potentially subjective factors that would weigh against whether the human contribution to the claimed invention rises to such a level that the claim as a whole meets § 101 requirements:

1)  Is the human contribution necessary to every practical use of the abstract idea and therefore is not truly limiting.

2)  Does the human contribution "amount to more than well-understood, routine, conventional activity previously engaged in by researchers in the field?"

3)  Does the human contribution consist of token or trivial limitations, such as insignificant post-solution activity?

4)  Is the human contribution a "field-of-use limitation . . . where the claim as written still effectively preempts all uses of a fundamental concept within the stated field?"

Applying this approach to the patents in suit, Judge Lourie found that all claims failed under § 101.  The representative method claim was found to be directed to the reduction of settlement risk using a third-party intermediary.  As such, Judge Lourie concluded that this claim recited an abstract idea -- a "disembodied concept, a basic building block of human ingenuity, untethered from any real-world application."  Therefore, he turned to whether the remaining aspects of the claim added anything of substance.  He concluded that they did not.

Notably, this method claim did not recite any required physical structure.  It did not include a memory, a processor, transmitters or receivers, or any other computer component or peripheral.  Despite the parties' stipulation that the claim was computer implemented, Judge Lourie indicated that such a limitation was "insignificant post-solution activity" and that "simply appending generic computer functionality to lend speed or efficiency to the performance of an otherwise abstract concept does not meaningfully limit claim scope for purposes of patent eligibility."  Thus, he concluded that "[a]s in Bilski, upholding Alice's claims to methods of financial intermediation would pre-empt use of this approach in all fields, and would effectively grant a monopoly over an abstract idea."

Judge Lourie similarly found the representative CRM claim unpatentable as well, despite its recitation of a tangible article of manufacture, which would ostensibly be a physical device.  This claim essentially recited the invention of the method claim, but in CRM form.  Judge Lourie asserted that "under § 101 we must look past drafting formalities and let the true substance of the claim guide our analysis."  Applying this analysis he concluded that the CRM claim was actually drawn to "the underlying method of reducing settlement risk using a third-party intermediary," and that it was merely a method claim in the guise of a device claim.  He further warned that one should not allow a competent draftsman to "endow abstract claims with patent-eligible status."

The representative system claim also fell under Judge Lourie's analysis.  This claim recites ample structure -- including a data storage unit and a computer that receives data, performs operations on the data, and generates an instruction to an "exchange institution."  Nonetheless, Judge Lourie found that the similarity between the method and system claims required application of the same abstract idea analysis for both.  In this case, the question was whether "the limitations of the claim, including any computer-based limitations, add enough beyond the abstract idea itself to limit the claim to a narrower, patent-eligible application of that idea."  Viewing the "generic" computer structure recited by the claim sufficient to "encompass any device capable of performing the same ubiquitous calculation, storage, and connectivity functions required by the method claims," Judge Lourie found that they did not because this structure did not provide a significant "inventive concept."  Summing up, he wrote that:

We are not here faced with a computer per se.  Such are surely patent-eligible machines.  We are faced with abstract methods coupled with computers adapted to perform those methods . . . .  Abstract methods do not become patent-eligible machines by being clothed in computer language.

In order to properly seek protection of their inventions, Applicants need to understand the requirements of § 101.  Despite the plurality's cry for "a consistent, cohesive, and accessible approach to the § 101 analysis," at best, a handful of dirt has been tossed into already muddied waters.  Judge Lourie's procedures for § 101 analysis allow significant opportunities for subjectivity on the part of the fact finder.  As a result, an Applicant's best practice for obtaining suitable protection of its computer-implemented technologies remains unclear.  A more detailed discussion of the open questions coming out of this decision will be the subject of future posts.

CLS Bank Int'l v. Alice Corp. (Fed. Cir. 2013) (en banc)
Opinion for the court per curiam; concurring opinion by Circuit Judge Lourie, joined by Circuit Judges Dyk, Prost, Reyna, and Wallach; concurring-in-part and dissenting-in-part opinion by Chief Judge Rader, joined by Circuit Judge Moore, and by Circuit Judges Linn and O'Malley as to all but part VI of that opinion; dissenting-in-part opinion by Circuit Judge Moore, joined by Chief Judge Rader and Circuit Judges Linn and O'Malley; concurring-in-part and dissenting-in-part opinion by Circuit Judge Newman; dissenting opinion by Circuit Judges Linn and O'Malley; additional reflections by Chief Judge Rader.

Rubin v. General Hospital Corp. (Fed. Cir. 2013)

By Donald Zuhn --

On March 28, the Federal Circuit in Rubin v. General Hospital Corp. affirmed judgment by the District Court for the District of Massachusetts dismissing the suit brought by Drs. Berish Rubin and Sylvia Anderson against The General Hospital Corporation requesting correction of U.S. Patent Nos. 7,388,093 and 7,407,756, which are assigned to General Hospital.  The '093 and '756 patents are directed to genetic mutations that cause the inherited disease Familial Dysautonomia (FD), also known as Riley-Day Syndrome, and methods for detecting FD.

Drs. Rubin and Anderson at the Department of Biological Sciences of Fordham University, and Drs. Slaugenhaupt and Gusella at Massachusetts General Hospital, had been independently conducting research to determine the genetic mutations disclosed in the '093 and '756 patents.  Drs. Rubin and Anderson identified two mutations in the gene encoding IkB kinase complex-associated protein that cause FD, and on December 20, 2000, submitted a paper describing these mutations to the American Journal of Human Genetics.  When submitting the paper, Dr. Rubin asked the Editor of the journal to not send the paper to Dr. Gusella and his colleagues at Mass General for peer-review.  On December 22, 2000, the Editor sent the abstract for the paper to Dr. Gusella.  Dr. Gusella declined to review the full paper, and on December 28, 2000, Drs. Gusella and Slaugenhaupt submitted their own paper identifying the same two mutations to the same journal (as of October 2000, Dr. Gusella had noted that his group had identified 184 candidate mutations, and as of December 12, 2000, further noted that the responsible mutations had not yet been identified).  Both papers were published in the January 22, 2001 issue of the journal.

On January 6, 2001, Drs. Gusella and Slaugenhaupt filed a provisional application describing the two mutations and claiming their diagnostic use.  On January 17, 2001, Drs. Rubin and Anderson filed their own provisional application describing the two mutations and claiming their diagnostic use.  The application filed by Drs. Gusella and Slaugenhaupt eventually resulted in the issuance of the '093 and '756 patents.  During prosecution of their application, Drs. Rubin and Anderson decided not to initiate an interference in the U.S. Patent and Trademark Office, despite the examiner's suggestion that they do so.

Rather than initiate an interference, Drs. Rubin and Anderson filed suit against Mass General seeking correction of inventorship of the '093 and '756 patents under 35 U.S.C. § 256.  They argued that Dr. Gusella's receipt of their abstract permitted Dr. Gusella's group to select and confirm the identity of the FD mutations and file their provisional patent application, and Drs. Rubin and Anderson asked to be substituted as the inventors of the '093 and '756 patents, or added as joint inventors.  Granting Mas General's motion for summary judgment, the District Court held that the inventorship could not be changed under § 256 because there was no "collaboration" between the two teams of scientists, and that Drs. Rubin and Anderson could not be added as joint inventors because they did not meet the requirements of § 116 for joint invention.  With respect to the correction of inventorship, the District Court also held that the complete substitution of inventorship is not a matter for § 256, but rather, is a claim for priority of invention of the subject matter, and priority should be resolved in an interference, not under § 256.

On appeal, the Federal Circuit determined that "the district court correctly ruled that the independent relationship between these teams of scientists, and the nature of this communication of information, do not support joint invention in accordance with §116, or warrant change or substitution of inventorship under §256."  The panel added that:

We agree with the district court that, whatever actions were taken after the Rubin/Anderson Abstract appeared uninvited on Dr. Gusella's desk, ultimately the dispute is of priority of invention; that is, which team was the first to conclusively identify the operative mutations.  The district court recognized that even if Drs. Gusella and Slaugenhaupt had completed this identification before they saw the Rubin/Anderson identification, it would still be necessary to determine priority of invention in order to resolve the patent rights.

The panel, therefore, concluded that the District Court acted within its authority in directing the parties to the USPTO to determine priority of invention, and affirmed the District Court's judgment of dismissal.

Rubin v. General Hospital Corp. (Fed. Cir. 2013)
Nonprecedential disposition
Panel: Circuit Judges Newman and Bryson and District Judge Fogel
Opinion by Circuit Judge Newman

Dawson v. Dawson (Fed. Cir. 2013)

By Donald Zuhn --

On March 25, the Federal Circuit in Dawson v. Dawson affirmed a determination by the Board of Patent Appeals and Interferences that the University of California, San Francisco (UCSF) failed to establish sole conception by Dr. Chandler Dawson of the claimed inventions in two patents assigned to InSite Vision Inc.  The case involved an interference between two patents, U.S. Patent Nos. 6,239,113 and 6,569,443, which name Dr. Dawson and Dr. Lyle Bowman as inventors and which are assigned to InSite, and an application which names Dr. Dawson as the sole inventor and which is assigned to UCSF.  The patents and application ay issue are directed to a method for topically treating and preventing infections of the eye.

In 1997, at a meeting of the World Health Organization Alliance for the Elimination of Trachoma, Dr. Dawson, who was employed by UCSF, gave a presentation on the topical use of an antibiotic called azithromycin (at right) to control trachoma (a bacterial infection of the eye).  A report of the meeting ("WHO Report") was subsequently released, which included a discussion of Dr. Dawson's presentation.  A second document ("WHO document"), which may have been an outline of Dr. Dawson's presentation, provided a similar discussion of the presentation.

Shortly after the meeting, Dr. Dawson asked Dr. Kenneth Chern to enlist the assistance of Dr. Bowman, an employee at InSite (a company involved in the research and development of ophthalmic products), in creating a suitable ophthalmic medication with azithromycin that could be applied topically to the eye.  Dr. Chern sent 100 mg of azithromycin to Dr. Bowman for formulating as a topical preparation.  Three weeks later, after not hearing back from Dr. Bowman, Dr. Chern sent azithromycin to Dr. Charles Leiter, a pharmacist associated with the same foundation as Dr. Chern, to formulate as an ointment or suspension.  Dr. Leiter prepared an ointment using a mineral oil and petrolatum carrier and containing 0.5% azithromycin by weight.  Upon receipt, Dr. Chern applied some of the ointment to his own eye to determine whether it could be well-tolerated, and informed Dr. Dawson of the results of his experiment.  Dr. Dawson subsequently left UCSF to work at InSite, and after joining InSite, was named with Dr. Bowman on a patent application that led to the issuance of the '113 and '443 patents.

Almost four years after the '443 patent issued, UCSF filed a patent application naming Dr. Dawson as an inventor, and copying the specification and claims from both the '113 and '443 patents in order to provoke an interference.  The BPAI declared two interferences between the InSite patents and UCSF's application, naming UCSF as the junior party (and therefore UCSFD bore the burden of proving, by a preponderance of the evidence, that Dr. Dawson alone had conceived of the inventions recited in the counts prior to InSite's March 31, 1999 filing date).  The count in Interference 105,719, which tracks claim 3 of the '113 patent, recites:

A process for treating an eye, which comprises:
    topically applying an aqueous polymeric suspension of an azalide antibiotic, wherein said suspension comprises water,
    0.01% to 1.0% of an azalide antibiotic, and
    0.1 to 10% of a polymeric suspending agent which is a water-swellable water-insoluble cross-linked carboxy-vinyl polymer which comprises at least 90% acrylic acid monomers and 0.1% to 5% crosslinking agent.

The count in Interference 105,729, which tracks claim 1 of the '443 patent, recites:

A process for treating an eye, comprising:
    topically applying an azalide antibiotic to an eye in an amount effective to treat infection in a tissue of the eye, wherein said topically applying comprises supplying a depot of a composition containing said azalide antibiotic on the eye.

On the issue of conception, the Board determined that UCSF had failed to prove sole conception by Dr. Dawson, finding that that Dr. Dawson did not fully appreciate how his idea was to be implemented in actual practice, and that it was only after Dr. Bowman became involved that "'something' significant happened," leading to the March 1999 filing of Dr. Dawson's and Dr. Bowman's application.  UCSF appealed the Board's decision, contending the Board erred in finding that Dr. Dawson did not conceive of the claimed inventions by himself prior to his collaboration with Dr. Bowman.

In a majority opinion written by Judge Bryson and joined by Judge Wallach, the Federal Circuit began by noting "that the nature of the evidence presented in this case is unusual," as the Court was "asked to decide whether and when an invention formed definitely, permanently, and particularly in the mind of the alleged inventor, but to do so without any testimony from the supposed inventor himself."  Instead of providing testimony from Dr. Dawson, UCSF contended that the WHO Report and the WHO document prove Dr. Dawson's conception, and that Dr. Leiter's preparation of an ointment for Dr. Chern provided further corroboration.  The Court, however, disagreed with UCSF's contention, stating that "[a]t best, . . . the WHO Report and WHO document announce a general idea, acknowledge many of the difficulties associated with making that idea operative, and offer some thoughts on how one might proceed (including by listing a few potential delivery vehicles)."  The Court explained (citations omitted) that:

The WHO document is entitled "Potential Use of Topical Azithromycin in Trachoma Control Programmes," and the WHO Report describes Dr. Dawson's presentation as a "preliminary report on the possibility of developing a topical application of azithromycin," while "recommend[ing] that [Dr.] Dawson continue to work with [others] to develop a topical application and report back at the next meeting."  A "preliminary" statement about a "possibility" or "potential use," alongside a recommendation for continued work and a "report back" in the future, falls short of a "'definite and permanent idea of the complete and operative invention, as it is hereafter to be applied in practice.'"

Stating that "[t]he inadequacy of UCSF's showing is equally clear in the context of the specific interference counts," the Court noted that UCSF's evidence failed to establish conception of the specific concentrations in the '719 count, and further, that UCSF failed to establish that Dr. Dawson on his own determined "an amount effective to treat infection in a tissue of the eye" as recited in the '729 count.

The Court also noted that the ointment prepared by Dr. Leiter for Dr. Chern did not establish that Dr. Dawson alone conceived of the subject matter of the counts because "[t]here is no evidence that Dr. Dawson instructed Dr. Chern to contact Dr. Leiter or otherwise had any direct connection to the preparation of the ointment."

On appeal, UCSF argued that the Board's decision on conception was infected by several errors in claim construction and admission of evidence.  In response to UCSF's argument that the preamble of the '719 count should not have been read as limiting, and that treatment can be proactive and can thus occur absent an active infection, the Court countered that "[t]he proper meaning and scope of the preamble . . . is irrelevant to our conclusion that UCSF failed to prove sole conception by Dr. Dawson."  In response to UCSF's argument that the Board erred in considering statements from the specifications of the '113 and '443 patents on the ground that those statements were inadmissible hearsay, the Court noted that "UCSF adopted the words in the '113 and '443 patents as its own when it 'copied' those words into the patent application that provoked these interferences."  In response to USCF's argument that the Board erred by failing to consider statements made by InSite in an opposition to a European patent application concerning the topical use of azithromycin (InSite had stated in opposition proceedings that the WHO document "disclos[es] . . . why topical azithromycin preparations for eye treatment are highly desirable" and provides "a concrete disclosure [of] how such preparations can be obtained" and "suggestions [on] how [they] could be made"), the Court determined that the Board did not abuse its discretion by following its general rule against giving controlling weight to documents from foreign patent proceedings.  The Court also pointed out that the Board had properly noted that the instant case involved the issues of conception and reduction to practice and not lack of novelty or inventive step, the latter of which were at issue in the opposition.

Writing in dissent, Judge Reyna stated that:

The record before us demonstrates that Dr. Dawson possessed a definite and permanent idea of his complete and operative invention when, in the summer of 1997, he delivered a related presentation at a conference of the World Health Organization ("WHO").  At that time, Dr. Dawson was employed by UCSF, not InSite.  Consequently, I find that Dr. Dawson, through UCSF, satisfied his burden of demonstrating prior conception.

The dissent continued by asserting that the WHO Report and WHO document teach each of the limitations of the '729 count, and establish that he had possession of each recited feature.  In particular, the WHO references disclose (1) treating an eye, (2) topically applying an azalide antibiotic (i.e., azithromycin) (3) an effective dose ("Dr. Dawson suggested that his azithromycin formulation would use the same dosage known for erythromycin," and the dose "0.5% by weight[] is used throughout Dr. Dawson's patent as a preferred formulation), (4) supplying a depot containing the azalide antibiotic ("[b]oth references contain the same table listing five alternative delivery depots, one of which is [InSite's] Durasite").  The dissent concluded that "Dr. Dawson's WHO presentation and the accompanying report disclose each element of at least the '729 count, and as such, the two WHO references are sufficient to demonstrate Dr. Dawson's prior conception."

With respect to Dr. Chern's experiment with Dr. Leiter's ointment, the dissent explained that:

In the interference proceeding, the Board considered whether Dr. Chern's experiment showed reduction to practice before the critical date.  The Board held that Dr. Chern's experiment could not be reduction to practice because Chern had not applied the ointment to an actual infection.  The Board based its determination on its construction of "treating" an eye, which it construed as "retarding or suppressing infection in a tissue of" an eye.  Because Dr. Chern had not applied the ointment to treat an actual infection, the Board held that Dr. Chern did not reduce Dr. Dawson's invention to practice.  The Board erred in two fundamental aspects.  First, the term "treating an eye" in the preamble of the count is not limiting.  Second, "treating an eye" does not require an actual infection.

The dissent concluded by stating that:

The question is:  because Dr. Dawson's WHO presentation demonstrated conception and Dr. Chern's experiment demonstrated reduction to practice, what is left to establish inventorship?  The majority opinion leaves open for interpretation whether commercialization is required for full conception.

But conception does not require commercialization, nor does commercialization establish initial invention.  On the contrary, the record shows that Dr. Dawson conceived his invention at UCSF.  He turned to Dr. Bowman at InSite only for assistance in commercializing his invention.

Dawson v. Dawson (Fed. Cir. 2013)
Panel: Circuit Judges Reyna, Bryson, and Wallach
Opinion by Circuit Judge Bryson; dissenting opinion by Circuit Judge Reyna

Allergan, Inc. v. Sandoz Inc. (Fed. Cir. 2013)

By Andrew Williams --

Can a method of treatment claim be inherent in the prior art if neither the formulation nor the method of using the formulation twice a day were in the prior art?  Earlier today,  the Federal Circuit determined in Allergen v. Sandoz that a claimed method for treating glaucoma (which differed from the three-times-a-day dosage regimens required of the individual components) was not inherently obvious, and thereby prevented a group of generic challengers from being able to market their own versions of Combigan^® before the expiration of the patent containing the claimed method.  However, Judge Dyk, dissenting-in-part, found no difference between the instant case and Federal Circuit precedent -- although the precedent relied upon was all directed to inherent anticipation.  Nevertheless, the majority and dissent agreed that the claims directed to the formulation itself were obvious in view of the prior art, and therefore reversed the lower court's finding of validity of all the claims.

This case involved Allergan's formulation for a combination eye-drop product marketed as Combigan^®, a product which combines a well-known alpha₂-agonist Alphagan^® (0.2% brimonidine) and a well-known beta-blocker Timoptic^® (0.5% timolol).  Allergan had found that by co-formulating these drugs, patient compliance increased because the drugs could now be administered at the same time, and because (unexpectedly) the number of daily administrations could be dropped from 3 to 2.  The inventors obtained four patents on this formulation and methods of its use, all stemming from an application filed on April 19, 2002, which Allergan listed in the Orange Book.  For the purposes of the appeal, the parties treated almost all of the asserted claims as one group, referring to claim 1 of U.S. Patent No. 7,323,463 ("the '463 patent") as the representative claim, which read:

1.  A composition comprising about 0.2% timolol by weight and about 0.5% brimonidine by weight as the sole active agents, in a single composition.

The only other asserted claim was claim 4 of U.S. Patent No. 7,030,149 ("the '149 patent"), which read:

4.  A method of reducing the number of daily topical ophthalmic doses of brimondine administered topically to an eye of a person in need thereof for the treatment of glaucoma or ocular hypertension from 3 to 2 times a day without loss of efficacy, wherein the concentration of brimonidine is 0.2% by weight, said method comprising administering said 0.2% brimonidine by weight and 0.5% timolol by weight in a single composition.

Sandoz Inc., Alcon Laboratories, Inc., Alcon Research Ltd., Alcon, Inc., and Falcon Pharmaceuticals, Ltd. (collectively, "Sandoz"), and the other defendants Apotex Inc. and Apotex Corp., and Watson Laboratories, Inc., each filed Abbreviated New Drug Applications with the FDA seeking to market generic versions of Combigan^®.  In turn, Allergan sued them under 35 U.S.C. § 271(e)(2)(A).  After a claim construction determination, the lower court granted summary judgment of non-infringement as to claims 1-3 of the '149 patent, and the parties stipulated to infringement of the remaining claims.  After a bench trial, the District Court found all of the claims nonobvious over the prior art.  The defendants appealed.

The Formulation Claims – Claim 1 of the '463 Patent as Representative

The lower court had rejected an invalidity allegation that Claim 1 of the '463 patent was obvious primarily in view of U.S. Patent No. 5,502,052 ("DeSantis").  This reference taught the use of a combination of alpha₂-agonists and beta-blockers for treating glaucoma, but did not teach that brimonidine could be one of those alpha₂-agonists.  Nevertheless, DeSantis incorporated by reference a publication by Timmermans, which disclosed brimonidine and its tartrate salt.  Also, even if not mentioned by name, the ranges of the components of claimed formulations fell within the ranges as taught by DeSantis -- 0.02 to 2.0% alpha₂-agonist and 0.01 to 3.0% beta-blocker.  Also in the art was a reference that taught the topical administration of 0.2% brimonidine with 0.5% timolol in combination, although spaced five minutes apart, and the fact that it was common to dose the serial application of these two drugs twice a day.  Moreover, there were only three known pharmaceutically acceptable alpha₂-agonists at the time for the treatment of glaucoma -- clonidine, apraclonidine, and brimonidine.  The Federal Circuit did not necessarily disagree with any of the factual findings of the lower court related to obviousness, but instead reversed because it believed that the facts instead supported a finding of obviousness.

Motivation to Combine

The lower court relied heavily on the fact that there would be no motivation to develop fixed combination products, even though such formulations might improve patient compliance, because the FDA does not consider patient compliance as a factor when approving new formulations.  The Federal Circuit noted that FDA approval might be a factor in an obviousness determination, for example when determining whether there was motivation to develop a drug or whether there was skepticism regarding efficacy.  However, it also noted that motivation to combine may be found in many different places, not just in the rationale used by the FDA as a basis for its approvals.  In view of the overwhelming amount of prior art related to the claimed formulation, the Federal Circuit thought there was sufficient support to find a motivation to combine, notwithstanding the FDA's approval process.  Somewhat lacking in the analysis, however, was how the FDA's position regarding patient compliance does factor into the obviousness determination.

Reasonable Expectation of Success

The lower court found that the unpredictability in the chemical arts weighed in favor of a finding of nonobviouness.  As a factor, the District Court considered Allergan's challenges formulating Combigan^®.  The Federal Circuit did not agree, because some degree of unpredictability is fine, provided there is a reasonable probability of success.  In this case, DeSanits provided that reasonable probability.  Moreover, Allergan's formulation difficulties stemmed from the fact that it was attempting to use a proprietary preservative.  There is no record of continued difficulties once its scientists switched to a commonly used preservative.  The fact that the claims were not drawn to the precise formulation Combigan^® was important, because there is no requirement that there be a reasonable expectation of success in formulating Combigan^®.

Teaching Away

The lower court had found factors that taught away from the claimed formulation, including the potential side effects, differing dosing regimens, and disparate half-lives of brimonidine and timolol.  However, as the Federal Circuit explained, the District Court did not consider the impact that these factors would have on the clear motivation to combine (probably because it did not find a motivation to combine).  Interestingly, the Federal Circuit pointed out that the lower court did not find that the prior art as a whole taught away from the claimed invention.  The Court, therefore, accepted the factual findings from below, but concluded that they did not render the invention nonobvious.

Secondary Factors

Finally, the Federal Circuit accepted all the lower court's factual findings with regard to secondary considerations of nonobviousness, but still found that they did not weigh heavily enough to overcome obviousness of the claims.  With regard to long-felt need, the District Court's findings were apparently entirely conclusory.  With regard to unexpected results, the lower court had found that the claimed formulations were able to overcome previous difficulties in treating patients with twice-per-day dosage regimens.  The Federal Circuit thought this was somewhat irrelevant.  The Court did agree that these results were unexpected.  However, while such results might be meaningful to method of treatment claims, they were not as relevant to the formulation claims.

The Method-of-Treatment Claim – Claim 4 of the '149 Patent

As shown above, the treatment claim has a couple of relevant limitations, including the above-referenced formulation of brimonidine and timolol, and the use of this formulation twice a day with the same efficacy as brimonidine administration three times a day.  The problem with administering brimonidine only twice a day was that efficacy would drop eight to nine hours after administration, in a phenomenon referred to as "afternoon trough."  The majority found that the defendants did not establish by clear and convincing evidence that the claimed method would have been obvious.  Importantly, the defendants apparently did not argue that the "efficacy limitation" is inherent to all fixed combination products containing brimonidine and timolol, or that a dose reduction would inherently flow from the obvious formulation included in the claims.  And, the defendants' citation to the success in using timolol with other non-alpha₂-agonist ophthalmic drugs with reduced doses was found to be irrelevant, because there was no reason why the use of these unrelated drugs would make the claimed method obvious.

Judge Dyk, in dissent, disagreed -- he would have also reversed the finding of nonobviousness of this claim.  He relied heavily on his belief that the method claim only contained one step -- applying a fixed combination of 0.2% brimonidine and 0.5% timolol twice a day.  It was not explained, however, why he considered two administrations to be a single step.  Nevertheless, Judge Dyk believed that the twice-a-day dosing of a formulation that was not in the prior art would have nonetheless been obvious to one skilled in the art, and that the alleged avoiding-"loss of efficacy" limitation was just the result of the claimed method.  As support for this proposition, Judge Dyk cited to three Federal Circuit cases:  Abbott Labs. v. Baxter Pharm. Prods., 471 F.3d 1363 (Fed. Cir. 2006); In re Cruciferous Sprout Litig., 301 F.3d 1343 (Fed. Cir. 2002), and Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001).  However, each of these cases relates to inherent anticipation, not inherent obviousness.  It is not self-evident that the reasoning behind allowing the inherent result flowing from the use of a prior art composition or method to anticipate a claim would apply with equal force to a composition or method that was only obvious in view of the prior art.  In other words, citation of these cases, without more, is like comparing apples with oranges.

Moreover, Judge Dyk does not appear to consider the fact that there were two limitations that were not taught in the prior art -- the formulation and its method of use.  It should not be sufficient to conclude that, just because a formulation was obvious, any method of using it must also be.  Granted, this case would have been completely different if the claimed formulation was taught in the prior art, and the only potentially obvious limitation was its use twice a day.  In such a case, it is possible that its use might have been obvious, and the "efficacy" result that flowed from it could therefore have been inherent.  This is, perhaps, why the majority agreed in footnote 1 that "the inherency doctrine may apply to an otherwise obvious claim" in some situations.  Nevertheless, this was not the case and, without more, the majority's position was more grounded in the facts of the case, and in the Court's precedent.

Allergan, Inc. v. Sandoz Inc. (Fed. Cir. 2013)
Panel:  Circuit Judges Dyk, Prost, and O'Malley
Opinion for the court by Circuit Judge Prost; opinion concurring-in-part and dissenting-in-part by Circuit Judge Dyk

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

By Michael Greenfield --

Contraceptives were the subject of the Federal Circuit's recent decision in Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.  But, unfortunately, it's a rather fact-specific case with nothing of prurient or even much general legal interest to spice up the lonely patent practioner's day.

The battle was over Bayer's RE37,564 patent and, specifically, claims 13 and 15:

13.    A combination product for oral contraception, comprising
    (a)    23 or 24 daily dosage units, each containing 0.020 mg of ethinylestradiol, and 2.5 to 3.0 mg of drospirenone, and
    (b)    5 or 4, respectively, active ingredient-free placebo pills or other indications to show that the daily administration of the 23 or 24 dosage units, respectively, is to be followed by 5 or 4, respectively, pill-free or placebo pill days, wherein each of the dosage units containing drospirenone contains the same amount of drospirenone.

15.       A combination preparation of claim 13, which comprises 24 dosage units and 4 placebo pills or other indications to show that no dosage unit or placebo pill is administered during the last 4 days of the menstrual cycle.

A purpose of the claimed invention was to provide an alternative to the standard 21/7 dosing regime of combined oral contraceptives ("COC"), which combined a synthetic progestin (e.g., drospirenone (DRSP)) and estrogen (e.g., ethinylestradiol, ("EE")).  In the 21/7 dosing regime, a woman takes a single, synthetic hormone-containing pill for 21 days followed by a period of 7 days of a placebo (i.e., a pill containing no hormone), also called "the pill-free interval."  The 21/7 regime is thought to mimick the normal menstrual cycle while providing a regular break from the exposure to the synthetic hormone, thereby, mitigating potential side effects.

To further reduce side effects, Bayer sought to reduce the daily dosage of the drugs.  In particular, they reduced the daily dose of EE from 150 µg/pill to 20 µg/pill.  But with the lower dose, some ovarian activity and follicular maturation can persist, and any intake errors (i.e., missed pills) could result in "escape" ovulation and unintended pregnancy.  To address this issue, Bayer increased the number of days on the hormone-containing pill and decreased the pill-free interval, coming up with the claims' 23/5 and 24/4 regimes and demonstrating that shortening the pill-free interval to four or five days (from seven) improved contraceptive efficacy.  Bayer was awarded a patent, which ultimately reissued as the '564 patent.

So, everybody was happy, at least until Watson Pharmaceuticals came along and sought to upset the apple cart.  Watson filed an ANDA and asserted that Bayer's patent was invalid as obvious.  Bayer took issue with this and litigation ensued as Bayer sued Watson for infringement under 35 USC § 271(e)(2) for the filing of the ANDA.

In the District Court both sides filed for summary judgment on the obviousness issue, Watson asserting that the claims of the '564 patent were obvious over numerous publications and Bayer responding nuh-uh (but, presumably, in a more elaborate and eloquent manner).  The District Court found Bayer's argument persuasive and held against Watson.  Watson, naturally, appealed.

Watson argued that that patent was obvious over Australian patent application 55094/90 ("AU'094") in view of any one of several other publications.  AU'094 disclosed COCs containing 20-40 µg EE and 1-10 mg DRSP per pill, which encompass the amounts in the '594 claims on appeal.  Watson further argued that the secondary publications each taught the 23/5 and/or 24/4 dosing regimes and suggested them as useful for shortening the pill-free interval and addressing the missed-pill problem, thus providing the motivation to combine such regimes with the AU'094 COCs.

Bayer disagreed.  They argued that AU'094 and at least one of the other secondary references were directed to narrow subpopulations of patients primarily in need of hormone–replacement therapy and, therefore, the ordinary artisan would not have combined those references when seeking to make a COC.  Bayer also argued that in view of the entrenched 21/7 regime and the perceived risks of increasing the days on hormone, the art as a whole taught away from the claimed COC.

The Federal Circuit agreed with Watson, holding that all the limitations of the claims were present in the prior art along with an express motivation to combine them.  AU'094 disclosed COCs encompassing those of the asserted claims.  A second publication, EP 0253607 ("EP'607") disclosed COCs with 8-30 µg/dose EE and suitable progestins (but not DRSP) as well as the asserted claims' 24/4 and 23/5 dosage regimes.  The Federal Circuit also noted that the prior art recognized the escape ovulation problem that could result through inadvertent extension of the pill-free interval with one or two missed pills.  And the Court pointed to Bayer's own expert, who acknowledged a greater risk of "missed pill" ovulation with low dose COCs.  As the prior art recognized the problem and suggested the claimed solution, the Court held that the claims were obvious.

Bayer countered with several arguments that the Federal Circuit swatted away like so many flies.  To Bayer's assertion that AU'094 and EP'607 were primarily directed to hormone replacement therapy, the Court responded that they plainly disclosed contraceptive applications as well.  To Bayer's assertion that conventional wisdom suggested the 21/7 dosing regime, the Court responded that this does not overcome the express teachings of the several applied publications to shorten the pill-free interval.  To Bayer's assertion that Goldstuck prior art taught decreasing the pill-free interval while concurrently increasing the hormone dose for at-risk patients, the Federal Circuit replied that these two measures were never linked as mutually dependent, each being expected to reduce missed-pill ovulation risk independent of the other.

The Federal Circuit similarly addressed in short order Bayer's evidence of secondary indicia of non-obviousness.  To Bayer's assertion of unexpected results of reducing follicular activity with the 25/3 and 24/4 regimes compared to the 21/7 regime, the Federal Circuit responded that that was just what would have been expected by administering additional active pills, a matter of "common sense," as even Bayer's expert agreed.  To Bayer's assertion that the FDA requested clinical safety and efficacy data to justify additional hormone exposure, the Federal Circuit merely responded that that the FDA was doing nothing more its job, i.e., requiring safety and efficacy data.  To Bayer's assertion that the invention "was widely praised by experts in the COC field," the Federal Circuit responded that several journal citations merely referred to Bayer's published results or discussed possible non-contraceptive indications for 24/4 COC regimens and, furthermore, the first-named author on an article praising the Bayer 24/4 COC regime as an "innovative strategy" happened to be the first-named inventor on the '564 patent.  And, finally, in response to Bayer's contention that the defendant's copying of the claimed COC preparations was evidence of non-obviousness, the Federal Circuit replied that the defendants had to copy the claimed preparations to demonstrate bioequivalence, as required for FDA approval.

And so ended the life of RE37,564.

Bayer Healthcare Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)
Panel:  Circuit Judges Lourie, Schall, and Prost
Opinion by Circuit Judge Lourie

Biogen Idec, Inc. v. GlaxoSmithKline LLC (Fed. Cir. 2013)

By Donald Zuhn --

Yesterday, in Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit affirmed the determination by the District Court for the Southern District of California that the claim term "anti-CD20 antibody" as used in U.S. Patent No. 7,682,612 was limited by prosecution history estoppel.  The '612 patent is directed to the treatment of hematologic malignancies associated with circulating tumor cells using anti-CD20 antibodies.  Representative claim 1 recites:

1.  A method of treating chronic lymphocytic leukemia in a human patient, comprising administering an anti-CD20 antibody to the patient in an amount effective to treat the chronic lymphocytic leukemia, wherein the method does not include treatment with a radiolabeled anti-CD20 antibody.

As the majority opinion notes, it was initially believed that only one large loop (epitope) of the CD20 antigen (at right) was exposed on the surface of cancerous B cells, and therefore, that there was only one suitable target for the anti-CD20 antibody.  However, after Biogen filed the application that issued as the '612 patent, other researchers discovered that the CD20 antigen had a second small loop to which certain anti-CD20 antibodies could bind.

During the prosecution of the application that issued as the '612 patent, the examiner rejected the claims because the specification did not provide enablement commensurate with the scope of the claimed invention, which the examiner contended included "any and all anti-CD20 antibodies, no matter the specificity or affinity for the specific epitope on the circulating tumor cells."  The examiner acknowledged that the specification was enabling for Biogen's chimeric gamma 1 anti-human CD20 antibody, Rituxan® (rituximab), but was silent concerning the specificity and affinity that would be necessary for other anti-CD20 antibodies.  In response to the rejection, Biogen stated that:

[E]ven though antibodies directed to the same antigen might have different affinities and functional characteristics, one of skill in the art could readily identify an antibody that binds to CD20 with similar affinity and specificity as does RITUXAN® using techniques that are well known in the art.  . . .  With that knowledge in hand, the skilled artisan could readily produce anti-CD20 antibodies using similar techniques, and screen such antibodies for those having an affinity and functional activity similar to RITUXAN®.

The examiner then withdrew the rejection and allowed the application.

In March 2010, Biogen filed suit against GlaxoSmithKline, asserting that GSK's anti-CD20 antibody Arzerra® (ofatumumab) infringed claims 1-4, 6, 8-10, 14-17, 20-22, and 58-60 of the '612 patent.  In contrast with Rituxan®, Arzerra® binds to the second small loop of the CD20 antigen, has a much greater affinity for the CD20 antigen, and is a fully human antibody.  The District Court conducted a Markman hearing to construe three terms, including the term "anti-CD20 antibody."  The District Court rejected Biogen's broad construction of "an antibody that binds to a cell surface CD20 antigen," and instead adopted GSK's construction "rituximab and antibodies that bind to the same epitope of the CD20 antigen with similar affinity and specificity as rituximab."  In adopting the latter construction, the District Court noted that prosecution history disclaimer applied because Biogen had limited the term to overcome the examiner's enablement rejection.  Following this construction, Biogen stipulated to noninfringement and appealed the District Court's construction to the Federal Circuit.

Writing for the majority, Judge Reyna notes that because neither the claims nor the specification compelled a construction that was contrary to the one offered by Biogen, the question before the Court was whether statements in the prosecution history were sufficient to overcome the heavy presumption that the term "anti-CD20 antibody" carries its full ordinary and customary meaning.  The majority concludes that Biogen's statements during prosecution were sufficient.  In particular, the majority observes that:

[R]ather than challenging the examiner's understanding of the crucial terms, the applicants argued that the specification was enabling for anti-CD20 antibodies with similar affinity and specificity as Rituxan®.  Indeed, the applicants conceded that other "antibodies directed to the same antigen [i.e., CD20] might have different affinities and functional characteristics," and limited their claims to antibodies similar to Rituxan® nonetheless.  . . .  [I]t is clear that they were limiting their invention to what the examiner believed they enabled: antibodies that have a similar specificity and affinity for the specific epitope to which Rituxan® binds.

The majority also found both of Biogen's arguments regarding why the plain and ordinary meaning of the term should control to be unpersuasive.  First, in response to Biogen's argument of claim differentiation (that claim 1 broadly covers any and all anti-CD20 antibodies and several dependent claims are directed to specific types of antibodies, i.e., chimeric, rituximab, humanized, and human), the majority counters that "[o]ur cases make clear . . . that where found, prosecution history disclaimer can overcome the presumption of claim differentiation."  In response to Biogen's second argument that the '612 patent incorporates U.S. Patent No. 5,736,137, and that the '137 patent's broader definition of "anti-CD20 antibody" should control, the majority states that "[t]he problem with this argument is that the '137 patent expressly and uniquely defines 'anti-CD20 antibody' for use therein, that is, within the '137 patent."

Writing in dissent, Judge Plager states that "[b]ecause I do not find anywhere in the majority opinion or in the prosecution history that clear and unmistakable evidence of a disclaimer as required by our precedents, I cannot agree with the majority that such a disclaimer was made by Biogen during the prosecution of its application for the '612 patent."  Noting that "[t]he only dispute is whether the applicants disclaimed the plain meaning of 'anti-CD20 antibody' during prosecution," Judge Plager states that "[t]he majority purports to tease out of the prosecution history such a disclaimer."  The dissent continues:

Nowhere in the prosecution history did the applicants state that antibodies that bind to the same epitope on CD20 with similar affinity and specificity as RITUXAN® must be used, or that antibodies lacking those characteristics must not be used.  To the contrary, the applicants repeatedly made clear -- including in the same discussion as the allegedly disclaiming statement -- that because the invention was based on the discovery that anti-CD20 antibodies could treat CLL, the claimed methods were not limited to the use of any particular type anti-CD20 antibody.

"Because the district court's construction eviscerates the 'clear and unmistakable' requirement for prosecution disclaimer," Judge Plager states that he "cannot join the majority in affirming that erroneous construction."

Biogen Idec, Inc. v. GlaxoSmithKline LLC (Fed. Cir. 2013)
Panel: Circuit Judges Dyk, Plager, and Reyna
Opinion by Circuit Judge Reyna; dissenting opinion by Circuit Judge Plager

In re Hubbell (Fed. Cir. 2013)

By Donald Zuhn --

In a 2-1 decision issued earlier today, the Federal Circuit affirmed a determination by the Board of Patent Appeals and Interferences upholding the rejection of the claims of U.S. Application No. 10/650,509 for obviousness-type double patenting over U.S. Patent No. 7,601,685.  The '509 application, which is assigned to the California Institute of Technology (Caltech), is directed to matrices containing bidomain peptides or proteins.  Claim 18 of the '509 application recites "[a] bidomain protein or peptide comprising a transglutaminase substrate domain and a polypeptide growth factor."  The named inventors on the '509 application are Jeffrey Hubbell, Jason Schense, Andreas Zich, and Heike Hall, all of whom were affiliated with Caltech at the time the claimed invention of the '509 application was made.

In 1998, some five years before the '509 application was filed, Dr. Hubbell moved from Caltech to Eidgenössische Technische Hochschule Zürich (ETH Zürich).  In 2002, the application that issued as the '685 patent was filed.  The '685 patent, which is jointly assigned to ETH Zürich and Universitat Zurich, lists Dr. Hubbell, Dr. Schense, and Shelly Sakiyama-Elbert as inventors (Anna Jen is also listed as an inventor on a Certificate of Correction).  Thus, the '509 application and '685 patent do not have common inventive entities or common owners.  Claim 1 of the '685 patent recites:

1. A fusion protein, comprising:
    (i) a first protein domain;
    (ii) a second protein domain; and
    (iii) an enzymatic or hydrolytic cleavage site between the first and the second domains;
    wherein the first domain is a growth factor selected from the group consisting of the platelet derived growth factor superfamily and the transforming growth factor beta (TGFβ) superfamily;
    wherein the second domain is a crosslinking Factor XIIIa substrate domain;
    wherein the enzymatic cleavage site is selected from the group consisting of proteolytic substrates and polysaccharide substrates, and
    wherein the hydrolytic cleavage site comprises a substrate with a linkage which undergoes hydrolysis by an acid or a base catalyzed reaction.

During prosecution, the Examiner rejected the claims of the '509 application for obviousness-type double patenting over, inter alia, the application that issued as the '685 patent.  In particular, the Examiner determined that the conflicting claims in the '685 patent were directed to species of the claimed invention of the '509 application and therefore anticipated the claimed invention of the '509 application.  On appeal, the Board affirmed the Examiner's obviousness-type double patenting rejection over the '685 patent, determining that claim 1 of the '685 patent recites a protein that contains both of the features required in rejected claim 18, and that claim 18's use of the term "comprising" allowed for inclusion of the additional elements recited in claim 1 of the '685 patent.  The Board also rejected Appellants' argument that common ownership was a requirement for obviousness-type double patenting, citing MPEP § 804(I)(A), which states that "[d]ouble patenting may exist between an issued patent and an application filed by the same inventive entity, or by a different inventive entity having a common inventor, and/or by a common assignee/owner."  Appellants appealed the Board's affirmance of the Examiner's rejection to the Federal Circuit.

On appeal before the Federal Circuit, Appellants argued that obviousness-type double patenting should not apply where an application and a conflicting patent share common inventors but do not have identical inventive entities, were never commonly owned, and are not subject to a joint research agreement.  Alternatively, Appellants argued that they should be allowed to file a terminal disclaimer as an equitable measure, or that the Court should employ a two-way obviousness analysis for the rejected claims.  The U.S. Patent and Trademark Office countered that (1) whether the '509 application and '685 patent were ever commonly owned was immaterial to the policy of preventing harassment by multiple assignees; (2) identity of inventors is not required where there is an overlap in the inventors; (3) Appellants had not established any grounds upon which they should be allowed to file a terminal disclaimer; and (4) Appellants were not entitled to a two-way obviousness analysis because they admitted to being partially responsible for the delay that caused the '685 patent claims to issue first.

Noting that the Board's affirmance was based in part on § 804(I)(A) of the MPEP, Judge O'Malley, writing for the majority, indicated that "the MPEP standard is consistent with the rationale we have used to support application of obviousness-type double patenting rejections."  The rationale being the concern over potential harassment of an infringer by multiple assignees asserting essentially the same patented invention (as well as preventing unjustified extension of the right to exclude).  Judge O'Malley also noted that it had previously rejected Appellants' argument that obviousness-type double patenting should never be applied in the absence of common ownership in two other cases:  In re Van Ornum, 686 F.2d 937 (CCPA 1982), where an obviousness-type double patenting rejection over a patent with a common inventor but no common ownership was affirmed, and In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009), where the reference patents and application at issue were related only by way of a single common inventor.  Although Appellants argued that Van Ornum and Fallaux were distinguishable because in those cases the applications at issue were once commonly owned, the majority noted that "the potential for harassment by multiple assignees would [still] exist," and therefore "[Appellants'] distinction does not alleviate the underlying harassment concerns here."  The majority also refused Appellants' invitation to create a specific exception barring application of obviousness-type double patenting in instances where the conflicting claims share only common inventors, rather than common ownership, declaring that "[w]e too can find no reasoned basis to differentiate between cases involving identical 'inventive entities' and those where the inventive entities are almost identical when assessing obviousness-type double patenting rejections."

The majority also refused to create a new equitable right to resort to terminal disclaimers in cases such as this one.  Finally, with regard to Appellant's argument that the rejected claims should be reconsidered under a two-way obviousness analysis, rather than the standard one-way test, the majority noted that "the two-way test is appropriate only in the 'unusual circumstance' where 'the PTO is solely responsible for the delay in causing the second-filed application to issue prior to the first.'"  In the instant case, Appellants "cannot establish that the PTO is solely responsible for any delays associated with the claims on appeal," because Appellants' counsel before the Board "specifically conceded that Hubbell was partially responsible for the delay that caused the '685 patent to issue before the application claims," and as the majority explained:

[T]he record reveals that, in June 2003, the examiner allowed claims very similar to those at issue on appeal.  Rather than permitting those claims to issue, [Appellants] failed to pay the issue fee, let the '918 application claims go abandoned, and filed the '509 application in August 2003.  These prosecution choices resulted in the foreseeable consequence that the '685 patent issued before the application claims on appeal.

Writing in dissent, Judge Newman begins by pointing out that:

In accordance with the law of double patenting, double patenting does not apply when the application and patent are of separate ownership and have separate inventive entities.  In such situation the appropriate examination path is on the merits of the invention, or through the interference or derivation procedures, or other standard protocol as may apply in the particular situation.  . . .  This court need not create a new protocol wherein the contributions of distinct entities and separate ownership are rejected for "double patenting" instead of examined under the established rules.

The court today not only finds "double patenting" when there is neither common inventorship nor common ownership, but having so found withholds the standard remedy of the terminal disclaimer, and simply denies the application.  This novel ruling is contrary to statute and precedent, with no policy justification for changing the law.

Following a short discussion of the evolution of the law of double patenting, Judge Newman concludes that:

The panel majority does not dispute that these are different inventive entities and that there is not common ownership.  However, the court rules that obviousness-type double patenting applies.  If there indeed is obviousness-type double patenting, then a terminal disclaimer is necessarily available.  However, the court rules that a terminal disclaimer is not available because there is not common ownership.  Yet if there is not common ownership or common inventorship, there cannot be double patenting.  On this circularity, the court denies the CalTech application on the ground of double patenting.

Noting that there was "no suggestion of any attempt to 'game' the system," Judge Newman ends her dissent by noting that unlike the majority, she would not have foreclosed Caltech's request for equitable relief in the form of authorization to file a terminal disclaimer.

In re Hubbell (Fed. Cir. 2013)
Panel: Circuit Judges Newman, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley; dissenting opinion by Circuit Judge Newman

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)

By Andrew Williams --

On the first day of February, the Federal Circuit rejected Impax's efforts to get out from under a preliminary injunction in a case captioned In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation.  The opinion wasn't released until February 14, 2013, however, because it contained confidential information that needed to be redacted.  The Federal Circuit also interpreted the settlement agreement between Impax and Cephalon (the patent holder), confirming the lower court's decision that the ability of Impax to begin selling generic AMRIX® under the agreement had not been triggered.  As a result, the discussion regarding the preliminary injunction was somewhat irrelevant, because Impax was otherwise precluded from marketing the drug.  The decision in this Eurand, Inc. v. Impax Labs., Inc. case is somewhat limited to the facts, because the injunction and settlement agreement discussed by the Court were specific to this case.  Nevertheless, a review of the Court's reasoning and analysis is relevant because other parties involved in Hatch-Waxman litigation may find themselves in similar situations.

This substantive issues related to validity for this case were discussed in detail in a Federal Circuit opinion of the same name that was handed down last year, as reported here.  The drug that was at issue in all of these cases was an extended-release formation of the muscle relaxant cyclobenzaprine hydrochloride, manufactured and sold under the tradename AMRIX® by Cephalon.  Shortly after receiving the NDA for this formation, Mylan Inc. and Mylan Pharmaceuticals, Inc. (collectively "Mylan") filed an ANDA to market a generic version of the drug, followed shortly by several other generic manufactures, including Impax.  The Federal Circuit ultimately found that the patents-at-issue in the case were valid and infringed by the various parties.

Nevertheless, Cephalon and Impax settled their dispute on the last day of trial.  In the settlement agreement, Cephalon granted Impax a non-exclusive license to the patents-in-suit, the timing of which was controlled by five different potential triggering events, the first (and latest) of which was the date one year prior to the expiration of one of the patents in suit.  The other events were tied to "Third-Party" generic manufacturers entering the market, whether by authorization, by launching "at risk," or by obtaining a final non-appealable judgment of non-infringement, invalidity, or unenforceability.  The parties also entered a "Transfer Price Agreement" ("TPA"), by which Impax agreed to market and sell Cephalon's generic AMRIX®, and Cephalon began supplying its generic product to Impax.

Cephalon also entered a "Sales Agent Agreement" with another generic manufacturer, Watson.  However, under this agreement, Watson was only given authority to solicit orders for Cephalon.  In fact, Cephalon maintained title of the drugs at all times until the drugs were transferred to the final customer.  Watson was foreclosed under the agreement to market or sell any other version of the drug.

After the bench trial, on May 12, 2011, the District Court issued its decision, finding the asserted claim invalid as obvious.  Mylan launched "at-risk" the next day.  In response, Cephalon instructed Watson to begin soliciting orders.  On May 24, 2011, the District Court enjoined both parties, along with all persons "acting in active concert or participation" with them, from selling their respective generic versions of the drug, in order to maintain the status quo pending appeal.  On November 7, 2011, Mylan asked the lower court to confirm that the injunction covered parties in privity with Cephalon, because Mylan had become aware that other generic manufacturers were planning to launch at the end of the 180-day marketing exclusivity period.  As a result, the District Court clarified its injunction by explicitly referencing that Impax was subject to the injunction.  Incidentally, because the lower court issued its May 2011 injunction after Mylan launched, Mylan lost almost all of its exclusivity period.  This may have been a more contentious point, but for the fact that the Federal Circuit overturned the lower court's validity decision.

Impax moved to modify both the May and November 2011, injunctions, and to enforce the settlement agreement by clarifying that Watson's launch was a triggering event for its own ability to enter the market.  The lower court confirmed that the May 24 injunction, as clarified by the November 8 order, was still in effect and that it prohibited Impax from selling any generic product.  It also concluded that Cephalon's use of Watson as a sales agent did not trigger Impax's right to begin selling its supply of Cephalon's drugs under the settlement agreement.  Impax appealed.

No Jurisdiction to Review Injunction

The Federal Circuit determined that Impax was subject to the May 2011 injunction, and that because Impax did not object to that injunction within the requisite 30 days, it did not have jurisdiction to review the propriety of the order.  The May 24, 2011 injunction prevented Mylan, Cephalon, and all persons "acting in active concert or participation" with these parties, from selling a generic version of AMRIX®.  Impax had argued that it was not subject to this injunction because it was not a party to the action when the District Court issued the injunction.  The Federal Circuit pointed out, however, that Impax was a party that was "acting in active concert or participation" with Cephalon.  Impax derived its right to sell generic AMRIX® from the Cephalon-Impax Agreement, and it could have only entered the market because of the settlement agreement.  Therefore, there was privity of contract between Impax and Cephalon, because a settlement agreement is akin to a contract.  Also, if Impax had attempted to sell the authorized generic product pursuant to the TPA, it would have been directly "acting in concert" with Cephalon.  As the Court pointed out, any alternative result would have allowed Cephalon to circumvent the injunction by funneling its generic product to Impax.

Impax also contended that the District Court's November 8, 2011 order modified the May 24, 2011 injunction, and its appeal of this modification was timely.  However, because Impax was subject to the earlier injunction, the Federal Circuit pointed out that the District Court's clarification made no substantive changes.  Therefore, the November 8, 2011 order did not give rise to an independent right to appeal.

In a final attempt to modify the injunction, Impax argued that it timely appealed the District Court's denial of its attempt to prospectively seek modification of the injunction.  The Federal Circuit agreed that it would have had jurisdiction over a modification of an injunction, or denial thereof, citing 28 U.S.C. § 1292(a)(1).  However, such review would be limited to the propriety of the denial, not the underlying injunction.  The Court rejected Impax's assertions that the circumstances had changed since the May 24, 2011 order was issued.  First, Impax asserted that it had been just recently added to the injunction, but the Federal Circuit had already addressed this issue.  Second, Impax alleged that the injunction needed to be modified because Mylan's exclusivity period had expired.  However, the length of this exclusivity period was known at the time of the original injunction, and therefore the predicted end of this period had no bearing on Impax's rights.  Finally, Impax argued that its receipt of authorized generic product from Cephalon somehow warranted modification of the injunction.  However, the May 24, 2011 order prohibited sale of these products, and Impax had received them months before it sought to modify the order.  Therefore, the Court did not consider this to be a "changed circumstance."  As a result, the Federal Circuit found no support for a modification of the injunction.

Cephlon's Appointment of Watson as Sale Agent Was Not A Trigger Event Under The Contract

The Federal Circuit also addressed Impax's challenge to the lower court's interpretation of the settlement agreement.  On its face, the Federal Circuit's decision should not extend beyond the contract between Cephalon and Impax.  However, because Court reasoning is applicable to the interpretation of other settlement agreements, it is worth reviewing.  Interestingly, for the present, this aspect of the decision appears to be irrelevant, because according to the District Court's docket, Impax is still subject to the preliminary injunction (and therefore couldn't sell any drugs anyway).  In other words, regardless of whether an event had triggered Impax's ability to sell generic AMRIX® under the settlement agreement, Impax was still barred from launching until the District Court lifts the injunction.

The relevant section of the settlement agreement is Section 3.2, in which five different "triggering events" dictate when Impax can enter the generic market.  The "trigger" in dispute is the third, which provides that Impax may enter the market on:

[T]he same entry date that any Third Party which is not entitled to First to File Exclusivity is licensed or authorized by [Cephalon] to begin selling Generic Equivalent Product in the Territory.

Impax alleged that Watson was such a "Third Party," but the Court disagreed.  A "Third Party" was defined in the agreement as a party that is not Anesta, Eurand, Cephalon, Impax, nor any of their affiliates.  As such, Cephalon's entry into the market was not defined to be a triggering event.  And, because Watson was no more than a sales agent for Cephalon, Watson was Cephalon based on the agreement.

Important in this determination was the fact that Cephalon was merely using Watson's expertise and distribution channels.  Watson had not filed its own ANDA to the product.  In fact, Watson was only soliciting orders, and was required to notify potential customers that it was only Cephalon's sales agent.  Moreover, Cephalon retained the right to set price floors, and retained title until the drugs were transferred to the customer.  Because Watson never obtained title to the product, it could not "sell" the generic drugs within the meaning of § 3.2(c).  The Court pointed out that if Watson was, in fact, characterized as a "Third Party," it would have meant that Cephalon would have needed to operate the entire production and distribution chain of its own generic product to avoid triggering Impax's ability to launch.  Otherwise, any party that would have aided Cephalon would have been considered a "Third Party."  The Court pointed out that this was a nonsensical result.

The Federal Circuit concluded by noting that this provision in the settlement agreement was meant to act as a "most favored nation" clause.  In other words, it was protection for Impax from losing market share from other generic manufacturer, whether they were authorized or whether they launched at risk.  This should serve as a warning to any generic company (or branded pharmaceutical company for that matter) to make sure any equivalent situations are properly addressed in any settlement agreements -- otherwise a similar outcome is almost guaranteed.

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation (Fed. Cir. 2013)
Panel: Circuit Judges Newman, O'Malley, and Reyna
Opinion by Circuit Judge O'Malley

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)

By Kevin E. Noonan --

Whether ANDA litigation has had a positive or negative impact on generic drug availability is an open question, in view of several recent reports looking at the effects such litigation has had on both branded and generic drugs over the past thirty years.  Indeed, the current squabble over "reverse payment" settlement agreements of lawsuits under the ANDA provisions of the Hatch-Waxman Act (codified at 35 U.S.C. § 271(e)(2)) involves many of these same issues, revolving around the question of whether it is prudent for both branded and generic parties of ANDA lawsuits to settle rather than wage protracted, often pyrrhic, patent litigation (see "FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation").  Occasionally, of course, both parties get an outcome they can live with, and one such occasion occurred today in Cephalon v. Watson Pharmaceuticals, where the Federal Circuit affirmed a District Court decision that the generic drug did not infringe the patent-in-suit but reversed the District Court on the issue of whether the patents were invalid for lack of enablement.

The case involved a formulation of fentanyl, an opioid sold by NDA holder Cephalon under the brand name FENTORA®.  Cephalon listed U.S. Patent Nos. 6,200,604 and 6,974,590 in the Orange Book and asserted both patents in response to Watson's ANDA filing; claim 1 of the '604 patent:

1.  A method of administering at least one systemically distributable pharmaceutical agent across the oral mucosa comprising:
    a) providing a solid oral dosage form including a pharmaceutically effective amount of an orally administerable medicament; and at least one effervescent agent in an amount sufficient to increase absorption of said orally administerable medicament across the oral mucosa; wherein said orally administerable medicament is not substantially encompassed by or dispersed in a material that prevents absorption of said medicament across the oral mucosa;
    b) placing said solid oral dosage form in the mouth of a patient so that saliva in said patient's mouth activates said at least one effervescent agent in said tablet; and
    c) holding said solid oral dosage form and the dissolving contents of said solid oral dosage form in the mouth of a patient whereby said at least one effervescent agent promotes absorption of said orally administerable medicament across the oral mucosa.

and claim 1 of the '590 patent:

1. A method of administration of fentanyl to a mammal across the oral mucosa thereof, said method comprising:
    providing a solid oral dosage form comprising fentanyl or a pharmaceutically acceptable salt thereof and at least one saliva activated effervescent agent in an amount sufficient to increase absorption of said fentanyl or pharmaceutically acceptable salt thereof across said oral mucosa, at least one pH adjusting substance, and wherein said amount of said at least one effervescent agent is between about 5% by weight and about 80% by weight; and buccally, sublingually or gingivally administrating said solid oral dosage form to said mammal.

are representative (emphases in original opinion).

The formulation involved orally administered fentanyl designed to use the mucosal membranes of the mouth and oral cavity to introduce the drug into the body (thus avoiding the gastrointestinal tract).  The claims of the patents-in-suit were directed to the use of effervescent agents as penetration enhancers to promote uptake of fentanyl (or other drugs) into the oral mucous membranes.  In addition, the patent claims included in the formulation a "pH adjusting substance" that worked together with the effervescent agent in promoting drug uptake.  As explained in the Federal Circuit opinion, effervescence agents falling within the scope of the patent claims included "at least one compound that evolves a gas," typically via a chemical reaction between the agent and water (saliva) in the mouth.  These agents included an acid source, such as citric acid, and a carbon dioxide source (such as carbonate or bicarbonate), wherein the reaction resulted in carbon dioxide production.  The pH adjusting substance was included because the effervescence reaction reduces the pH of saliva in the mouth, which can affect the solubility of fentanyl or other drug in the formulation.

The District Court found that Watson's ANDA product did not infringe, based on its construction of the claim term "at least one [saliva activated] effervescent agent in an amount sufficient to increase absorption . . . across [the] oral mucosa."  In the District Court's construction, the effervescent agent was required to be activated by contact with saliva, which raised the question of whether the potassium bicarbonate and mannitol components of Watson's accused infringing generic drug reacted to have this effect.  (Cephalon's Fentora® product contained fentanyl citrate, mannitol, sodium starch glycolate, magenesium stearate, citric acid, sodium bicarbonate, and sodium carbonate, wherein the sodium bicarbonate and citric acid are an effervescent couple that react to evolve carbon dioxide, whereas Watson's generic version contained fentanyl citrate and mannitol, sodium starch glycolate, potassium bicarbonate, and magnesium stearate.)  The District Court did not credit Cephalon's expert's testimony that mannitol was the acidic component of an effervescent agent, despite testimony that the higher the mannitol concentration levels the more acidic a water solution containing it, in part because Cephalon provided no evidence of the effect of mannitol on saliva.  Rather, the Court determined that Watson's expert was more persuasive when he testified that "the important piece of information that is missing [in this case] is what the potential or alleged acidity of mannitol in either artificial saliva or, even more important, in the human mouth . . . and there is no evidence that mannitol would be acidic under those conditions."

Regarding invalidity, the District Court construed the term "effervescent agent" to require that "at least one compound that evolves gas by means of an effervescent reaction" (emphasis in original opinion) and further determined that the claim language required the "effervescent agent" to be a single compound.  Watson argued that the "effervescent agent" is disclosed in the Cephalon patents as comprising a "couple" (the acidic compound and the carbon dioxide-releasing compound) and thus that the term should require "a combination of two or more compounds that evolve gas."  Under the District Court's construction, the soluble acid source must be in a separate dosage form from the effervescent agent itself and that these separate dosage forms be co-administered.  Using this construction, the District Court found that the patents-in-suit were not enabling, being devoid of any disclosure relating to co-administration of two separate dosage forms and thus requiring undue experimentation.

The Federal Circuit reversed in part and affirmed in part, in an opinion by Judge Wallach joined by Judges Bryson and Reyna.  The opinion affirmed the finding of no infringement on the grounds that there was no clear error by the District Court in deciding in Watson's favor on this issue.  With regard to invalidity, the panel noted that the District Court erred by reasoning that Watson had raised a prima facie case of non-enablement against Cephalon's claims, which Cephalon did not rebut at trial.  The panel, citing Morton Int'l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1469–70 (Fed. Cir. 1993), invoked the statutory presumption of validity in asserting that this was error, and that the challenger (Watson) bore the burden of proving invalidity by clear and convincing evidence.  Turning to this question, the panel considered the District Court's reliance on Watson's proffered expert testimony that amounted (according to the Federal Circuit) to mere "ipse dixit" opinion that did not rise to the level of clear and convincing evidence.  And the District Court's interpretation of Cephalon's expert's testimony regarding whether experimentation per se would be required to satisfy the enablement portion of the statute in view of the District Court's claim construction was also improper, according to the opinion, because the mere fact of experimentation is not the standard; the question is whether whatever experimentation that may be required is undue.  Here, the Federal Circuit considered Watson's showing that the extent of experimentation that might be required was undue to be insufficient to arise to the level of clear and convincing evidence.  Specifically, the panel stated that "[u]nsubstantiated statements indicating that experimentation would be 'difficult' and 'complicated are not sufficient" to establish undue experimentation.  Thus, Watson had failed to establish non-enablement as a matter of law and the panel reversed.

Cephalon, Inc. v. Watson Pharmaceuticals, Inc. (Fed. Cir. 2013)
Panel: Circuit Judges Reyna, Bryson, and Wallach
Opinion by Circuit Judge Wallach

Allergan, Inc. v. Barr Laboratories, Inc. (Fed. Cir. 2013)

By Michael Greenfield --

Those of you who dabble with chemical structures while prosecuting or litigating pharmaceutical patents may find Allergan v. Barr Laboratories, Inc., interesting.  In this ANDA litigation brought by Allergan against Barr, Teva, and Sandoz ("Barr"), the Federal Circuit opined on issues of claim construction and obviousness with respect to Allergan's Lumigan®, an ophthalmic solution used to treat high eye pressure in people with open-angle glaucoma or ocular hypertension.  The active ingredient in Lumigan® is bimatoprost (cyclopentane N-ethyl heptenamide-5-cis-2-(3α-hydroxy-5-phenyl-1-trans-pentenyl)-3, 5-dihydroxy, [1α,2β,3α,5α]):

(The ethyl amide moiety in the red square is where all the action was focused in the case.)  Allergan asserted claim 10 of U.S. Patent No. 5,688,819 ("the '819 patent"), which recited a method of treating ocular hypertension or glaucoma with a compound selected from a Marksuh group of five compounds listed by their chemical name.  Bimatoprost was one of them.

Claim Constructions

Barr had argued that bimatoprost did not fall within the scope of claim 5, from which claim 10 ultimately depended.  Claim 5 recited a method of treating ocular hypertension or glaucoma using a compound of formula

where Z can be =O and X can be –N(R₄)₂, "wherein R⁴ is selected from the group consisting of hydrogen, a lower alkyl radical having from one to six carbon atoms . . . ."  The issue was framed as whether claim 5 encompassed compounds in which the two R₄ moieties of "-N(R₄)₂" must be identical or could differ (as required by bimatoprost, where one R₄ moiety must be hydrogen and the other C₂-alkyl).  Both the District Court and the Federal Circuit held that claim 5 encompassed compounds in which the R₄ moieties were non-identical.

Barr argued that the plain meaning of "-N(R₄)₂" required identical R₄ moieties, relying on extrinsic evidence such as, for example, expert testimony that "[t]he (X)_y nomenclature" was "commonly used" to represent identical substituents.  The Federal Circuit was unpersuaded, relying heavily on Phillips v. AWH Corp. for the proposition that claim terms are to be given the meaning as one of ordinary skill in the art would understand them in the context of how they are used in the patent at issue and concluding, "[t]he inventor's lexicography governs when the specification reveals a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess."

In arriving at the conclusion that "-N(R₄)₂" encompassed compounds in which the R₄ moieties were non-identical, the Court pointed to the fact that of the five compounds recited in claim 10 (which, you'll remember, depended from claim 5), three (including bimatoprost) possessed an "-N(R₄)₂" moiety having non-identical R₄ moieties.  The Court also noted that same relationship between claim 18 (which recited the same three compounds) and claim 11 (which recited a method of treating other diseases using compounds defined in the same manner as claim 5.  (It's of some interest to note that the specification used the exact same language at issue in the claims.)  And, finally, the Court noted that the specification disclosed the same three compounds as useful in the pharmaceutical compositions and methods of the invention.  The Court held that in this context the patent clearly manifested that "-N(R₄)₂" encompassed compounds with non-identical R₄ moieties.

Practice tip:  Save yourself a lot of heartache and your client a lot of money, and in these situations define R₄ more clearly, such as, "each R₄ is independently selected from . . . ."

Obviousness

The Federal Circuit next considered the Barr's assertion that claim 10 (the method of treating glaucoma using one of bimatoprost or four other compounds) was obvious, first (a) dismissing the credibility of the defendants' expert, who was described as being "eviscerated" (ouch!) on cross examination and whose testimony was "flawed on a fundamental level" and (b) determining that the nature of the involved technology did not lend itself to lay interpretation, but required expert testimony.  This appears to have left Barr in the position of having to rely on the plaintiff's experts, an uncomfortable position, one imagines, at best.  As explained below, and not surprisingly, the defendants were unable to extract the support they needed to carry their burden of proving the claim obvious.

Barr asserted that bimatroprost was obvious over the isopropyl ester analog of compound 2 of Stjernschantz (WO 90/02253 [sic, WO 90/02553]),

which was disclosed as useful for treating the very same conditions as bimatoprost.  The defendants argued that the plaintiff's expert testimony supported three facts necessary to establish obviousness:

(1)    Stjernschantz taught that bimatoprost-free acid lowered intraocular pressure;
(2)    Stjernschantz's compound 2 hydrolyzed into bimatoprost-free acid when placed in the eye; and
(3)    a skilled artisan would have known that substituting an amide for the ester at the C-1 position would result in a prodrug that hydrolyzed into bimatoprost-free acid in the eye.

In not so many words, the Federal Circuit held, "close, but no cigar," finding that although Allergan's expert testimony supported the first two points, the testimony in fact contradicted the third point.  Allergan's expert testified that an amide (such as found in bimatoprost) converts into a carboxylic acid at such a low rate ("500-year half life" of an amide in water) that one of ordinary skill in the art would not have considered it as a prodrug.  With Barr left empty-handed expert-wise, Allergan's expert opinion prevailed, and the Federal Circuit upheld the District Court's finding that claim 10 was not invalid as obvious.

Allergan, Inc. v. Barr Laboratories, Inc. (Fed. Cir. 2013)
Panel: Chief Judge Rader and Circuit Judges Bryson and Wallach
Opinion by Circuit Judge Wallach

In re Rosuvastatin Calcium Patent Litigation (Fed. Cir. 2012)

By Andrew Williams --

Late last year, in AstraZeneca v. Aurobindo (In re Rosuvastatin Calcium Patent Litigation), the Federal Circuit affirmed that a reissue patent covering the active ingredient of Crestor® was valid, enforceable, and infringed by all parties.  In so doing, the Court discussed what it meant to be the submitter of an ANDA for the purposes of infringement within the Hatch Waxman scheme of 35 U.S.C. § 271(e)(2).  In addition, the Court provided a lengthy explanation about what it means to have a patent deemed wholly or partially inoperative or invalid "through error without any deceptive intention," such that it is entitled to take advantage of the reissue statute of 35 U.S.C. § 251.  In this case, the majority reviewed the background, prosecution history and District Court's analysis and determined that the lower court correctly found that Patent Office correctly allowed the patent holders to seek reissue of the patent at issue.  However, Judge Mayer in dissent disagreed, because in his view the prosecutors' actions were intentional, and therefore could not be considered error.  Moreover, the dissent noted that the patent holder did not present any evidence that it acted without deceptive intent, which he noted is required to seek reissue.  As a result, he would have found the patent invalid for improper reissue.  The Federal Circuit also affirmed the District Court's determinations regarding obviousness and lack of intent necessary to find inequitable conduct.

The drug at issue in this case was rosuvastatin, the calcium salt of which is sold as the active ingredient of Crestor®.  The compound was developed at Shionogi Seiyaku Kabushiki Kaisha ("Shionogi") in 1991, when its scientists were looking for a statin with reduced side effects as compared to the known statins at that time.  The sale and use of this drug was approved by the FDA on August 12, 2003.  The drug was so successful that several generic producers filed abbreviated new drug applications related to it.  The resulting infringement suits against Aurobindo Pharma Ltd, Mylan Pharmaceuticals, Inc., Apotex Corp. (USA), Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc., Sun Pharmaceuticals Industries, Ltd., Teva Pharmaceuticals USA, Inc., Par Pharmaceuticals, Inc., and Sandoz, Inc. were consolidated in the U.S. District Court for the District of Delaware.  The lower court ruled that U.S. Patent No. RE37,314 ("the '314 patent") was not invalid as obvious over the prior art, not unenforceable due to a failure to file material references before the patent issued, properly reissued despite awareness of these material references at the time, and infringed by all parties.  All defendants conceded infringement except a Canadian generic manufacturer's U.S. subsidiary that alleged it only signed the ANDA application but also intended to market the drug in the U.S.  The defendants' appealed, and the Federal Circuit affirmed on all grounds, with a dissent from Judge Mayer, who would have invalidated the patent due to improper reissue.

Infringement

Only one defendant, Apotex U.S., challenged infringement because it alleged that it was not the "submitter" of the ANDA in question.  The patent statute provides that submitting an ANDA is an act of infringement pursuant to 35 U.S.C. 271(e)(2)(A):

(2) It shall be an act of infringement to submit—
    (A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent . . . if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.

Apotex U.S. presented several arguments in the District Court as to why it was not the "submitter" for the purposes of this statute.  Principally, Apotex U.S. asserted that it only signed and filed the ANDA as the agent for Apotex Canada, and therefore the interests of Apotex Canada would be unfairly affected because it was not subject to personal jurisdiction in Delaware.  The District Court deemed this "due process violation" argument unpersuasive because the Apotex Canada's rights were being represented by its agent and subsidiary, Apotex U.S.  Moreover, Apotex U.S. not only signed and filed the ANDA, but it participated in the ANDA's preparation and represented that it would be selling the product in this country.  The District Court determined that the definition of a "submitter" for the purposes of this statute includes a "subsidiary of a foreign ANDA applicant, which signs an ANDA as the agent . . . and which intends to benefit directly if the ANDA is approved."  The Federal Circuit did not find any error with this holding.

Apotex U.S. made additional arguments as to why it was not the ANDA submitter, all of which the District Court found unpersuasive.  For example, Apotex U.S. argued that Apotex Canada made the Paragraph IV certification, and that it was this certification that was the infringing act under § 271(e)(2).  However, as can be seen from the express language of the statute, as reproduced above, there is no mention of patent certification, much less an indication that it is the patent certification that gives rise to infringement liability.  Apotex U.S. also argued that § 271(e)(2) mentions 21 U.S.C. § 355(j) (as section 505(j) of the Federal Food, Drug, and Cosmetic Act), and therefore incorporates all of F.D.C.A act's requirements to establish infringement liability.  In addition, Apotex U.S. asserted that § 271(e)(2) makes no mention of active involvement, or parent-subsidiary relationships, and therefore these factors are irrelevant to the submitter issue.  It is of interest to note that, in order to avoid infringement liability, Apotex U.S. both requested that § 271(e)(2) be read literally, and asserted that the Act must incorporate requirements not expressly stated in the statute.  Nevertheless, the Federal Circuit concluded that the District Court did not err in finding all of these arguments unpersuasive.

The Federal Circuit's opinion provides very little (if any) reasoning why the District Court did not err in holding Apotex U.S. a properly named defendant in this case.  Instead, Judge Plager provided a concurrence to clarify his understanding as to why Apotex U.S. should be treated as the ANDA submitter.  § 271(e) has at least two requirements, according to Judge Plager:  (1) submission of an application (2) to obtain approval to engage in the commercial manufacture, use, or sale of a drug claimed in a patent.  First, it was noted that the statute was clearly not meant to apply to an individual, such as an attorney, who prepares and submits an application for the real party in interest.  The important inquiry, however, is whether the statute is meant to apply to an agent that has a financial interest in the manufacture and distribution of the drug.  Judge Plager pointed out that it was logical that such an agent should fall within the scope of the statue.  Nevertheless, in this case, Apotex U.S. had more than just a financial interest; it was going to be engaging in the commercial manufacture.  Therefore, under the "financial interest" standard, and certainly under the "active involvement in commercial manufacture" standard, Judge Plager believed that the District Court did not err in finding Apotex U.S. liable for infringement.

Reissue

All of the defendants argued that the '314 patent was improperly reissued because there was allegedly (1) no error and (2) deceptive intent.  The reissue statue states that a patent holder can seek reissue of a patent when the patent is deemed inoperative or invalid "through error without any deceptive intention."  35 U.S.C. § 251.  This analysis is very fact intensive, and in fact, the majority used this fact in its reasoning to affirm the lower court's determination (because there were insufficient facts to overturn the decision).  Therefore, at least a brief review of the facts is necessary.

As explained by the Court's opinion, when Shionogi scientists obtained favorable results with certain modified pyrimidine compounds, including rosuvastatin, an employee in the patent department, Ms. Kitamura, obtained prior art search reports related to these products.  Included in these searches was a Sandoz European application, which included a compound that differed from rosuvastatin by one side chain constituent, and a Bayer Japanese application that described a class of statins to which rosuvastatin belonged, although without specifically identifying rosuvastatin.  Based on these results, Ms. Kitamura prepared and filed a Japanese patent application, to which the U.S. patent at issue claimed priority.  Ms. Kitamura left Shionogi about six weeks after the U.S. application was filed.  Mr. Shibata assumed responsibility for this application family and subsequently received an EPO search report that identified the Sandoz application as relevant art.  Mr. Shibata asked the scientists to compare the Shionogi compounds with those identified in the Sandoz and Bayer applications.  However, no IDS was filed before U.S. Patent No. 5,260,440 ("the '440 patent") issued (the 314 patent was a reissue of the '440 patent).  Also of note, the '440 patent did not contain a specific claim directed solely to rosuvastatin.  Only after AstraZeneca and Shionogi began license negotiations were these oversights discovered, and Shionogi shortly thereafter filed a reissue application.  Because the examiner rejected the generic claims in view of the Bayer reference, the claims were limited to rosuvastatin and its salts.  The reissue granted as the '314 patent.

With regard to whether there was error in the original patent, the Defendants asserted that deliberate prosecution decisions can never be corrected through reissue.  As such, because Shionogi deliberately presented only generic claims and allegedly deliberately presented claims that overlap with the Sandoz reference, the reissue was improper.  The case of In re Serenkin, 479 F.3d 1359 (Fed. Cir. 2007), was cited for this proposition.  However, this case involved an attorney that sought to add eight sheets of drawings to a pending PCT application, and in so doing, agreed to give up its priority date and settle for a filing date of the date on which the drawings were added.  After the patent holder attempted to "correct" the priority date through reissue back to that originally claimed, the Serenkin court pointed out that it was impermissible to undo the consequence of a conscious decision to give up a priority claim.  Important in that determination was that the attorney took action with the knowledge of what the consequences would be.  The Court's decision in the present case pointed out that, in some sense, all prosecution decisions are deliberate.  However, the purpose of the reissue statute was to fix such errors, provided there was no evidence that the claimed subjected matter was intentionally omitted or abandoned.  In other words, the important consideration for whether there was "error" is whether the correction sought encompasses "inadvertence, accidents, [or] mistakes."

The issue of deceptive intent can be intertwined with the issue of whether there was an error in the first place, but the Defendants also asserted that the Shionogi patent department intentionally withheld the prior art reference in order to obtain claims that overlapped the Sandoz reference.  They argued that the "deceptive intent" standard in the reissue statute requires less rigorous proof than that for establishing inequitable conduct.  However, the Federal Circuit could find no sound basis for such a distinction.  Ultimately, the Court relied on the lower court assessment of the live testimony of the "purported culprits," which found no evidence of deceptive intent that would have made the reissue improper.  Because it could find no error with this ruling, the majority affirmed.

A few of the issues raised by dissent are worth mentioning.  First, Judge Mayer took issue with the fact that "[n]ot a single inventor or patent prosecutor testified that he or she unknowingly or inadvertently introduced the overlap between Sandoz and claim 1."  However, the dissent doesn't comment on what the burden of proof or the burden of persuasion was in this case.  The Patent Office had already reissued the patent in question, and so it should have been entitled to the presumption of validity, which requires clear and convincing evidence to overcome.  The dissent appears to suggest, instead, that the burden was on the reissue patent holder to defend the reissued patent.  Unfortunately, most of the cases cited by the dissent were appeals from parties seeking reissues from the Patent Office.  In such cases, the procedural posture was different, because in such cases, it was the patent holder's burden to establish that it was entitled to a reissue.  When the proper burdens are considered, along with the fact that the District Court was able to weigh the live testimony of the witnesses, it would appear that the majority was correct in affirming the decision.

In addition, the dissent acknowledges that reissue is only proper if the error results from inadvertence, accident, or mistake.  However, Judge Mayer states on a couple of occasions that Shionogi "made an error in judgment," presumably suggesting that judgment errors could never be inadvertent, accidental, or mistaken.  To the contrary, all reissue errors can ultimately be considered errors in judgment, much like the majority noted with the Serenkin case that all prosecution decisions are ultimately deliberate.  If "lack of error in judgment" were the standard, it is unlikely that anyone would be entitled to seek a reissue patent.

Finally, the dissent notes that "[e]quity dictates that a patentee exercises due diligence in seeking to rectify a defect in his patent."  However, the dissent starts this "due diligence" clock from the date that Shionogi became aware of the Sandoz reference.  Instead, as the majority points out, Shionogi did act diligently, filing the reissue application almost immediately after the error was discovered.  If it were any differently, then the rest of the analysis regarding error and deceptive intent would have been unnecessary.  In fact, part of the error that entitled the patent holder to seek reissue was not appreciating that the claims as filed and issued would cover Sandoz.  The same error cannot be used to be justify reissue on one hand, and deny it for lack of diligence on the other.

In re Rosuvastatin Calcium Patent Litigation (Fed. Cir. 2012)
Panel: Circuit Judges Newman, Mayer, and Plager
Opinion of the court by Circuit Judge Newman; concurring opinion by Circuit Judge Plager; dissenting opinion by Circuit Judge Mayer

Top Stories of 2012: #4 to #7

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  On Monday and Tuesday, we counted down stories #15 to #8, and today we count down stories #7 to #4 as we work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

7.  Federal Circuit Interprets § 271(e)(1) Safe Harbor as Extending to Post-approval Activities

In a case involving whether certain post-approval activities fall within the "safe harbor" of 35 U.S.C. § 271(e)(1), a divided panel of the Federal Circuit in August vacated a preliminary injunction granted by the District Court, holding that acts taken after approval fell with the safe harbor.  According to the majority, it was significant that Congress had not (expressly) limited the scope of the safe harbor to the Food, Drug and Cosmetic Act but had "broadly" included within the scope of the safe harbor "any federal law" that "regulates the manufacture, use, or sale of drugs."  Thus, the majority rejected Momenta's contention that the process and quality control information obtained from Amphastar's infringement was not submitted to the FDA but was retained by defendants, as these "batch records" must be maintained "for at least one year after expiration of the batch" of generic enoxaparin and must be "readily available for authorized inspection" by the FDA."  The majority opinion states that "[w]e therefore hold that post-approval studies that are 'reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs' fall within the scope of the § 271(e)(1) safe harbor."  Momenta's request for rehearing en banc was denied by the Federal Circuit in November.

For information regarding this and other related topics, please see:

• "Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals, Inc.: 'The Rest of the Story,'" August 13, 2012
• "Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. (Fed. Cir. 2012)," August 9, 2012
• "Chief Judge Rader (Not Surprisingly) Gets it Right about Chimerical 'Tragedy of the Anti-Commons,'" August 6, 2012

6.  Implementation of Biosimilar Regulatory Pathway Proceeds Despite Opposition

In February, the U.S. Food and Drug Administration published its long-awaited draft guidance on the development of biosimilar products.  The FDA's guidance consisted of three documents:  Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.  The FDA then spent the next few months collecting comments regarding the draft guidance, and in May held a hearing on the draft guidance, where researchers, payors, patient and physician groups, and industry advocates provided their thoughts on the FDA's first attempt to clarify the logistics as to the operation of the BPCIA.  The FDA's efforts to implement the BPCIA, however, did not push implementation of the biosimilar regulatory pathway up to #6 on this year's list.  No, it was the Supreme Court's landmark decision in June upholding the Patient Protection and Affordable Care Act (PPACA) -- of which the BPCIA is a part -- as constitutional under the taxation clause of the Constitution that lifted this topic to #6.  While the Supreme Court's decision in National Federation of Independent Business v. Sebelius did not constitute a direct challenge to the BPCIA, there were a handful of direct challenges to aspects of the BPCIA.  For example, President Obama took yet another shot at the 12-year data exclusivity period specified under the BPCIA in his 2013 budget proposal, calling for a modification of the length of exclusivity to facilitate faster development of generic biologics by "award[ing] brand biologic manufacturers seven years of exclusivity rather than 12 years under current law."  The same modification had been included in the President's 2012 budget proposal.  In addition, Abbott filed a Citizen Petition with the FDA in April, requesting that the agency refrain from accepting biosimilar applications under the BPCIA that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to March 23, 2010 (when the PPACA was signed into law).  Interestingly, in a letter to the FDA, Rep. Anna Eshoo (D-CA), who was one of the principal authors of the BPCIA, stated that "[w]hile Abbott's Citizen Petition argues that pre-BPCIA approved biologic products cannot be subject to the law, l want to state very emphatically that it was Congressional intent for the new pathway to apply to biologics approved before and after the passage of the Affordable Care Act."  In October, the FDA sent a letter to Abbott noting that the agency "has been unable to reach a decision on [Abbott's] petition because it raises complex issues requiring extensive review and analysis by Agency officials."  The agency did not provide a date by which it would respond.

For information regarding this and other related topics, please see:

• "Rep. Eshoo Expresses Views on Abbott's Biosimilars Petition in Letter to FDA," October 25, 2012
• "FDA Continues to Review Abbott Petition on Biosimilars," October 24, 2012
• "Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars," June 28, 2012
• "BIO International Convention 2012 Preview - Part II: BIO and Biosimilar Regulations throughout the World," June 12, 2012
• "House Passes User Fee Bill," May 31, 2012
• "Senate Passes User Fee Bill," May 29, 2012
• "FDA Holds Public Hearing on Biosimilar Draft Guidance," May 20, 2012
• "BIO Comments on FDA Biosimilars Guidance: Demand More Testing, Permit Fewer Differences," April 25, 2012
• "Abbott Asks FDA to Refuse Certain Biosimilar Applications," April 23, 2012
• "FDA Discusses Initial Considerations for Biosimilar Guidance Documents," February 27, 2012
• "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements," February 21, 2012
• "More on FDA Draft Guidelines for 'Follow-on' Biologic Drug Approval Pathway," February 14, 2012
• "FDA Publishes Draft Guidelines for Biosimilar Product Development," February 9, 2012

5.  Federal Circuit Confirms Patent Eligibility of Isolated DNA

In August, the Federal Circuit in Association for Molecular Pathology v. U.S. Patent and Trademark Office, decided on remand that, the Supreme Court's decision in Mayo v. Prometheus notwithstanding, claims to isolated human DNA satisfy the requirements of 35 U.S.C. § 101.  Each of Judge Lourie's majority opinion, Judge Moore's concurring opinion, and Judge Bryson's opinion concurring in part and dissenting in part substantially tracked their opinions when the panel first decided AMP v. USPTO.  Had the case ended here, the Federal Circuit's decision would have placed higher on our list (perhaps foreshadowing one of the stories to be discussed in the final installment of our Top Stories series).

For information regarding this and other related topics, please see:

• "Patent Eligibility and Biology," August 23, 2012
• "Association for Molecular Pathology v. United States Patent and Trademark Office (Fed. Cir. 2012)," August 16, 2012
• "AMP v. USPTO -- Federal Circuit Confirms Patent Eligibility of Isolated DNA," August 16, 2012
• "The Proper Scope of DNA (or "Gene") Patent Claims," August 1, 2012
• "Myriad and Prometheus: Do Patents 'Preempt' Follow-On Research?" July 29, 2012
• "Federal Circuit Hears Oral Argument in AMP v. USPTO Remand," July 23, 2012
• "Myriad Genetics Files Supplemental Brief in AMP v. USPTO," July 19, 2012
• "Supplemental Brief for Appellees in AMP v. USPTO," July 19, 2012
• "Biopharmaceutical Companies Weigh-In on Myriad Case," July 17, 2012
• "Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible," July 16, 2012
• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Biotech Companies Send Letter on Myriad Case to Attorney General and Solicitor General," June 19, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012
• "The Aussies Are At It Again," June 14, 2012
• "Federal Circuit Declines Invitation to Reconsider Standing Question," June 13, 2012
• "Plaintiffs Respond to Myriad's 'Suggestion' of Mootness or, Alternatively, Motion for Remand in AMP v. USPTO," June 10, 2012
• "Myriad Files Motion 'Suggesting' Mootness or Seeking Remand in AMP v. USPTO," May 30, 2012
• "Federal Circuit Sets Schedule for AMP v. USPTO," April 30, 2012
• "Supreme Court Remands Myriad Case," March 26, 2012

4.  Supreme Court Grants Certiorari in Monsanto v. Bowman

In October, the Supreme Court granted certiorari in Monsanto v. Bowman, against the advice of the U.S. Solicitor General.  In Bowman, Monsanto's complaint arose from farmer Bowman's "second planting" of herbicide resistant seed that was made using so-called "commodity seed" (seed sold by farmers to local grain elevators for commodity use, for example, as cattle feed).  After planting this seed, which was significantly cheaper than Roundup Ready® seed, farmer Bowman tested the crop for Roundup® resistance and found that substantial amounts of the seed were resistant.  He used Roundup® on these plantings and then replanted the seed.  The District Court granted summary judgment of patent infringement and entered judgment against farmer Bowman, and the Federal Circuit affirmed.  The question presented to the Supreme Court is:

Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?

For information regarding this and other related topics, please see:

• "Supreme Court Grants Certiorari in Monsanto v. Bowman," October 22, 2012
• "Bowman Responds to Solicitor General," September 12, 2012
• "Solicitor General Recommends the Supreme Court Deny Cert in Bowman v. Monsanto," August 30, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

Top Stories of 2012: #8 to #11

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Yesterday, we counted down stories #15 to #12, and today we count down stories #11 to #8 as we work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

11.  Patent Law Changes Abroad

In December, the European Parliament adopted two draft regulations on the creation of the unitary patent, and an agreement establishing the Unified Patent Court (UPC), a specialized court having exclusive jurisdiction over infringement and validity questions related to unitary patents, is expected to be signed next month.  The European Union, however, was not the only governing body making patent news abroad.  In Australia, significant amendments were made to that country's patent laws through enactment of the Intellectual Property Laws Amendment (Raising the Bar) Act 2012, with the new provisions scheduled to take effect on April 15, 2013.  Those provisions will raise Australia's patentability threshold and specification requirements, and are intended to raise the quality of granted patents in Australia to a level that is more consistent with the standards set in the U.S., Japan, and Europe.  In Israel, the adoption of a set of amendments to the Israel patent statute establish 18-month publication, submission of prior art by third parties, and third party requests for expedited examination of patent applications.

For information regarding this and other related topics, please see:

• "Parliament Approves EU Unitary Patent Package," December 17, 2012
• "European Parliament Adopts Draft Regulations on Unitary Patent," December 12, 2012
• "Unitary Patent & Unified Patent Court," December 12, 2012
• "Progress for Single European Patent and Litigation System," November 12, 2012
• "Australia Reforms Its Patents Act 1990," August 29, 2012
• "Recent Amendments to the Israel Patent Statute: Pulling the Pace of Prosecution from the Purview of the Applicant," August 7, 2012
• "EU Patent Is Finally Born," July 2, 2012

10.  Federal Circuit Issues Fractured En Banc Decision on Divided Infringement Cases

On August 31, the Federal Circuit issued its en banc decision in Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp., reversing the District Court in both cases and remanding for reconsideration.  A majority consisting of Chief Judge Rader and Circuit Judges Lourie, Bryson, Moore, Reyna, and Wallach (with Circuit Judges Newman, Linn, Dyk, Prost, and O'Malley dissenting) expressly overruled BMC Resources, Inc. v. Paymentech, L.P., 498 F.3d 1373 (Fed. Cir. 2007), which held that there must be a single actor (or a second actor acting under the control of another) for infringement to lie.  According to the majority, all the steps of the claimed method still need to be performed, but it is not necessary to prove a "single entity" performed them.  The majority opinion, if upheld, would be a boon for biotechnology, if only because it would provide another way for claim drafters to protect diagnostic method claims.  However, it is unlikely that the Supreme Court will deny certiorari in a case of statutory construction where the Federal Circuit is so plainly fractured.  (According to the Supreme Court's website, the deadline for filing a petition for a writ of certiorari was December 28, 2012.)

For information regarding this and other related topics, please see:

• "Akamai Technologies, Inc. v. Limelight Networks, Inc. and McKesson Technologies, Inc. v. Epic Systems Corp. (Fed. Cir. 2012) (en banc)," September 4, 2012

9.  More USPTO PTA Interpretations Questioned

In 2012, the District Courts for the District of Columbia and the Eastern District of Virginia sided with a number of patentees in determining that certain practices used by the U.S. Patent and Trademark Office in determining Patent Term Adjustment (PTA) were improper.  In ArQule, Inc. v. Kappos, the District Court for the District of Columbia found that the Office's practice of counting weekends and holidays as applicant delay under 37 C.F.R. § 1.704(b) (while permitting responses filed by the next business day to be considered timely under 35 U.S.C. § 21(b)) was improper.  In Exelixis, Inc. v. Kappos, the Eastern District of Virginia disagreed with the Office's practice of negating B delay in circumstances where an applicant had responded to a final rejection by filing a request for continued examination (RCE).  According to the District Court, the statute "makes [it] clear that once the three year clock has run, PTA is to be awarded on a day for day basis regardless of subsequent events" in the Court's view.  As a result, RCEs filed after the three-year date should not toll the amount of B-Delay to be awarded to the patentee.  The District Court for the District of Columbia adopted the rationale of the Eastern District of Virginia in Novartis AG v. Kappos, finding that PTA should not be reduced by time attributable to an RCE where the RCE is filed after the expiration of the three year guarantee period specified in the statute.  The Court in Novartis, however, refused to toll the 180-day after issuance deadline for filing suit against the USPTO Director to challenge a PTA determination (for one of 23 patents at issue in the case, where the Office had failed to issue a determination on reconsideration within the 180-day period of 35 U.S.C. § 154(b)(4)(A), but Novartis had filed suit within 180 days of the Office's determination on reconsideration, the Court did toll the start of the 180-day period).  The Court issued a warning to patentees that may be dissatisfied with PTA determinations by the Office that are based on different theories than those presented in Wyeth, ArQule, or Exelixis, stating that "Novartis was free to raise the same issues that Wyeth and Abbott Laboratories raised in their lawsuits within the 180 days after their patents were granted."

For information regarding this and other related topics, please see:

• "Novartis AG v. Kappos (D.D.C. 2012)," November 27, 2012
• "Exelixis, Inc. v. Kappos (E.D. Va. 2012)," November 8, 2012
• "ArQule v. Kappos: Enjoy Your Weekend, or What a Difference a Day (or Two or Three) of PTA Can Make," October 1, 2012
• "USPTO Proposes Change to PTA Provisions Regarding Appellate Review," January 9, 2012

8.  Supreme Court to Resolve Circuit Split on Reverse Payment Settlement (Pay-for-Delay) Agreements

Last month, the Supreme Court granted certiorari in Federal Trade Commission v. Watson Pharmaceuticals, Inc., one of two cases with certiorari petitions before the Court relating to reverse payment settlement (or pay-for-delay) agreements in ANDA litigation under the Hatch Waxman Act.  The Court's decision to grant certiorari marks the culmination of almost a decade of effort by the Federal Trade Commission to get a reverse payment case before the Court.  What clinched the effort this time was the decision in the K-Dur case by the Third Circuit in favor of the FTC's position, finding such settlements to be presumptively anticompetitive and subject to a "rule of reason" antitrust analysis.  This result was contrary to decisions in the 11th Circuit (Valley Drug Co. v. Geneva Pharmaceuticals, Inc., 344 F.3d 1294 (11th Cir. 2003) and Schering-Plough Corp. v. Federal Trade Commission, 402 F.3d 1056 (11th Cir. 2005)); 2nd Circuit (In re Tamoxifen Citrate Antitrust Litigation, 466 F.3d 187 (2d Cir. 2006) and Arkansas Carpenters Health & Welfare Fund v. Bayer AG, 604 F.3d 98, 105 (2d Cir. 2010)); and the Federal Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation, 544 F.3d 1323 (Fed. Cir. 2008)) that such agreements are legal provided that they stay within the legitimate bounds of the patent grant (applying the "scope of the patent" test).  (It should be noted that the lone appellate exception (before K-Dur), In re Cardizem CD Antitrust Litigation, 332 F.3d 896 (6th Cir. 2003), involved different facts leading to the conclusion that there was anticompetitive behavior.)

For information regarding this and other related topics, please see:

• "Supreme Court to Review Reverse Payment Settlement Agreements," December 9, 2012
• "FTC Moves as Amicus in Effexor Litigation, and Gets Its (Well-Earned) Comeuppance," October 18, 2012
• "FTC Asks Supreme Court to Play Favorites in Reverse Payment Settlement Agreement Cases," October 16, 2012
• "Amici File Briefs Supporting Certiorari in K-Dur Case -- Part II," October 10, 2012
• "Amici File Briefs Supporting Certiorari in K-Dur Case," October 8, 2012
• "GPhA Files Amicus Brief in K-Dur Case," October 3, 2012
• "Bayer Files Amicus Brief in K-Dur Case," September 27, 2012
• "PhRMA Files Amicus Brief in K-Dur Case," September 26, 2012
• "Should Presumptions Be Avoided in the Reverse Payment Debate?" September 21, 2012
• "Generic Defendant Petitions for Certiorari in K-Dur Litigation," September 17, 2012
• "Merck Asks Supreme Court to Review Third Circuit K–Dur Decision," August 28, 2012
• "The Federal Trade Commission Finally Wins One," July 18, 2012
• "Federal Trade Commission v. Watson Pharmaceuticals, Inc. (11th Cir. 2012)," April 30, 2012
• "Latest Legislative Attempt on Reverse Payment ANDA Settlements," February 27, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

Top Stories of 2012: #12 to #15

By Donald Zuhn --

Reflecting upon the events of the past twelve months, Patent Docs presents its sixth annual list of top biotech/pharma patent stories.  For 2012, we identified fifteen stories that were covered on Patent Docs last year that we believe had (or are likely to have) the greatest impact on biotech/pharma patent practitioners and applicants.  Today, we count down stories #15 to #12, and then throughout the week, we will work our way towards the top three stories of 2012.  As with our other lists (2011, 2010, 2009, 2008, and 2007), links to our coverage of these stories (as well as a few links to articles on related topics) have been provided in case you missed the articles the first time around or wish to go back and have another look.  As always, we love to hear from Patent Docs readers, so if you think we left something off the list or disagree with anything we included, please let us know.

15.  USPTO Continues Efforts to Cut Application Backlog and Pendency

In November, the U.S. Patent and Trademark Office released its Performance and Accountability Report for Fiscal Year (FY) 2012, which indicated that the Office had met all of its annual performance targets.  For one of those targets -- average total pendency -- the Office not only hit its target by achieving a 32.4-month pendency (versus the target of 34.7 months), but it surpassed the average pendency achieved in each of the three previous fiscal years.  The Office also noted that despite an increase in application filings (565,566 in FY 2012 versus 537,171 in FY 2011), the number of applications awaiting action dropped from 690,967 in FY 2011 to 633,812 in FY 2012 (the fourth consecutive year that the number of applications awaiting action had dropped) and the total number of pending applications decreased from 1,168,928 in FY 2011 to 1,157,147 in FY 2012.  However, despite the improving numbers, the Office has continued to seek ways in which to cut the application backlog and application pendency.  One issue on which the Office has focused its attention recently is the rising number of Requests for Continued Examination (RCEs).  Earlier this month, the Office published a notice in the Federal Register (77 Fed. Reg. 72830) seeking public feedback on RCE practice.  The notice, which indicated that the Office has a backlog of more than 90,000 applications that have not been examined since an RCE was filed, described some of the Office's efforts to reduce the RCE backlog, including the Quick Path Information Disclosure Statement (QPIDS) pilot program and the After Final Consideration Pilot (AFCP).  Not surprisingly, the notice does not discuss the Office's efforts to decrease RCE filings by raising the cost of filing a first RCE to $1,200 (from the current fee of $930), and further raise the cost of filing subsequent RCEs to $1,700, a proposal that the Patent Public Advisory Committee (PPAC) has called "illogical."  Comments to the Office's notice can be submitted until February 4, 2013 (see link below for information regarding the submission of comments).

For information regarding this and other related topics, please see:

• "USPTO Seeks Public Feedback on RCE Practice," December 13, 2012
• "USPTO News Briefs," June 21, 2012
• "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program," May 10, 2012
• "USPTO to Assess After Final Consideration Pilot Program," April 5, 2012

14.  USPTO and Applicants Deal with Intersection of Patent and Copyright Law

In January, the Office of the General Counsel for the U.S. Patent and Trademark Office issued a memorandum in response to several inquiries the Office had received concerning copyright infringement and the use of non-patent literature (NPL) in the examination process.  In that memo, USPTO General Counsel Bernard Knight, Jr. deemed the following practices to be protected by the doctrine of fair use:  (1) the Office's practice of making copies of copyrighted NPL and providing such copies to an applicant in the course of patent examination; (2) the Office's practice of providing certified copies of entire file histories, including copyrighted NPL, to members of the public for a fee; and (3) the copying of copyrighted NPL by patent applicants and their attorneys and the submission of those copies to the USPTO pursuant to the USPTO's disclosure requirements.  The memo was timely given separate lawsuits brought by a publishing company against two law firms in February.  (Because one of the firms is McDonnell Boehnen Hulbert & Berghoff LLP, where the Patent Docs authors and contributors work, Patent Docs has not provided any coverage of these cases.  However, former MBHB attorney Dennis Crouch has covered the cases on his Patently-O weblog; see here and here, for example.)

For information regarding this and other related topics, please see:

• "USPTO Issues Memo on Use of Non-Patent Literature During Examination," January 23, 2012

13.  Congress Works to "Correct and Improve" Leahy-Smith America Invents Act

On November 30, Rep. Lamar Smith (R-TX) introduced a bill (H.R. 6621) entitled "To correct and improve certain provisions of the Leahy-Smith America Invents Act and title 35, United States Code."  Demonstrating that you cannot judge a bill by its title, the legislation contained provisions having nothing to do with any of the AIA's provisions, including one that would have effectively eliminated patent rights for the ~200 pending U.S. patent applications having a filing date prior to June 7, 1995 (when legislation enabling the provisions to the Uruguay Rounds of the General Agreement on Tariffs and Trade (GATT) were enacted).  This section, however, was replaced with a provision requiring a report to Congress on the status of pre-GATT applications before the House passed the bill by a 308-89 vote, and even that changed section was replaced with a clerical amendment in the Senate version of the bill.  Following passage of the further amended bill by the Senate, the bill stalled back at the House when Rep. Bobby Scott (D-VA) objected to a vote on the grounds that a quorum was not present.

For information regarding this and other related topics, please see:

• "The Status Quo Reigns in Senate's Version of H.R. 6621," December 30, 2012
• "Congressional Corrections Regarding H.R. 6621," December 20, 2012
• "Congressional Misunderstandings (Apparently) Motivate H.R. 6621," December 20, 2012
• "The Plot Thickens around H.R. 6621," December 18, 2012
• "Pre-GATT Patent Applications Threatened by Lamar Smith's H.R. 6621," December 6, 2012

12.  Federal Circuit Defines Presumption of Enablement for Prior Publications

On July 27, the Federal Circuit issued a decision in In re Antor Corp. that increased the burden on proving patentability created by prior art references for patent applicants and patentees by defining a presumption of enablement not only for prior patents and published patent applications but also for all prior printed publications, regardless of source of provenance.  The Antor decision is likely to have important implications for practitioners attempting to provide patent protection for biotechnology-based inventions.  This is because the inventiveness of biotechnology inventions is often assessed in view of prior art produced by university researchers, and it is a feature of some of this art that portions therein are reserved for what can most kindly be called discussions of possible future implications and applications of a scientific result (or unkindly, unsupported flights of fancy).  However, the presence of such language in scientific references such as journal articles not expressly provides a much more robust source of prior art, insofar as anything said in a prior art printed publication now falls expressly within the presumption that it is enabled.  While in many cases this will not pose an insurmountable challenge, it can be expected at the very least to increase the difficulties and cost of obtaining patents, and to open up a host of new prior art for use in invalidity defenses.

For information regarding this and other related topics, please see:

• "In re Antor Media Corp. (Fed. Cir. 2012)," August 20, 2012

Image of New Year's Eve ball drop for 2012 in Times Square (above) by Replytojain, from the Wikipedia Commons under the Creative Commons Attribution-ShareAlike 3.0 Unported license.

In re Ditto (Fed. Cir. 2012)

Cats and the Federal Circuit

By Kevin E. Noonan --

Unlike dog breeds that tend to be of ancient vintage (Labra-doodles and Yorkie-poos to the contrary), many cat breeds are of relatively recent parentage.  While there are many naturally occurring breeds (such as Maine Coons and Norwegian Forest Cats), a surprising number of cat breeds were developed in the last 50 years or so.  The most recent (and perhaps most extreme) are Savannahs, that are the result of breeding between a domestic short-haired cat and a serval, a wild, undomesticated African cat.  The Federal Circuit had the opportunity to opine on whether another (relatively) recent cat breed, the Pixie-Bob (at right), was patent-eligible subject matter or novel in an appeal from rejection on both these grounds before the Patent Office.  While the Court avoided the statutory subject matter question, it affirmed rejection for lack of novelty for the remarkably named applicant, Frank Robert Ditto.

Mr. Ditto claimed a breed of cats produced by mating a bobcat, lynx or bobcat-lynx mix with a domestic cat.  The sole independent claim is directed to "[a] domestic cat breed produced by breeding a purebred cat produced by mating a Bobcat, Lynx, or Bobcat Lynx species with a domestic cat," with dependent claims reciting various phenotypic characteristics of the cats (in most part relating to the cats' propensity to vocalize).  As explained in the specification, the breed has a unique combination of domesticated behaviors and "the spirit and disposition of the wild" cat as well as other specific traits (including "a variety of colors, have hind legs that are larger than their front legs, may have spotted fur or a stump tail, and have 'sturdy muscular bodies.'"

The Board affirmed the Examiner's rejection of §§ 101 and 102 grounds.  The basis for the § 101 rejection was that the breed was a "product of nature" that resulted from breedings that occurred in the wild.  The Board affirmed this rejection insofar as the claims did not require any particular degree of interbreeding and that naturally occurring cats could satisfy the limitations recited in claim 1.  With regard to the § 102 rejections, the Examiner cited two prior art references:  a 1994 Seattle Times article by Green relating to a Pixie-Bob produced by mating of a wild bobcat and a domestic cat (in a family barn without human intervention); and a 1995 Bellingham Herald article by Porter describing the Pixie-Bob breed and its introduction to The International Cat Association (TICA) as an "official" cat breed.  These references also satisfied the limitations recited in claim 1 on similar grounds, i.e., that there was no limitation as to the degree of breeding required and that "there was no evidence . . . suggest[ing] any difference between the Pixie-Bob cat [described in the cited prior art] and the claimed cats."

The Federal Circuit affirmed in a per curiam opinion before Judges Dyk, Prost, and Reyna.  Their opinion did not address the § 101 rejection, finding sufficient evidence that the claims were anticipated under § 102.  According to the panel, the term "purebred" was properly given its "broadest reasonable interpretation," particularly in view of the lack of any particular definition in Inventor Ditto's specification.  And the panel apparently relied on a dictionary definition of "breed" as meaning "a distinctive group of domestic animals differentiated from the wild type under the influence of man and usu[ally] incapable of maintaining its distinctive qualities in nature," citing Webster's Third New International Dictionary of the English Language 274 (1993).  Like the Board, the panel rejected Inventor Ditto's argument that the Green and Porter references did not describe a breeding that had achieved the desired level of domesticity (particularly with reference to the TICA "SBT" breeding standards).  Tellingly, Inventor Ditto's filing date (March 25, 1999) was after the date (May 1, 1998) when TICA accepted the Pixie-Bob as a recognized breed.  According to the panel, both the Green and Porter references disclosed characteristics and features of the Pixie-Bob cats that are distinctive and comprise the "desired effects" recited as a limitation in Inventor Ditto's claims.

The panel's decision finishes the patenting process for Inventor Ditto.  However, the "product of nature" rejection before the Office remains unscrutinized and intriguing (and, truthfully and in full compliance with the Supreme Court's analytical protocol, is based in part on the prior existence -- i.e., on § 102 grounds -- of the breeding in nature).  But the question can be presented more starkly with the Savannah cat mentioned above.  This cat is bred solely with human intervention (there is no evidence that the African serval ever mated in the wild with a domestic cat and certainly not with an American domestic cat).  In addition, males in the F1 generation are sterile; indeed, it is not until the F4 generation that fertile males are produced.  This required backcrossing into the domesticated cat stock in order to produce cats that breed "true," i.e., that have both parents of the Savannah breed.  All of these aspects evince the "hand of man" and represent something that is the "product of human ingenuity 'having a distinctive name, character [and] use,'" Chakrabarty at 310, citing Hartranft v. Wiegmann, 121 U. S. 609, 121 U. S. 615 (1887).  Thus it is clear under prevailing precedent that the Savannah cat should comprise patent-eligible subject matter.  Although this question is beyond the scope of the question presented to the Supreme Court in the Myriad case or in Mayo v. Prometheus, the question remains whether this Court would find these "routine" and "conventional" breeding methods to provide "enough" for the Savannah cat to be "more than" a product of nature and become a patent-eligible product of man.

In re Ditto (Fed. Cir. 2012)
Panel: Circuit Judges Dyk, Prost, and Reyna
Opinion per curiam

Image of Pixie-bobs (above) by Angie 1900, from the Wikipedia Commons under the Creative Commons Attribution 3.0 Unported license.

Solicitor General Counsels against Certiorari Grant on Claim Construction

By Kevin E. Noonan --

There are more issues in patent law that the Supreme Court may consider than those raised by Association for Molecular Pathology v. Myriad Genetics, and as if to illustrate that point, the Solicitor General filed his brief at the end of November in Retractable Techs., Inc. v. Becton, Dickinson & Co.  The Questions Presented by Petitioner Retractable Technologies are these:

1.  Whether a court, in construing a disputed term in a patent claim, may draw inferences from the patentee's use of the same term elsewhere in the patent's specification.

2.  Whether, in reviewing a district court's interpretation of a patent claim, the court of appeals should give deference to the district court's resolution of subsidiary factual questions.

In the Solicitor General's view, "neither of the questions set forth in the petition for a writ of certiorari warrants review in this case."

To recap the proceedings below, Retractable Technologies sued Becton Dickinson for infringing claims of U.S. Patent Nos. 5,632,733; 6,090,077; and 7,351,224.  These patent claims were directed to syringes configured to retract the needle into the body of the syringe after use, to reduce the likelihood of needle-stick injury.  The claim term at issue was "body," specifically whether the term should be construed to be limited to single-piece versus multiple piece embodiments.  The District Court construed "body" as "a hollow outer structure that houses the syringe's components," and concluded that the term "body" was not limited to a one-piece structure.

The Federal Circuit reversed, in a decision by Judge Lourie joined by Judge Plager and (in part) by Chief Judge Rader.  The panel reversed the District Court with regard to meaning of "body," finding that the term should be limited to a one-piece structure.  The panel found that the claim language was not determinative, and disclosure in the specification supported its one-piece body construction.  The specification described the claimed invention as comprising a one-piece body, all the figures illustrated syringes comprising a one-piece body, and the specification disparaged prior art syringes made of multiple piece bodies.  Moreover, there was no disclosure of a multiple piece syringe body in specification.  In reversing the District Court's construction, the majority said:

There is a fine line between construing the claims in light of the specification and improperly importing a limitation from the specification into the claims.  In reviewing the intrinsic record to construe the claims, we strive to capture the scope of the actual invention, rather than strictly limit the scope of claims to disclosed embodiments or allow the claim language to become divorced from what the specification conveys is the invention.

(citations omitted)

Judge Plager filed a concurring opinion expanding on this theme, saying that "the claims cannot go beyond the actual invention that entitles the inventor to a patent" and that "the [patentee's] obligation [was] to make full disclosure of what is actually invented, and to claim that and nothing more."  Chief Judge Rader, dissenting-in-part, argued the primacy of the claim language, and that it is impermissible to read limitations from the specification into the claims.

These disagreements regarding both the proper claim construction here and the proper method for performing claim construction generally also arose in the Federal Circuit's decision not to grant en banc review.  Two dissents were filed in the Court's decision not to hear the claim construction decision en banc:  one by Judge Moore, joined by Chief Judge Rader, and another by Judge O'Malley.  Judge Moore's dissent characterized claim construction as "the single most important event in the course of a patent litigation."  However, the Federal Circuit's rules for making claim construction determinations remain "ill-defined and inconsistently applied," even by the Court in her view.  While citing commentators to support this conclusion, this dissent focused on the question at issue in Retractable Technologies and, according to Judge Moore, arose generally from a deficiency in the Court's application of the law:  where to draw the "fine line" between "construing the claims in light of the specification and improperly importing a limitation from the specification into the claims."  Her dissent contended that this was the case to consider the issues of "the role of the specification in construing the claims and whether deference should be given to the district court in the claim construction process."

Judge Moore relied principally on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), and the "bedrock principle" that "the claims of a patent define the invention to which the patentee is entitled the right to exclude."  She discounted the concerns voiced by the Retractable Technologies majority, including that "the metes and bounds of what the inventor claims extend beyond what he has invented or disclosed in the specification."  In that case, the question would be one of validity rather than claim construction, she stated, and it is not the role of the court to "tailor the claim language to the invention disclosed."  Citing Phillips, the dissent relies on the mantra that the "plain meaning" of the clams controls (and the dissent voiced surprise that this question was not resolved in Phillips).  Judge Moore stated her (stringent) standard for the relationship between the claims and the specification:  "the specification cannot be used to narrow a claim term -- to deviate from the plain and ordinary meaning -- unless the inventor acted as his own lexicographer or intentionally disclaimed or disavowed claim scope," citing Phillips and Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1327 (Fed. Cir. 2002).  Any deviation from this procedure should be applied narrowly, in her opinion, and specifically, her dissent opined that the choice of an overbroad term may affect validity but should not be considered for claim construction.  Following a detailed recitation of the facts and legal principles enunciated in Phillips, the dissent contrasted the majority decision in Phillips with the panel decision here:  in the absence of "disclaimer or special lexicography," the plain meaning standard must be applied.  And the evidence, according to this dissent, failed to support a claim limited to single-body embodiments.

Judge Moore identified the problem with the panel decision with particularity:

The error in Retractable is the majority's attempt to rewrite the claims to better conform to what it discerns is the "invention" of the patent instead of construing the language of the claim.  Indeed, the majority candidly explained that its construction, limiting "body" to a one-piece body, "is required to tether the claims to what the specifications indicate the inventor actually invented."

While agreeing that the specification and claims must comply with the requirements of 35 U.S.C. § 112, her dissent stated simply that the Court "does not rewrite claims"; this is not a case, Judge Moore contended, where "the majority is choosing between two equally plausible plain meanings and adopting the one that comports with the disclosure in the specification."  Rather, this case was illustrative that there is "a fundamental split within the court as to the meaning of Phillips and Markman as well as the proper approach to claim interpretation."  That was enough to convince Judge Moore and Chief Judge Rader that claim construction required reconsideration by the court en banc.  Judge Moore also wrote that this case had a procedural posture that would permit the court to set forth the extent to which the "mongrel practice" of claim construction would permit or require deference to a district court's factual determinations under Markman v.Westview Instruments, Inc., 517 U.S. 370, 378 (1996).

Judge O'Malley dissented separately, a posture reflecting her singular experience as a district court judge tasked with performing factual determinations in support of claim construction decisions.  She was forthright:  "[i]t is time to revisit and reverse our decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998) (en banc)," if only because "the court's decision necessarily would change if even minimal deference were afforded to the trial judge's claim construction."  Her dissent noted that the Court's decision to give no deference to district court factual determinations was not required by the Supreme Court in Markman, and indeed the High Court "did not affirm this court's earlier conclusion that resort to a jury was unnecessary because claim construction is a pure question of law."  She believes the appellate court's decision to be "ill considered" when it was enunciated thirteen years ago and that it has not proven "beneficial" to patent jurisprudence "in the long run."

Reflecting her own experience, Judge O'Malley opined that:

[D]istrict judges have been trained to -- and do -- engage in detailed and thoughtful analysis of the claim construction issues presented to them.  They conduct live hearings with argument and testimony, sometimes covering several days, and certainly always extending beyond the mere minutes that courts of appeals have to devote to live exchanges with counsel.  Simply, "the trial court has tools to acquire and evaluate evidence that this court lacks."  Cybor, 138 F.3d at 1477 (Rader, J., dissenting).

She went on to say that "[w]hile no one would urge deference to cryptic, unthinking rulings born of little or no real inquiry, where, as here, the trial court has thoroughly vetted all relevant aspects of the claim constructions at issue, 'careful consideration of the institutional advantages of the district court would counsel deference.'"  Reciting the history of the case, she noted that these claims had been construed by two separate district court judges and that the asserted "wrongdoing" reversed by the panel decision "did not promote the consistency and uniformity in patent law that Cybor was intended to foster; the decision here accomplished the opposite."

In Judge O'Malley's view, the panel did not misapply the claim construction canons in Phillips; rather, she merely disagreed with their application.  But this fact, and the experience of the panel members that they "could not agree on the proper claim construction in this case, despite careful consideration of their respective obligations under Phillips," strongly suggested to Judge O'Malley that the "complicated and fact-intensive nature of claim construction" mandates "the need to rethink our approach to it."  For her, the "review of extensive documentary evidence" and possibly expert testimony suggest factual, not legal questions are being posed to the Court.  And:

Where, as here, there is fair debate about the scope of the invention after application of Phillips's principles, we should defer to reasoned district court choices.  Reasonable minds can -- and do -- differ over the correct interpretation of the term "body" as used in the patent in suit.  These are not the circumstances under which we should be reversing carefully reasoned claim constructions and putting aside years of litigation in the process.

Against this backdrop, the Solicitor General's brief concluded that, first, "Petitioners identify no unsettled question of claim construction methodology warranting this court's review," and second, "[t}his case is not an appropriate vehicle for determining what standard of appellate review should apply to a district court's subsidiary factual findings in claim construction."  The brief based its first argument, that there is no unsettled question, on the majority's reliance on Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc), cert. denied, 546 U.U. 1170 (2006).  There is no dispute between the Federal Circuit judges and thus nothing for the Court of review, according to the brief, because there is "broad agreement" in the Federal Circuit that both plain meaning and specification should be considered.  The brief characterizes a patent as an "integrated legal document," and thus, although the claims are what defines the scope of the right to exclude, claims must be interpreted according to the specification, citing United States v. Adams, 383 U.S. 39 (1966); Schriber-Schroth Co. c. Cleveland Trust Co., 311 U.S. 211 (1940); Brooks v. Fiske, 56 U.S. 212 (1854).  "At bottom, then, the task of claim construction is to ascertain the meaning of the actual claim language approved by the U.S. Patent and Trademark Office, as "explained by and read in connection with the specification" in the Solicitor's view, citing Carnegie Steel Co. v. Cambria Iron Co., 185 U.S. 403, 432 (1902).  Again citing Phillips, the Solicitor General asserts that "[t]he Federal Circuit has faithfully implemented those principles in considering questions of claim construction."  Curiously, the brief accentuates the near unanimity achieved by the Federal Circuit in Phillips, ignoring the different views enunciated by the Federal Circuit in this case (and ignoring the changed composition of the lower court in the intervening time since Phillips).  Instead of different doctrinal camps, the Solicitor General sees the differing results as merely reflecting the "case-by-case" nature of claim construction.  Turning to the case at bar, although acknowledging that the question is "close," the brief maintains that the Federal Circuit came to the right decision in this case.

Even if the Court believes that Federal Circuit jurisprudence in this area is in need of reconciliation by the Court, the Solicitor General asserts that "[t}his case is not an appropriate vehicle for determining what standard of appellate review should apply to a district court's subsidiary factual findings in claim construction."  The reason is simple:  there is no factual determination by the district court at issue here.  Indeed, "[i]n an appropriate case, this court's intervention might be warranted to determine the proper standard of appellate review of district court factual determinations that bear on the interpretation of disputed patent claims" according to the Solicitor General's brief.  But this is not that case.  Here, the District Court relied "solely" on the parties' legal arguments, thus not raising the issue the petitioners ask the Court to resolve.  Moreover, the Federal Circuit's decision in Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448 (Fed. Cir. 1998), that factual determinations by a district court were due no deference on review, is "amply support[ed]" by the Court's Markman decision in the Solicitor's view.  The brief engages in the fiction that Cybor does not preclude deference to a district court's factual findings, but maintains its position that, regardless of the Federal Circuit's treatment in other cases there is no basis warranting review on this question in this case.

The Solicitor General maintains that "the question whether deferential review is appropriate in those circumstances is of substantial and ongoing importance in patent law" but "[t]hat issue is not properly presented in this case, however, because the district court did not make any factual findings or resolve any evidentiary disputes in interpreting the patent claims at issue here."

Taking into account the five "active" judges who voted to grant rehearing in Amgen Inc. v. Hoechst Marion Rousell, Inc., 469 F.3d 1039 (Fed. Cir. 2006), and contrary to the Solicitor General's views on the matter, the evidence suggests that the active members of the Federal Circuit are almost evenly split on the question of whether to grand en banc review, and by implication revisit the Court's decision in Cybor.  And an honest assessment of the Federal Circuit's jurisprudence supports the Petitioner's view that the Federal Circuit is split, at least loosely, into those judges who believe that claims must be strictly construed according to the specification in order to limit their scope to "what the inventor has invented," and those judges who believe that the plain meaning of the claim language is the primary determinant of the scope and meaning of the claims.  The Solicitor General discounts this evidence in encouraging the Supreme Court not to grant cert.  In view of the cases where the Supreme Court has already granted certiorari this term, and the continuing pattern of the Court to ignore the recommendations of the Solicitor General's Office, and the apparently unsettled posture of the question of claim construction in the Federal Circuit, there is a fair likelihood that the Supreme Court will decide that its supervision is required in yet another area of patent law.

PerkinElmer Inc. v. Intema Ltd. (Fed. Cir. 2012)

By Kevin E. Noonan --

The Federal Circuit made its first attempt to implement the Supreme Court's nearly opaque jurisprudence on the scope of patent eligibility for diagnostic method claims (as set forth in Mayo v. Prometheus) in PerkinElmer, Inc. v. Intema Ltd., decided today.  (The Court's AMP v. Myriad case doesn't really count, as the diagnostic method claims in Myriad had already been held patent-ineligible under the "machine-or-transformation" test set forth in In re Bilski, and the Supreme Court's Mayo decision certainly didn't expand the scope of patent eligibility.)

The case involved claims from U.S. Patent No. 6,573,103 for prenatal diagnostic testing for Down's syndrome, intended to avoid the need for invasive testing like chorionic villus sampling that incurs the risk of miscarriage.  Claims 1 and 20 were set forth by the Federal Circuit panel as being representative:

Claim 1.  A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
    measuring the level of at least one screening marker from a first trimester of pregnancy by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
    measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one first screening marker from the first trimester of pregnancy, by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . . ;
    and determining the risk of Down's syndrome by comparing the measured levels of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from the second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.

Claim 20.  A method of determining whether a pregnant woman is at an increased risk of having a fetus with Down's syndrome, the method comprising the steps of:
    measuring the level of at least one first screening marker from a first trimester of pregnancy by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one first ultrasound screening marker from an ultrasound scan . . . ;
    determining a first risk estimate of Down's syndrome by comparing the measured level of the at least one first screening marker level from the first trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies;
    comparing the first risk estimate with a predetermined cut-off level to initially classify the pregnant woman as screen- positive or screen-negative based on the comparison;
    and if the pregnant woman is initially classified as screen-negative; measuring the level of at least one second screening marker from a second trimester of pregnancy, the at least one second screening marker from the second trimester of pregnancy being different from the at least one
first screening marker from the first trimester of pregnancy, by:
        (i) assaying a sample . . . ; and/or
        (ii) measuring at least one second ultrasound screening marker from an ultrasound scan . . .
    and determining the risk of Down's syndrome by comparing the measured level of both the at least one first screening marker from the first trimester of pregnancy and the at least one second screening marker from second trimester of pregnancy with observed relative frequency distributions of marker levels in Down's syndrome pregnancies and in unaffected pregnancies.

The panel opinion apprehends that the "key difference" between these claims was the segregation of patients into positive or negative groups, wherein only the positive groups are screened in the second trimester, embodied in the "determining step" as the "key limitation."  The District Court had construed this "key limitation" as determining a risk of Down's syndrome by comparing distributions of certain markers in Down's syndrome pregnancies and "unaffected" pregnancies, and then combining the screened markers into a single risk calculation based on the results from the first and second trimester screenings.  The District Court rejected PerkinElmer's summary judgment motion of patent ineligibility under § 101 (and granted Intema's summary judgment motion on patent eligibility) on the grounds that the claims are directed at a data-gathering method comprising measuring steps that satisfied the machine-or-transformation test (assaying a blood sample was transformative in the District Court's view).

The panel opinion written by Judge O'Malley and joined by Judges Bryson and Wallach, reversed the District Court's finding of patent-eligible subject matter (and affirmed summary judgment against Intema on anticipation and obviousness grounds), based on the Supreme Court's Mayo decision and the Federal Circuit's Myriad decision.  "The key distinction," according to the Court, "which bears on our decision today[] is between claims that recite ineligible subject matter, and no more, and claims to specific inventive applications of that subject matter."  The opinion goes on to say that the basis for making this distinction is that claims to specific applications of "patent-ineligible subject matter" (i.e., "laws of nature, natural phenomenon or abstract ideas") "do not risk the broad preemption of 'the basic tools of scientific and technological work,'" citing Benson v. Gottschalk, 409 U.S. 63, 67 (1972).  In the panel's view, the claimed methods do not contain an "inventive concept" (defined as in Mayo as "other elements or a combination of elements [] sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself" and because these claims "contain[] nothing more than 'well-understood, routine, conventional activity previously engaged in by researchers in the field.'"

The opinion then sets forth how it arrived at this conclusion, which in a nutshell was that the panel did not see any distinction between these claims and the Mayo or Myriad claims.  While relying on extensive language from the Court's Mayo decision, the analysis focuses much more closely on the similarities between the claims at bar and the Myriad claims (calling them "indistinguishable" from the claims in Myriad).  The similarities reside completely in the fact that the Intema claims and the Myriad claims involve comparing measured biological information (between wildtype and mutant BRCA genes in Myriad and between Down's pregnancies and unaffected pregnancies here), which the panel characterizes as being merely mental activity regarding a naturally occurring relationship).  These two characteristics of the claims -- that they recite "mental steps" and "natural laws" -- are sufficient to render them patent-ineligible unless, according to the opinion, they also contain that ineffable "something more" required by the Supreme Court's Mayo opinion.  Surveying the claims, the opinion states that the "measuring" steps are insufficient, because (as in Mayo) the method steps encompass any and all methods for measuring the markers.  Here, the patentee's attempts to provide broad support for the invention was held against them, wherein the specification was cited for reciting that "'[t]he individual measurements are obtained through known methods. . . .  Any markers which are effective at each particular stage may be selected.'"  As a result, the panel was able to characterize the measuring steps as encompassing "well-understood, routine, conventional activity previously engaged in by scientists who work in the field."

Similarly, the "determining" step (characterized by the District Court as a "key" limitation) was thought by the panel to comprise merely the "mental step" of comparing marker levels in Down's and unaffected pregnancies, and that the "comparing" methods comprise statistical analysis was not enough:  these are also "well-understood" and "conventional" (although the opinion does not establish that it was conventional to apply Gaussian statistics for such comparisons, the patentee's further recitations in the specification that "Any of the known statistical techniques may be used.  Preferably the multivariate Gaussian model is used, which is appropriate where the observed distributions are reasonably Gaussian. Such multivariate Gaussian analysis is in itself known . . . ." clearly suffices to support the panel's conclusion that the statistical handling of the data was routine and conventional).  Also in this regard the panel recognizes that, as in Myriad, there is no requirement that an actual assay (BRCA gene sequencing in Myriad, taking an ultrasound here) must actually be performed; the claims are satisfied by making the comparison itself (between two printouts of gene sequences in Myriad, or between two ultrasound images here), making it a simple matter to construe the claims as encompassing the merely mental step of "comparing."

The panel gets to the heart of the matter by reaching the preemption issue, wherein "anyone who wants to use this mental step or natural law must follow the claimed process" and the root of the problem, that "there is no requirement that a doctor act on the calculated risk," both because the claims do not recite a treatment step and because the claims purportedly impact the activities of medical doctors treating patients (albeit through the intermediary of a commercial (or at least for-profit) testing laboratory (and the panel goes on to support this conclusion with reference to the different patent-eligibility fates of the claims in Classen v. Biogen Idec, where the presence of an immunization step distinguished patent-eligible from patent-ineligible subject matter).

The Court asserts the most troubling basis for its decision by comparing the claims here with Claim 20 in Myriad's U.S. Patent No. 5,747,282.  The patent-eligible distinction, according to this panel, is that in Claim 20 the cell that was used to compare growth rates in the presence or absence of a test compound was non-naturally occurring (and constituted patent-eligible subject matter, and thus "their inclusion in the process made the claims patent-eligible despite the reference to an otherwise ineligible mental step."

The panel enters into Supreme Court-sanctioned flights of fancy in finding that the claims also fail the machine-or-transformation test, on the grounds that "measuring" marker levels is not transformative because "it could be performed 'without transforming the [sample], should science develop a totally different system for [assaying for a biochemical screening marker] that did not involve such a transformation,'" citing Mayo.

While it is apparent that the point is that the claims are overbroad in this respect, it should not be too much to ask that courts base their opinions (with regard to conventionality) on the conditions and limitations existing in the reality we happen to inhabit at the time they render a decision, not some hypothetical Never-Never Land of their own imagination.

This case stands as the most recent cautionary tale of how diagnostic methods claims must be crafted -- narrow, specific, encompassing particular assaying and detection steps, and encompassing some (any) patentable feature other than the naturally occurring correlation between a marker and disease.  It may be hoped that claims drawn to a novel marker, or to the new appreciation that a known marker was diagnostically relevant to a particular disease, contained in claim language reciting sufficient specificity to recited methods, will be enough to pass muster.  After all, Intema's claims (and the claims of most existing diagnostic method patents granted prior to the Mayo decision) were drafted without foreknowledge of the Supreme Court's return to the Benson/Flook era in Mayo, and its targeting of any claim that may impact medical treatment.  Of course, the lesson from Mayo, and this case, is that such inventions should not be patented, but rather kept in a tight black box where patient data is gathered (including for security some unnecessary data) and a clinically established correlation produced.  This is, of course, the antithesis of a patent regime intended to "Promote the Progress . . . of the Useful Arts" but in a capitalist society, diagnostic assays cannot reasonably be expected to be developed, or distributed, free of charge.  Perhaps the courts, and the medical community, will come to face this reality before it is too late.

PerkinElmer, Inc. v. Intema Ltd. (Fed. Cir. 2012)
Panel: Circuit Judges Bryson, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley

Hoffmann-La Roche Inc. v. Apotex Inc. (Fed. Cir. 2012)

By Andrew Williams --

Last week, in Hoffmann-La Roche Inc. v. Apotex Inc., the Federal Circuit affirmed the denial of a request for a preliminary injunction from the U.S. District Court for the District of New Jersey related to the sale of Roche's osteoporosis drug Boniva®.  The lower court had found that Roche failed to establish a reasonable likelihood that it would prevail against the obviousness challenges from the ANDA filers in the case.  Because the majority of the three-judge panel of the Federal Circuit believed that the lower court did not abuse its discretion in denying the request, the decision was affirmed.  However, Judge Newman dissented because she believed, in part, that the lower court and the majority did not properly consider the equities in the case.  The dissent summed up the case with the statement:  "[t]he only issue on this appeal is whether to preserve the status quo during this litigation, or whether to change it irretrievably."  Judge Newman disagreed with the majority because, according to her, not only did the equities favor an injunction for Roche, but if the lower court had not ignored the evidence of unpredictable results in the art, it would have found that Roche had established a reasonable likelihood of defending the validity of its patents.

Boniva®, the drug at issue in this case, is approved by the FDA as a once-monthly treatment of osteoporosis in post-menopausal women.  The active ingredient is ibandronate, the use of which was already known in the art for the treatment for osteoporosis.  However, when administered on a continuous basis, it can cause skin irritations and result in side effects in the digestive tract.  Roche's scientists discovered that instead of daily dosings, a once-monthly dose of 150 mg could also be effective without causing the adverse conditions.  Based on this work, Roche owns two patents, U.S. Patent Nos. 7,410,957 and 7,718,634, with method of treatment claims that cover the FDA-approved use.  In 2007, Apotex, Watson Laboratories, Inc., and Mylan Inc. filed separate ANDAs to engage in the commercial manufacture, use, or sale of generic versions of once-monthly ibandronate products to treat osteoporosis.  The present action was brought in the New Jersey District Court, and during the pretrial proceedings, Roche filed the present motion for preliminary injunction.  The lower court denied this motion for the sole reason that Roche failed to establish a reasonable likelihood that it would prevail against an obviousness challenge from the Defendants in view of six prior art references.  Roche appealed.

The majority began its discussion by pointing out that the grant or denial of a preliminary injunction is within the sound discretion of the lower court, and that reversal is appropriate if one or more of the findings were clearly erroneous, such that the lower court could be said to have abused its discretion.  To receive such a request, Roche needed to establish that there was "a reasonable likelihood of success on the merits," which in this case was a likelihood that Roche would withstand an obviousness challenge in light of the burdens and presumptions that inure at trial.  In fact, the majority pointed out that Roche did not challenge the framework employed by the lower court.  Instead, Roche challenged the lower court's decision because it believed that the court applied an "obviousness to try" standard, and that the court failed to consider evidence of unexpected results.

The majority disagreed with both of Roche's criticisms of the lower court's analysis.  First, the majority pointed out that the District Court carefully evaluated each of the six references and the testimony of Roche's own expert.  The lower court determined that the prior art evidenced a trend towards intermittent (such as once-monthly) dosing of ibandronate based on the total amount of ibandronate dosed in the same period under continuous (for example, once-daily) administration.  In fact, Roche's expert conceded:  (1) that one of the references provided a motivation to investigate monthly dosing of ibandronate, (2) that in the 2000-02 timeframe, the art was trending towards longer interval dosing, (3) that by the critical date, a skilled artisan would have had reason to investigate once-monthly treatment, (4) that determining a dose within a given broad range is a relatively routine matter, and (5) that by May 2002, one of skill in the art would have had a reasonable expectation that a once-monthly dose of ibandronate would have had some effectiveness.  With regard to the objective evidence of non-obviousness, the lower court had found that Roche failed to detail its position, much less substantively point out the evidence.  Instead, Roche apparently "incorporated by reference" its summary judgment pleading, which itself apparently only contained a few conclusory sentences with citation to the record.  As a result, the lower court apparently did not consider this information.  In siding with the District Court on this issue, the majority cited to the 7th Circuit Court of Appeals in noting that district court judges "are not archaeologists," and that it is not a district court's burden to "excavate masses of papers in search of revealing tidbits."

Finally, in response to the dissent's criticisms, the majority found that it owed deference to the lower court.  Ultimately, the majority found no evidence of any clearly erroneous findings, much less any abuse of discretion on behalf of the lower court in denying the request for the preliminary injunction.  Of note, during this appeal, the District Court concluded in May on a motion for summary judgment that the claims of one of the patents would have been obvious in view of the same art (plus three additional references), and made a similar finding with regard to the claims of the second patent earlier this month.  Of course, even though it is interesting that Roche was ultimately unsuccessful in fending off the obviousness challenge at the lower court, those judgments are still subject to appeal, and appropriately played no role in the majority's decision.

Judge Newman in dissent complained that the equities in this case were not properly weighed, because if they had been, the result would have been the preservation of the status quo -- in other words, the ANDA filers would not have been allowed to market their products regardless of the expiration of the 30-month stay.  Judge Newman pointed out the "panoply of biological and clinical evaluations" needed to bring an effective and safe drug to market, and the "millions of dollars" consumed to obtain regulatory approval.  She noted that bringing a drug to market required a "heavy risk-laden investment," one which the defendants were now trying to enjoy with no cost or risk of failure.  The problem with this analysis is that this criticism applies in every ANDA case, and therefore following this logic, an NDA holder would always get a preliminary injunction to maintain its exclusive rights until at least the conclusion of litigation.  Whereas there is some appeal to this position, because it takes into account the substantial costs and risks of brining a drug to market, the Hatch Waxman statute clearly contemplates the ability of an ANDA filer to get approval at the end of the 30-month stay, and to "launch at risk" should the litigation still be ongoing at the time.  In other words, Congress contemplated that not all preliminary injunctions would be granted, so the mere fact that a generic manufacturer files an ANDA should not be the sole determining factor whether an injunction should issue.

Judge Newman also criticized the lower court's refusal to consider Roche's evidence of unpredictable results.  She pointed out that, apparently, both parties had cited to their respective summary judgment briefs in their filings for the present action.  Nevertheless, Roche had the burden of establishing that it deserved a preliminary injunction, so if the parties were at fault for this practice, it should disproportionally affect Roche.  Judge Newman also stressed the clear and convincing standard required to invalidate an issued patent, and that this burden was even greater in this case because the cited references were considered by the examiner and rejected.  Therefore, in the end, Judge Newman believed that because of the equities in this case and the presumption of validity of the patents, "the fair and just action [would have been] to preserve the status quo during the litigation."

Hoffmann-La Roche Inc. v. Apotex Inc. (Fed. Cir. 2012)
Nonprecedential disposition
Panel:  Circuit Judges Newman, Lourie, and O'Malley
Opinion by Circuit Judge Lourie; dissenting opinion by Circuit Judge Newman

Pozen Inc. v. Par Pharmaceutical, Inc. (Fed. Cir. 2012)

By Andrew Williams --

Last week, in Pozen Inc. v. Par Pharmaceutical, Inc., the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Texas that two patents that describe treating migraines by combining two known drugs in a single dose had not been shown to be obvious or inadequately described, and that in addition to these patents being infringed by three separate ANDA filers, two generic drug companies were also found to infringe a third patent to a co-formulated tablets under the doctrine of equivalents.  The Federal Circuit agreed that the prior art would not have provided a motivation to combine these two drugs to a person of skill in the art, and therefore could not render the patent invalid for obviousness.  The Court also agreed that one of ordinary skill in the art would understand that the inventors had possession of packaging or instructions for the use of their tablet.  With regard to infringement, the Federal Circuit agreed that Pozen did not need to show testing to establish that the limitation "independent dissolution" was met by the doctrine of equivalents.  Finally, the majority held that even though "substantially all" was already a "fuzzy" term, it was still entitled to equivalents.

The reference drug product at issue in this case was Treximet®, which is a combination of sumatriptan, a 5-HT receptor agonist effective at treating migraines, and naproxen, a widely known non-steroidal anti-inflammatory drug ("NSAID").  Pozen markets Treximet® in partnership with GlaxoSmithKline, and holds three patents to the co-administration of these drugs.  The claims at issue in this case include:

• claim 15 of U.S. Patent No. 6,060,499 ("the '499 patent"), drawn to therapeutic packages for dispensing one or more unit doses of sumatriptan and naproxen at specific concentrations;

• claims 11, 12, 24, 26, 27, 29, and 30 of U.S. Patent No. 6,586,458 ("the '458 patent"), drawn to pharmaceutical compositions in unit dosage forms which comprise a 5-HT agonist and a long-acting NSAID; and

• claim 2 of U.S. Patent No. 7,332,183 ("the '183 patent"), drawn to a multilayer pharmaceutical tablet in which "substantially all" of the 5-HT agonist is in the first layer, and "substantially all"  of the naproxen is in the second layer, and in which the dissolution of the naproxen occurs independently of the other drug.

Three generic companies, Par Pharmaceuticals, Inc. ("Par"), Alphapharm Pty Ltd. ("Alphapharm"), and Dr. Reddy's Laboratories, Inc. ("DRL") (collectively "Appellants") filed three separate ANDAs to market generic versions of Treximet®.  In turn, Pozen filed suit in the Eastern District of Texas.  The lower court held a claim construction hearing, followed by a five-day bench trial in which the patents-in-suit were held to be valid and infringed, either literally or under the doctrine of equivalents.  However, after the claim construction ruling and before trial, Pozen stipulated to a judgment of non-infringement of the '183 patent in favor of Alphapharm, and therefor Alphapharm's only interest in the appeal was the validity of the '499 and '458 patents.

Validity – Non-obviousness

The first issue related to the lower court's non-obviousness determination that the Federal Circuit addressed was whether the claims required "simultaneous administration" of the two drugs.  Par pointed out that all of the claims recited the limitation "concomitant administration," and because the District Court construed this term to mean "[g]iven in close enough temporal proximity to allow their individual therapeutic effects to overlap," than the two drugs in the prior art need not have been administered at the same time.  However, the Federal Circuit was not persuaded, because all of the asserted claims also contained the limitation "unit dose form," "unit doses," or "unit dosage form(s)," and all parties agreed that these terms meant "single drug administration entity(ies)."  Therefore, irrespective of the fact that the claims had the broader term, the "unit dose" limitation necessarily limited the claims to "simultaneous administration."

Even though this claim construction issue would have been determinative for an anticipation allegation, a reference that discloses administration of two drugs, albeit not at the same time, could still render a simultaneous-administration claim obvious to one skilled in the art.  Therefore, the Court analyzed each of the four cited references.  Interestingly, most, if not all, of these references evidenced the actual administration of these two drugs to at least one patient in "temporal proximity" to each other.  Nevertheless, because these references did not tout the advantages of the combination of these drugs, they could not be used as motivation to combine sumatriptan and naproxen.  In fact, most of the references highlighted other factors for the patients' positive response.  For example, one of the patients in one of the references was also receiving acupuncture, and the authors attributed this to the successful treatment of the patient's migraines.  A second factor considered by the Court for at least some of these references was that they did not disclose the "efficacy limitations" recited in the claims.  One could argue that the particular efficacy would be "inherent" in the co-administration of the drugs, but it is important to keep in mind that one skilled in the art would not have been motivated to combine these drugs to obtain this result without an explicit teaching.  As a result, the panel agreed with the District Court that appellants failed to meet their burden to rebut the presumption that one of ordinary skill in the art would not have combined these two drugs in order to benefit from the longer lasting efficacy as compared to taking either agent alone.

Par also alleged that the '183 multilayer tablet patent was obvious in view of the '499 patent combined with the prior art or the knowledge of a person of ordinary skill in the art.  Par argued that the prior art taught that naproxen has low solubility in the stomach, which would impede the dissolution of sumatriptan if co-administered, and that multilayer tablets were well known in the art.  However, during prosecution, the Patent Office had allowed these claims even in view of similar art.  Moreover, the fact that multilayer tablets were commonly used did not necessarily mean that Pozen's claimed dosage form of these two drugs was obvious.  Par also alleged that the lower court used two different meanings of "independent dissolution" in its infringement analysis and its validity analysis, but the Federal Circuit failed to see the difference.  Therefore, the Court concluded that appellants had failed to rebut the presumption of validity of these claims.

Validity – Written Description

Appellants also alleged that claim 15 of the '499 patent lacked an adequate written description because it contained the limitations "therapeutic package," "finished pharmaceutical container," and "said container further containing or comprising labeling directing the use of said package in the treatment of migraine," all of which were added during prosecution, but none of which appear in the specification.  The Federal Circuit, however, did not take such a narrow view of the requirement of 35 U.S.C. § 112, ¶ 1.  Instead, what is required is that the specification reasonably convey to a skilled artisan that the inventor had possession of the invention.  Moreover, a person comes to the patent with the knowledge of what has come before.  Therefore, because it was well known in the art that pharmaceutical dosages are administered in containers or packaging with labels and inserts containing instructions, such information need not be explicitly disclosed in the specification.

The slightly troubling aspect of the Court's decision is that it appears to have taken the position that because the use of packaging or instructions would have been obvious at the time of filing, such information need not have been included in the specification.  Unfortunately, what is missing from the decision is why these limitations were added in the first place.  If they were added to overcome cited art, it would be somewhat inconsistent to say that the other prior art can provide the support for the new limitation being used to distinguish the invention.  Nevertheless, appellants did not make such an argument, so any potential inconsistency was not in front of the Federal Circuit.

Infringement

Because the Court affirmed the lower court's finding of validity of the '499 and '458 patent claims, and because apparently none of the three defendants challenged the finding of infringement with regard to these two patents, the injunction preventing all three ANDA filers from making or selling their respective products would have been maintained based solely on these patents.  Nevertheless, Par and DRL appealed the finding that their respective ANDA products infringed claim 2 of the '183 patent multilayer tablet patent under the doctrine of equivalents.  Pozen had stipulated to a judgment of non-infringement of the '183 in favor of Alphapharm, and so it had no interest in this part of the appeal

The following is a reproduction of claims 1 and 2 of the '183 patent:

1.  A multilayer pharmaceutical tablet comprising naproxen and a triptan and, wherein: a) substantially all of said triptan is in a first layer of said tablet and substantially all of said naproxen is in a second, separate layer; and b) said first layer and said second layer are in a side by side arrangement such that the dissolution of said naproxen occurs independently of said triptan.

2.  The tablet of claim 1, wherein said naproxen is in the form of naproxen sodium at between 200 and 600 mg.

Par and DRL first challenged the finding of infringement with respect to the "independent dissolution" limitation.  The parties had agreed that this limitation required that "[d]issolution of naproxen . . . and triptan from the multilayer tablet occurs in the same amount of time ± 10% as when the same amount of naproxen . . . and triptan are given separately."  Both Par and DRL complained that no evidence was presented at trial demonstrating that the comparison as required by the claims was ever undertaken.  The District Court, however, found the required evidence in the FDA filings of these two companies, as well as the expert testimony.  The Federal Circuit took it a step further, noting that under the doctrine of equivalents, Pozen was not required to show an actual comparison.  Instead, Pozen only needed to show that the ANDA products performed the same function in the same way to achieve the same result as the claimed element.  This, of course, begs the question of how you can show the same result without testing, but the Court nevertheless concluded that Par and DRL presented no basis for setting aside the finding of infringement.

In addition, Par and DRL challenged the finding of equivalents to the claim term "substantially all."  This term was construed consistent with the specification to mean that "at least 90%, and preferably greater than 95%, of the total triptan present in the tablet is included within one distinct layer and at least 90%, and preferably greater than 95%, of the naproxen present in the tablet is included within a second distinct layer."  Par formulated its tablet to avoid infringement, putting only 85% of the tablets naproxen in the second layer.  Conversely, DRL formulated its tablet to have only 85% of its sumatriptan in one of the layers.  Par argued that the word "substantially" was "fuzzy," and itself was already being used to capture values lower than 100%.  Therefore, it argued, the claims should not be found to encompass equivalents of equivalents.  DRL argued that the scope of equivalents was already within the scope of the claim, and therefore the District Court had erred in granting a range beyond this.  The majority pointed out, however, that the doctrine of equivalents is not foreclosed just because a range is claimed.  As such, the change from 90% to 85% could be fairly characterized as an insubstantial change.  Moreover, the Court did not find that the District Court had erred in finding that the ANDA products had the same function of having "separate, distinct layers of sumatriptan and naproxen," that they achieved this function in the same way, by creating physical barriers, and that the result was the same -- separating the naproxen from the sumatriptan.

Judge Clevenger dissented with respect to this finding.  He noted that the District Court never directly addressed the issue whether a layer with 85% was an equivalent to a layer of 90%, and preferably 95%.  Instead, he believed that the lower court skirted the numerical equivalents issue by only asking whether the accused product had the equivalent of a second layer with substantially all of the required ingredient.  He, therefore, would not have affirmed this finding.

Pozen Inc. v. Par Pharmaceutical, Inc. (Fed. Cir. 2012)
Panel: Circuit Judges Newman, Clevenger, and Wallach
Opinion by Circuit Judge Wallach; dissenting-in-part opinion by Circuit Judge Clevenger