Patent Docs

Webinar on Patent Reissue Process

Strafford will be offering a webinar/teleconference entitled "Strategic Use of Patent Reissue After the AIA -- Correcting Errors in Patents, Determining Whether and When to Pursue a Reissue Application, and Mastering the Recapture Rule" on October 31, 2013 from 1:00 to 2:30 pm (EDT).  Thomas L. Irving of Finnegan Henderson Farabow Garrett & Dunner; Donna M. Meuth, Senior Patent Counsel, Intellectual Property for Eisai, Andover; Erika H. Arner of Finnegan Henderson Farabow Garrett & Dunner; and Deborah M. Herzfeld of Finnegan Henderson Farabow Garrett & Dunner will discuss the America Invents Act's (AIA) impact on the patent reissue process, the pros and cons of using reissue to correct patent errors, the rule against recapture, and the effect on reissue.  The webinar will review the following questions:

• What factors should be considered when determining whether to start the reissue process?
• What are the implications of the AIA changes for patent reissue?
• What are the risks and limitations of using reissue proceedings to resolve patent validity issues?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by October 4, 2013 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

IPO Webinar on Inducing Infringement

The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "Inducing Infringement: Latest Developments" on September 26, 2013 beginning at 2:00 pm (ET).  A panel consisting of Eric Weisblatt of Wiley Rein LLP, Ted Sichelman of the University of San Diego Law School, and Joseph Kirincich of Avaya will consider the following questions:

• What has been the impact of Global-Tech v. SEB so far at district courts?
• Have plaintiffs been able to meet the higher bar of "willful blindness" to prove inducement?
• How have successful plaintiffs overcome the higher bar?
• What is both the immediate and long-term effect on patent litigation of Commil's holding about a good faith belief in invalidity?  For instance, were the jury instructions wrong in many cases since SEB and will some defendants attempt to have those cases retried?
• Should corporations revert to getting an opinion of counsel about invalidity upon receipt of letter of notice alerting them to possible infringement, reversing the trend toward "doing without" that was set in motion by the Federal Circuit's 2007 Seagate opinion on the standard for willfulness?
• What are best practices for opinion letters now?

The registration fee for the webinar is $120 (government and academic rates are available upon request).  Those interested in registering for the webinar can do so here.

Webinar on IP Due Diligence

Strafford will be offering a webinar/teleconference entitled "IP Due Diligence in M&A Transactions -- Conducting IP Investigations and Leveraging Results During Deal Negotiations" on October 29, 2013 from 1:00 to 2:30 pm (EDT).  Carey C. Jordan of McDermott Will & Emery and Jeffrey A. Wolfson of Haynes Boone will provide guidance to counsel conducting intellectual property (IP) due diligence for merger and acquisition (M&A) deals, and outline best practices for conducting the IP investigation and leveraging investigation results in negotiating pricing and other deal terms.  The webinar will review the following questions:

• What are the best approaches for counsel to identify the IP assets to review during due diligence?
• How should counsel address IP ownership questions that arise during due diligence?
• What impact will the America Invents Act have on the due diligence process?
• How can counsel leverage information obtained during the due diligence process in deal negotiations?

The registration fee for the webinar is $297 ($362 for registration and CLE processing).  Those registering by October 4, 2013 will receive a $50 discount.  Those interested in registering for the webinar, can do so here.

Webinar on Patent Trolls

Technology Transfer Tactics will be offering a webinar entitled "Patent 'Trolls' Under Fire: Strategies, Tactics and Legislation Impacting University Patents & Licensing" on October 22, 2013 from 1:00 to 2:00 pm (Eastern).  Scott A. McKeown and Kevin B. Laurence of Oblon Spivak will cover the following topics:

• The latest on anti-troll initiatives, including executive orders, proposed legislation, and USPTO actions;
• AIA's impact on patent assertion and patent valuation;
• How anti-troll initiatives will affect licensing activity;
• Why and how software-related patents may need rethinking and careful claim drafting;
• How Vermont's passage of an anti-troll bill may resonate nationwide;
• Dealing with new post-grant challenges to your patents;
• How Nebraska's warning on patent assertion affected frivolous infringement claims;
• The optimal response to a troll's demand letter;
• How your own patent assertion decisions and strategies may be impacted;
• Initial assessment of troll infringement claims;
• Counterclaiming based on Unfair Trade Practices;
• Changing standards for functional claims;
• Assessing other options for counterattack; and
• When does a university cross the line into patent assertion territory.

The registration fee for the webinar is $197.  Those interested in registering for the webinar, can do so here.

Defendants' Response to Myriad's Preliminary Injunction Motions

Myriad Genetics v. Ambry Genetics Corp. and Myriad Genetics v. Gene By Gene Ltd.

By Kevin E. Noonan --

Last month, Ambry Genetics and Gene By Gene responded to Myriad's motion for preliminary injunction in a 109 page brief that sets out its invalidity case as well as the basis for its antitrust counterclaims.  Supported by declarations from numerous luminaries and illuminaries in the gene patenting debate (including several of the individual plaintiffs in the Myriad case, and anti-gene patenting economist and Nobel Prize winner Joseph Stiglitz), the brief makes its points good and bad in an exhaustive fashion.  Not surprisingly, the brief focuses on the Supreme Court's decision in the AMP v. Myriad Genetics case, categorical exclusion being the easiest and most direct for the defendants to prevail.  The brief also alleges invalidity for anticipation or obviousness and non-infringement, as well as challenging Myriad's claims of irreparable harm, the balance of the hardships and the public interest, the latter based on the generic testing being "critical to patient care" (indeed, as in AMP, the intuitively persuasive argument is that patients will benefit, regardless of the evidence for or against that proposition).

The brief leads with its most compelling argument:  that the Supreme Court's Myriad decision drew the patent eligibility line at whether a claimed DNA molecule had the same sequence as the molecule as it is found in nature, not whether the molecule was synthesized in the laboratory (the latter argument was persuasive to Judge Moore at the Federal Circuit).  Less so is their reading of the applicability of the Court's Mayo decision, which defendants' argue invalidate Myriad's claims because the steps of amplifying and sequencing DNA was "well-understood, routine and conventional."  While certainly not yet settled, Myriad's method claims are expressly outside the Supreme Court's Myriad decision and could fall within the scope of "applications" of the determination of the BRCA gene sequences the Court seemed to view with considerably more favor that the genomic DNA claims in the Myriad decision.

The brief challenges Myriad even as to the statement of facts, in enumerated fashion and asserts its own Statement of Facts, supported by several declarations by putative experts.  Many of these facts reconstruct the development of genetic diagnostic testing in the early 1990's, purporting that such testing was "widely used" and that the genetic variation in the BRCA genes was known prior to Myriad's patents (providing part of the factual bases for defendants' invalidity contentions).  Additional facts include mapping studies that located the BRCA 1 and BRCA 2 genes to within 2-6 centiMorgans of chromosome-specific markers.  (The speciousness of this argument is illustrated by the following graphic illustrating imperfectly the differences in scale between kilobases and centiMorgans):

Interestingly, Gene By Gene's factual statement is framed in what the company "intends" to do, rather than is actually doing with regard to BRCA testing.  The defendants also assert so-called "equitable" factual considerations regarding harm to them if enjoined, the fact that Myriad has not sued other putative providers, and that many patients "who want BRCA 1/2 testing cannot afford Myriad's BRCA 1/2 test price," and that Myriad's tests do not identify up to 10% of (rearrangement) mutations (begging the question of whether Myriad's asserted claims encompass such testing).  And the brief cites San Francisco geneticist Robert Nussbaum regarding Myriad's proprietary genetic mutation database to support its argument that Myriad's frequency of variant of unknown significance cannot be verified.

Defendants' legal arguments regarding Myriad's asserted composition of matter (probes and primer) claims start (and could end) with the Supreme Court's Myriad decision as the underpinnings of their argument that Myriad is not likely to prevail on the merits.  Defendants' interpretation of the Supreme Court's Myriad decision (if correct, which it likely is) is dispositive:

If the DNA primer nucleotide sequence created in the lab corresponds to a natural DNA nucleotide sequence, then it is an unpatentable product of nature under Myriad.

Defendants cite portions of the specifications of the patents-in-suit as well as Myriad's arguments before the District Court, Federal Circuit, and Supreme Court to establish the distinction between natural and non-naturally occurring DNA, with genomic DNA and oligonucleotide primers in the former category and cDNA in the latter category.  Under this analysis, the primers and probes recited in Myriad's asserted composition of matter claims fall within the scope of patent-ineligible subject matter according to the Supreme Court's Myriad decision.  In this way, defendants argue that claims 29 and 30 of the '492 patent and claims 16 and 17 of the '282 patent are invalid as being directed to patent-ineligible subject matter (albeit based on one of the more strikingly inaccurate quotes from the Court's Myriad decision, no doubt being one of the factors that prompted Justice Scalia's concurrence).  Unfortunately, the brief also reiterates the Court's misjudgment regarding the significance of the informational content of the primers as being dispositive, which might be compelling if the genetic information was itself either patent eligible or patented.

Turning to the method claims, defendants' arguments focus on the Court's Mayo v. Prometheus decision, in a manner that ignores portions of the Myriad decision that arguably distinguish Mayo from Myriad's asserted method claims.  According to defendants, Myriad's method claims are patent-ineligible for reciting a law of nature using only "well-understood, routine and conventional methods," specifically PCR amplification and nucleotide sequencing.  In defendants' view, they are merely an "artifice of patent drafting" (proving if nothing else that Supreme Court Justices should avoid dicta illustrating their prejudices more than illuminating the law), arguing that as dependent claims from method claims invalidated by the District Court and Federal Circuit (and not reviewed by the Supreme Court), these claims are also patent ineligible.  Defendants analogize the BRCA genes with previously unknown laws of nature, which are then analyzed using "well-understood, routine and conventional" PCR and sequencing methods.  Where this analysis falls apart, of course, is that the subject matter of the Mayo claims was in all aspects "well-understood, routine and conventional."  Here, the "law of nature" is that some mutations are associated with disease and others are not; the distinction with the Mayo claims is that the isolated BRCA genes themselves were not in the prior art, in contrast with the step of administering 6-thioguanine to Crohn's disease patients.  And there is no support for the proposition that, because the isolated BRCA genes themselves are not patent-eligible the method for determining a risk of disease by detecting certain mutations would not be.  Importantly, the Supreme Court suggested that these types of claims may be patent eligible precisely because Myriad was the first to identify the BRCA genes:

[T]his case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes.  Judge Bryson aptly noted that, "[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims [including the ones asserted in Myriad's complaint against Ambry and Gene By Gene] are limited to such applications."

It is also relevant that defendants attempt to bootstrap the District Court decision on claims arguably much broader and less specific than the now-asserted claims against Myriad, which would reward defendants for the AMP plaintiffs' strategic decision not to include these claims in its complaint.

Defendants also argue that Myriad's asserted composition of matter claims are invalid under §§ 102, 103 and/or 112.  Regarding § 102, defendants first assert particular priority dates for specific claims based on the presence of specific disclosure in various applications in the priority chain of Myriad's asserted patents.  Defendants then assert prior art, available at these several dates, in support of their anticipation arguments.  None of this art discloses isolated human chromosomal DNA within the scope of the patent claims, i.e., that were sufficiently circumscribed in the vicinity of the BRCA genes that would have permitted the genes to be sequenced with the technology available in the 1992-1996 time frame.  And indeed, the BRCA genes were not; ironically, one of the arguments asserted against Myriad in other contexts is that Myriad was not the first to isolate the BRCA 2 gene and that there is some question about its priority over Mary Claire King's lab regarding the BRCA 1 gene.  However, because the asserted claims recite primers that amplify "all or a portion" of the BRCA 1 gene, some of these allegations are sufficiently specific regarding disclosure of primers for chromosome 17 markers that turned out to be portions of the BRCA genes that they may support a determination that Myriad has not shown a likelihood of success on the merits with regard to the assertion of these claims.  In this regard, the arguments for the BRCA 1 claims are more likely to be persuasive than the arguments for the BRCA 2 claims, insofar as the primers for the chromosome 13 marker disclosed in the prior art are located entirely within an intron.

Defendants direct their obviousness attack under § 103 to Myriad's method claims.  Here, the argument is that the amplifying and sequencing steps would have been obvious as a solution to the problem of identifying disease-associated BRCA 1 and BRCA 2 gene mutations.  The obviousness of the BRCA genes is indicated by the knowledge in the art that there were genes on chromosomes 13 and 17 associated by genetic linkage analysis with a higher risk of developing ovarian and breast cancer, respectively.  Finding the genes amounted to nothing more than "tedious, but straightforward [] mapping of human traits," according to plaintiffs.  Most of this argument is precatory in nature "[h]aving stood on the shoulders of giants, Plaintiffs sought to claim the kingdom," and defendants reiterate their mantra of "using well-understood, routine and conventional" methods to isolate BRCA genomic DNA.  This is not the test, however; indeed, the argument runs contrary to the express language of the statute, wherein "[p]atentability shall not be negatived by the manner in which an invention is made."  The conventionality vel non of the methods would certainly be relevant for claims to methods of isolating BRCA gene DNA, but the methods themselves are irrelevant to the non-obviousness of the genes themselves.  (It is amusing that defendants contend that "[t]he sizable investment by Plaintiffs' corporate partners and the federal government evidences (sic) Plaintiff's reasonable expectation of success in isolating the BRCA genes.")  And In re Kubin is not to the contrary (despite defendants' argument), insofar as the facts in that case involved a next generation of cDNA (not genomic) cloning and had the benefit of specific antibodies to the gene product not present for the BRCA genes.  Having asserted the obviousness of the genes themselves, defendants then assert that the methods claimed by Myriad would also have been obvious (again equated with the "well-understood, routine and conventional").

With regard to certain claims (including claim 5 of the '721 patent) defendants argue that the existence in the prior art of methods that detected variants in the BRCA1 gene not associated with disease renders obvious claims directed to variants that are associated with disease, "because it would have been obvious to identify additional polymorphisms."  And Myriad's own '282 patent is cites as § 102(e) prior art in asserting some of these obviousness arguments.  Whatever else can be said about this litigation, it is clear that Myriad's claims will get a full assessment of their patentability under the substantive portions of the patent statute.

Finally, defendants argue that certain of Myriad's asserted patent claims (including claim 7 of the '282 patent and claim 30 of the '492 patent) are invalid under § 112 for indefiniteness for being insolubly ambiguous with regard to amplification of exons and introns.  Claim 4 of the '155 patent is asserted to be invalid for failure to satisfy the written description requirement (by reciting only variants that do not lead to an increase susceptibility for cancer).

Turning to non-infringement, defendants allege that Myriad has not "pinpointed specific evidence" to support infringement of its asserted composition of matter claims, characterizing Myriad's assertions as "speculations" regarding defendants' allegedly infringing activities.  Defendants argue, for example, that the composition claim term that the primers are "derived from" or "isolated from" the human BRCA genes to mean "wholly derived from" (of "wholly isolated from") and thus the presence of heterologous sequences in Ambry's and Gene By Gene's primers place their methods outside the scope of literal infringement.  Regarding the method claims, defendants argue that there is a similar lack of specificity regarding evidence of infringement.  And insofar as Myriad's claims are directed to analyzing mRNA or cDNA (as in claim 8 of the '441 patent and claim 4 of the '857 patent), defendants argue that neither one of them determines BRCA gene sequences from that source, and in other instances (claim 5 of the '721 patent and claims 2 and 4 of the '155 patent) defendants argue that they don't "compare patient sequences to contiguous cDNA sequences."  In their most interesting argument, defendants assert that they do not infringe because "they do not use or intend to use probes specific for any known variations of BRCA1 that predispose a patient to certain cancers," "[t]hat is, the probes that Ambry and Gene by Gene uses or will use will only identify BRCA1 and are not specific for any particular allele, as required by the claim."

In the final portion of the brief, defendants turn to the other requirements for obtaining a preliminary injunction:  irreparable harm, the balance of the hardships tipping in favor of Myriad, and the public interest.  The irreparable harm argument emphasizes Myriad's position as a "monopolist" and the amount of money Myriad has made (and cites Myriad's Dr. Skolnick's unfortunate interview with a POV journalist enshrined in the documentary film "In the Family").  Defendants also cite the institutional inertia attendant upon Myriad's agreements with insurance companies and other providers that are not capable of shifting providers quickly (although the price difference could certainly be expected to do so, and slow adoption has not been the case with other examples, such as generic replacement of patented drugs).  Defendants emphasize the benefits their lower priced tests confer on patients, and the possibility of "meaningful second opinion testing" (emphasis in brief).  Defendants challenge Myriad's assertion of the risk of "reputational" harm, and further argue that Myriad's "inconsistent" enforcement of its patents (Myriad allegedly is permitting "at least five other laboratories" to provide BRCA gene testing) mitigates against its allegations of "irreparable harm."  The balance of the hardships, according to defendants is not with Myriad, due to its profits over the past 17 years, but with Ambry and Gene By Gene, who will lose the "first mover" advantage of their early entry into the market and Ambry's $46.7 million investment (an argument undercut by their earlier argument that "at least five other laboratories" are providing BRCA gene testing).

Defendants of course emphasize the public interest in this "life-saving technology":

This is precisely the kind of case where consideration of the public interest compels denial of injunctive relief.  Indeed, courts have rejected injunctive relief on public interest grounds where removal of the accused product or process could have serious consequences on public heath -- even when the patentee has satisfied its burden as to the other factors.  See, e.g., Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446, 1458 (Fed. Cir. 1988).

This argument is followed by statistics on the number of women at risk of breast cancer and the number who are expected to die from the disease.

Somewhat curiously, defendants argue that the Court should deny the injunction because doctors and patients prefer their testing over Myriad's (despite their earlier contention that Gene By Gene is not yet offering the test).  The basis for this "preference" is that Ambry and Gene By Gene will offer "multi-gene" testing, which defendants characterize as "comprehensive testing."  In their final argument, defendants assert that Myriad does not offer "transparency, access and affordability" in its testing, which defendants will offer to the public's benefit.

Unfortunately, the brief ends with citations to arguments that Myriad's patents have harmed innovation because they have "blocked important follow on scientific research, hindered collaborative data collection and sharing, halted patient screenings at cancer diagnostic facilities, and prevented others from developing and/or offering additional, alternative, and more affordable technologies."  The bases for at least some of these arguments are that Myriad enforced its patents against academic medicine that intended to charge its patients, activities clearly constituting infringement.  And these assertions fly in the face of the more than 10,000 scientific research papers on the BRCA genes while Myriad's patents have been in force.

Myriad has replied, and that brief will be the subject of a future post.

The War on Patent Trolls -- Congress Prepares for Battle

By Andrew Williams --

In case it was not clear that Congress is serious about combatting the perceived problem of "patent trolls," Sen. Patrick Leahy (Vermont) and Sen. Mike Lee (Utah) published an opinion piece this week on the POLITICO.com website, which is now entitled "America's Patent Problem."  Both Senators are members of the Senate Judiciary Committee, chaired by Sen. Leahy (at right), the committee which has jurisdiction over patents, copyrights, and trademarks.  The article started from the premise that there are patent holders that are abusing the system, and that this abuse has resulted in a drag on the economy.  The example of "patent misuse" that the article highlighted is a patent holder that insists that Wi-Fi routers infringe its patents.  Sen. Leahy and Sen. Lee (below) took the position that, even if this patent holder's infringement allegations are legitimate, it should only be allowed to sue the companies that make and sell the routers, not the small businesses that are using these routers.  But, the small business examples to which the authors pointed included "hotels or small coffee shops" -- entities which others have referred to as "end-users" of the technology.  It is hard to believe, though, that these small businesses are using these routers for non-commercial purposes.  Even if the "hotels and coffee shops" don't charge their customers for the use of the Wi-Fi, it is almost certain that they seek to attract customers with the service.  More importantly, a patent holder's rights are not limited to preventing the making and selling of a patented product.  Instead, 35 U.S.C. § 271(a) provides that "whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent" (emphasis added).  Thus, it is unclear what the justification is for excluding such "end-users" in this case, especially when the "end-users" is more likely than not using this technology for commercial purposes.  The Senators did not provide an answer.

To be fair, we are not taking any position on the merits of the case to which this example refers.  Indeed, the Senators themselves did not provide any specifics; for example, no parties or patent numbers are cited.  Instead, Senators Leahy and Lee focused on the fact that certain patent holders are targeting small businesses for the sole reason that the cost of settling can be far less than defending against a lawsuit.  This may be true.  However, it is difficult to distinguish between such alleged tactics and the licensing efforts of "legitimate patent holders."  Instead, the authors concluded (without much explanation) that "this misuse of the patent system" does not belong to "the patent system provided for in our Constitution."

But is this true?  Not if an article that appeared on the Forbes website on Tuesday is to be believed.  Former undersecretary of commerce and director of the U.S Patent and Trademark Office Jon Dudas (at right), and author of the book "Rembrandts in the Attic," David Kline, wrote a piece entitled "Thank the Founding Fathers for the Open Market in Patents."  Contrary to the sentiment expressed by Senators Leahy and Lee, and almost every report in the mainstream press, Mr. Dudas and Mr. Kline (below) explained that the founding fathers not only anticipated non-practicing entities, they encouraged them.  Of course, these are the same founding fathers that provided for a patent system in the Constitution, and helped to draft that first patent act.  The authors pointed out that the young American economy needed a kick-start because, at that time, "the U.S. had a lower standard of living than many South American countries."  The founders looked to the British patent system, but according to Bowdoin College historian Zorina Khan, this system had high fees ("11 times the per capita income of the average citizen") and a working requirement (they had to practice the invention).  The article continued by citing the work of historians Naomi Lamoreaux from Yale and the late Kenneth Sokoloff of UCLA, who explained that the founders wanted to design a system that would "stimulate the inventive genius and entrepreneurial energy of the common man," even if such individuals could not commercialize their own inventions.  They accomplished this by instituting fees much lower than in Britain, not imposing a working requirement, and by expressly allowing the sale and licensing of patent rights.  The article continued to cite the work of professors Lamoreaux and Sokoloff, who explained that new intermediaries (think non-practicing entities) "'lowered the transaction costs and improved the efficiency' of the trade in and commercialization of patented technology."  Mr. Dudas and Mr. Kline concluded that this system, which is currently embodied by universities and industry NPEs, has sparked many new products and businesses over years.

Mr. Dudas and Mr. Kline warned, therefore, that not all non-practicing entities should be lumped together into the designation of "Patent Troll."  Nevertheless, this appears to be exactly what Congress is doing.  Senators Leahy and Lee explained that their committee is working "on a bipartisan basis" to address this so-called Patent Troll problem.  In addition, they are coordinating with the Representative Bob Goodlatte, chairman of the House Judiciary Committee.  The stated goal for this legislation is to "make it harder for bad actors to succeed, while preserving what has made America's patent system great."  Of course, that is easier said than done, and the difficulty is narrowly crafting such legislation to specifically address the perceived problem without also ensnaring all of the so-call "legitimate patent holders," or without introducing unexpected negative consequences for the patent system as a whole.  Some of the suggested legislation includes increasing transparency of patent ownership, protecting the end-users when the manufacturers should be the real defendants, and improving the process for reviewing patents at the Patent Office (although it is unclear why Sen. Leahy did not mention the post-issuance review procedures of the Leahy-Smith America Invents Act in his article).  We have previously reported on some of the proposed legislation, and we will continue monitor and report on the activity of Congress.  It is likely that with so much momentum and apparent public support, there will probably be some sort of bill passed in the next year or so.  We can only hope that in doing so, Congress does not toss out the proverbial baby with the bathwater.

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

• "The GAO Issues a Report on Patent Litigation Trends -- It Turns Out that the Sky Is Not Falling," August 29, 2013
• "New Patent Litigation Bill Introduced in House," July 16, 2013
• "Congress Continues Efforts to "Reform" U.S. Patent Law," June 10, 2013
• ""When the Patent System is Attacked!" -- The White House Task Force on High-Tech Patent Issues," June 4, 2013
• "The More the Merrier: The Journal Joins the Times in Complaining about Patents," April 20, 2011
• "In Defense of Patents (And Even Their "Trolls")," Fenruary 21, 2007

USPTO Expands and Extends Patent Prosecution Highway Programs

By Donald Zuhn --

USPTO Implements PPH 2.0 Programs with NRIP and DKPTO

On September 12, the U.S. Patent and Trademark Office announced the implementation of a Patent Prosecution Highway (PPH) 2.0 program with the Nicaraguan Registry of Intellectual Property (NRIP).  On May 1, the USPTO also announced the implementation of a PPH 2.0 program with the Danish Patent and Trademark Office (DKPTO).  The implementation of the PPH 2.0 programs with the NRIP, which commenced on September 5, 2013 and will run indefinitely, and the DKPTO, which commenced on June 3, 2013 and will run indefinitely, brings the number of PPH 2.0 participating offices to fifteen, including the USPTO, Canadian Intellectual Property Office (CIPO), Danish Patent and Trademark Office (DKPTO), European Patent Office (EPO), German Patent and Trade Mark Office (DPMA), Japan Patent Office (JPO), Intellectual Property Office of the Philippines (IPOPHL), IP Australia (IPAU), Korean Intellectual Property Office (KIPO), National Board of Patents and Registration of Finland (NBPR), Portugal National Institute of Industrial Property (INPI-PT), Federal Service on Intellectual Property, Patents & Trademarks of Russia (ROSPATENT), Spanish Patent and Trademark Office (SPTO), and United Kingdom Intellectual Property Office (UKIPO).

In order to participate in any of the PPH 2.0 programs in the USPTO, applicants must satisfy the following requirements:

1.  One of the other PPH 2.0 participating offices has determined that at least one claim is allowable/patentable (under the PPH 2.0 program, applicants no longer need to submit a copy of the allowed claim or any English translation thereof).

2.  The application before the PPH 2.0 participating office (i.e., containing the allowable/patentable claim) and the U.S. application for which participation in the PPH 2.0 program is being requested must have the same priority/filing date.

3.  All claims on file, as originally filed, or as amended in the U.S. application must sufficiently correspond to one or more of the claims indicated as allowable in the application filed in the PPH 2.0 participating office (the USPTO notice states that "[a] claim is considered to 'sufficiently correspond' where, accounting for differences due to translations and claim format, the claim in the U.S. application is of the same or similar scope as a claim indicated as allowable in the application filed in the PPH 2.0 participating office").  Under the PPH 2.0 program, applicants must submit a claims correspondence table (in English), indicating how all the claims in the U.S. application correspond to the allowable/patentable claims in the application filed in the PPH 2.0 participating office.

4.  Examination of the U.S. application for which participation in the PPH 2.0 program is being requested has not yet begun.

5.  The applicant has filed a request to participate in the PPH 2.0 program.

6.  The applicant must submit a copy of the office action issued just prior to the "Decision to Grant a Patent" (along with an English translation, which may be a machine translation) for the application before the PPH 2.0 participating office (under the PPH 2.0 program, applicants no longer need to submit a statement that the English translation is accurate).

7.  The applicant must submit an information disclosure statement listing all documents cited in the office action of the PPH 2.0 participating office.

8.  All of the documents described above must be filed via the EFS-Web and indexed using the document description:  "Petition to make special under Patent Pros Hwy."

Additional information regarding the PPH 2.0 program with NRIP can be found here.

USPTO Continues PPH Programs with IPOCZ, ILPO, and PRV

On September 11, the U.S. Patent and Trademark Office announced the continuation of a patent prosecution highway (PPH) pilot program and a PPH pilot program based on Patent Cooperation Treaty (PCT) work products (PCT-PPH) with the Industrial Property Office of the Czech Republic (IPOCZ).  The USPTO-IPOCZ PPH permits an applicant having an application whose claims have been allowed in the IPOCZ to fast track the examination of an application in the USPTO, such that the latter application is examined out of turn.  In particular, an applicant receiving a ruling from the IPOCZ that at least one claim in an application is patentable may request that the USPTO fast track the examination of corresponding claims in the corresponding application in that office.  Under the PCT-PPH pilot program, an applicant receiving a written opinion or international preliminary examination report in a PCT application that indicates at least one claim in the PCT application has novelty, inventive step, and industrial applicability, where the USPTO was the International Searching Authority or the International Preliminary Examining Authority, may request that the IPOCZ fast track the examination of corresponding claims in an application filed with the IPOCZ.  Both pilot programs have been extended indefinitely.

On August 1, the USPTO announced the continuation of a PCT-PPH pilot program with the Israel Patent Office (ILPO).  On June 1, the USPTO also announced the continuation of a PCT-PPH pilot program with the Swedish Patent and Registration Office (PRV).  Both PCT-PPH pilot programs have been extended indefinitely.

The USPTO currently has twenty-five PPH programs (full or pilot) in place with IP Australia (IP AU), the Austrian Patent Office (APO), the Canadian Intellectual Property Office (CIPO), China's State Intellectual Property Office (SIPO), the Colombian Superintendence of Industry and Commerce (SIC), the Industrial Property Office of the Czech Republic (IPOCZ), the Danish Patent and Trademark Office (DKPTO), the European Patent Office (EPO), the National Board of Patents and Registration of Finland (NBPR), the German Patent and Trade Mark Office (DPMA), the Hungarian Intellectual Property Office (HIPO), the Icelandic Patent Office (IPO), the Israel Patent Office (ILPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the Mexican Institute of Industrial Property (IMPI), the Nicaraguan Registry of Intellectual Property (NRIP), the Norwegian Industrial Property Office (NIPO), the Intellectual Property Office of the Philippines (IPOPHL), the Portugal National Institute of Industrial Property (INPI-PT), the Russian Federal Service for Intellectual Property, Patents and Trademarks (ROSPATENT), the Intellectual Property Office of Singapore (IPOS), the Spanish Patent and Trademark Office (SPTO), the Taiwan Intellectual Property Office (TIPO), and the United Kingdom Intellectual Property Office (UK IPO).  The USPTO has also established thirteen PCT-PPH programs with other patent offices:  IP AU, APO, CIPO, SIPO, IPOCZ, EPO, NBPR, ILPO, JPO, KIPO, the Nordic Patent Institute (NPI), ROSPATENT, SPTO, and the Swedish Patent and Registration Office (PRV).  Additional information regarding the various PPH and PCT-PPH programs, as well as links to the appropriate request forms to be used for each program, can be found here.

USPTO Implements PCT-PPH with CIPO

On May 17, the U.S. Patent and Trademark Office announced that it was establishing a PCT-PPH pilot program with the Canadian Intellectual Property Office (CIPO).  Under the new pilot program, which went into effect on January 31, an applicant receiving a written opinion or international preliminary examination report in a PCT application that indicates at least one claim in the PCT application has novelty, inventive step, and industrial applicability, where the USPTO or CIPO was the International Searching Authority or the International Preliminary Examining Authority, may request that the other office fast track the examination of corresponding claims in an application filed with that office.  The USPTO- CIPO PCT-PPH pilot program is scheduled to expire on January 30, 2015, but may be extended if necessary to adequately assess the feasibility of the program.

USPTO Establishes Permanent PCT-PPH Program with NBPR

Earlier this year, the U.S. Patent and Trademark Office announced that it was establishing a permanent PCT-PPH program with the National Board of Patents and Registration of Finland (NBPR), effective as of January 24, 2013.  In making the announcement, the USPTO noted that "[t]he results of the PCT-PPH pilot program showed that applicants have been able to expeditiously obtain a patent at an early stage by utilizing petition to make special procedures, based on claims in a corresponding PCT application that were found to have novelty, inventive step, and industrial applicability by either the USPTO or the NBPR acting as the International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA)," adding that "[t]he results of the PCT-PPH pilot program further show that the USPTO and the NBPR have been able to reduce duplication of search efforts by exploiting the search and examination results in PCT applications to the maximum extent practicable."

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)

By Kevin E. Noonan --

Last week, the Federal Circuit in a non-precedential opinion, invalidated claims to Orange Book-listed patents on omega-three fatty acid formulations in Pronova Biopharma Norge v. Teva Pharmaceuticals USA.  The grounds for reversing the District Court's finding that the defendant had not established invalidity under the public use statutory bar under 35 U.S.C. § 102(b) was based on the Court's determination that Pronova's predecessor in interest had permitted unrestricted use of formulations falling with the scope of the claims and disregarded Pronova's argument that public use was negated because there was insufficient evidence that the use was for the inventions' intended purpose.

The case concerned U.S. Patents Nos. 5,502,077 and 5,656,667 involved in ANDA litigation between Pronova and, in separate ANDAs, Teva and Par Pharmaceuticals, who propounded Paragraph IV letters contending that these patents were invalid and non-infringed by their generic formulations of the branded drug Lovaza®.  The drug comprised a formulation of certain omega-3 and omega-6 fatty acids derived from fish oils for prevention of heart disease and other cardiovascular ailments specifically, hypertriglyceridemia, based on evidence of native populations with diets high in fish.  The District Court found the patents infringed, not proven invalid by clear and convincing evidence, and not unenforceable for inequitable conduct.

The following claims were at issue for the '667 patent:

20. A pharmaceutical mixed-fatty-acids composition in which
    a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and
    b) (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of at least one percent by weight, [or] wherein at least 85% by weight of the composition is comprised of long chain omega-3 fatty acids, [or] wherein the EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes 25 to 45% by weight of the composition, [or] wherein C 20:4 omega-6 fatty acid constitutes at least one percent by weight of the composition, [or] wherein C 22:5 omega-3 fatty acid constitutes at least one percent by weight of the composition, [or] wherein the (all-Z omega-3) -6,9,12,15,18-heneicosapentaenoic acid is present in an amount of from 1 to 4% by weight, [and] wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.

44.  A pharmaceutical mixed-fatty-acids composition in which
    a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and
    b) at least 3% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms, [or] wherein the EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes 25 to 45% by weight of the composition, [or] wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1, and wherein the fatty acids are present in ethyl ester form.

50. A pharmaceutical mixed-fatty-acids composition in which
    a) at least 90% by weight of the composition is comprised of long chain, polyunsaturated, omega-3 fatty acids;
    b) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:1 to 2:1, with the EPA constituting 40 to 60% by weight of the composition and the DHA constituting 25 to 45% by weight of the composition;
    c) at least 4.5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms;
    d) from 1 to 4% by weight of the composition is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid; and
    e) the composition is in oral dosage form and includes an effective amount of a pharmaceutically acceptable antioxidant, wherein the fatty acids are present in ethyl ester form.

(where text in italics was recited in independent claims incorporated into the dependent claims) (claim 50 was asserted only against Teva).  Also in the litigation at the District Court was claim 9 of the '077 patent; however, this patent expired n March 2013 and the Federal Circuit thus did not react any issues regarding this patent.

The facts surrounding defendants' arguments for an invalidating public use involved transfer of samples of formulations falling within the scope of the asserted claims by Pronova' predecessor in interest in the patents, all of which occurred prior to the critical date of the '677 patent.  These transfers included samples sent to Dr. Victor Skrinska, with disclosure of the contents of the formulations, with no restrictions, confidentiality requirements, or obligations to report the results of any experiments performed using the formulations.  Dr. Skrinska analyzed the contents of the formulations but did not perform any testing on the clinical use or benefits of the formulations (although he did administer capsules of the formulation "to himself and others").  There were also three other instances of alleged public use:  to Dr. Peterson of General Mills; to Dr. Davis of the University of Colorado; and Dr. Nordoy of the University of Oregon.  The Federal Circuit's opinion states that "the distributions to Peterson and Davis were (1) unrestricted; (2) non-experimental; and (3) for purposes of generating interest in the product" and that Dr. Nordoy actually performed "an experimental bioavailability study" on the formulation.  The District Court held that there was insufficient evidence to rebut Pronova's argument that Dr. Nordoy's use was an exempted experimental use and that there was also insufficient evidence that Drs. Peterson or Davis had used the formulations for their intended purpose and thus did not constitute an invalidating public use.  And the District Court further held that Dr. Skrinska's use was not invalidating, "apparently [because the District Court agreed with Pronova] that an invalidating use of a pharmaceutical compound must be for the purposes identified in the patents-in-suit."  The District Court further "discredited" Dr. Skrinska's testimony in rejecting defendants' public use argument for invalidity.

In an opinion by Judge O'Malley, joined by Judges Dyk and Wallach, the Federal Circuit reversed as to the public use determination, and remanded with instructions that the District Court enter judgment in favor of defendants.  Assessing the Court's public use jurisprudence in light of relevant Supreme Court precedent, the panel agreed with defendants that "[a]n invalidating public use need not be the intended use of the invention disclosed or claimed in the patent as long as the invention is fully disclosed without restriction."  Under this precedent, the Court asserts that "either public accessibility or commercial exploitation" qualifies as public use, citing Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005).  The Invitrogen court also held that the Supreme Court's "ready for patenting" test (Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67–68 (1998)) applies to public use as well as the on-sale bar (and here, the Court says there is no question that the invention was ready for patenting at the time of the alleged instances of public use).

According to the panel, the standard for public use is where "a completed invention is used in public, without restriction," citing Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351, 1355 (Fed. Cir. 2013).  Public use can be negated where there exists disclosure under a confidentiality agreement or "similar expectations of secrecy," Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1379 (Fed. Cir. 2005), or where some but not all aspects of an invention are disclosed, citing W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1549 (Fed. Cir. 1983); Janssen Pharmaceutica, N.V. v. Eon Labs Mfg., Inc., 134 F. App'x 425, 431 (Fed. Cir. 2005) (all aspects of the invention must be disclosed).  The "seminal case" is Egbert v. Lippmann, 104 U.S. 333, 336 (1881) (the corset case), where the Court posed the essential question:  "[w]as the invention's use public in the sense that it was made available to others with no limitation or restriction?"  One measure of the extent to which the disclosure is confidential (as opposed to "public") is "the amount of control which the discloser retains over the invention during the uses in question," citing Lough v. Brunswick Corp., 86 F.3d 1113, 1121 (Fed. Cir. 1996) (insufficient control); Eolas Technologies Inc. v. Microsoft Corp., 399 F.3d 1325 (Fed. Cir. 2005) (unrestricted disclosure to employees); Beachcombers, International, Inc. v. Wildewood Creative Products, Inc., 31 F.3d 1154 (Fed. Cir. 1994) (unrestricted disclosure to party-goers); and Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 1265–67 (Fed. Cir. 1986) (inventor retained control of puzzle and information).  Finally, the panel cited the "sophistication of those to whom disclosure was made" as a factor in the extent to which a use is a public use.

Applying these principles, the panel held that the disclosure (by transfer of samples of the formulation) constituted an invalidating public use.  Factors supporting this determination were that the transfer contained no evidence of confidentiality restrictions and the fact that Pronova conceded there was no experimental use involved in this transfer.  The panel concluded that the transfer was "with no secrecy obligation or limitation for [Dr. Skrinska's] unfettered use" and that the shipment of the formulations "made public all aspects of the claimed inventions, since it included a certificate of analysis revealing the composition of the supplied products."  It was also undisputed that Dr. Skrinska was "one highly skilled in the art, with the full ability to know, understand, and fully disclose the invention to others" (and that there was evidence at trial that Dr. Skrinska had disclosed the information he had on the formulations with colleagues and "other members of the medical community" without restriction.  In sum (particularly with regard to Pronova's argument that Dr. Skrinska had not used the formulation for its intended use):

Where, as here . . . a compound is provided without restriction to one highly skilled in the art, that compound's formulation is disclosed in detail, and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one.  Once the formulation was disclosed in full to Skrinska, without any restriction on its use, it had been released into the "public domain" for purposes of § 102(b).

Pronova Biopharma Norge AS v. Teva Pharmaceuticals USA, Inc. (Fed Cir. 2013)
Nonprecedential disposition
Panel: Circuit Judges Dyk, O'Malley, and Wallach
Opinion by Circuit Judge O'Malley

Court Report

        By Sherri Oslick --

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

Roche Palo Alto LLC et al. v. Mylan Pharmaceuticals Inc.
1:13-cv-01532; filed September 4, 2013 in the District Court of Delaware

• Plaintiffs:  Roche Palo Alto LLC; Genentech Inc.
• Defendant:  Mylan Pharmaceuticals Inc.

Roche Palo Alto LLC et al. v. Watson Laboratories Inc. - Florida
1:13-cv-01533; filed September 4, 2013 in the District Court of Delaware

• Plaintiffs:  Roche Palo Alto LLC; Genentech Inc.
• Defendant:  Watson Laboratories Inc. – Florida

The complaints in these cases are substantially identical.  Infringement of U.S. Patent No. 6,083,953 ("2-(2-amino-1,6-dihydro-6-oxo-purin-9-yl)methoxy-1,3-propanediol Derivative," issued July 4, 2000) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Roche's Valcyte® (valganciclovir hydrochloride, used to treat cytomegalovirus retinitis and cytomegalovirus disease).  View the complaint here.

Gilead Sciences, Inc. v. Merck & Co, Inc. et al.
3:13-cv-04057; filed August 30, 2013 in the Northern District of California

• Plaintiff:  Gilead Sciences, Inc.
• Defendants:  Merck & Co, Inc.; Merck Sharp and Dohme Corp.; Isis Pharmaceuticals, Inc.

Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 7,105,499 ("Nucleoside Derivatives as Inhibitors of RNA-Dependent RNA Viral Polymerase," issued September 12, 2006) and 8,481,712 (same title, issued July 9, 2013) based on Gilead's anticipated marketing and sale of its sofosbuvir product for the treatment of Hepatitis C Virus.  View the complaint here.

Takeda Pharmaceuticals USA Inc. v. Par Pharmaceutical Companies Inc. et al.
1:13-cv-01524; filed August 30, 2013 in the District Court of Delaware

• Plaintiff:  Takeda Pharmaceuticals USA Inc.
• Defendants:  Par Pharmaceutical Companies Inc.; Par Pharmaceutical Inc.

Infringement of U.S Patent Nos. 7,906,519 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued March 15, 2011), 7,935,731 ("Methods for Concomitant Administration of Colchicine and Macrolide Antibiotics," issued May 11, 2011), 8,093,298 (same title, issued January 10, 2012), 7,964,648 ("Methods for Concomitant Administration of Colchicine and a Second Active Agent," issued June 21, 2011), and 8,093,297 (same title, issued January 10, 2012) following Par's filing of an ANDA to manufacture a generic version of Takeda's Colcrys® (single-ingredient colchicine product, used to treat Familial Mediterranean Fever).  View the complaint here.

Genzyme Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
1:13-cv-01506; filed August 29, 2013 in the District Court of Delaware

• Plaintiffs:  Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendants:  Dr. Reddy's Laboratories Ltd.; Dr. Reddy's Laboratories Inc.

Genzyme Corp. et al. v. Sandoz Inc.
1:13-cv-01507; filed August 29, 2013 in the District Court of Delaware

• Plaintiffs:  Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendant:  Sandoz Inc.

Genzyme Corp. et al. v. Teva Pharmaceuticals USA Inc.
1:13-cv-01508; filed August 29, 2013 in the District Court of Delaware

• Plaintiffs:  Genzyme Corp.; Sanofi-Aventis U.S. LLC
• Defendant:  Teva Pharmaceuticals USA Inc.

The complaints in these cases are substantially identical.  Infringement of U.S. Patent Nos. RE42,152 ("Aromatic-linked polyamine macrocyclic compounds with anti-HIV activity" issued February 15, 2011), 7,897,590 ("Methods to mobilize progenitor/stem cells" issued March 1, 2011), and 6,987,102 ("Methods to mobilize progenitor/stem cells" issued January 17, 2006) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Genzyme's Mozobil® (plerixafor solution for injection, used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma and multiple myeloma).  View the Dr. Reddy's complaint here.

Takeda Pharmaceutical Co. et al. v. Mylan Pharmaceuticals Inc. et al.
1:13-cv-00197; filed August 29, 2013 in the Northern District of West Virginia

• Plaintiffs:  Takeda Pharmaceutical Co.; Takeda Pharmaceuticals U.S.A., Inc.; Takeda Pharmaceuticals America, Inc.
• Defendants:  Mylan Pharmaceuticals Inc.; Mylan Inc.

Infringement of U.S. Patent Nos. U.S. Patent Nos. 6,462,058 ("Benzimidazole Compound Crystal," issued October 8, 2002), 6,664,276 (same title, issued December 16, 2003), 6,939,971 (same title, issued September 6, 2005), 7,285,668 ("Process for the Crystallization of (R)- or (S)-Lansoprazole," issued October 23, 2007), 7,790,755 ("Controlled Release Preparation," issued September 7, 2010), 8,173,158 ("Methods of Treating Gastrointestinal Disorders Independent of the Intake of Food," issued May 8, 2012), and 8,461,187 ("Multiple PPI Dosage Form," issued June 11, 2013) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Takeda's Dexilant® (dexlansoprazole, used for the treatment of all grades of erosive esophagitis, maintaining healing of esophagitis, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease).  View the complaint here.

Conference & CLE Calendar

September 15-17, 2013 - 41st IPO Annual Meeting (Intellectual Property Owners Association) - Boston, MA

September 16, 2013 - America Invents Act (AIA) Second Anniversary Forum (U.S. Patent and Trademark Office) - 1:00 to 5:00 pm (ET)

September 16, 2013 - The European Unitary Patent: Strategic Considerations for a New Era (McDonnell Boehnen Hulbert & Berghoff LLP & Nederlandsch Octrooibureau) - Chicago, IL

September 17-18, 2013 - FDA Boot Camp*** (American Conference Institute) - Boston, MA

September 18, 2013 - Conflicts in Patent Prosecution: Avoiding the Ethical Pitfalls Minimizing Risks of Malpractice Liability and Ethics Sanctions (Strafford) - 1:00 to 2:30 pm (EDT)

September 19, 2013 - Biosimilars and the BPCI Act: Where Are We Now and Where Are We Going? (American Bar Association (ABA) Section of Science and Technology, Section of Intellectual Property Law, and Center for Professional Development) - 2:00 to 3:30 pm (Eastern)

September 23-24, 2013 - International Congress on Paragraph IV Litigation*** (Momentum) - New York, NY

September 26, 2013 - Supreme Court IP Review (IIT Chicago-Kent College of Law) - Chicago, IL

October 1, 2013 - 2013 Intellectual Property Continuing Legal Education Seminar (DuPont and the Widener University School of Law) - Wilmington, DE

October 3, 2013 - Resolving IP Disputes: Calling for an Alternative Paradigm (University of Missouri School of Law's Center for the Study of Dispute Resolution and Journal of Dispute Resolution) - University of Missouri School of Law

October 3-4, 2013 - Paragraph IV Disputes*** (American Conference Institute) - Chicago, IL

October 9, 2013 - Biosimilars: Navigating FDA's Evolving Approval Pathway, Protecting Patents and Trade Secrets (Strafford) - 1:00 to 2:30 pm (EDT)

October 10, 2013 - Recent Judicial Decisions Impacting Technology Licensing (McDonnell Boehnen Hulbert & Berghoff LLP) - 10:00 to 11:15 am (CT)

October 15-17, 2013 - Business of Biosimilars*** (Institute for International Research) - Boston, MA

November 4-5, 2013 - FDA Boot Camp Devices Edition*** (American Conference Institute) - Chicago, IL

November 4-5, 2013 - Trade Secrets: Protecting Your Intellectual Capital and Confidential Business Information*** (American Conference Institute) - Chicago, IL

November 6-8, 2013 - 2013 Fall Intellectual Property Counsels Committee (IPCC) Conference (Biotechnology Industry Organization) - Washington, DC

November 17-20, 2013 - Creating and Leveraging Intellectual Property in Developing Countries: A Power Tool for Social and Economic Growth*** (Companies and IP Commission and National IP Management Office of South Africa) - Durban, South Africa

December 9-10, 2013 - Patent Infringement Litigation Summit (Legal iQ (IQPC)) - San Francisco, CA

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

News from Abroad: EPO Proposal Would Remove Time Limit for Divisional Filing

Editor's note: The following notice was reprinted with permission from Forresters.

Our August 2013 News item: "EPO divisional deadline U-turn in the offing..." seems prescient.  We now learn that the EPO has made formal proposals to remove the current two-year time limit for filing divisionals.

Instead, the EPO proposes that applicants can file divisionals (and divisionals from divisionals) for as long as the original application is pending.  The EPO also wants to increase the filing fee for second and subsequent generation divisionals.

The proposals aim for 1 April 2014 to formulate and introduce appropriate amended rules.  Under the current proposals, applicants with a pending application (not granted, refused or abandoned) on 1 April 2014, can use it as the basis for a divisional application, even if the current two year limit has expired.

We recommend that you identify currently pending European patent applications where the divisional due date has expired, or will do before 1 April 2014.  If you are still interested in filing a divisional from any of these, you should slow prosecution as much as you can.  There are techniques enabling you to draw out EPO procedures, and we would be pleased to advise you on those.

2013 BIO IPCC Fall Conference

The Biotechnology Industry Organization (BIO) will be holding its 2013 Fall Intellectual Property Counsels Committee (IPCC) Conference on November 6-8, 2013 in Washington, DC.

The conference will offer presentations on the following topics:

Wednesday, November 6:

• Inter Partes Review Strategy After a Year's Worth of Experience (Pre-Conference Workshop)

Thursday, November 7:

• Biosimilars War Games - Business and Regulatory Considerations
• Biosimilars War Games - Preparation for Litigation
• Patent Reform 2.0 -- The Next Wave (working luncheon)
• Cases to Watch
• The Honorable Judge Kathleen M. O'Malley, Circuit Judge, U.S. Court of Appeals for the Federal Circuit (keynote speaker)

Friday, November 8:

• Does Myriad Matter?
• Is There a New Paradigm for Indirect Infringement?

In addition, there will be a welcome reception at the Hotel Monaco from 5:30 pm to 7:30 pm on November 6, and an Odyssey Dinner Cruise from 5:30 pm to 10:00 pm on November 7.

A program agenda for this conference, including a list of speakers and descriptions of the presentations and events can be obtained here.

Registration information can be found here.  Additional information regarding the conference can be found at the conference website.

Patent Infringement Litigation Summit

Legal iQ (IQPC) will be holding a Patent Infringement Litigation Summit on December 9-10, 2013 in San Francisco, CA.  IQPC faculty will help attendees:

• Develop in-house expertise to facilitate smart decision-making at threshold moments and strong partnerships with outside counsel;
• Work with outside counsel in an efficient way to maximize results while minimizing cost;
• Empower your legal department with proactive strategies to reduce the unexpected workload burdens that come with patent litigation; and
• Influence and respond to changes in the patent reform landscape.

In particular, IQPC faculty will offer presentations on the following topics:

• Organizing the legal team: Effective strategies for finding the right counsel & establishing strong, efficient working relationships between in-house & outside counsel (focus session);
• Helping the judge & jury navigate complicated, technical cases to make well-informed decisions;
• Developing a customized in-house approach to handling patent infringement litigation: One size does not fit all;
• Negotiating & using alternative fee arrangements to achieve more cost certainty;
• Making sound business decisions: Considerations in evaluating whether to litigate or settle;
• Developing clear expectations & obligations within joint defense groups to maximize value & reduce redundancy;
• Navigating the new post-grant review landscape: How to use IPR successfully;
• Using the ITC's new program for early determination of potentially dispositive issues to limit unnecessary adjudication in complaints involving standard essential patents or NPEs;
• Strategies for early establishment of appropriate discovery limitations to avoid burdensome, costly, unnecessary discovery;
• Safely navigating the uncertain damages landscape;
• In-depth review of recent case law: What new developments mean for patent litigation practice;
• Managing your patent portfolio & developing an understanding of the patent landscape to avoid unexpected suits; and
• What you need to know about defensive patent aggregation & other proactive practices.

Two additional workshops will also be offered.  The first workshop, entitled "Working the Rules: A Sampling of the Procedures in the Most Litigated Jurisdiction," will be offered from 7:30 to 9:30 am on December 9, 2013.  The second workshop, entitled "Efficient Discovery Practices to Make the Process Less Cumbersome & Manage Costs" will be offered from 7:30 to 9:30 am on December 10, 2013.

An agenda for the conference can be found here (Day 1) and here (Day 2).  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee is $1,399 (conference alone), $549 (either workshop), or $1,899 (conference and both workshops).  Those registering by October 4, 2013 will receive a $400 discount off the conference alone or conference and both workshops, and those registering by November 8, 2013 will receive a $200 discount off the conference alone or conference and both workshops.  Those interested in registering for the conference can do so here.

Patent Docs is a media partner of the IQPC Patent Infringement Litigation Summit.

St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)

By Kevin E. Noonan --

The Federal Circuit revisited the extent of the safe harbor from the judicially created doctrine of obviousness-type double patenting carved out by 35 U.S.C. § 121 in St. Jude Medical, Inc. v. Access Closure Inc.  Unlike earlier decisions regarding whether continuation or continuation-in-part applications could benefit from the safe harbor, here the Court considered the effects of election-of-species requirements on whether there is consonance between claims in one patent over those on a related patent in which such a requirement is imposed.

The patents in suit, U.S. Patent No. 7,008,439 (Janzen patent; claims 7, 8 and 9); 5,275,616, and 5,716,375 (Fowler patents, claim 14 and claim 21, respectively), were directed to apparatus, methods, or both for sealing vascular puncture that arises, inter alia, when a vein or artery is punctured as part of a medical procedure, and provides an alternative to applying direct pressure to seal the wound.  Regarding the Janzen patent, three claims were asserted below and considered by the Court in its opinion:

U.S. Patent No. 7,008,439:

7.  A device for closing a puncture in a wall of an artery comprising: an elongated member having a distal end, said elongated member sized to be fitted through a passageway leading to said puncture so that said distal end is disposed near said puncture in said artery, separable plug means for plugging said puncture being disposed in said elongated member, movable guide means extending longitudinally through said elongated member and said plug means for extension through said puncture for guiding said plug means to said puncture, and means for ejecting said plug means from said distal end of said elongated member so as to place said plug means in blocking relation with said puncture, so as to seal said puncture [A device as claimed in claim 1], wherein said plug means includes an orifice therethrough, said guide means being disposed through said orifice, said orifice automatically closing when said guide means is removed therefrom.

8.  A device for closing a puncture in a wall of an artery comprising: an elongated member having a distal end, said elongated member sized to be fitted through a passageway leading to said puncture so that said distal end is disposed near said puncture in said artery, a separable plug member for plugging said puncture being disposed in said elongated member, a movable guide element extending longitudinally through said elongated member and said plug member for extension through said puncture for guiding said plug member to said puncture, and an ejecting mechanism for ejecting said plug member from said distal end of said elongated member so as to place said plug member in blocking relation with said puncture, so as to seal said puncture.

9.  A method of closing a puncture in a wall of an artery made for the purpose of moving an elongated cardiac catheter into the artery in which an exterior guide tube is extended through a passage leading to the puncture and through the puncture in the wall of the artery and into the artery so a to enable the catheter to be guidingly moved through the guide tube and into the artery, the method comprising the steps of: withdrawing the cardiac catheter and moving the guide tube outwardly so that it no longer extends within the puncture, extending a plug having a removable guide wire extending longitudinally therethrough so that the guide wire extends from the plug through said puncture, moving the plug inwardly along the guide wire into blocking relation with said puncture, and withdrawing the guide wire from the plug so as to leave the plug sealed in blocking relation with said puncture.

(where the italicized portion of claim 7 recites the limitations of claim 1 from which claim 7 is a dependent claim).

The following related patents are relevant to the double patenting issues before the Court:

• Grandparent application, USSN 07/746,339, now U.S. Patent No. 5,391,183
• Divisional application USSN 08/318,380, now U.S. Patent No. 5,830,130
• Continuation granted as Janzen patent, second continuation U.S. Patent 5,725,498

The U.S. Patent and Trademark Office imposed a restriction requirement in the '339 application ("the grandparent application), wherein Group I was directed to apparatus claims and Group II directed to method claims.  The Office also imposed an election-of-species requirement between Species A, B, and C:

• Species A:  Claims relating to the apparatus comprising a solid tissue dilator;
• Species B:  Claims relating to the apparatus comprising a hollow dilator and guidewire;
• Species C:  Claims relating to the apparatus comprising a guidewire and no dilator.

In the '339 application, the Applicant elected Group I, Species B, and claims to these embodiments granted in the '183 patent.  In the first divisional application (the '380 application), the examiner imposed a similar restriction requirement and applicant elected claims of Group I, Species B that granted in the '130 patent.  The '439 patent-in-suit (the Janzen application) contains claims to both Group I and Group II, each electing Species C.  And a second continuation (that granted as the '498 patent) contained claims to Group II but without election of any particular species.

The District Court held that the safe harbor provisions of 35 U.S.C. § 121 protected the claims of the Janzen patent from invalidity under obviousness-type double patenting.  The Federal Circuit reversed, in an opinion by Judge Plager, joined by Judges Lourie and Wallach, with a concurring opinion by Judge Lourie.

The Court reiterated its interpretation of the statute:

A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them if the divisional application is filed before the issuance of the patent on the other application.

(which it opined is "not a model of clarity") that what is required is "consonance," i.e., later-filed applications must conform to the "lines of demarcation" set up by a restriction requirement, citing Gerber Garment Tech., Inc. v. Lectra Sys., Inc., 916 F.2d 683, 688 (Fed. Cir. 1990).  It is not a violation of consonance if two or more non-elected inventions are pursued in a subsequent application, the Court noted, citing Boehringer Ingelheim Int'l GmbH v. Barr Labs, Inc., 592 F.3d 1340, 1350 (Fed. Cir. 2010), but "a divisional application filed as a result of a restriction requirement may not contain claims drawn to the invention set forth in the claims elected and prosecuted to patent in the parent application."

As the opinion sets out, the consonance requirement is applied to the patent "challenged for double patenting" as well as the reference patent.  And here, the panel states that consonance "requires that the challenged (Janzen) patent, the reference patent, and the patent in which the restriction requirement was imposed (the restricted patent, i.e. the '183 grandparent patent) do not claim any of the same inventions identified by the examiner.  In this case, the question of whether the requirement is fulfilled depends on the effect of the election of species requirement.  ACI contended below that the election was irrelevant to the consonance question, while St. Jude argued that the election of species must be considered in determining whether consonance was satisfied.  The Court held that not only was the election of species relevant but that the result of the combination of restriction and election was the identification of six separate, patentably distinct inventions:  Group I, Species A; Group I, Species B; Group I, Species C; Group II, Species A; Group II, Species B; and Group II, Species C.  Under this standard, the grandparent patent contained claims to one invention (Group I, Species C) and the Janzen patent contained claims to two other inventions (Group I, Species B and Group II, Species B).

The opinion notes the basis in the regulations for election of species requirements (37 C.F.R. § 1.146):

In the first action on an application containing a generic claim to a generic invention (genus) and claims to more than one patentably distinct species embraced thereby, the examiner may require the applicant in the reply to that action to elect a species of his or her invention to which his or her claim will be restricted if no claim to the genus is found to be allowable.

(emphasis added).

The key to the Court's decision in applying the statute in this instance is the italicized phrase "if no claim to the genus is found to be allowable," i.e., there is no generic claim in the grandparent application.  That is the case here, which results in the election of species being a restriction of the claims in the grandparent application for purposes of applying Section 121.  (The opinion notes that the restriction requirement in the grandparent application expressly stated the rule.)  This outcome is a rational one, according to the Court:

It makes logical sense that the election of species affected the line of demarcation when no claim was generic.  If the election of species did not affect the line, double patenting would have prevented the Janzen applicant from obtaining valid claims directed to non-elected species.  This result would be unfair since it was the examiner, not the applicant, who created the further division of the application with the election of species, and the examiner already stated on the record that the non-elected species were patentably distinct from the elected species.  The unfairness of the result would violate the purpose of the safe harbor.

Having established the parameters of the restriction the Court then assessed whether there was consonance.  While the difference in elected species distinguished the Janzen patent from the grandparent '339 application, the panel found no such distinction with the claims of the second continuation (the '498 patent), which contained claims directed to Group II without any limitations as to species.  Accordingly, the claims of this second continuation were not consonant with the claims of the Janzen patent, which are directed, inter alia, to inventions of Group II, Species C.  The claims of the Janzen patent were thus not patentably distinct from the claims of the second continuation and the Court found them invalid for obviousness-type double patenting.

ACI also appealed the District Court's determination that the claims of the Fowler patents were not obvious.  The following are the claims that were at issue:

U.S. Patent No. 5,275,616:

14.  A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of the patient; through the lumen of a blood vessel and into the blood vessel of a patient, the method including the steps of:
    forming a vessel plug of a material which is absorbable in the body of the patient and wherein the vessel plug is formed to include distal and proximal ends therein and is dimensioned to be received in the incision; and
    positioning the vessel plug in the incision such that the distal end of the vessel plug is located proximally of the blood vessel to seal the incision from the flow of blood passing through the blood vessel, [The method of claim 9] further including the step of inflating a member on an insertion member to identify the location of the blood vessel adjacent to the incision.

(where the italicized portion of claim 14 recites the limitations of claim 9 from which claim 14 is a dependent claim); and,

U.S. Patent No. 5,716,375:

21.  An insertion assembly for sealing an incision in the body of a patient wherein the incision extends from the skin of the patient into a blood vessel of the patient, said insertion assembly comprising in combination:
    a vessel plug which is constructed of a material that is absorbable within the body of a patient and which seals the incision from the flow of blood therethrough; and
    an elongate positioning member having a passage way therein for the receipt of said vessel plug therein, and at least a portion of said positioning member is expandable so that it has an outer diameter in use which is greater than the diameter of the incision to position said vessel plug in the incision proximally of the blood vessel such that said vessel plug obstructs the flow of blood through the incision without extending into the blood vessel.

ACI argued that these claims were obvious over two prior art references:  a 1988 scientific journal article to Takayasu, which disclosed a method and apparatus for sealing punctures in a liver vein using "a compressed 'gelfoam stick'"; and a 1971 scientific journal article to Smiley, which disclosed using a balloon catheter.  ACI argued that these references demonstrated that the problem the Fowler's patents addressed -- how to restore hemostatis to a punctured blood vessel -- was known and that these references disclosed methods for solving the problem.  The skilled worker would have had a reasonable expectation of achieving the claimed invention by combining the Takayasu and Smiley references and thus were obvious under 35 U.S.C. § 103.

The Federal Circuit agreed with St. Jude's argument that their claimed invention contained limitations and features not disclosed in the cited prior art that distinguished their claims from the hypothetical combination of the teachings of the Takayasu and Smiley references.  Rather than combining the references, the Court held that the disclosed elements useful for stemming blood flow from a puncture -– a gelfoam stick or a balloon -– would be considered alternatives and the skilled worker would not combine the references.  Nor was the panel convinced that the skilled worker would use an "invasive" balloon rather than non-invasive methods (x-ray or ultrasound) used in the art to check the position of the gelfoam in the wound.  The Court characterized as "a logical chasm" the differences between the art and the invention, and further noted that "[e]ven under our "expansive and flexible" obviousness analysis (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415, (2007)), we must guard against "hindsight bias" and "ex post reasoning," which "compels [the Court] to reject ACI's argument."

Judge Lourie provided a concurring opinion, which agreed with the result but rejected the panel's analysis elevating the election of species requirement to a formal restriction.  In Judge Lourie's view:

In a nutshell, this case is resolved by the failure of the granted Janzen and '498 (sibling) patents to maintain consonance with the original restriction requirement.  The accompanying requirement for election of species, which perhaps raises an issue of first impression, is a complication that should not come into play in deciding the appeal.

According to Judge Lourie, the presence of both method and apparatus claims in the Janzen patent is enough to vitiate consonance with the grandparent application, which contains claims to apparatus ("It is the opposite of consonant.")  That is enough to reach the conclusion announced in the panel decision, and thus while Judge Lourie believed that "the majority opinion overcomplicates the analysis of this appeal and improperly commingles restriction practice with election of species practice," he concurred with the decision.

St. Jude Medical, Inc. v. Access Closure, Inc. (Fed. Cir. 2013)
Panel: Circuit Judges Lourie, Plager, and Wallach
Opinion by Circuit Judge Plager; concurring opinion by Circuit Judge Lourie