The Authors and Contributors of "Patent Docs" are patent attorneys and agents, many of whom hold doctorates in a diverse array of disciplines.
"Patent Docs" does not contain any legal advice whatsoever. This weblog is for informational purposes only, and its publication does not create an attorney-client relationship. In addition, nothing on "Patent Docs" constitutes a solicitation for business. This weblog is intended primarily for other attorneys. Moreover, "Patent Docs" is the personal weblog of the Authors; it is not edited by the Authors' employers or clients and, as such, no part of this weblog may be so attributed. All posts on "Patent Docs" should be double-checked for their accuracy and current applicability.
The ABA Journal, the American Bar Association's flagship magazine, has announced its annual list of the 100 best legal blogs -- or blawgs -- following a nomination process that began over the summer (see "ABA Journal Accepting Nominations for 8th Annual Blawg 100"). The 100 blogs selected by the ABA Journal were chosen from a list of more than 4,000 law blogs. The 100 honorees on the 2014 list have been divided into thirteen categories: Criminal Justice, Tort/Consumer, Law Practice Management, Legal Research/Legal Writing, Litigation, Niche, News/Analysis, Labor & Employment, For Fun, Profs, Intellectual Property, Careers/Law Schools, News/Courts, and Legal Tech. Seven honorees of the 2014 Blawg 100 were selected in the Intellectual Property category, including Patent Docs, which was selected to the Blawg 100 for the third year in a row. The other blogs selected to the IP Law category were Biederman Blog; Trademark & Copyright Law; Rebecca Tushnet's 43(B)log; Hollywood, Esq.; DuetsBlog; and Trademarkology. Biederman Blog, Rebecca Tushnet's 43(B)log, and Hollywood, Esq., like Patent Docs, were all repeat nominees.
An alphabetical list of the 2014 Blawg 100 can be found here and a list of the top blawgs sorted by category can be found here. In announcing the 2014 Blawg 100, ABA Journal Editor and Publisher Allen Pusey noted that law blogs are "[n]o longer to be confused as a fad or the realm of the tech-savvy," but rather are "rooted in the legal media landscape." He observed that "[w]hile traditional media sources often break news, law blogs dive deeper to offer insight into what the news means for clients, the legal profession and the public," and indicated that the blogs making the 2014 Blawg 100 "are well-written and, more often than not, entertaining."
Now that the ABA Journal has selected its Blawg 100 for 2014, it is asking readers to choose their favorites from among the top 100. In order to vote for your favorites, you will first have to register here (registration is free). Readers can then vote for their favorite blogs here. According to the ABA Journal, each person gets a total of 13 votes, to distribute as they see fit among the blogs they like, with a limit of one vote per person, per blog. Voting will conclude on December 19, 2014, and the winners will be announced in January.
In addition to releasing its 8th annual Blawg 100, the ABA Journal added ten new inductees to the Blawg 100 Hall of Fame, featuring law blogs that have "consistently been outstanding throughout multiple Blawg 100 lists." The Blawg 100 Hall of Fame currently includes Patently-O (2012 Hall inductee) and IPWatchdog (2013 Hall inductee). A list of the thirty Blawg 100 Hall of Fame inductees can be found here.
We would like to thank our readers for nominating Patent Docs for the Blawg 100, and we would like to thank the ABA Journal for making Patent Docs a 2014 Blawg 100 honoree.
The Constitution gives Congress the power to grant copyright and patent protection in the same part of Article I, specifically in Section 8, Clause 8:
To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.
This coincidence of these Powers has raised questions of whether development of the law in one area can affect the law in the other, for example, with regard to concepts such as exhaustion and extraterritoriality (see "Microsoft Corp. v. AT&T Corp. (2007)"). Both of these issues arose in the copyright case of Kirtsaeng v John Wiley & Sons case decided by the Supreme Court last term; while the immediate effect of this decision on patent law was unclear, recent developments may make the case very relevant and very dangerous for continued pharmaceutical innovation.
Briefly, the case involved a copyright infringement action brought by Wiley against a Thailand national, Supap Kirtsaeng, who was studying in the U.S. and arranged to have copies of textbooks sold in Thailand sent to him by his relatives for resale in the U.S. Because Wiley (like many U.S. publishers) sells the same textbook at a much lower price in countries like Thailand than they cost in the U.S., Mr. Kirtsaeng was able to sell the books sent to him from abroad on eBay, ultimately making $1.2 million in revenues (there was a dispute, not relevant to the Court's decision, about the amount of this total that was profit, but presumably it was worth Mr. Kirtsaeng's while to continue his business while studying in the U.S.). Although Wiley prevailed in the district court and before the Second Circuit, the Supreme Court reversed, on the grounds that the "first sale doctrine" permitted resale of legally obtained copyrighted works without obtaining the copyright owner's permission, and that U.S. copyright law, and the notice on the textbooks purchased in Thailand that they were only authorized for sale outside the U.S., did not mandate a different outcome or trump the first sale doctrine. As a result, Wiley increased the cost of its textbooks sold abroad.
This case has clear implications for branded drugs, which are often sold ex-U.S. for less than the same drugs costs at home; at least some of these cost differences are the result of foreign governments regulating the cost of branded drugs. This is not a phenomenon limited to developing or Third World countries: European countries having a nationalized health care system (i.e., all of them) also have varying levels of cost controls for branded drugs, along with regimes for generic versions of these drugs after expiration of some term of exclusivity for the branded versions. And many countries such as Brazil, China, India, Russia, and Thailand have relied upon international treaty provisions (such as the Doha Declaration under the auspices of the World Trade Organization) to provide government-subsidized generic versions of branded drugs at prices much lower than the prevailing price in Western countries. These differences in costs have not affected U.S. prices because, unlike textbooks, branded drugs cannot be reimported into the U.S. under FDA regulations and U.S. law.
That may be changing, however, in view of a N.Y. Times report yesterday on bipartisan efforts to reduce drug prices by permitting reimportation. The Times reports, in an article by Elisabeth Rosenthal, that Senator Amy Klobuchar (D-MN) is planning to revive a prior bill that would permit reimportation from Canada, a country whose national health service regulates the price of branded and generic drugs. She is supported in these efforts by Senator John McCain (R-AZ) and undoubtedly other Senators will join in the effort. The impetus for action now, according to Ms. Rosenthal, is not that branded drug prices are high (although there is certainly concern about the price of some drugs, particularly biologic drugs directed towards intractable diseases like cancer); rather, it is the rising price of generic drugs that has raised concerns. Last Thursday, a Senate panel of the Senate Subcommittee on Primary Health and Aging, chaired by Sen. Bernie Sanders (I-VT) investigated the issue, hearing from Professor Stephen Schondelmeyer, University of Minnesota; Dr. Aaron Kesselheim of the Harvard Medical School; and Mr. Rob Frankil, who testified on behalf of the National Community Pharmacists Association who had requested Congressional action. (Three generic drug company executives declined the panel's invitation to testify, according to the Times report.) The testimony included reports of generic drug costs increasing by ~8,000 percent (i.e., 80-fold, for doxyxycline) and over 300 percent for ten other generic drugs. These increases are recent (over the past few months), and the causes attributed to the increases range from shortages in active pharmaceutical ingredient supplies, manufacturing problems, and consolidation of drug companies by mergers and acquisitions. As can be expected, the Senate panel heard calls for greater government regulation and application of drug rebate requirements to Medicare and Medicaid to apply to generic drugs, just as they now apply to branded drugs.
More troubling long-term is the solution proposed by Senator Klobuchar, allowing importation from Canada; Maine is already permitting its residents to purchase some drugs from Canada, Great Britain, Australia, and New Zealand in contravention of U.S. law. The crisis in the cost of generic drugs has made this solution particularly attractive, because paradoxically the cost of a generic version of a drug in the U.S. can be higher than the cost of the branded drug in Canada. The Times article illustrates this situation for digoxin, where a 90-day supply of the generic drug costs $187 in New York while the same amount of the branded version, sold as Lanoxin, costs $24.30 in Canada. The comparisons are similar for an inflammatory bowel disease drug ($1,625 for the generic in the U.S., $155.70 for the branded version in Canada) and the cholesterol drug Pravachol ($230 U.S. generic/$31.50 branded Canadian). With these differential costs plans permitting branded drug reimportation begin to have political force, as does the aging of the population where more people will be covered by Medicare and costs to the government will rise accordingly.
If successful, these efforts will create a situation akin to the consequences of the Kirtsaeng case in the copyright arena. Here, however, innovator drug companies will not have the option, exercised by Wiley, of increasing prices abroad to make reimportation less economically attractive. The prevalence of ANDA litigation in the U.S. over the past thirty years is one indication of the importance of exclusivity, and the attendant profits that result from exclusivity, to pharmaceutical innovation. Should those profits decrease significantly, the return on investment for innovator drugs will fall, and the calculus of investment that supports new drug development will be affected unpredictably (but not positively; the unpredictability resides in how much the ROI will change and how that will affect investment decisions). A common criticism aimed at branded drugmakers is the frequency with which they develop "me too" and next generation versions of already marketed drugs rather than create innovative new treatments and therapies. The same uncertainties in drug development that make such behavior sound economically also impact the decision to develop new drugs, and policies that reduce ROI for such new drugs (which bear the greatest economic risk) are unlikely to promote innovation.
It is ironic that the U.S. Supreme Court has based many of its recent decisions limiting patent eligibility on a purported concern that patents can inhibit innovation. They do not, of course, but policies that make it economically unsound to invest in drug development may certainly do so. Such policies are likely to be just as welcome by the general public as such Supreme Court decisions, and just as likely to have exactly the opposite effect (here, on affordable drugs) than their supporters envision.
For additional information on this and other related topics, please see:
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of Pennsylvania
• Plaintiff: Par Pharmaceutical, Inc. • Defendants: Glaxosmithkline LLC; Aptalis Pharma US, Inc.; Aptalis Pharmatech, Inc.; Aptalis Pharma Canada Inc.
Declaratory judgment of non-infringement of U.S. Patent No. 7,919,115 ("Orally Disintegrating Tablet Compositions of Lamotrigine," issued April 5, 2011) based on Par's filing of an ANDA (and Paragraph IV certification) to manufacture a generic version of GSK's Lamictal ODT® (orally disintegrating lamotrigine tablets). View the complaint here.
Teva Pharmaceuticals USA Inc. et al. v. Synthon Pharmaceuticals, Inc. et al. 1:14-cv-01419; filed November 18, 2014 in the District Court of Delaware
• Plaintiffs: Teva Pharmaceuticals USA Inc.; Teva Pharmaceutical Industries Ltd; Teva Neuroscience Inc; Yeda Research and Development Co Ltd. • Defendants: Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon s.r.o. Blansko
Teva Pharmaceuticals USA, Inc. et al. v. Synthon Pharmaceuticals, Inc. et al. 1:14-cv-00975; filed November 19, 2014 in the Middle District of North Carolina
• Plaintiffs: Teva Pharmaceuticals USA, Inc.; Teva Pharmaceutical Industries Ltd.; Teva Neuroscience, Inc.; Yeda Research and Development Co., Ltd. • Defendants: Synthon Pharmaceuticals, Inc.; Synthon B.V.; Synthon s.r.o. Blansko
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 8,232,250 ("Low Frequency Glatiramer AcetateTherapy," issued July 31, 2012) and 8,399,413 (same title, issued March 19, 2013) following a Paragraph IV certification as part of Synthon's filing of an ANDA to manufacture a generic version of Teva's Copaxone® (glatiramer acetate injection, used for the reduction or frequency of relapses in patients with relapsing-remitting multiple sclerosis). View the Delaware complaint here.
Amgen Inc. v. Sanofi et al. 1:14-cv-01414; filed November 17, 2014 in the District Court of Delaware
• Plaintiff: Amgen Inc. • Defendants: Sanofi ; Sanofi-Aventis U.S. LLC; Aventisub LLC; Regeneron Pharmaceuticals Inc.
Infringement of U.S. Patent No. 8,889,834 ("Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)," issued November 18, 2014) based on defendants' current and/or imminent manufacture, use, sale, offer to sell, and/or importation into the U.S. of alirocumab, an anti-PCSK9 antibody (used to treat dyslipidemia and other cholesterol disorders). View the complaint here.
BioMarin Pharmaceutical Inc. et al. v. Dr. Reddy's Laboratories, Inc. et al. 3:14-cv-07203; filed November 17, 2014 in the District Court of New Jersey
• Plaintiffs: BioMarin Pharmaceutical Inc.; Merck & Cie • Defendants: Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories, Ltd.
Infringement of U.S. Patent Nos. 7,566,462 ("Stable Tablet Formulation," issued July 28, 2009), 7,566,714 ("Methods and Compositions for the Treatment of Metabolic Disorders," issued July 28, 2009), 7,612,073 ("Methods of Administering Tetrahydrobiopterin, Associated Compositions, and Methods of Measuring," issued November 3, 2009), 8,003,126 ("Stable Table Formulation," issued August 23, 2011), 8,067,416 ("Methods and Compositions for the Treatment of Metabolic Disorders," issued November 29, 2011), RE43,797 ("Methods of Administering Tetrahydrobiopterin," issued November 6, 2012), and 8,318,745 ("Crystalline Forms of (6R)-L-Erythro-Tetrahydrobiopterin Dihydrochloride," issued November 27, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of BioMarin's Kuvan® (sapropterin dihydrochloride, used to reduce blood phenylalanine levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria). View the complaint here.
Purdue Pharma L.P. v. Watson Laboratories Inc. 1:14-cv-01410; filed November 14, 2014 in the District Court of Delaware
Infringement of U.S. Patent Nos. RE41,408 ("Method of Providing Sustained Analgesia with Buprenorphine," issued June 29, 2010), RE41,489 (same title, issued August 10, 2010), and RE41,571 (same title, issued August 24, 2010) following a Paragraph IV certification as part of Watson's amendment of its ANDA (adding another dosage) to manufacture a generic version of Purdue Pharma's Butrans® (buprenorphine transdermal, used for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate). View the complaint here.
In Genetic Technologies Ltd. v. Laboratory Corp. of America Holdings, yet another district court (actually, a magistrate judge) has succumbed to the siren song, or drank the Kool-Aid, or (fill in your favorite Apocalyptic metaphor here) of applying the Supreme Court's Mayo v. Prometheus decision in ways not required by the decision, that produce an entirely subjective standard for patent eligibility, and that are arguably contrary to how the Court itself explained its earlier decision in the CLS Bank v. Alice case.
The case concerned U.S. Patent No. 7,615,342, wherein Genetic Technologies asserted claim 1:
1. A method to predict potential sprinting, strength, or power performance in a human comprising: a) analyzing a sample obtained from the human for the presence of one or more genetic variations in α-actinin-3 (ACTN3) gene; b) detecting the presence of two 577R alleles at the loci encoding amino acid number 577 of the α-actinin-3 (ACTN3) protein; and c) predicting the potential sprinting, strength, or power performance of the human, wherein the presence of two copies of the 577R allele is positively associated with potential sprinting, strength, or power performance.
Defendants include LabCorp Holdings, LabCorp America, and 23andMe, and Magistrate Judge Christopher J. Burke rendered his decision on a motion to dismiss under Federal Rule of Civil Procedure 12(b)(6), alleging failure to state a claim because the '342 patent claims were invalid as claiming patent ineligible subject matter. Within days of the Magistrate Judge's Report and Recommendation, the parties filed a joint stipulation of dismissal with prejudice.
The Magistrate Judge's Report and Recommendation contains an interesting procedural background, wherein Chief Judge Leonard P. Stark referred the case to the Magistrate for pretrial matters "including the resolution of case-dispositive motions." Instead of filing an Answer to the complaint, the defendants submitted their motion, which was followed by ten "supplemental letters . . . appris[ing] the Court of recent opinions -- including a number of important decisions by the Supreme Court -- that might impact review of the Section 101-related issues" before the Court. This authority included Uniloc USA Inc. v. Rackspace Hosting Inc. (E.D. Tex. Mar. 27, 2013) (directed, according to defendants, to "a method for processing certain types of numbers in a computer"); Ultramercial Inc. v. Hulu LLC (Fed. Cir. June 21, 2013) (related, according to plaintiff, to "methods for distributing copyrighted materials over the Internet where the end user would receive the copyrighted product for free after viewing an advertisement"); Association for Molecular Pathology v. Myriad Genetics (2013) (which defendants asserted "bears more closely on [the] motion than does Ultramercial" and is related to the question of patent eligibility of natural phenomena, which the Court set forth the "contours of the doctrine" in Mayo); Ubicom, LLC v. Zappos IP Inc. (D. Del. Nov. 13, 2013) (which defendants assert "demonstrates that even after Ultramercial , it is permissible to grant motions to dismiss on patentable subject matter in appropriate cases"); Cyberfone Systems, LLC v. CNN Interactive Group (Fed. Cir. Feb. 26, 2014) (wherein defendants assert that there is no requirement for claim construction before deciding subject matter eligibility); Alice Corp. v. CLS Bank Int'l (2014) (a case defendants assert "is central to the resolution of [the] motion") and plaintiff's response; defendant's notice of the Supreme Court's decision to vacate the Federal Circuit's Ultramercial decision and plaintiff's response and defendants' reply, a total of ten citations of authority from March 25, 2013 through July 7, 2014.
Arriving at the merits, the Magistrate Judge set out what he characterized as "the general framework for Section 101 analyses," and then applied it to the facts and allegations in Genetic Technologies' complaint. This analysis encompasses the familiar litany that Congress intended the scope of patent eligibility to be broad, but that this breadth was circumscribed by the Supreme Court's "exceptions" related to natural laws, abstract ideas, and natural phenomenon. The Magistrate Judge also noted that the Supreme Court has recognized that too broad an application of these judicial exceptions would "eviscerate" patent law because "all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena or abstract ideas," citing Mayo.
The Magistrate Judge then cited the Federal Circuit, Accenture Global Servs., GmbH v. Guidewire Software, Inc. (Fed. Cir. 2013), and District of Delaware precedent, Comcast IP Holdings L LLC v. Sprint Commc'ns Co. L.P. (D. Del. July 16, 2014), for the appropriate test. The two-prong test used by the Magistrate Judge is first, to identify whether the invention recited by the claims "fits within one of the four statutory classes." Second, the court must determine whether, despite satisfying the first prong the claims recite subject matter falling within the scope of one of the judicial exceptions. The Magistrate Judge then cited portions of the Supreme Court's decision in CLS Bank v. Alice directed towards "the search for an inventive concept."
The decision set forth in the Report and Recommendation begins by holding that the motion was not premature. In doing so, the Magistrate faulted plaintiffs for not "articulat[ing] why there are any disputed areas of fact relevant to the resolution of the Motion" (emphasis in report). The Magistrate also cited the Federal Circuit's CyberFone and Bancorp decisions, and Judge Mayer's concurring opinion in I/P Engine Inc. v. AOL Inc. (Fed. Cir. Aug. 15, 2014) for the proposition that claim construction is not always necessary for a § 101 patent eligibility determination. In a footnote, the Magistrate also noted that the Supreme Court has held that the "clear and convincing evidence" standard "does not apply to pure questions of law," citing Microsoft Corp. v. i4i Ltd Partnership (2011). In those cases where a plaintiff asserts a need for claim construction, the Magistrate states that the matter can be resolved simply by adopting plaintiff's claim construction, citing UbiComm and Content Extraction & Transmission LLC v. Wells Fargo Bank, Nat'/ Assoc. (D.N.J. July 31, 2013). In addition, the Magistrate noted that the only claim term at issue was "predicting," and the Judge adopted Genetic Technologies' construction for this term.
The Magistrate then set forth the basis for his decision that claim 1 does not satisfy the patent eligibility standard of § 101, relying on Myriad, Mayo and Perkin Elmer, Inc. v. Intema Ltd. (Fed. Cir. 2012), and setting forth his understanding of these decisions. While entirely conventional, the Magistrate's analysis focused on the preemptive effects of the claims in Mayo and Perkin Elmer and the risk of "tying up future innovation premised on laws of nature," characterizing the Mayo claims as being of "sweeping nature" and the Perkin Elmer claims as encompassing any known measuring method. From this assessment it was a short step to including in the definition of "known methods" those that are "routine, conventional and well-understood."
The Magistrate then concluded that claim 1 of the '342 patent "contains" a law of nature, based on the "broad manner" that the Mayo Court defined a law of nature ("[A] patent that ... describes [a relationship that is the consequence of entirely natural processes] sets forth a natural law"). The "correlation" between athletic performance and inheritance of particular alleles of genes encoding α-actinin-3 is "the handiwork of nature," according to the Magistrate, something that "man did not do anything to bring about this relationship." The Magistrate concluded that the claim did not "amount to a patent-eligible application of" that natural law. In answering in the negative, the Magistrate applied the now-common practice of assessing the nature of each of the steps of the claim individually, which it identified as an "analyzing" step, a "detecting" step, and a "predicting" step. Because the "analyzing step does not recite a novel analyzing method this step does not provide the needed "something more," with the Court citing (out of context) Justice Thomas's statement that "[had] Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent" (inapposite here because the question before the Magistrate was not the question before the Supreme Court in Myriad). The Magistrate also cited the District Court's decision in Ariosa v. Sequenom that arrived at a similar (erroneous) conclusion. As in the Ariosa case, the Magistrate cites patentee's own specification for the breadth of analytical methods that can be employed in this step.
The Magistrate applied this same reasoning to the detecting step, using patentee's statements in the specification to support his conclusion. And the "predicting" step suffers from the same fate as the "wherein" causes in the claims at issue in Mayo, as being merely an "instruction [to] apply the [natural] law" or, alternatively, "insignificant post-solution activity" (rendering the actual invention, the ability to predict a phenotype from a detectable phenotype, into insignificance). In this regard the Report also cites the distinctions set forth by the Federal Circuit in the two claim types suffering different invalidating fates in Classen Immunotherapies, Inc. v. Biogen IDEC, wherein claims to "reviewing effects of known immunization schedules" were not patent eligible, but that claims that "required the 'further act of immunization'" "moved the claim from 'abstract scientific principle to specific application.'"
Having disassembled the claim and analyzed its component recited limitations individually, it is not surprising that the Magistrate could not discern subject matter eligibility in the claims considered "as a whole," because inter alia the claim did not "recite an application that amounts to significantly more than a patent upon the natural law itself,'" citing Mayo and Ariosa. Finally, as in Mayo the Magistrate concluded that the general nature of the claim language raises the possibility that the claims could "inhibit the development of new processes that make use in some way of the claimed method for analyzing and detecting the particular genetic variation" and stifle future innovation.
The case presents two troublesome trends. First, patentees are now at risk of not even getting their day in court, and not getting the statutory presumption of validity, because courts are empowered by decisions such as these to render decisions without claim construction, or production of clear and convincing evidence of patent ineligibility. The second trend is for courts to require novel methods for obtaining, analyzing, or detecting evidence of anything that can be cast as a natural law, over-interpreting Justice Breyer's proscription against what is routine, conventional or well-understood. Extended to its logical conclusion assessing the patent eligibility of any diagnostic method claim as the Magistrate Judge does in this case, or the District Court judge did in Ariosa (or, arguably, how the Federal Circuit panel did in the Perkin Elmer case) will preclude patent eligibility for all such claims. It is possible that the Supreme Court intended this result. But considering the damaging effects this would have on future innovation, and the disruption of settled expectations that the Court itself has warned should be avoided, it seems only prudent for the lower courts (and the PTO) to give the Court the prerogative of saying so itself.
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases.
Sucampo AG et al. v. Dr. Reddy's Laboratories, Inc. et al. 3:14-cv-07114; filed November 12, 2014 in the District Court of New Jersey
• Plaintiffs: Sucampo AG; Sucampo Pharmaceuticals, Inc.; R-Tech Ueno, Ltd.; Takeda Pharmaceutical Co. Ltd.; Takeda Pharmaceuticals USA, Inc.; Takeda Pharmaceuticals America, Inc. • Defendants: Dr. Reddy's Laboratories, Inc.; Dr. Reddy's Laboratories Ltd.
Infringement of U.S. Patent Nos. 6,414,016 ("Anti-Constipation Composition," issued July 2, 2002), 7,795,312 ("Method for Treating Abdominal Discomfort," issued September 14, 2010), 8,071,613 ("Anti-Constipation Composition," issued December 6, 2011), 8,097,653 ("Dosage Unit Comprising a Prostaglandin Analog for Treating Constipation," issued January 17, 2012), 8,389,542 (same title, issued March 5, 2013), 8,026,393 ("Soft-Gelatin Capsule Formulation," issued September 27, 2011), and 8,338,639 (same title, issued December 25, 2012) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Amitiza® (lubiprostone, used to treat Chronic Idiopathic Constipation in adults and to treat Irritable Bowel Syndrome with Constipation in women 18 years of age and older). View the complaint here.
Baxter Healthcare Corp. et al. v. Agila Specialties Private Ltd. et al. 2:14-cv-07094; filed November 12, 2014 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 6,310,094 ("Ready-to-Use Esmolol Solution," issued October 30, 2001) and 6,528,540 ("Esmolol Formulation," issued March 4, 2003) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Baxter's Brevibloc® (esmolol hydrochloride, used for the rapid control of the heart rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of the heart rate with a short-acting agent is desirable). View the complaint here.
Amgen Inc. v. Sanofi et al. 1:14-cv-01393; filed November 11, 2014 in the District Court of Delaware
• Plaintiff: Amgen Inc. • Defendants: Sanofi; Sanofi-Aventis U.S. LLC; Aventisub LLC; Regeneron Pharmaceuticals Inc.
Infringement of U.S. Patent No. 8,883,983 ("Antigen Binding Proteins to Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9)," issued November 11, 2014) based on defendants' current and/or imminent manufacture, use, sale, offer to sell, and/or importation into the U.S. of alirocumab, an anti-PCSK9 antibody (used to treat dyslipidemia and other cholesterol disorders). View the complaint here.
Genovis AB et al. v. Promega Corp. 1:14-cv-01391; filed November 10, 2014 in the District Court of Delaware
• Plaintiffs: Genovis AB; Hansa Medical AB • Defendant: Promega Corp.
Infringement of U.S. Patent No. 7,666,582 ("IDES, An IgG-Degrading Enzyme of Streptococcus Pyogenes," issued February 23, 2010), licensed to Genovis, based on Promega's manufacture, use, sale, or offer of sale of its IdeS Protease. View the complaint here.
Biomune Co. v. Merial Ltd. et al. 2:14-cv-02567; filed November 10, 2014 in the District Court of Kansas
Declaratory judgment of non-infringement and invalidity of U.S. Patent Nos. 6,660,272 ("Porcine Circoviruses, Vaccines, and Diagnostic Reagents," issued October 17, 2006) and 7,122,192 (same title, issued December 9, 2003) based on Biomune's manufacture and sale of its Porcine Circovirus Vaccine, Type-2, Killed Virus-Mycoplasma Hyopneumonia Bacterin. View the complaint here.
Shire Development LLC et al. v. Natco Pharma Ltd. 2:14-cv-07053 filed November 10, 2014 in the District Court of New Jersey
• Plaintiffs: Shire Development LLC; Shire Canada Inc.; Shire International Licensing B.V. • Defendant: Natco Pharma Ltd.
Infringement of U.S. Patent Nos. 5,968,976 ("Pharmaceutical Composition Containing Selected Lanthanum Carbonate Hydrates," issued October 19, 1999), 7,381,428 ("Stabilized Lanthanum Carbonate Compositions," issued June 3, 2008), and 7,465,465 ("Pharmaceutical Formulation Comprising Lanthanum Compounds," issued December 16, 2008) following a Paragraph IV certification as part of Natco's filing of an ANDA to manufacture a generic version of Shire's Fosrenol® (lanthanum carbonate chewable tablets, used for the reduction of serum phosphate in patients with end stage renal disease). View the complaint here.
Otsuka Pharmaceutical Co., Ltd. v. Actavis Elizabeth LLC et al. 1:14-cv-07106; filed November 10, 2014 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 8,580,796 ("Low Hygroscopic Aripiprazole Drug Substance and Process for the Preparation Thereof," issued November 12, 2013), 8,642,760 (same title, issued February 4, 2014), and 8,759,350 ("Carbostyril Derivatives and Serotonin Reuptake Inhibitors for Treatment of Mood Disorders," issued June 24, 2014) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Otsuka's Abilify® (aripiprazole, used to treat bipolar disorder and schizophrenia). View the complaint here.
Pfizer Inc. et al. v. Tiger Pharmaceuticals, LLC 1:14-cv-08958; filed November 10, 2014 in the Southern District of New York
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,124,363 ("Dofetilide Polymorphs," issued September 26, 2000) following a Paragraph IV certification as part of Tiger's filing of an ANDA to manufacture a generic version of Pfizer's Tikosyn® (dofetilide, used for the maintenance of normal sinus rhythm in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm and for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm). View the New York complaint here.
The American University Washington College of Law Program on Information Justice and Intellectual Property is hosting a program entitled "The Role of Patents in Pharmaceutical Innovation: Lessons to Be Learned" from 4:30 to 6:00 pm (Eastern) on November 24, 2014 at the American University Washington College of Law in Washington, DC. Public Citizen Global Access to Medicines Attorney Burcu Kilic will discuss her new book Boosting Pharmaceutical Innovation In The Post-TRIPS Era: Real-Life Lessons for the Developing World, which investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, the book identifies the key issues relevant to the revival of local pharmaceutical industries. The program will also include a panel including Sean Flynn of the American University Washington College of Law and Walter Park of the American University Department of Economics.
Additional information about the program, including registration information and an agenda, can be found here.
The Federal Circuit made it clear earlier today that district courts should freely grant stays in view of Covered Business Method ("CBM") patent reviews instituted by the Patent Trial and Appeal Board ("PTAB"). In Versata Software, Inc. v. Callidus Software, Inc., the Court reversed and remanded a United States District Court for the District of Delaware's denial of a motion to stay. The Court determined that an analysis of the factors outlined in § 18(b) of the America Invents Act ("AIA") "strongly favor[ed]" the stay. In fact, the Federal Circuit appeared to stop just short of mandating stays in such cases. And, even though the AIA provides that the Federal Circuit may review such district court's decision de novo in order to "ensure consistent application and established precedent," (AIA § 18(b)(2)), the Court indicated that the outcome would have been the same if analyzed under the traditional abuse-of-discretion standard. As a result, this case may have implications for district court stays in other post-issuance proceedings, such as Inter Partes Review ("IPR"), because despite not having the same articulated factors in the statute, the factors commonly used by district courts for analyzing such motions are similar.
To provide a brief context, the present case stems from a July 19, 2012 action in which Versata sued Callidus in the Delaware district court alleging infringement of three patents related to the "management and tracking of sales information by a financial services company." Callidus tried to both dismiss the case on the pleadings and transfer it to the Northern District of California. Both motions were denied. Callidus subsequently answered and counterclaimed, asserting its own patents. Callidus also filed a first set of CBM petitions which challenged all of the claims of one of the patents, but only selected claims of the other two patents. When the PTAB instituted CBM review of this first set, Delaware Judge Robinson stayed the proceedings with respect to the one patent, but denied the stay with respect to the other two. Callidus filed an interlocutory appeal pursuant to § 18(b)(2) of the AIA. While the appeal was pending, a second set of CBM petitions were acted upon by the PTAB, resulting in trial initiation for the remaining claims.
For those not aware, the AIA contained a section on requesting a stay of a civil action in the CBM portion of statute. This section provides for which factors must be considered, and allows for immediate interlocutory appeal. Specifically, the Court must look at:
(A) whether a stay, or the denial thereof, will simplify the issues in question and streamline the trial;
(B) whether discovery is complete and whether a trial date has been set;
(C) whether a stay, or the denial thereof, would unduly prejudice the nonmoving party or present a clear tactical advantage for the moving party; and
(D) whether a stay, or the denial thereof, will reduce the burden of litigation on the parties and on the court.
AIA, §18(b)(1). Of course, this is not significantly different than the factors used by district courts in general in determining whether to grant a stay. For example, Judge Robinson recently articulated the factors to consider in the IPR context in another case: "(a) whether the granting of a stay would cause the non-moving party to suffer undue prejudice from any delay or allow the moving party to gain a clear tactical advantage over the non-moving party; (b) whether a stay will simplify the issues for trial; and (3) whether discovery is complete and a trial date is set." Peschke Map Tech., LLC v. J.J. Gumberg Co., Civ. No. 12-1525-SLR (D. Del. April 24, 2014).
In the present case, Judge Robinson acknowledged "the presence of Congress' thumb on the scales of justice," but still concluded that a complete stay would "not simplify the issues or reduce the burdens of litigation." The Federal Circuit disagreed, but in view of different facts than what the lower court was considering. With regard to the first issue -- whether a stay would simplify the issues or streamline the trial -- Judge Robinson noted that Callidus did not include all of the claims in the CBM petition. Therefore, with regard to the patents that only had a subset of patents being reviewed, she denied the motion. The Federal Circuit turned this into "a categorical rule" on her part ("if any asserted claims are not also challenged in the CBM proceeding, this factor disfavors a stay"), and deemed the rule inappropriate. But Judge Robinson never articulated such a rule, and any such extrapolation from her decision is impossible because the sample size is too small to be meaningful. Moreover, the Federal Circuit took judicial notice of the fact that all of the patent claims are now involved in an instituted CBM review. Using the "categorical rule," because every claim has now been instituted by the PTAB, there is "little doubt that issues will be simplified." Nevertheless, the important take-away from the Federal Circuit regarding this factor is that a stay can be warranted even if the CBM proceedings will not simplify all of the invalidity issues at trial (whether all of the claims, or all of the invalidity defenses).
With regard to the second factor, Judge Robinson did little more than highlight that discovery was not complete, and that the trial date was within months of when the CBMs were expected to be concluded. The Federal Circuit took issue with this, criticizing her failure to explain why the seven month difference between the anticipated conclusion of CBM review and the start of trial counseled against a stay. The Court was also clear that the date from which this factor must be analyzed is the day the motion is filed, not the date it is considered. A problem occurs, however, when the motion to stay is filed at the same time as the CBM petitions. Courts are rarely going to grant stay for proceedings that may never materialize. Therefore, instead of denying the motion outright, Judge Robinson postponed the decision until after review was instituted. In the interim, discovery progressed. It seems illogical to pretend that the intervening time did not occur. This problem could be solved by encouraging lower courts to deny stay motions without prejudice, or providing leave to refile on institution of the CBM.
The factor that the lower court spent the most time highlighting was Callidus' tactical advantage in filing the stay. Judge Robinson was influenced by the fact that Callidus asserted its own patents. The implication was that the Callidus was using the "stay card" as a sword and a shield. If granted, only Versata would now be at risk. The Federal Circuit's responded by pointing out Callidus intended to stay the entire case. However, no such indication appears in Judge Robinson's opinion. It is possible that such a position was only adopted during appeal. Judge Robinson does make a point of noting that Callidus is defending itself "aggressively," by filing motions to dismiss, and motions to transfer, the case. The Appeals Court responded noted that Judge Robinson never explains why the use of such motions was "improper." In fact, apparently Versata never alleged that they were improper either. Without some such indication, this factor strongly favors a stay, according to the Court.
Finally, with regard to the last fact, Judge Robinson noted that "Callidus' tactics have actually increased the burdens of litigation, rather than reduced them." The problem is that this is a retrospective analysis, but it is the prospective impact that is important. When reviewed properly, according to the Federal Circuit, it becomes clear that a stay will reduce future burdens. Altogether, the Court found that the factors strongly favored a stay.
The outcome of this case was similar to that in VirtualAgility Inc. v. Salesforce.com, Inc., 759 F.2d 1307, 1312-12 (Fed. Cir. 2014). In that case, the panel majority also reversed and remanded. The one distinction was that in VirtualAgility Inc., Judge Newman dissented. She believed a trial judge's decision to stay an infringement action should be consigned to the judge's discretion.
An important question is whether this case will have any impact on stays in cases with corresponding IPRs, and other such proceedings before the PTAB. On the one hand, the IPR-section of the AIA does not articulate factors, and it contains a less deferential standard of review. On the other hand, the factors are common, and the lower courts will likely look to this case and VirtualAgility for guidance. Even if it will be more difficult to reverse and remand a denial of stay in the IPR context, the application of the factors from these cases could be persuasive to the lower courts. As such, the outcome of CBM decisions becomes more relevant to those that have little to no experience with the practice. Therefore, it would behoove all patent attorneys practicing before the PTAB to pay attention to these CBM decisions, and how the Federal Circuit is interpreting the statute.
Prioritized Examination Interim Rule Adopted As Final
Last March, we reported on an interim rule implemented by the U.S. Patent and Trademark Office that expanded the time periods for meeting certain requirements for filing a request for Track I prioritized examination (see "USPTO to Permit Delay in Meeting Certain Prioritized Examination Requirements"). Under the interim rule, the requirements for which the time periods were expanded included: the submission, upon filing, of an inventor's oath or declaration and all required fees, as well as an application containing no more than four independent claims, thirty total claims, and no multiple dependent claims. In particular, the rules changes (1) postponed the requirement to file an inventor's oath or declaration if an application data sheet meeting the conditions specified in 37 CFR 1.53(f)(3)(i) is present upon filing, (2) provided a non-extendable one-month period (following notification of noncompliance from the Office) to file an amendment to cancel any independent claims in excess of four, any total claims in excess of thirty, or any multiple dependent claim, and (3) no longer required the payment of excess claims fees or the application size fee upon filing.
In a final rule published in the Federal Register last week (79 Fed. Reg. 68124), the Office noted that it had received no comments from the public regarding the interim rule, and therefore adopted as final the amendments to the rules of practice set forth in the interim rule. The final rule took effect as of November 14, 2014, and applies to applications filed under 35 U.S.C. § 111(a) on or after September 16, 2012, in which a first action has not been mailed.
USPTO Extends Quick Path Information Disclosure Statement Pilot Program
The U.S. Patent and Trademark Office recently noted on its website that the Quick Path Information Disclosure Statement (QPIDS) pilot program has been extended to September 30, 2015. The QPIDS pilot program, which was implemented by the Office in May of 2012, allows applicants to have an Information Disclosure Statement (IDS) considered after the issue fee has been paid and without having to file a Request for Continued Examination (RCE) (see "USPTO Announces Quick Path Information Disclosure Statement (QPIDS) Pilot Program").
Under the QPIDS pilot program, an examiner will consider IDS submissions made after the issue fee has been paid (and provided that the conditions below are met) to determine whether prosecution should be reopened. Where the examiner determines that no item of information in the IDS necessitates reopening prosecution, the Office will issue a corrected notice of allowability and the application will pass to issue, thereby eliminating the delays and costs associated with RCE practice. To be eligible to participate in the pilot program, an application must be an allowed utility or reissue application for which the issue fee has been paid and the patent has not yet issued, and a QPIDS submission must be made electronically via the EFS-Web. The QPIDS submission must include the following:
• A transmittal form that designates the submission as a QPIDS submission (e.g., form PTO/SB/09); • An IDS accompanied by a timeliness statement set forth in 37 CFR 1.97(e), with the IDS fee set forth in 37 CFR 1.17(p) -- note: the QPIDS pilot program does not eliminate the requirements that an IDS be accompanied by the statement of 37 C.F.R. § 1.97(e)(1) or (2) and the fee set forth in 37 C.F.R. § 1.17(p)). • A Web-based ePetition to withdraw from issue under 37 CFR 1.313(c)(2), with the petition fee set forth in 37 CFR 1.17(h); and • An RCE, which will be treated as a "conditional" RCE, with the RCE fee under 37 C.F.R. 1.17(e) -- note: the IDS fee under 37 C.F.R. § 1.17(p) will be automatically returned if the examiner decides to reopen prosecution, necessitating that the RCE be processed, and the RCE fee will be automatically returned if the examiner determines that prosecution need not be reopened.
Additional information regarding the QPIDS pilot program can be found on the Office's QPIDS webpage.
USPTO Extends After Final Consideration Pilot 2.0 Program
The U.S. Patent and Trademark Office also recently noted on its website that the After Final Consideration Pilot 2.0 (AFCP 2.0) program has been extended to September 30, 2015. The AFCP, which was implemented in April 2012 (see "USPTO to Assess After Final Consideration Pilot Program") and then modified in May 2013 (see "USPTO News Briefs"), provides examiners with a limited amount of non-production time -- three hours for utility and reissue applications -- to consider responses filed following a final rejection.
In implementing the original AFCP, the Office described six limited situations in which further amendments or arguments may be considered under the AFCP:
1. The amendment places the application in condition for allowance by canceling claims or complying with formal requirement(s) in response to objection(s) made in the final office action. 2. The amendment places the application in condition for allowance by rewriting objected-to claims in independent form. 3. The amendment places the application in condition for allowance by incorporating limitations from objected-to claims into independent claims, if the new claim can be determined to be allowable with only a limited amount of further consideration or search. 4. The amendment can be determined to place the application in condition for allowance with only a limited amount of further search or consideration, even if new claims are added without cancelling a corresponding number of finally rejected claims. 5. The amendment can be determined to place the application in condition for allowance by adding new limitation(s) which require only a limited amount of further consideration or search. 6. The response comprises a perfected 37 CFR 1.131 or 37 CFR 1.132 affidavit or declaration (i.e. a new declaration which corrects formal defects noted in a prior affidavit or declaration) which can be determined to place the application in condition for allowance with only a limited amount of further search or consideration[.]
When the Office implemented the AFCP 2.0 program, it described three main differences between the original AFCP and the AFCP 2.0: (1) an applicant must file a request to participate in the AFCP 2.0; (2) a response after final rejection under the AFCP 2.0 must include an amendment to at least one independent claim; and (3) when a response does not result in a determination that all pending claims are in condition for allowance, the examiner will request an interview with the applicant to discuss the response. The requirements for participating in the AFCP 2.0 are as follows:
(1) a transmittal form that requests consideration under AFCP 2.0 (the Office suggests that applicants use form PTO/SB/434); (2) a response under 37 CFR 1.116, including an amendment to at least one independent claim that does not broaden the scope of the independent claim in any aspect; (3) a statement that the applicant is willing and available to participate in any interview initiated by the examiner concerning the accompanying response (according to the notice, "willing and available" means that the applicant is able to schedule the interview within ten (10) calendar days from the date the examiner first contacts the applicant); (4) any necessary fees (e.g., a request filed more than three months after the mailing of a final rejection must include the appropriate fee for an extension of time under 37 C.F.R. § 1.136(a)); and (5) the required papers must be filed via the EFS-Web.
In extending the AFCP 2.0 program, the Office notes that applicants submitting AFCP 2.0 requests will begin receiving a specialized form (PTO-2323) in response to requests. The new form will communicate the status of the submission, and if applicable, also accompany an interview summary. According to the Office, the new form is designed to more clearly indicate how the AFCP submission was treated by the examiner. Additional information regarding the AFCP 2.0 program can be found on the Office's AFCP 2.0 webpage.