Patent Docs

Webinar on PTAB Rules Changes

Strafford will be offering a webinar/teleconference entitled "USPTO Rule Changes for PTAB Trial Proceedings -- Navigating Changes to New Testimonial Evidence, Rule 11-Like Requirement, Claim Construction Standard, Motions to Amend, and More" on October 1, 2015 from 1:00 to 2:30 pm (EDT).  Michael J. Flibbert, Thomas L. Irving, Partner, and Dr. Amanda K. Murphy of Finnegan Henderson Farabow Garrett & Dunner will provide patent counsel with an in-depth review of the U.S. Patent and Trademark Office's newly proposed rule changes for PTAB trial practice, and discuss the potential implications of the changes and address what counsel needs to do now regarding matters that could be impacted if/when the rule is adopted.  The webinar will review the following questions:

• What is the potential impact of patent owners being able to submit declarations with preliminary responses? How will it change strategy?
• What approach should patent counsel take regarding the standard of review if the expiration date is in dispute?
• How will counsel need to alter their approach in light of the proposed rule changes?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

AIPLA Webinar on Unitary Patent Protection

The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "Unitary Patent Protection in Europe - An Attunement on the Upcoming New System" on October 7, 2015 from 12:30 - 2:00 pm (Eastern).  Jim Bell of Cabinet Beau de Lomenie will moderate a panel consisting of Markus B. Boelling  and Thomas Koerfer of Mitscherlich PartmbB.  The panel will provide an overview on the new Unitary Patent system, including its advantages and drawbacks, describe the nature of the new patent and the related prosecution process, and discuss the introduction of the Unified Patent Court.  The webinar will enable participants to make informed decisions on the most urgently upcoming issues related to patent protection in Europe.

The registration fee for the program is $95 (AIPLA member rate) or $150 (non-member rate).  Those interested in registering for the program, can do so here.

Webinar on Patent Prosecution Strategies

Strafford will be offering a webinar/teleconference entitled "Proactive Patent Procurement and Prosecution Strategies: Minimizing the Threat of Post-Grant Challenges -- Insulating Your Patent Portfolio From New Threats" on October 8, 2015 from 1:00 to 2:30 pm (EDT).  Margaret A. Focarino and Scott A. McKeown of Oblon McClelland Maier & Neustadt will provide patent counsel with an overview of the current USPTO's Patent Trial & Appeal Board (PTAB) and patent litigation landscape with an eye toward emerging trends and challenges for patents owners, and offer best practices to minimize the threat of post-grant patent challenges as well as prosecution strategies to strengthen and/or insulate patent portfolios from PTAB attack.  The webinar will review the following questions:

• What are the emerging challenges for patent owners under the current PTAB landscape?
• What is the PTAB’s impact on patent portfolios and what steps can counsel take to strengthen portfolios?
• What proactive steps in patent procurement and prosecution can counsel take to minimize the threat of post-grant challenges?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those interested in registering for the webinar, can do so here.

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: WARF, Marshfield Clinic, and MCIS, Inc.

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Today, we review the brief submitted by the Wisconsin Alumni Research Foundation (WARF), the Marshfield Clinic and MCIS, Inc.

In the brief's Statement of Interest, the WARF amicus states that it is "a non-profit organization that supports and promotes scientific research at the University of Wisconsin–Madison by patenting inventions and discoveries of university researchers and licensing them for commercial use."  The Marshfield Clinic is "a non-profit clinic whose mission is to serve patients through research and education as well as providing accessible, high-quality care," and MCIS (a Marshfield Clinic affiliate) "produces medical information products and services that enable effective, efficient practice of medicine at an affordable cost."

These amici assert "a strong interest [] in the patent-eligibility question this case presents because they have commercialized other ground-breaking medical therapies and products and aim to continue doing so for the benefit of both their institutions and the public they serve."

The brief makes three arguments in favor of en banc reconsideration:  first, that the Supreme Court's precedents in Mayo and Alice v. CLS Bank is limited ("no more and no less") to preventing patenting of natural phenomena, laws of nature and abstract ideas.  Second, this precedent is not intended and does not require invalidation of claims to applications of natural phenomena that do not monopolize the phenomenon per se.  Finally, they argue that the panel erred by misinterpreting Sequenom's claims when it found isolation, amplification and analysis of cffDNA from maternal blood and other fluids to be conventional.

In making their first argument, the brief cites Justice Thomas's Myriad opinion for the proposition that "practical applications and variations of natural phenomena, laws of nature, and abstract ideas are patent-eligible" (emphasis in the brief), as well as Diamond v. Diehr, Diamond v Chakrabarty, Mackay Radio & Tel. Co. v. Radio Corp of Am., and LeRoy v. Tatham.  Mayo did not overturn this prior precedent, and amici argue that the Mayo opinion (as explained in Alice) was intended to prevent the "clever draftsman" from "avoid[ing] the exceptions to patent-eligibility by gussying up the claims with extra verbiage or trivial additional elements."  But the brief argues that the use of the concepts of "conventionality" and "transformation" in the Mayo/Alice decisions was not intended to require an analysis of the claims with regard to those concepts "for their own sake":  "[i]nstead, the critical question is whether a patent impermissibly claims and prevents others from using a natural phenomenon, law of nature, or abstract idea itself, or instead permissibly claims a practical application of one of those things" they argue.  The brief illustrates this argument by citing the comparison in the Mayo opinion itself between the Prometheus claims (which were invalidated because "they 'effectively claim[ed] the underlying laws of nature themselves'") and Diehr's claims to transformative methods for curing rubber (which "did not 'seek to pre-empt the use of [the Arrhenius] equation' but instead 'transformed the process into an inventive application of the formula' and sought 'only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process'".

Having set the stage with this argument, the brief then goes on to state what the Mayo/Alice opinions do not do:  preclude patenting of applications of natural phenomena, laws of nature or abstract ideas.  These amici argue that the Myriad opinion stated that while "isolated naturally occurring DNA is not patent-eligible, innovative methods of isolating or manipulating DNA may be" and that "practical applications of knowledge about gene sequences may be patentable even though the sequences themselves are not."  Extending this analysis to Sequenom's claims, they acknowledge that Isis (the patent owner) could not have patented the mere discovery that cffDNA was present in maternal blood (the natural phenomenon) or the cffDNA itself (the natural product that would be invalid under Myriad).  But if Sequenom had invented "innovative methods of isolating cffDNA in maternal fluids" that would have been patent eligible, and likewise what the inventors of Sequenom's asserted claims had invented should also be patent eligible as a practical application of the discovery of cffDNA in maternal blood.  And these amici remind the Court that the inventors did not attempt to patent either the cffDNA or claim all practical uses of their discovery:  indeed, the claims are directed to detecting only paternally derived cffDNA, which the brief characterizes as only "one fraction of the naturally occurring cffDNA."  And the brief argues that there existed "practical alternative detection methods that do not involve fractionation and amplification of the cffDNA" and thus (sub silencio) that the claims do not preempt every use of the discovery that cffDNA (both maternally as well as paternally derived) can be found in maternal blood of a pregnant woman.

Finally, the brief addresses what these amici (as well as the parties and other amici) identify as the panel's (and the District Court's) error:  determining that the isolation, amplification and sequencing steps are "conventional" and thus fail to satisfy the second step of the Mayo/Alice inquiry.  The first source of error was in "isolating the steps [recited in the method claims] rather than considering them as an 'ordered combination' as taught by Alice, [] Mayo, [[] and Diehr []."  And the brief makes the point argued by the parties and amici, both in the District Court and before the panel, that no matter how conventional the recited steps in these methods may be generically, it was not conventional to apply them to detecting cffDNA from maternal blood because (prior to the inventors' discovery) "no one thought cffDNA was present in maternal fluids."  This is in contrast to the circumstances involved in the Prometheus claims invalidated by the Court's Mayo opinion, where everything except the observed correlation between drug concentration in blood and therapeutic effect had been performed in the prior art.  The brief acknowledges the Supreme Court's importation of obviousness-type considerations into the patent eligibility analysis ("[f]or good or bad'), but cites In re Ochiai for the principle that a compound is not obvious when neither the starting materials nor the product are known in the prior art, even if the chemical reaction converting one to the other was "conventional."  71 F.3d 1565 (Fed. Cir. 1995).  This is analogous to the situation here, and thus the same conclusion should be reached.

The most idiosyncratic portion of the brief is the inclusion of a joke (which we would be remiss not to include in this post):

A physicist, a chemist, and an economist are stranded on a desert island.  A can of food washes ashore, but they but have no can opener.  The physicist devises an ingenious plan relying on leverage and gravity.  The chemist proposes a clever plan based on heat and pressure.  To which the economist responds, "Let's assume we have a can opener, and from there the solution is easy."

The lesson is that in reality (instead of the fantasy land that follows from some instances of how the Supreme Court's patent eligibility jurisprudence has been applied), the existence of the can opener cannot be assumed (just as a proper assessment of patent eligibility cannot assume the existence of paternally derived cffDNA in maternal blood and thus anything that is done with this unknown natural phenomenon cannot be "conventional."  In this regard the brief cites Justice Stevens' notion in dissent in Diehr that "a natural law (or phenomenon) should be 'treated for § 101 purposes as though it were a familiar part of the prior art.'"  But that is not the law, as the amici point out, because the Diehr majority rejected this rhetorical flourish, stating that "[i]t was inappropriate to dissect the claims into old and new elements and then ignore the presence of the old elements in the analysis."  And while the brief does not connect the dots in this way, can't it correctly be said that what the Diehr majority feared from the dissenters' approach has come to pass under Mayo/Alice ("the dissenters' approach 'would, if carried to its extreme, make all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious'")?

These amici were represented by Michelle Umberger, Michael Osterhoff anf Dan Bagatell of Perkins Coie.

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA," September 16, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs. Today, we review the brief submitted by the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America.

In the brief's Statement of Interest, amicus BIO states that it is "the world's largest biotechnology trade association, with over 1,100 members worldwide involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products."  As for PhRMA, it is "a voluntary, nonprofit association representing the nation's leading research-based pharmaceutical and biotechnology companies," which companies "are dedicated to discovering medicines that enable patients to lead longer, healthier, and more productive lives."  Amici are filing this brief because they are "concerned that the development and commercialization of a range of biotechnologies will be impeded if this Court does not address the mounting uncertainty currently afflicting patentable subject matter jurisprudence."

The brief makes three arguments in favor of en banc reconsideration:  first, that the panel decision has "exacerbated uncertainty" on the question of the extent to which biotechnological innovation is patent eligible; second, that the Federal Circuit should "clarify the contours" of the framework enunciated by the Supreme Court in its Mayo decision; and third, that there is a need for the Federal Circuit to provide a "coherent articulation of the policy basis for the patent eligibility requirement" in the first place, "consistent with the overarching objectives of the patent system.

Regarding the first argument, the brief notes that the growth of the biotechnology industry in America was spurred by the expansive reading of patent eligibility provided by the Diamond v. Chakrabarty decision (447 U.S. 303 (1980)), but reminds the en banc Court that more recent Supreme Court decisions have been interpreted by the Patent Office and inferior courts in such a way that there is "a level of uncertainty about the scope of patent-eligible subject matter that is unprecedented in the history of biotechnology."  In addition to this change in longstanding policy, the brief notes that America's "trading partners are growing concerned about a widening U.S. departure from internationally prevailing standards for patent eligibility of at least some biotechnologies" due to how these decisions are being interpreted.  This is particularly true in the Patent Office, where "[w]ith each new PTO guidance, biotech companies have observed an increasing rate of claim rejections" for inventions comprising inter alia "novel antibiotic molecules, industrial enzymes, diagnostic processes, and crop protection products."  This uncertainty has spilled over to the courts, where "[e]ven if a biotechnology firm succeeds in overcoming a rejection on patent-eligibility grounds in the PTO, the unsettled state of the law creates doubt about whether such issued patents would withstand challenge."  Indeed, the brief argues that the "vast majority" of decisions have resulted in patent invalidation on subject matter eligibility grounds, citing the Office's own "July 2015 Update: Subject Matter Eligibility" report, where twenty-two of twenty-four subject matter eligibility decisions before the Federal Circuit resulted in all claims being deemed patent ineligible (thankfully, not all of which are for biotechnology or pharmaceutical inventions).  This situation amounts to a "dark cloud overshadowing thousands of [] biotechnology patents," with a resulting disruption of expectations for past investors and a chilling effect on the attractiveness of investment in future inventions.  The brief cites former Chief Judge Rader's dissent in In re Bilski, for his point that investors can and will put their money into inventions more certain than the "discovery of 'scientific relationships' within the body that diagnose breast cancer or Lou Gehrig's disease or Parkinson's []."  545 F.3d 943, 1014 (Fed. Cir. 2008).

The brief then turns to the root source of the problem, the need for the Federal Circuit (in the first instance; it is Pollyannaish to think this story will end anywhere other than the Supreme Court) to clarify what the High Court meant in setting out the analytical framework in Mayo as "explained" in Alice v. CLS Bank.  These amici argue that the very nature of the test indicates that the Court expected the first step to perform a "meaningful gatekeeping function," and that the panel "missed an opportunity to clarify if and how this gatekeeping function operates in biotechnology."  The brief cites the panel's infamous rationale that the claims are "directed to detecting the presence of a naturally occurring thing or natural phenomenon" as satisfying step I of the Mayo/Alice test, arguing that "it is difficult to see how any analytical or detection method would ever not satisfy Step I, so long as that method is designed to detect something that occurs naturally."  This "uncritical" assessment renders Step I "superfluous for a vast array of technologies," including of course diagnostic method claims but "also forensic, geological or atmospheric testing, petrochemical or metallurgical analysis, and even radioisotope dating in archaeology."  And the distinctions fostered by the panel's application of the Supreme Court's precedents makes no sense, the brief contrasting detecting "man-made toxic contaminants in drinking water" (putatively patent eligible) from "waterborne natural pathogens" (which would not be).  The brief also warns of the negative effects the panel's ruling would have on personalized medicine, because this technology "inherently rel[ies] on the detection or evaluation of a patient-specific trait, or on a patient's physiological response to a treatment," which of course would be considered to be "directed to" a natural phenomenon according to the panel's "uncritical or undifferentiated application of Step I."

The panel's decision does not fare any better with regard to Step II of the Mayo/Alice test according to these amici.  The brief maintains that the panel confused "the interplay of analysis for 'inventive concept' and 'preemption,'" because these two concepts "are not connected" and "threaten to drive the development of patent eligibility doctrine in different directions."  This argument is illustrated by an example of how applying a biological natural phenomenon may be "the only practical use of the phenomenon apparent at the time of invention" and thus being completely preemptive, despite the existence of an inventive concept.  On the other hand, the brief asks whether avoiding preemption by including conventional steps should remove the need for an inventive concept.

Regarding how the panel interpreted "Inventive concept" is "likewise problematic" according to these amici.  They point out that it will frequently be the case that just those types of inventions that have advanced biotechnology can be readily "deconstructed into a mere combination of natural phenomena and known techniques" as the panel did to Sequenom's claims.  They point out that these types of inventions "translate nascent technology into commercial products that provide meaningful benefits to society."  But frequently the clinical tests that are the basis for diagnostics, while being "extremely important innovations" "generally involve the use of conventional techniques" (such as those in Sequenom's claims, "polymerase chain reaction (PCR) and electrophoresis" for amplifying and analyzing DNA.  It makes "good sense" to develop reliable diagnostic tests using these methods, but in the context of recent case law (including this case) the amici argue that courts "could generally preclude patent eligibility for diagnostic tests simply because the most practical means for administering the tests involves the use of conventional techniques."

The brief perhaps gives the Mayo Court too much credit for being concerned with saving "meritorious" inventions in the way the decision did not reverse Diamond v. Diehr; according to the amici "the Supreme Court apparently assumed the existence of limiting principles that would maintain patent eligibility for truly meritorious inventions."  (It is at least equally likely that the Court was willing to sacrifice such inventions regardless of their merit provided that inventions the Court considered ineligible were precluded from patentability.)  Nevertheless, the brief discerns in the Mayo opinion a consideration that the Mayo Court acknowledged an inventive concept in the Diehr claims based on the objectives of patent law wherein "that when these objectives are satisfied, a claim reciting the application of an excluded law of nature with conventional and well-known process steps can be patent eligible."  And the lack of preemption in the Diehr claims noted by the Mayo Court was "given short shrift" by the panel, another source of its analytical error.

The conclusion of this section of the brief puts the lie to the specious suggestion that diagnostic method claims that recite "some new methodology for analyzing DNA" as a way to avoid the purported subject matter eligibility deficiencies found by the panel.  This suggestion ignores the commercial realities that such claims would be of little value, say these amici, because they would "permit competitors to perform equivalent diagnostic tests using conventional methodology without any liability."

In its boldest pronouncement, the brief states that:

En banc reconsideration would allow this court to address the nature of the limiting principles suggested in Mayo.  Alternatively, if this court finds that Supreme Court precedent does not provide for limiting principles that provide a meaningful opportunity for patenting important biotechnology innovations, that would suggest a need for the Supreme Court to readdress the contours of patent eligibility in the context of biotechnology.  This case would be an appropriate vehicle to alert the Supreme Court to the urgent need for this clarification.

And the brief concludes by reminding the Court that precisely those claims Judge Bryson identified as being patent eligible alternatives to the diagnostic method claims the District Court found were patent ineligible (the Supreme Court noting these alternatives with approval in its Myriad decision) were later declared ineligible on subject matter grounds in University of Utah Research Foundation v. Ambry Genetics Corp., 774 F.3d 755 (Fed. Cir. 2014).

These amici were represented by Li Westerlund of Bavarian Nordic Inc. and Christopher M. Holman of Hovey Williams LLP and the University of Missouri-Kansas City School of Law.

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.," September 15, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.

By Kevin E. Noonan --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Today, we review the brief submitted by Amarantus Bioscience Holdings, Personalis, Inc., and Population Diagnostics, Inc.

In the brief's Statement of Interest, the amici state that they are companies that "discover and provide diagnostic tests that use exomes, genomes, and genetic biomarkers" and that their "ability [] to attract investment and to continue operations depends on ensuring that claims to such tests recite patentable subject matter."  From its website, Amarantus is "a publicly traded biotechnology company focused on developing therapeutic products with the potential for orphan drug designation in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, and diagnostics in neurology."  Personalis describes itself as a company that "provides researchers and clinicians accurate DNA sequencing and interpretation of human exomes and genomes" and that "support[s] researchers engaging in case-control, family-based, or proband-only genomic studies of disease, pharmacogenomics, and cancer."  The Population Diagnostics website characterizes the company's activities as "accelerating the delivery of personalized medicine diagnostic and therapeutic products to enable safe, low-cost, and more effective healthcare for patients."

The brief argues that the panel decision deprives the district courts and the U.S. Patent and Trademark Office of the guidance it should get from the Federal Circuit.  According to the brief, the Supreme Court has consistently held that claims must be considered as a whole, and that not doing so (which the brief contends was the flaw in the panel's decision) leads to "arbitrary and inconsistent results."  Specifically, the brief states that the Federal Circuit, as "the only Federal appeals court for patents" has an opportunity that it should not forego to provide "workable" guidance in properly applying § 101 of the Patent Act.  Such guidance should promulgate "a flexible, workable framework" within prevailing Supreme Court precedent, particularly under Mayo v. Prometheus and Alice v. CLS Bank.  And such guidance, according to these amici, rests on the principle that "claims be construed as a whole before validity is determined."

In this regard, the brief interprets the Supreme Court's language in setting forth the framework in the Alice case as requiring the "claims as a whole" analysis.  This standard finds support in the brief in language from Parker v. Flook and Diamond v. Diehr (an argument with some force, in view of the diametrically opposed precedential history of these cases).  The advantage of performing the Alice analysis based on the claims as a whole, according to these amici, is that it "produces a flexible, workable analysis that allows for fact-driven, nuanced decisions of patent-subject matter eligibility [by e]mploying ordinary claim construction."

Failure to perform the Alice analysis based on considering the claims as a whole, in contrast, results in a "lack of consistency" that the amici urge the Court to cure en banc.  The consequences of this lack of predictability harms "parties trying to obtain and defend good patents, harms parties trying to invalidate bad patents, and harms innovation in large technology sectors including personalized medicine, diagnostics, and software."  The brief mentions the relaxation of the standard of requiring claim construction as set forth in the Court's en banc decision in In re Bilski to a more recent panel decision eschewing this requirement in Bancorp Servs., L.L.C. v. Sun Life Assurance Co., 687 F.3d 1266, 1273 (Fed. Cir. 2012).  But "[u]ntethering claim validity from claim construction leaves the courts (and the USPTO) without any predictable constraints on how the determination will be conducted," the amici argue.  And as a consequence, the panel in this case (as well as the panel in the Bancorp case and perhaps others) have contravened the statute (35 U.S.C. § 112(b)) and prior precedent (In re Hiniker, 150 F.3d 1362, 1369 (Fed. Cir. 1998)) in adopting this relaxed standard of performing the § 101 analysis without considering the claims as a whole.

As a result, the amici argue, the courts and PTO have improperly applied the first step in the Alice framework, wherein rather than determining whether the claims are "directed to" a judicial exception to patent eligibility instead they have merely determined whether an exception is present in the claim.  This argument is supported by a quote from the panel decision in this case, where the amici argue the panel improperly applied the Alice test at least with regard to claim 25; specifically comparing:

[T]he asserted claims of the '540 patent are directed to a multistep method that starts with cffDNA . . . a naturally occurring non-cellular fetal DNA that circulates freely in the blood stream of a pregnant woman.  See, e.g., '540 patent claims 1, 24, 25. . . .  The method ends with paternally inherited cffDNA, which is also a natural phenomenon.  The method therefore begins and ends with a natural phenomenon.  Thus, the claims are directed to matter that is naturally occurring.  Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1376 (Fed. Cir. 2015).

with the claim language:

[M]ethod for performing a prenatal diagnosis on a maternal blood sample [comprising] . . . [A] obtaining a non-cellular fraction of the blood sample [B] amplifying a paternally inherited nucleic acid from the non-cellular fraction and [C] performing nucleic acid analysis on the amplified nucleic acid to detect paternablly inhereited fetal nucleic acid [italics in the brief].

From this the amici contend that "[c]learly, claim 25 includes in it numerous limitations, i.e., [A]-[C], that do not start and end with the same product," in support of their argument that the panel misapplied the Alice framework in arriving at its conclusion of patent ineligibility for Sequenom's claims.  The panel's misapplication of the test "opens a Pandora's box" because it "abstracts the claimed invention to a general concept in a way that is unprecedented for claim construction."

These amici further argue that the Federal Circuit has "addressed similar improper abstraction" in other areas of patent law and focused its analysis on the claims and specification.  In this section, the brief makes an analogy with how the Federal Circuit has applied the obviousness analysis in design patent law, where the Court has prohibited just the type of abstraction the amici find the panel employed in this case.  Here, in contrast, the brief asserts that the panel has succumbed to "excessive abstraction" in applying the analytical framework set forth in Alice with regard to the first prong of the analysis, and in doing so has rendered the second step a "foregone conclusion."

The amici then provide their views on the proper application of the patent eligibility analysis:

To avoid untethered abstraction, courts and the USPTO should consider: (i) the claims as a whole, (ii) in light of the specification, (iii) from the perspective of a skilled artisan, as well as (iv) the problem being solved by, (v) and the state of the art at the time of, the claimed invention.

The brief concludes with a discussion of the practical effects of this abstraction regarding the first step of the Alice test, wherein the search for the elusive "something more" in Justice Breyer's Mayo opinion permits courts and the PTO to dismiss affirmatively recited claim limitations as being "merely conventional" (as occurred in both the District Court and panel decisions in this case).  Here the brief contrasts the way the panel applied these steps in Sequenom's claims with how the panel (using the same framework) could have (or rather, would have) applied the Alice test to the claims in the Diehr opinion.  And as other amici have done, the consequence is that this panel would have declared the Diehr claims to be patent ineligible, in clear contradiction of the Supreme Court's decision that Diehr's claims recited patent-eligible subject matter.

These amici were represented by Maya Skubatch, Richard Torczon, Charles J. Andres, Jr. and Gideon A. Schor, Wilson Sonsini Goodrich & Rosati.

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine," September 14, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Coalition for 21st Century Medicine

By Donald Zuhn --

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted claims of U.S. Patent No. 6,258,540 (see "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)").  Last month, Sequenom filed a petition for rehearing en banc, arguing that the panel's decision in June was inconsistent with the Supreme Court's decisions in Diamond v. Diehr, 450 U.S. 175 (1981), Mayo v. Prometheus Laboratories, 132 S. Ct. 1289 (2012), and Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013, and that the panel's decision poses a threat to patent protection in multiple fields of invention.  On August 27, twelve amicus curiae briefs were filed in support of Sequenom's petition for rehearing en banc.  Over the next few weeks, Patent Docs will examine these amicus briefs.  Today, we review the brief submitted by the Coalition for 21st Century Medicine.

In its brief, the Coalition describes itself as an organization "represent[ing] more than two dozen of the world's most renowned molecular diagnostic companies, clinical laboratories, and patient advocacy groups, as well as researchers, physicians, and venture capitalists involved in the industry, all of whom agree that continuous diagnostic innovation is essential to help patients and healthcare professionals make better, more informed treatment decisions and continue to improve patient outcomes."  A list of the Coalition's members can be found here.

The Coalition's brief begins by declaring that "[r]ecent panel decisions issued by this Court have improperly expanded the scope of the Supreme Court's narrow holdings in the life sciences to exclude entire categories of invention from patent eligibility, injected an element of arbitrariness into patent examination, and made it nearly impossible for stakeholders to enforce thousands of issued claims."  The brief then presents three arguments for the Federal Circuit to grant Sequenom's petition for rehearing en banc.

The Coalition first argues that the Federal Circuit should grant en banc review of the Ariosa panel decision "to prevent expansion of the Supreme Court's narrow holdings under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), and Mayo Collaborative Servs. v. Prometheus Labs, 132 S. Ct. 1289 (2012)," stating that recent panel decisions by the Court "have improperly extended Mayo and Myriad to exclude entire categories of invention from patent eligibility."  Noting that the U.S. Patent and Trademark Office has taken its cue from the Federal Circuit and "has in turn interpreted those panel decisions expansively in its guidance for the examining corps," and that the Office's guidance has been "again over-extended by individual examiners to arbitrarily reject claims to subject matter that would have been patent eligible under the original narrow Supreme Court holdings," the Coalition contends that "[t]he en banc Federal Circuit holds the pivotal position in this spiral of ineligibility."

With regard to its second argument for granting Sequenom's petition, the Coalition states that recent Supreme Court case law excludes relatively little subject matter from eligibility under § 101.  The brief argues that the Federal Circuit's approach to subject matter eligibility "should be guided -- as it once was -- by the simple principle that a patent claim is presumptively eligible for patenting under §101 unless the plain language of the statute or binding precedent clearly excludes it," stating that "[a] careful reading of the Supreme Court's recent decisions on patent eligibility in the life sciences shows that the scope of subject matter excluded by each is quite modest."  The Coalition then briefly examines what it contends were the Supreme Court's narrow holdings of Mayo and Myriad, arguing that "a faithful reading of Mayo leads to the conclusion that a process comprises patent eligible subject matter provided it differs in at least one material element from what was routine, conventional and well-understood in the art," and explaining that the Myriad Court "went out of its way to emphasize the limited extent of the subject matter it excluded from patent eligibility in the final sentence of the opinion" (which states "[w]e merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material").

The Coalition closes the brief by arguing that the Ariosa panel decision exemplifies the improper expansion of the Supreme Court's narrow holding in Mayo.  With regard to this argument, the brief first asserts that the Ariosa panel failed to correctly define the subject matter of the claims at issue in that case, stating that:

Sequenom neither invented nor sought to claim cffDNA.  Nor did Sequenom seek to preempt all methods of testing cffDNA, or even all methods of testing cffDNA in maternal blood.

The brief next asserts that the Ariosa panel wrongly suggested that diagnostic claims are prima facie patent ineligible, arguing that:

This troubling expansion of Mayo sets a dangerous precedent for the precision medicine industry in particular because a typical diagnostic test begins by "detecting a natural phenomenon."  If allowed to stand, this newly-minted expansion of Mayo would potentially render all diagnostic inventions prima facie patent ineligible and subject them to the vagaries of the subjective "significantly more" inquiry that the PTO has struggled to apply consistently.

The Coalition suggests that "[t]he opinion's failure to mention Diamond v. Diehr, 450 U.S. 175 (1981), further shows a willingness to expand Myriad and Mayo to exclude ever more inventions."  The brief finally asserts that the Ariosa panel improperly conflated the patent eligibility test of Mayo with a traditional obviousness analysis.  The Coalition concludes the final section of its brief by "urg[ing] the full Court to unequivocally reject this aspect of the majority's opinion and clarify that Mayo sets forth at most a §102-like eligibility analysis limited to what was routine, conventional and well-understood at the time of filing" (emphasis in original).

For additional information regarding this topic, please see:

• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: IPO," September 8, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: Professors Lefstin and Menell," September 6, 2015
• "Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: 23 Law Professors," September 3, 2015
• "Amici Support Sequenom's Petition for Rehearing En Banc," August 28, 2015
• "Sequenom Requests Rehearing En Banc," August 18, 2015
• "Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015), June 22, 2015

Court Report

        By Sherri Oslick --

About Court Report:  Each week we will report briefly on recently filed biotech and pharma cases.

Senju Pharmaceutical Co. et al. v. Watson Laboratories, Inc. et al.
1:15-cv-05591; filed July 16, 2015 in the District Court of New Jersey

• Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb Inc.; Bausch & Lomb Pharma Holdings Corp.
• Defendants:  Watson Laboratories, Inc.; Actavis, Inc.; Actavis Pharma, Inc.

Infringement of U.S. Patent Nos. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012), 8,669,290 (same title, issued March 1, 2014), 8,754,131 (same title, issued June 17, 2014), 8,871,813 (same title, issued October 28, 2014), and 8,927,606 (same title, issued January 6, 2015) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

Gilead Sciences, Inc. et al. v. Sigmapharm Laboratories, LLC
2:15-cv-03950; filed July 16, 2015 in the Eastern District of Pennsylvania

• Plaintiffs:  Gilead Sciences, Inc.; Royalty Pharma Collection Trust
• Defendant:  Sigmapharm Laboratories, LLC

Infringement of U.S. Patent No. RE42,462 ("Carboxylic Acid Derivatives, Their Preparation and Use," issued June 14, 2011) following a Paragraph IV certification as part of Signmapharm's filing of an ANDA to manufacture a generic version of Gilead's Letairis® (ambrisentan, used to treat pulmonary arterial hypertension).  View the complaint here.

Celgene Corporation et al. v. Teva Pharmaceuticals USA, Inc.
1:15-cv-00589; filed July 10, 2015 in the District Court of Delaware

• Plaintiffs:  Celgene Corporation; Astellas Pharma, Inc.
• Defendant:  Teva Pharmaceuticals USA, Inc.

Infringement of U.S. Patent Nos. 7,608,280 ("Method of Producing FR901228," issued October 27, 2009) and 7,611,724 (same title, issued November 3, 2009) following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of Celgene's Istodax® (romidepsin for injection, used to treatment of peripheral and cutaneous T-cell lymphoma).  View the complaint here.

Eli Lilly and Company v. Mylan Laboratories Ltd. et al.
1:15-cv-01083; filed July 10, 2015 in the Southern District of Indiana

• Plaintiff:  Eli Lilly and Company
• Defendants:  Mylan Laboratories Ltd.; Mylan Inc.; Mylan Pharmaceuticals Inc.

Infringement of U.S. Patent No. 7,772,209 ("Novel Antifolate Combination Therapies," issued August 10, 2010) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Lilly's Alimta® (pemetrexed for injection, used to treat malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer).  View the complaint here.

Eli Lilly and Company et al. v. Lupin Pharmaceuticals, Inc. et al.
1:15-cv-00877; filed July 9, 2015 in the Eastern District of Virginia

• Plaintiffs:  Eli Lilly and Company; Eli Lilly Exports S.A.; Acrux DDS Pty Ltd.
• Defendants:  Lupin Pharmaceuticals, Inc.; Lupin Ltd.

Infringement of U.S. Patent Nos. 8,435,944 ("Method and Composition for Transdermal Drug Delivery," issued May 7, 2013), 8,419,307 ("Spreading Implement," issued April 16, 2013), 8,177,449 (same title, issued May 15, 2012), 8,807,861 (same title, issued August 19, 2014), and 8,993,520 ("Method and Composition for Transdermal Drug Delivery," issued March 31, 2015) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of Eli Lilly's Axiron® (testosterone metered transdermal solution, used to treat males for conditions associated with a deficiency or absence of endogenous testosterone).  View the complaint here.

Conference & CLE Calendar

September 14, 2015 - Biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting (U.S. Patent and Trademark Office)

September 15-17, 2015 - World IP Forum (Intellectual Professionals LLP) - Bangkok, Thailand

September 17, 2015 - "Professional Negligence: Real-Life Case Studies in IP Malpractice & How to Avoid Them" (American Intellectual Property Law Association) - 12:30 - 2:00 pm (Eastern)

September 17, 2015 - "Post-Grant Patent Opposition in Europe and the U.S." (The Knowledge Group) - 12:00 to 2:00 pm (ET)

September 17, 2015 - "New Litigation Scenarios after Akamai: Fact Pattern Hypotheticals" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

September 18, 2015 - IP & Diagnostics Symposium (Biotechnology Industry Organization) - Alexandria, VA

September 18, 2015 - Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) - San Francisco, CA

September 22, 2015 - "The Evolving World of Biosimilars Litigation" (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 am to 11:15 am (CT)

September 22, 2015 - "Advanced Conflict Waivers: How to Avoid Unpleasant Surprises" (Intellectual Property Owners Association) - 2:00 to 3:00 pm (ET)

September 23, 2015 - "Pharma Leaders IP Conference" (J A Kemp) - London

September 24, 2015 - "Trade Secrets and Cybersecurity: Protecting Intellectual Property, Mitigating Loss and Navigating Legal Responses" (Strafford) - 1:00 to 2:30 pm (EDT)

September 24, 2015 - "Patent Term Adjustments and Extensions: Leveraging Recent Decisions and USPTO Rule Changes" (Strafford) - 1:00 to 2:30 pm (EDT)

September 24, 2015 - "IP Licensing:  Implications & Best Practices in Light of Brulotte [Kimble v. Marvel]" (American Intellectual Property Law Association)

September 24-25, 2015 - Advanced Patent Law Seminar (Chisum Patent Academy) - Washington, DC

September 24-25, 2015 - Seminar on European Patent Law (Grünecker) - Munich, Germany

September 27-29, 2015 - 43rd Annual Meeting (Intellectual Property Owners Association) - Chicago, IL

September 30 to October 1, 2015 - Paragraph IV Disputes master symposium (American Conference Institute) - Chicago, IL

September 30 to October 1, 2015 - FDA Boot Camp (American Conference Institute) - Boston, MA

October 2, 2015 - Developments in Pharmaceutical and Biotech Patent Law 2015 (Practising Law Institute) - New York, NY

***Patent Docs is a media partner of this conference or CLE

IPO Webinar on Advanced Conflict Waivers

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Advanced Conflict Waivers: How to Avoid Unpleasant Surprises" on September 22, 2015 from 2:00 to 3:00 pm (ET).  Lisa Dolak, University of Syracuse School of Law; Jennifer Johnson of DuPont; and Daniel Tabak of Cohen & Gresser will discuss the enforceability of advance waiver conflict waivers, including a recent case from the Western District of Pennsylvania, in which a law firm was enjoined from representing a company that had launched an unfriendly takeover bid for another of the firm's clients, despite the existence of an advance waiver between the law firm and the target company.

The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

Webcast on Post-Grant Patent Opposition

The Knowledge Group will offer a live webcast entitled "Post-Grant Patent Opposition in Europe and the U.S." on September 17, 2015 from 12:00 to 2:00 pm (ET).  Christopher P. Carroll of Ropes & Gray LLP; Heather M. Petruzzi of WilmerHale; Michael T. Siekman of Wolf Greenfield; Richard F. Giunta of Wolf Greenfield; Eugene T. Perez of Birch, Stewart, Kolasch & Birch, LLP; Claus Elmeros of HØIBERG A/S; and Sander van Rijnswou, PhD, LLB of DeltaPatents will review the grounds for Post-Grant Patent Opposition in Europe and the U.S. and discuss how they differ from those in Europe.  The panel will also discuss how discovery and expert testimony affect the opposition, and strategies counsel use to optimize post-grant patent oppositions in Europe and the U.S.  The panel will cover the following issues:

• America Invents Act (AIA)
• European Patent Convention (EPC)
• Post-grant Patent Oppositions
• Patent Litigation
    -- European Proceedings
    -- U.S. Proceedings
• Primary similarities
• Primary differences
• Timelines
• Consistency Across Jurisdictions
• Post-grant Opposition Protection

The registration fee for the webcast is $299 to $349 (regular rate) or $149 (government/nonprofit rate).  Those interested in registering for the webinar can do so here.

AIPLA CLE Program on IP Licensing

The American Intellectual Property Law Association (AIPLA) will be offering a webinar on "IP Licensing:  Implications & Best Practices in Light of Brulotte [Kimble v. Marvel]" on September 24, 2015.  The Program includes a simultaneous in-person and live video conference, originating from Washington, DC, with remote sites in Boston, New York, and Palo Alto.  Courtenay Brinckerhoff of Foley & Lardner, LLP; Ronald J. Kamis of Prismatic Law Group, PLLC; Mita Mukherjee, Senior Corporate Counsel, MedImmune, LLC; and Kimberly J. Wade of Freeman Wade, LLP will discuss the case law leading up to the Kimble v. Marvel decision, the decision itself, what royalty strategies to pursue, as well as what remedies are available post Kimble v. Marvel.

The registration fee for the program is $35 (includes lunch or breakfast).  Those interested in registering for the program, can do so here.

IPO Webinar on Litigation Scenarios after Akamai

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "New Litigation Scenarios after Akamai: Fact Pattern Hypotheticals" on September 17, 2015 from 2:00 to 3:00 pm (ET).  Paul Berghoff of McDonnell Boehnen Hulbert & Berghoff LLP, Andrei Iancu of Irell & Manella LLP, and Steve Moore of Kilpatrick Townsend & Stockton LLP will discuss the Federal Circuit's August 13 en banc decision in Akamai Technologies Inc. v. Limelight Networks, Inc.

The registration fee for the webinar is $130 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

Amgen v. Sandoz Update -- En Banc Rehearing Petitions Filed

By Andrew Williams --

On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act ("BPCIA"). As we reported at the time, the decision from the three judge panel was seriously fractured, with an outcome that would make neither party happy.  Not surprisingly, therefore, on August 20, 2015, both Amgen and Sandoz filed petitions for an en banc rehearing.  Amgen, of course, argued that the disclosure provisions of the BPCIA required that Sandoz supply a copy of its biosimilar application within 20 days after its application was accepted for review by the FDA.  Sandoz, in turn, argued that the BPCIA does not require waiting until the FDA approves the biosimilar application before 180-day notice has to be provided.  In essence, Sandoz argued, the Court's decision resulted in an improper extension of exclusivity by six months.  And, in turn, on September 8, 2015, both parties filed responses, explained how the three-judge panel got its part of the case correct.

In addition to that briefing, three amicus curiae briefs were either filed, or requested to be filed -- all of which supported the Sandoz petition.  These briefs were submitted by (1) the Biosimilars Council, a division of the Generic Pharmaceutical Association ("GPhA"), (2) Mylan Inc, and (3) Hospira, Inc. and Celltrion.

The one issue that all of the parties agreed upon was that it is appropriate for en banc rehearing to occur at this time.  This was due in part to the fractured nature of the decision, and because this case was a matter of first impression.  In addition, as Amgen put it, this case was one "of critical importance to the biopharmaceutical industry."  Therefore, "to help guide this developing industry," Amgen asserted that the full Court should rehear the decision now.  Sandoz highlighted the fact that if the fragmented panel decision were to be left unreviewed, "the ruling would delay access by patients to all biosimilars . . . ."  Because "[e]ach panel member had a different interpretation of this important statute," Sandoz continued, the full Court should weigh in to prevent "the fragmented interpretation [from binding] industry, district courts, and subsequent panels of this Court."  And, Hospira pointed out that en banc review was required now because "resolving this case will establish the competitive framework that governs the biosimilars industry."

Amgen, naturally, focused on the rehearing the outcome of the disclosure and exchange provisions of the BPCIA.  Amgen explained the balance that Congress attempted to create by allowing biosimilar applicants to rely on the approval data obtained by the innovator company, on the one hand, and protecting the public's interest in innovation by requiring the disclosure of information necessary to determine whether patent infringement has or will occur on the other hand.  In fact, Amgen identified five ways in which Congress made clear that the disclosure provisions were mandatory.  First, Congress tied the applicant's choice of the biosimilar "(k)" pathway to providing the requisite information (like the aBLA application) to the reference product sponsor by its use of the word "shall":  "When a subsection (k) applicant submits an application under subsection (k), such applicant shall provide . . . the information required to be produced pursuant to" the BPCIA.  Second, Congress used the mandatory word "shall."  Third, Congress demonstrated its ability to use non-mandatory language elsewhere.  Fourth, in several other places in the statute, Congress referred to the aBLA and manufacturing information as the "required" information.  And fifth, Congress included manufacturing-process patents in the dispute-resolution regime (in other words, the type of information that is supposed to be discussed).  This is, of course, in contradistinction to the Hatch Waxman scheme, which does not provide for the assertion of such patents prior to launch.

Most of the substance of Amgen briefing, however, focused on the remedy.  This is likely because the panel appeared to agree in principle in the opinion that the "shall" provision was mandatory.  However, because the statute appeared to already include a remedy (the ability to bring a patent infringement suit), the majority held that this was the sole remedy.  Therefore, the Court found that it was not possible to compel compliance with this section, recover damages, or otherwise seek relief.  Amgen also addressed the wording of newly added 35 U.S.C. § 271(e)(2)(C)(ii), which appears to define the act of infringement in such cases.  Amgen argued to the contrary, asserting that this section of the Patent Act determines the "scope" of infringement -- that under this section, the reference product sponsor is free to bring an infringement suit with regard to any patent that could have been identified during the "patent dance."  This was not meant to be the only remedy, however, according to Amgen.

Sandoz, in turn, explained why the Court's holding with regard to the 180-day notice provision was incorrect.  The problem, according to Sandoz, was that by requiring approval of the application before notice can be provided necessarily increases the exclusivity period from 12 years to 12 ½ years.  The excuse that the Congress established the 180 days to allow the reference product sponsor time to seek a preliminary injunction was unconvincing to Sandoz.  This goal does not require that notice be "post-approval," but instead is accomplished simply by giving notice prior to marketing.  And allowing notice to be pre-approval does not subvert the larger role that this provision is supposed to play, according Sandoz, in lifting the "stay" on artificial-infringement declaratory judgement suits.  Of course, Sandoz ignores the fact that this advantage is illusory for reference product sponsors in cases such as this one, where the biosimilar application was not provided.  In these cases, the reference product sponsor can already bring a declaratory judgment infringement suit as the statutory remedy (although only for patents claiming the biological product or a use thereof).  Therefore, very little is gained by the reference product sponsor if notice can be provided pre-approval.  Because of this, if a biosimilar applicant chooses to withhold its application, it has little disincentive to giving notice of commercial marketing on the day the application is accepted by the FDA.

We will continue to monitor this case and report on any decision by the Court.