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  • Patenting Necessary for Continued Innovation in Biotech/Pharma Industries, Academics Conclude

    By Kevin E. Noonan —

    Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical.  This has been due in part to political opposition to licensing university technology (and the purported soiling of the purity of the academic mission), the desire of corporate entities (foreign and domestic) to simply appropriate that technology, and the uneven distribution of university patent success stories (an outcome experienced tech transfer managers both understand and expect — one of the few truths in Bessen and Meurer's Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk is that most patents outside the biotech/pharma area are not "blockbusters").

    CoverWhich makes notable the recent report from Mari Lundeby-Grepstad and David Tordrup of the London School of Economics, and Tina Craig and David Taylor of the School of Pharmacy the University of Central London.  This report, entitled "Patients' Needs, Medicines Innovation and the Global Public's Interests: Achieving affordable universal care, enhanced public health and sustained investment in better treatments" was funded by the International Alliance of Patients' Organizations, which characterizes itself as "a global voice for patients."  The Report's conclusions and assumptions are set forth on the first page of the Report:

    • In 1900 world-wide average life expectancy at birth was no more than 40 years. Today it is about 70 years for men and women combined. Advances in medicine, surgery and medicines (ranging from antibiotics and anti-virals through to vaccines against diseases like pneumonia, hepatitis and HPV and drugs that reduce stroke and heart disease risks) have accounted for about half the improvements in health achieved since 1950.

    • As life expectancy rises and birth rates fall people's values alter, and societies go through profound changes. Providing universal access to health care typically becomes an increased priority, while relationships between health care professionals and health service users become less directive and more questioning. The influence of patients and patient organisations on health policies and practices tends to increase. They develop enhanced roles in areas such as research and clinical trial governance and health technology assessment.

    • There are important opportunities for pharmaceutical and other innovations to contribute further to improving the global public's health in areas ranging from the diagnosis, prevention and treatment of tropical infections through to the management of the common non-communicable conditions. There also are over 6,000 rare diseases that collectively affect 100 million people in the 'developed' OECD nations and up to 500 million world-wide. Many are currently difficult to diagnose and lack definitive treatments.

    • By 2050 further progress towards universal health care coverage and delivery, combined with ongoing health technology innovation, could virtually eliminate disease related child and working age adult deaths. It should also support active ageing in ways that cannot be achieved by life style changes alone. Realising such gains will depend on the political will needed to provide better health care combined with continuing public and private investment in high risk research in spheres such as medicines development.

    • Patients and patient organisations have important interests in both funding innovation and assuring access to effective treatments after they have been developed. Following concerns about the cost of and access to new HIV medicines in the 1990s, some commentators question the value of intellectual property rights (IPRs) such as pharmaceutical patents because they increase the prices of recent therapeutic developments. But without intellectual property rights private investment in high risk biomedical research would be very unlikely to take place. This would almost certainly have negative 'knock on' effects on public funding for fundamental research.

    • There is little realistic possibility that alternatives such as offering State or private donor backed prizes for developing therapeutic innovations could ever fully substitute for patents and regulatory data exclusivity based approaches to maintaining private investment in biopharmaceutical innovation. But initiatives like the recently proposed Health Impact Fund, Advanced Market Commitments and the examples set by organisations such as the Gates Foundation may usefully augment IPR based provisions.

    • If access to new 'essential' medicines is to be enhanced in ways that do not undermine innovative capacity, well designed national and international purchasing arrangements backed by differential pricing strategies are likely to play key roles. There is a case for the global extension of the periods of intellectual property protection available to health technology innovators, balanced by increased minimal cost supply obligations in poor communities.

    • Differential pricing between and within markets should allow innovators to enhance access to IP protected products without losing income and so reducing investment capacity. However, inappropriate movements of medicines between markets and resentments in higher price areas can make such schemes difficult to implement. International agreements about the principles and criteria on which differential pricing and allied approaches (including voluntary IPR and licence sharing) might in future enhance their viability.

    • Patient organisations should seek to clarify the definitions of essential medicines and public health emergencies. This could help protect world-wide public interests and prevent the inappropriate use of powers like compulsory medicines licensing.

    • There are uncertainties as to how robust intellectual property rights should be in order to sustain ongoing investments in high risk research. Individuals and organisations seeking to defend patient and public interests in maintaining the conditions needed for continuing innovation may be exposed to charges that they are defending commercial rather than health interests. Yet under-investing in research for the future would harm the interests of both patients and the global public. Lives lost and years of disability caused because innovations have been delayed can never be regained.

    • Measures developed by health economists to guide short term health resource allocation decisions under-estimate the long term society-wide value derived from medicinal and allied innovations. Because of the economics of their development and supply new medicines typically become – after the expiry of IP rights – low cost resources for long periods of time. This is a powerful reason for continuing to invest in innovative research in order to improve established treatments and create fundamentally new opportunities for the relief of suffering, the elimination of diseases and the enhancement of life.

    The conclusions are supported by the evidence set forth in the Report.  The policy dichotomy is recited explicitly:

    The advocates of intellectual property provisions such as patents and the temporary monopolies they award see them as an essential element in the infrastructure that underpins the global financing of medical and pharmaceutical research.  By contrast, critics say that they inhibit competition and free trade and deny poorer people low cost access to medicines and other goods that they need.

    The authors assert that there is no "scientific way to judge which of these approaches are correct, assuming there are 'elements of truth in both'" on both economic and ethical grounds.  But the Report cautions that while it would be "unacceptable if poor patients were routinely denied life saving treatments commonly available in affluent communities," it would also be ineffective to reduce patent rights through compulsory licensing and other actions that "sacrifice[] innovators' intellectual property rights.

    The Report characterizes innovation in the therapeutic space (including biologic and traditional small molecule drugs) as being "high technology products which are costly and risky to develop, but once marketed are often relatively inexpensive to copy."  Under these realities, "research based pharmaceutical producers are unusually reliant on the temporary shielding from unregulated free market forces that intellectual property rights provide," according to the Report.  Innovation remains important for "neglected tropical diseases" (like Chagas disease and schistosomiasis) and non-communicable diseases of aging like Alzheimers' disease, not to mention the estimated six to seven thousand "rare" diseases that affect up to 100 million people, against a backdrop of current biologic drug development that is palliative rather than curative and combines high cost with small increases in life expectancy.  In addition, so-called "lifestyle" changes will not be enough to significantly increase life expectancy, either as a global or regional average or in places in the world (such as Africa and India) where life expectancy has not reached Western levels.

    The "necessary conditions for innovation," according to the Report, include recognized need (although the Report also recognizes innovation that creates or recognizes the need and note that "directed" innovative efforts can be counter productive), funding, human and cultural factors that encourage innovative thinking.  The need for funding is illustrated by the cost of pharmaceutical research and development over the past twenty years in the U.S., Europe and Japan:

    Chart
    The authors conclude from this data that "modern medicines [like much modern technology] are high technology products," but differ from other high tech products by not comprising multiple parts (indeed, most often consisting of an active pharmaceutical ingredient and much more fungible excipients or other formulation components), which makes patent protection even more important for the underlying active ingredient.  There exists the paradox that while the cost of developing drugs increases (when R&D costs are added to regulatory approval costs), the size of the consumer pool is being reduced by high costs (reducing the size of the patient pool that can afford the drugs), generic competition, and the size of the relevant patient population inter alia related to more rare disorders.  As a consequence, there may be even greater economic pressure for exclusivity for such drugs even at a time that reducing drug costs is the goal of most countries around the world (albeit for different reasons).  (This tendency is illustrated by the length of the market exclusivity period in the Biologic Drug Act portion of the Affordable Healthcare Act and the complexity of the patent litigation provisions of the Act.)  Consequently:

    The danger for patients and the other beneficiaries of pharmaceutical innovation is that if the prospect of private profit from the supply of new medicines declines, so too in time will public investment in the discovery processes that open the way to their development.  There is also a possibility that, despite the importance of public sector values, a decline in commercial ethos driven innovation will weaken the efficiency of the overall system.  The key point to emphasise is that publicly and privately funded agencies have vital and mutually complementary roles to play in pharmaceutical and other science based innovative processes [citing Mazzucato, 2013].

    After providing a brief review of patenting and other intellectual property throughout the ages (including evidence that "patent medicines" were in fact adulterated forms of conventional but unpatented medicaments), the authors set forth a series of examples, including anti-retroviral drugs, in the context of challenges and failures of the system of intellectual property rights, international trade, and governmental intervention in providing such drugs to patients without the economic wherewithal to obtain them.  Accordingly:

    The past weaknesses of not only pharmaceutical industry but also some governments' approaches to this area has in recent decades done much to increase patient and wider public concerns about the negative public health impacts of IPRs.  The development of effective anti-HIV drugs was a triumph for research based companies and their University and other public sector partners.  However, the reputational damage to the innovative pharmaceutical industry associated with HIV patients not being able to afford life saving treatment has been comparable to that inflicted by the Thalidomide tragedy of the early 1960s.

    Also mentioned are the varying estimated costs of new drug development, which the authors conclude is much closer to the $1 billion estimate by the pharmaceutical industry than the $100 million estimate by commentators like Light and Lexchin (2012, Pharmaceutical research and development: what do we get for all that money? British Medical Journal, 345:e4348), as well as comparisons of profitability between the pharmaceutical and biotech industries compared with other industries, concluding that in all industries "there is a relationship between the share of total income devoted to research and development and profitability [wherein] [t]he more the relative amount invested in innovation the higher the level of return," which has benefited these industries.  But the authors caution that "taking [the] unusually high proportion of {biotech and pharma company] income[s] on R&D [] their returns are not out of line with those of other successful industries."

    Provocatively, the authors also pose the question of "[f]rom a public health viewpoint, would it matter if pharmaceutical patents were abolished," concluding that while there are instances of "market failure" (where there is little financial incentive to innovate for populations too small or impoverished for a company to profit from its efforts), "commercially funded pharmaceutical innovation facilitated by the existence of IPRs makes valuable contributions to the well-being of people everywhere in the world," citing the work of Pogge (2005, Human rights and global health: a research program. Metaphilosophy, 36, 182-209.), Sonderholm (2010, A reform proposal in need of reform: a critique of Thomas Pogge's proposal for how to incentivize research and development of essential drugs. Public health ethics, 3, 167-177), and Dimasi and Grabowski (2007b, Should the patent system for new medicines be abolished? Clinical pharmacology and therapeutics, 82, 488-490).  The alternative, the authors propose, is the need for "augmented" methods to encourage innovation in such circumstances, such as orphan drug laws in the U.S. and Europe.  And while the Report notes that "from the perspective of politicians and planners based in countries with very limited financial resources, IP 'sharing' and the granting of CLs is likely to appear attractive," "patient groups and others seeking to defend the interests of not only the poorest in the global community but also people with currently untreatable conditions might be better advised to focus on seeking the free or 'marginal cost' supply of essential new medicines in communities that are unable to pay more, while recognising that global welfare will be further enhanced if innovators retain an ability to generate substantive returns elsewhere in the global market place."

    The Report also questions whether the TRIPS agreement prevented poor countries getting access to "essential" medicines (it did not, thanks in part to the Doha Declaration and how that instrument was implemented by countries such as Brazil and India with regard to compulsory licensing); the effects of "ever-greening" patented drugs (which is less of a problem when the "original" form of the drug remains available, as a generic equivalent or otherwise); the Myriad case involving patents on genetic material (the authors believing that the Supreme Court decision "provides significant assurance that IPRs cannot be used to inhibit fundamental research"), and whether new forms of intellectual property are needed (the authors concluding that "although governments may impose price controls on pharmaceuticals with the objective of curbing costs, there is from a patient and global public interest standpoint a counterbalancing need to ensure that spending on developing innovative technologies is not unduly restricted").

    Finally, the Report considers proposals, by Pogge and Hollis and others, that financing of biopharmaceutical research be "completely separated" from commercial sales of medicine, stating that "in some circumstances" that might be desireable (such as novel funding from groups like the Gates Foundation for specific projects such as development of new medicines for malaria) or suggestions that prizes be offered for developing new medicines in specific, "high priority" fields (although the authors note that "in complex and fast evolving fields there is a danger they may lack the flexibility needed to maintain their relevance to changing public and patient needs" and "[t]he extent to which such an approach could be scaled up beyond the occasional 'once-off' level is also uncertain, and there is no evidence to suggest that a prize based approach could ever fully replace existing IPRs").

    Overall, the Report provides a balanced assessment of the challenges and possibilities of pharmaceutical development in the 21st Century and the appropriate role of intellectual property rights in fostering future progress.  The authors conclude that:

    In the final analysis intellectual property laws represent a logically coherent, market led rather than centrally directed, mechanism for 'taxing' the use of recent innovations in order to defend public interests in incentivising continuing investment in areas like medicines discovery.  This serves the interests of people with presently untreatable conditions, and underpins the funding of incremental and 'step change' innovation alike.

  • Consumer Watchdog Replies to United States Brief on Standing Issue

    By Donald Zuhn —

    Consumer WatchdogIn December, the Federal Circuit invited the United States to address the issue of whether Consumer Watchdog had Article III standing to pursue an appeal of a decision by the Board of Patent Appeals and Interferences affirming the patentability of U.S. Patent No. 7,029,913, which is assigned to the Wisconsin Alumni Research Foundation (WARF).  The appeal arose from an inter partes reexamination of the '913 patent that Consumer Watchdog filed in 2006.  On January 17, the government argued that Consumer Watchdog lacked standing, and therefore, that its appeal should be dismissed (see "United States Argues That Consumer Watchdog Lacks Standing to Appeal Board Decision on WARF Patent").

    In a brief filed on January 27, Consumer Watchdog argued that it indeed had standing to pursue the appeal.  Consumer Watchdog opened by contending that:

    [N]one of the parties who are merely interested in th[e] patentability [of the '913 patent] has standing to bring this case.  Instead, only one party has standing to appeal the adverse decision of the PTO in inter partes reexamination number 95/000154 pursuant to 35 U.S.C. §§141 and 315(b)(1).  Consumer Watchdog is that party.

    Consumer Watchdog acknowledges that "[a]s the Government pointed out repeatedly in its brief, the PTO could have declined CW's request for reexamination altogether, making the two statutes inapplicable to CW" (citations omitted).  However, the brief argues that "[a]fter CW completed that task and participated in the reexamination and Board of Patent Appeals and Interferences appeal for over five years at the PTO, the government's characterization of CW as 'wholly a stranger to the '913 patent' is hardly accurate" (citations omitted).

    Consumer Watchdog contends that it has a concrete, differentiated interest in the Board's decision affirming the patentability of the '913 patent.  The brief states that:

    The government action that CW seeks to challenge here is not, as the Government insinuates, the patenting of a claimed invention, which applies equally to all people in the United States save the patentee.  Instead, it is the PTO's specific action of, after granting CW's request for reexamination of the '913 patent, issuing a decision with which CW was dissatisfied in the reexamination, an action that applies uniquely to CW.

    Reiterating an argument in support of standing from its previous brief, Consumer Watchdog points to "three contexts in which petitioners who had requested and been denied a particular agency action sought and received judicial review, under a statute granting requesters that review, without showing injury independent of the denial."  Those three contexts consisted of requests under FECA and FOA, as well as the inter partes reexamination statutory scheme at issue here.  With respect to the latter, the brief notes that "[t]his Court has heard no less than four cases by third-party requesters who did not show independent injury."  In contrast, the brief points out that "[t]he Government does not reference a single case in which a denied requester who cited a statute granting judicial review to such denied requesters needed to prove injury to show standing."  While the government cited to cases under the APA and EPA, Consumer Watchdog suggests that "[w]hat distinguishes the APA/EPA cases from the FOIA/FECA/inter partes reexam cases is that, in the former cases, the plaintiffs sought review under statutes that didn't designate them as the precise parties to whom review was available," and therefore, contends that "[a]n independent showing of injury was thus necessary for standing."

    According to the brief, the government creates an unsupportable loophole by arguing that a finding of no standing for Consumer Watchdog would not prevent the Court from finding standing for other third-party requesters of inter partes reexaminations whose disputes are unripe for declaratory judgment jurisdiction.  In particular, Consumer Watchdog argues that:

    [A]n inter partes review decision favorable to patentability would injure a prospective competitor only in exactly the same way that CW is injured here.  The competitor would have spent substantial resources on a proceeding that did not change its inability to practice the claimed invention, and it would be estopped from challenging the validity of the upheld claims in the future.  If the Court does not find standing for CW in this case, it cannot justifiably find standing for other third-party requesters whose cases are unripe for declaratory judgment jurisdiction.

    The brief criticizes the government's failure "to address the pragmatic catastrophe of its suggestion," asking whether the Court will need to schedule preliminary standing hearings in all such cases before it can reach the merits.  The brief also asks "[i]f the facts and circumstances change throughout the proceeding, should the Court be forced to continually measure the then-present motivations and intentions of the third party requester, deciding that maybe today the intentions are sufficient for standing, but tomorrow they are not?"

    Finally, Consumer Watchdog argues that the government's position would create an asymmetrical scheme in which the third-party requester, but not the patentee, would be denied the right to appeal an adverse decision.  The brief explains that:

    A rule that certain third-party requesters, competitors or not, lack the right to appeal a decision that would unquestionably be appealable by the adverse party if reversed is tantamount to saying to prospective third-party requesters, "You may participate, but only until you lose."  According to the government, if a patentee wins at the PTO, the requester may not appeal to the Court, and the matter is over.  If a patentee loses at the PTO, however, then it may indeed appeal to the Court, where if it wins, the challenger would not have the right to seek further review either en banc or from the Supreme Court.

    Consumer Watchdog concludes by arguing that "[s]uch an asymmetrical ending to what Congress unambiguously intended to be an inter partes proceeding is unjust and violates principles of fundamental fairness."

    In a letter to the Court, WARF's counsel noted that "[b]ecause Appellee Wisconsin Alumni Research Foundation fundamentally agrees with the United States' position as applied to the facts of this case — specifically, that Consumer Watchdog lacks Article III standing to pursue its appeal in this Court — Appellee declines the Court's invitation to file a responsive brief."

  • Court Report

            By Sherri Oslick —

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

    Novartis Pharmaceuticals Corp. et al. v. Dr. Reddy's Laboratories Ltd. et al.
    1:14-cv-00157; filed February 5, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG
    • Defendants:  Dr. Reddy's Laboratories Ltd; Dr. Reddy's Laboratories Inc.

    Infringement of U.S. Patent No. 6,894,051 ("Crystal Modification of a N-phenyl-2-pyrimidineamine Derivative, Processes for Its Manufacture and Its Use," issued May 17, 2005) following a Paragraph IV certification as part of Dr. Reddy's filing of an ANDA to manufacture a generic version of Novartis' Gleevec® (imatinib mesylate, used for various indications, including treatment of myeloid leukemia).  View the complaint here.

    Monsanto Co. et al. v. Ponder et al.
    7:14-cv-00013 filed February 5, 2014 in the Middle District of Georgia

    • Plaintiffs:  Monsanto Co.; Monsanto Technology LLC
    • Defendants:  Christopher Ponder; Chris Ponder Farms LLC

    Infringement of U.S. Patent Nos. 6,949,696 ("Chimeric Figwort Mosaic Virus-Elongation Factor 1 α Promoters and Methods of Using Them," issued September 27, 2005) and 7,064,249 ("Plants Transformed to Express CRY2A δ-Endotoxins," issued June 20, 2006) based on defendant's use of cotton seed produced from earlier planted Roundup Ready® Flex, Bollgard II®, and/or Roundup Ready® Flex with Bollgard II® cotton seed, or combinations thereof.  View the complaint here.

    Teijin Ltd. et al. v. Ranbaxy Laboratories Ltd. et al.
    1:14-cv-00117; filed January 31, 2014 in the District Court of Delaware

    • Plaintiffs:  Teijin Ltd.; Teijin Pharma Ltd.; Takeda Pharmaceuticals U.S.A., Inc.
    • Defendants:  Ranbaxy Laboratories Ltd.; Ranbaxy Pharmaceuticals Inc.; Ranbaxy Inc.

    Infringement of U.S. Patent No. 6,225,474 ("Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and Method of Producing the Same," issued May 1, 2001) following a Paragraph IV certification as part of Ranbaxy's filing of an ANDA to manufacture a generic version of Takeda's Uloric® (febuxostat, used for the chronic management of hyperuricemia in patients with gout).  View the complaint here.

    Cephalon Inc. v. Actavis LLC et al.
    1:14-cv-00122; filed January 31, 2014 in the District Court of Delaware

    • Plaintiff:  Cephalon Inc.
    • Defendants:  Actavis LLC; Actavis Elizabeth LLC

    Infringement of U.S. Patent Nos. 8,445,524 ("Solid Forms of Bendamustine Hydrochloride," issued May 21, 2013) and 8,436,190 ("Bendamustine Pharmaceutical Compositions," issued May 7, 2013) following a Paragraph IV certification as part of Actavis' filing of an ANDA to manufacture a generic version of Cephalon's Treanda® (bendamustine hydrochloride, used to treat chronic lymphocytic leukemia and non-Hodgkin's lymphoma).  View the complaint here.

    Forest Laboratories Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
    1:14-cv-00121; filed January 31, 2014 in the District Court of Delaware

    • Plaintiffs:  Forest Laboratories Inc.; Forest Laboratories Holdings Ltd.; Merz Pharma GmbH & Co. KGaA; Merz Pharmaceuticals GmbH; Adamas Pharmaceuticals Inc.
    • Defendant:  Teva Pharmaceuticals USA Inc.; Wockhardt USA LLC; Wockhardt Bio AG; Wockhardt Ltd.; Sun Pharma Global FZE; Sun Pharmaceutical Industries, Ltd.

    Infringement of U.S. Patent Nos. 5,061,703 ("Adamantane Derivatives in the Prevention and Treatment of Cerebral Ischemia," issued on October 29, 1991), 8,039,009 ("Modified Release Formulations of Memantine Oral dosage Forms," issued October 18, 2011), 8,168,209 ("Method and Composition for Administering an NMDA Receptor Antagonist to a Subject," issued May 1, 2012), 8,173,708 (same title, issued May 8, 2012), 8,283,379 ("Method and Compositions for the Treatment of CNS-Related Conditions," issued October 9, 2012), 8,329,752 ("Composition for Administering an NMDA Receptor Antagonist to a Subject," issued December 11, 2012), 8,362,085 ("Method for Administering an NMDA Receptor Antagonist to a Subject," issued January 29, 2013), and 8,598,233 (same title, issued December 3, 2013) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Forest's Namenda XR® (memantine hydrochloride extended release, used for the treatment of moderate to severe dementia of the Alzheimer's type).  View the complaint here.

    Phigenix, Inc. v. Genentech, Inc.
    1:14-cv-00287; filed January 31, 2014 in the Northern District of Georgia

    Infringement of U.S. Patent No. 8,080,534 ("Targeting PAX2 for the Treatment of Breast Cancer," issued December 20, 2011) based on Genentech's manufacture and sale of its Kadcyla® (ado-trastuzumab emtansine, used to treat patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination).  View the complaint here.

    Senju Pharmaceutical Co., Ltd. et al. v. Lupin, Ltd. et al.
    1:14-cv-00667; filed January 31, 2014 in the District Court of New Jersey

    • Plaintiffs:  Senju Pharmaceutical Co., Ltd.; Bausch & Lomb, Inc.; Bausch and Lomb Pharma Holdings Corp.
    • Defendants:  Lupin, Ltd.; Lupin Pharmaceuticals, Inc.

    Infringement of U.S. Patent No. 8,129,431 ("Aqueous Liquid Preparation Containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid," issued March 6, 2012) following a Paragraph IV certification as part of Lupin's filing of an ANDA to manufacture a generic version of B&L's Prolensa® (bromfenac ophthalmic solution, used to treat postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery).  View the complaint here.

    Sanofi-Aventis U.S. LLC et al. v. Eli Lilly and Company
    1:14-cv-00113; filed January 30, 2014 in the District Court of Delaware

    • Plaintiffs:  Sanofi-Aventis U.S. LLC; Sanofi-Aventis Deutschland GmbH
    • Defendant:  Eli Lilly and Company

    Infringement of U.S. Patent Nos. 8,556,864 ("Drive Mechanisms Suitable for Use in Drug Delivery Devices," issued October 15, 2013), 8,603,044 ("Pen-Type Injector," issued December 10, 2013), 7,476,652 ("Acidic Insulin Preparations Having Improved Stability," issued January 13, 2009), and 7,713,930 (same title, issued May 11, 2010) following a Paragraph IV certification as part of Lilly's filing of an NDA (under § 505(b)(2) of the Food, Drug and Cosmetic Act) to manufacture an insulin glargine for injection in a prefilled insulin delivery device, comparable to Sanofi's Lantus® and Lantus® SoloSTAR® products (insulin glargine [rDNA origin] for injection, used to treat diabetes).  View the complaint here.

  • Conference & CLE Calendar

    CalendarFebruary 13, 2014 – "Proactive Patent Procurement and Prosecution Strategies: Minimizing the Threat of Post-Grant Challenges — Insulating Your Patent Portfolio From New Threats" (Strafford) – 1:00 to 2:30 pm (EST)

    February 18, 2014 – "Proposed Patent Reform Legislation: How It May Impact You (Especially if You Are Not Considered to be a 'Patent Troll'" (McDonnell Boehnen Hulbert & Berghoff LLP) – 10:00 to 11:15 am (CT)

    February 19-20, 2014 – AIA Post-Grant Patent Practice Conference (International Intellectual Property Institute and Bloomberg BNA) – Arlington, VA

    February 20, 2014 – "Protecting IP Rights in Joint Development Agreements and Strategic Alliances — Structuring JDAs to Apportion Contributed, Joint and Derivative IP; Planning for Involuntary Early Endings; and Avoiding Unintended Consequences" (Strafford) – 1:00 to 2:30 pm (EST)

    February 26-27, 2014 – Pharmaceutical and Biotechnology Patent Life Cycles and Portfolio Strategies*** (American Conference Institute) – New York, NY

    February 27, 2014 – "Patent Inventorship: Best Practices for Determination and Correction — Drawing the Line Between Inventor and Contributor, Leveraging Lessons From Year One of the AIA" (Strafford) – 1:00 to 2:30 pm (EST)

    February 28, 2014 – 58th Annual Intellectual Property Law Conference (John Marshall Law School Center for Intellectual Property Law) – Chicago, IL

    March 5-7, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) – Cincinnati, OH

    March 12-13, 2014 – FDA Boot Camp*** (American Conference Institute) – New York, NY

    March 24-26, 2014 – Medical Device Patents*** (American Conference Institute) – Chicago, IL

    March 25, 2014 – 24th Annual Conference on USPTO Law and Practice (PTO Day) (Intellectual Property Owners Association and U.S. Patent and Trademark Office) – Washington, D.C.

    March 26-27, 2014 – Biotech Patenting*** (C5) – Munich, Germany

    March 31 to April 2, 2014 - Life Sciences Collaborative Agreements and Acquisitions*** (American Conference Institute) - New York, NY

    August 13-15, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

    August 18-20, 2014 – Advanced Patent Law Seminars (Chisum Patent Academy) - Seattle, WA

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

  • PTO Day

    USPTO SealThe Intellectual Property Owners Association (IPO) and U.S. Patent and Trademark Office will be co-sponsoring the 24th Annual Conference on USPTO Law and Practice (PTO Day) on March 25, 2014 in Washington, D.C.

    The PTO Day program includes patent general sessions on the following topics:

    • USPTO Year in Review; Glossary Initiative/Electronic Tools; Working Together to Improve Patent Examination Pendency and Quality
    • Recent Patent Case Law Update

    And breakout sessions on the following topics:

    • Legislative Update and Strategies for Success in Post-Grant Proceedings
    • Patenting Emerging Technologies and Design Patents
    • Patent Ethics: USPTO Final Rules; Administrative Law Primer for Ethical Rulemaking and Commenting; Properly Identifying the Real Party in Interest

    IPO #2In addition, USPTO Deputy Director Michelle Lee will provide a luncheon address.  A copy of the program, including an agenda, can be found here.

    The registration fee for the conference ranges from $225 (government/academic registration) to $700 (general registration).  Those interested in registering can do so here.

  • Gene-by-Gene Cries Uncle, Settles with Myriad Genetics

    By Kevin E. Noonan —

    Gene by GeneGene-by-Gene, Inc. was one of the first direct-to-consumer (DTC) genetic diagnostics companies to announce that it would offer BRCA1/BRCA2 testing after the Supreme Court's decision last June that certain of Myriad Genetics' claims (those that encompassed isolated genomic DNA) were invalid for reciting patent-ineligible subject matter.  And Gene-by-Gene was one of the first DTC genetic diagnostic companies sued by Myriad for offering such testing. (see "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes"), followed by lawsuits against several other companies offering or threatening to offer Myriad's BRCA tests.

    MyriadNow, Gene-by-Gene has become the first DTC genetic diagnostic company to settle with Myriad, in what can only be characterized as complete victory for the patentee.  Under the terms of the agreement, Gene-by-Gene will immediately cease "selling or marketing" BRCA gene tests, either as standalone tests or as part of a wider panel in the U.S.  The company will be able to offer "whole genome" testing and exome testing, as well as "custom" array products for Mendelian-inherited disease and disorders (which may include the BRCA genes).  This agreement will last until either February 12, 2016 or the expiration date of the last-to-expire valid patent claims of any of the patents in the Myriad v. Gene-by-Gene lawsuit (which include U.S. Patent Nos. 5,709,999; 5,747,282; 5,753,441; 5,837,492; 6,033,857; 5,654,155; 5,750,400; 6,951,721; and 7,250,497).  Myriad's suit against Gene-by-Gene was dismissed without prejudice, leaving open the possibility for Myriad to reinstitute the lawsuit should Gene-by-Gene violate any of the terms of the agreement.

    There was a great deal of crowing by the ACLU and its friends and supporters when the Supreme Court rendered its decision, while cooler (and more experienced) commentators noted that Myriad had many more patent claims not challenged by the plaintiffs in the AMP v. Myriad Genetics case.  This settlement indicates that, at least for one company, the prospect of successfully challenging Myriad's remaining patent estate was sufficiently daunting that litigation was not a happy prospect.  This settlement also suggests that the ACLU failed in its purported goal of making BRCA testing more widely available than it has become due to Myriad's efforts over the past 17 years.

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

    • " Invitae Files Motion to Dismiss for Lack of Personal Jurisdiction in Myriad Genetics v. Invitae Corp.," December 11, 2013
    • " Myriad Genetics Sues LabCorp over BRCA Gene Testing," December 4, 2013
    • " Myriad Genetics Sues Invitae over BRCA Gene Testing and Invitae Sues Right Back," November 27, 2013
    • "Where Do We Stand?" October 31, 2013
    • "Defendants' Oppose Myriad's Motions to Dismiss Antitrust Counterclaims," October 28, 2013
    • "Myriad Genetics Files Amended Complaint Relating to Colon Cancer Genetic Diagnostic Testing," October 23, 2013
    • "Myriad Genetics Sues Quest for Patent Infringement," October 22, 2013
    • "Myriad Sues GeneDx on BRCA and Other Genetic Diagnostic Patents," October 21, 2013
    • "Diagnostics Giant Quest Files Declaratory Judgment Action against Myriad Genetics," October 13, 2013
    • "Bay Area Genetic Diagnostics Company Files Declaratory Judgment Action against Myriad Genetics," October 10, 2013
    • "Preliminary Injunction in Myriad v. Ambry and Gene-by Gene: Myriad Replies," October 9, 2013
    • "Defendants' Response to Myriad's Preliminary Injunction Motions," September 19, 2013
    • "Myriad Moves to Dismiss Ambry's Antitrust Counterclaims on Noerr-Pennington Doctrine," August 28, 2013
    • "Amici Submit Brief in Support of Ambry Genetics and Gene by Gene," August 27, 2013
    • "Ambry Responds to Myriad Lawsuit," August 7, 2013
    • "Why Does Myriad Think It Can Win BRCA Gene Lawsuits?" July 30, 2013
    • "Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes," July 10, 2013
    • "Myriad Genetics Files Suit Against Ambry Genetics for Genetic Diagnostic Testing of BRCA Genes," July 9, 2013

  • Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2014)

    By Andrew Williams —

    The standard of review at the Federal Circuit is important.  Even though it often appears like cases are re-litigated at the Appeals Court, it is actually very difficult (or at least should be) to overturn a lower court's factual determinations.  This is especially true for a finding that a patent was not shown to be invalid, because the burden at the trial court is clear and convincing evidence.  Moreover, the standard of review for any factual determination made by the lower court is "clear error."  This high standard might just have been the reason that the Federal Circuit upheld the validity of Pfizer’s Lyrica® patents earlier today in Pfizer Inc. v. Teva Pharmaceuticals USA, Inc.

    PfizerLyrica® is a drug for treating seizures and certain types of pain.  The present case was brought pursuant to the Hatch-Waxman scheme of 35 U.S.C. § 271(e)(2) after several companies filed ANDAs to market a generic version of this drug.  These companies included Teva, Sun Pharma Global, Inc, Mylan Pharmaceuticals, and about nine other companies.  Plaintiffs, which included Pfizer, CP Pharmaceuticals International C.V., Warner-Lambert Company LLC, and Northwestern University, asserted two patents, U.S. Patent No. 6,197,819 ("'819 patent") and U.S. Reissue Patent No. RE41,920 ("RE '920 patent").  Ultimately, only claim 2 of the '819 patent was at issue on appeal.  This claim reads:

    2.  4-amino-3-(2-methylpropyl) butanoic acid, or a pharmaceutically acceptable salt thereof.

    This compound is also known as 3-isobutylGABA.  The active ingredient in Lyrica® is the S-enantiomer of this compound, which is specifically claimed in claim 1 of the same patent.  Based on the lower court claim construction of claim 2, the Appellants stipulated to infringement.  In addition, the trial court found that the Appellants had not established with clear and convincing evidence that claim 2 was invalid as non-enabled, not described, or obvious.  As their moniker would suggest, the Appellants appealed these determinations.

    Claim Construction and Infringement

    The first issue was the construction of the claim term "4-amino-3-(2-methylpropyl) butanoic acid."  Of course, claim construction is a matter of law, which the Federal Circuit reviews de novo, thanks to Cybor Corp.  The lower court had construed this term to cover 3-isobutylGABA generally, and therefore it would cover racemic mixtures, pure enantiomers, or any ratio in between.  The Appellants alleged that the term should be limited to the racemic (50:50) mixture, based on statements made in the specification and the prosecution history.  They were, of course, advocating such a construction because their proposed products contained non-racemic mixtures, and therefore would have avoided infringement.

    Nevertheless, the Federal Circuit agreed with the lower court that the plain and ordinary meaning of the claim term does not include such a narrowing limitation.  In fact, the Court noted that the use of the terms "racemate," "racemic," the prefix (R,S) by the inventors in the application indicated that they had no such intention to so limit the claims.  "[T]he patentee's use of the prefix in the tables demonstrates that it knew how to specify racemic 3-isobutylGABA as distinguished from the compound generally and chose not to do so in claim 2."  Slip Opinion at 9-10.  The Appellants pointed to the fact that only racemic mixtures were discussed in the "results" section of the specification.  However, "[a]bsent a clear disavowal or lexicographic definition in the specification or the prosecution history, the reporting of test results limited to a racemate does not warrant importing a racemic limitation into claim 2."  Because Appellants stipulated to infringement under this construction, the Court affirmed that finding.

    Enablement

    Even though enablement is a question of law, and therefore reviewed without deference, the underlying factual inquiries are reviewed for clear error.  The District Court had held that a person of ordinary skill in the art could have made the claimed 3-isobutylGABA compound with no more than routine experimentation based on the disclosure in the '692 application's specification.  The '692 application was filed in 1990, and if it did not enable claim 2, intervening art before the '819 patents filing date may have invalidated the claim.  The Appellants had argued that, because the 3-isobutylGABA claim term was construed to cover all enantiomeric ratios, the patent disclosure must teach "every conceivable mixture," including 100% pure enantiomers.  The trial court had found that there was no dispute that the co-inventors were the first to create and claim the "3-isobutylGABA" chemical compound.  In addition, the court had found that the specification stated that "enantiomers may be prepared or isolated by methods already well known in the art," and that there was sufficient support for this statement based on "the prior art, the prosecution history, and witnesses' trial testimonies."  Id. at 12.

    The Federal Circuit did not believe that this determination was clearly erroneous, and therefore it affirmed that claim 2 was not invalid for lack of enablement.  In response to the Appellants' contention that the specification provides no guidance as to how to purify the two enantiomers, the Federal Circuit stated that "the inventors were not required to provide a detailed recipe for preparing every conceivable permutation of the compound they invented to be entitled to a claim covering that compound."  Id.  The Court pointed out that "[w]here a claim has been construed to cover a chemical compound, the specification is not deficient merely because it does not disclose how to prepare a particular form or mixture — among hundreds of possible permutations — of that compound."  Id.  In other words, the Federal Circuit appears to be saying that to satisfy the enablement requirement, one need not enable the entire scope of genus claim.  This is at least true if the methods of generating the full scope are well known in the art.

    Written Description

    Of all of the Appellants, only Sun pursued invalidity of claim 2 for failing the written description requirement.  This determination is a question of fact, and therefore is reviewed for clear error.  Sun's principal argument was that the '692 application discloses nothing that would suggest that the inventors could isolate the individual enantiomers.  As such, they could not have been in possession of the entire scope of claim 2.  In fact, later applications provided support for the proposition that the inventors were not able to separate the enantiomers as of the filing date of the '692 application.  Nevertheless, the Federal Circuit found that Sun's argument was "surprisingly similar" to the other parties' position on enablement.  Important in the Court's decision was that claim 2 was a genus claim that encompassed all mixtures of the enantiomers.  "But written description does not require inventors, at the time of their application for a patent, to reduce to practice and be in physical possession of every species . . . of a genus . . . claim."  Id. at 14.  It probably did not help Sun's cause that the lower court found that it presented a "dearth of evidence at trial . . . ."  Id. at 13.  As such, the Federal Circuit affirmed the lower court's finding that the '692 application contained an adequate written description for claim 2.

    Obviousness

    Finally, the Federal Circuit affirmed the lower court's determination that the claimed invention was not obvious.  Such a determination is legal in nature, but it is based on underlying facts.  The Appellants' argued on appeal that the lower court committed clear error for failing to find the following:  (1) that three references, U.S. Patent No. 4,322,440 ("Fish"), U.S. Patent No. 5,051,448 ("Shashoua"), and a 1962 article ("Colonge"), taught that isopropylGABA may have anticonvulsant activity; (2) that a skilled artisan would have expected 3-isobutylGABA would have had the same activity as isopropylGABA because of structural similarity; and (3) 3-alkylGABA, a prior art compound, provided the motivation to try other alkyl substituents at the 3-position.  However, the Court suggested that the Appellants' real failing was that "the evidence presented at trial was too sparse."  Id.  at 17.

    The determination that a new chemical compound is obvious is a two-step process.  First, the court must determine whether a particular "lead" compound would have been selected by a skilled artisan.  Second, it must be established that one skilled in the art would have been motivated to modify the lead compound to derive the claimed invention.  Unfortunately for Appellants, the record below contained "scant evidence" to establish either gabapentin or 3-isopropylGABA as lead compounds.  Even though Appellants may have established that both of these compounds were being tested for anticonvulsant effects, Appellants presented "no testimony establishing its being tested prior to the discovery of 3-isobutylGABA."  Id. at 18.  With regard to gabapentin, the Court found that "there was no evidence in the record of motivation for a skilled artisan to modify gabapentin for further anticonvulsant research."  Id.  The evidence related to 3-isopropylGABA was described as "just as meager."  Id.  Even though Fish, Shashoua, and Colonge may have disclosed the compound, the lower court found that the record lacked "any explanation for 'what structures were important for anticonvulsant activity[.]'"  Id.  As such, there was simply no reason to select 3-isopropylGABA for further modification.

    There was also a lack of evidence to establish the second step.  Appellants alleged that the three prior art references would have taught modifying the 3-position with "lower alkyl substitutes."  However, even though these references disclosed "trillions" of compounds, they did not call out alkyl groups, much less isobutyl substitutions.  "Indeed, a vague suggestion in the prior art pointing to a broad class of compounds, without any teaching particularly identifying isobutyl among the millions of potential compounds, is not a teaching of 'specific molecular modifications' required by [Federal Circuit] precedent."  Id. at 20.  The lower court had found that Pfizer credibly established that drug discovery in the anticonvulsant field was "complicated," "highly unpredictable," and "largely conducted through trial and error."  Id.  As such, there would have been no reasonable expectation of success to teach any substitution at the 3-position.

    The important take away lesson from this case is to focus on the standard of review at the Federal Circuit, especially if you are challenging a finding that a patent is not invalid.  It is also essential that get all of your evidence in at trial.  This is because if you need to prove that the lower court's determination was clearly erroneous, you had better have presented sufficient evidence at trial to establish that fact.

    Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2014)
    Nonprecedential disposition
    Panel:  Chief Judge Rader and Circuit Judges Prost and Moore
    Opinion by Circuit Judge Prost

  • United States Argues That Consumer Watchdog Lacks Standing to Appeal Board Decision on WARF Patent

    By Donald Zuhn —

    Department of Justice (DOJ) SealIn December, the Federal Circuit invited the United States to address the issue of whether Consumer Watchdog had Article III standing to pursue an appeal of a decision by the Board of Patent Appeals and Interferences affirming the patentability of U.S. Patent No. 7,029,913, which is assigned to the Wisconsin Alumni Research Foundation (WARF).  The appeal arose from an inter partes reexamination of the '913 patent that Consumer Watchdog, which describes itself as a not-for-profit public charity dedicated to providing a voice for taxpayers and consumers in special interest-dominated public discourse, government and politics, filed in 2006 (see "Consumer Watchdog Argues That WARF Stem Cell Patent Is Invalid under § 101").

    Consumer WatchdogIn a  brief submitted by the United States on January 17, the government argued that Consumer Watchdog lacked standing, and therefore, that its appeal should be dismissed.  Noting that unless a party has a concrete and particularized interest in the question presented, neither the Federal Circuit nor any other Article III court had the power to render judgment.  "Because Consumer Watchdog fails to identify any concrete or particularized interest in the patentability of the invention claimed in . . . the '913 patent[]," the government declared that "it lacks standing to invoke this Court’s jurisdiction."  The brief explains that "Consumer Watchdog does not suggest that it is an actual or prospective competitor or licensee of . . . WARF[], nor does it assert any concrete interest in the invention claimed in the ’913 patent."

    WARFWhile noting that "Congress may — and commonly does — authorize administrative agencies to take action or issue decisions at the behest of parties who lack any particularized interest in the subject matter of the proceeding," the government states that "[w]hen the petitioner in such a proceeding later seeks judicial review in an Article III court,  . . . 'the constitutional requirement that it have standing kicks in.'"  The government suggests that in many cases, the petitioner's standing to appeal will be apparent.  For example, the brief notes that if the Board had determined that the '913 patent was unpatentable, "there would have been little doubt regarding WARF's standing to appeal that adverse decision."  However, the government argues that Consumer Watchdog cannot appeal the Board's decision affirming the patentability of the '913 patent "unless it can identify some particularized, real-world consequence of that decision for Consumer Watchdog itself."  Although "Consumer Watchdog is plainly adverse to WARF and believes the ’913 patent to be invalid," the brief asserts that this alone is insufficient to demonstrate the existence of a justiciable case or controversy.  The government explains that Consumer Watchdog "claims no commercial interest in the subject matter of the ’913 patent; it faces no plausible risk of an infringement claim; it is neither a prospective competitor nor a prospective licensee of WARF[; n]or does Consumer Watchdog assert any basis for associational or representative standing."  As a result, the government contends that Consumer Watchdog lacks standing to appeal the Board's reexamination decision because, "as far as the organization's own concrete interests are concerned, it does not matter whether PTO got the right answer."

    In response to Consumer Watchdog's argument that there is no standing problem because Congress and the President gave the courts the power to resolve such disputes, the brief counters that "Congress did not give third-party requesters a right to obtain reexamination of an issued patent, but only the right to request reexamination," adding that Congress also specified that Office's decision whether to grant such a request "shall be final and non-appealable" (emphasis in brief).  Thus, the government argues that "the essential constitutional requirement remains that a party invoking this Court’s jurisdiction must have some concrete stake in the outcome," and with respect to the Board's decision regarding the '913 patent, Consumer Watchdog had no such stake in the outcome.

    In the brief's final section, the government suggests that the Federal Circuit "may [also] wish to make clear in dismissing this case for lack of Article III jurisdiction that appeals from PTO post-grant proceedings are not necessarily governed by the same Article III inquiry that governs the availability of declaratory judgment relief in federal district courts."  The brief explains that:

    The question is important because competitors and other likely users of the AIA's inter partes review and post-grant review procedures may be loath to commence such proceedings if they believe that this Court's review will only be available in circumstances in which a conventional declaratory judgment action for patent invalidity would otherwise lie — particularly given the AIA's strict statutory estoppel provisions.

    Responses by Consumer Watchdog and WARF to the United States brief will be covered in subsequent posts.

  • Consolidated Appropriations Act Provides for Public Access to Federal Research

    By Donald Zuhn —

    Washington - Capitol #3Last month, President Obama signed the Consolidated Appropriations Act, 2014, which makes consolidated appropriations for the fiscal year ending September 30, 2014.  One provision of the 639-page Act, which can be found in Division B (concerning appropriations for Commerce, Justice, Science, and Related Agencies), specifies that certain Federal agencies must develop a Federal research public access policy.  In particular, the section states:

    SEC. 527.  Each Federal agency, or in the case of an agency with multiple bureaus, each bureau (or operating division) funded under this Act that has research and development expenditures in excess of $100,000,000 per year shall develop a Federal research public access policy that provides for —
        (1) the submission to the agency, agency bureau, or designated entity acting on behalf of the agency, a machine-readable version of the author’s final peer-reviewed manuscripts that have been accepted for publication in peer-reviewed journals describing research supported, in whole or in part, from funding by the Federal Government;
        (2) free online public access to such final peer-reviewed manuscripts or published versions not later than 12 months after the official date of publication; and
        (3) compliance with all relevant copyright laws.

    The above provision is similar to legislation that was introduced in both the House and Senate last year (see "Legislation Introduced to Develop Public Access Policies for Federal Research").  That legislation, entitled the Fair Access to Science and Technology Research Act of 2013 ("FASTR"), would have required Federal agencies with research expenditures of more than $100,000,000 to develop a public access policy providing for the submission of manuscripts accepted for publication in peer-reviewed journals that result from research that has been supported by Federal funding, which in turn would have been made available online to the public no later than six months after publication.  Unlike § 527 of the Consolidated Appropriations Act, FASTR would have excluded, inter alia, "research resulting in works that generate revenue or royalties for authors (such as books) or patentable discoveries, to the extent necessary to protect a copyright or patent" (emphasis added).

  • Court Report – Part II

            By Sherri Oslick —

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

    Novartis Pharmaceuticals Corp. et al. v. Noven Pharmaceuticals Inc. et al.
    1:14-cv-00111; filed January 30, 2014 in the District Court of Delaware

    • Plaintiffs:  Novartis Pharmaceuticals Corp.; Novartis AG; Novartis Pharma AG; Novartis International Pharmaceutical, LTD; LTS Lohmann Therapie-Systeme AG
    • Defendants:  Noven Pharmaceuticals Inc.; Noven Therapeutics LLC; Hisamitsu Pharmaceutical Co. Inc.

    Infringement of U.S. Patent Nos. 6,316,023 ("TTS Containing an Antioxidant," issued November 13, 2001) and 6,335,031 (same title, issued January 1, 2002) following a Paragraph IV certification as part of Noven's filing of an ANDA to manufacture a generic version of Novartis' Exelon® Patch (rivastigmine tartrate, used to treat mild to moderate dementia of the Alzheimer's type, and mild to moderate dementia associated with Parkinson's disease).  View the complaint here.

    Idenix Pharmaceuticals Inc. et al. v. Gilead Pharmasset LLC
    1:14-cv-00109; filed January 29, 2014 in the District Court of Delaware

    • Plaintiffs:  Idenix Pharmaceuticals Inc.; Universita Degli Studi di Cagliari; Centre National de la Recherche Scientifique; L' Universite Montpellier II
    • Defendant:  Gilead Pharmasset LLC

    Review of the decision of the Patent Trial and Appeal Board awarding priority of invention to Gilead in the interference between U.S. Patent Application No. 12/131,868 ("Modified 2' and 3' Nucleoside Prodrugs For Treating Flaviviridae Infections," filed June 2, 2008), assigned to Idenix  and U.S. Patent No. 7,429,572 ("Modified Fluorinated Nucleoside Analogues," issued September 30, 2008), assigned to Gilead.  View the complaint here.

    Alcon Research, Ltd. et al. v. Cipla Ltd. et al.
    1:14-cv-00131; filed January 29, 2014 in the Southern District of Indiana

    • Plaintiffs:  Alcon Research, Ltd.; Alcon Pharmaceuticals, Ltd.
    • Defendants:  Cipla Ltd.; Cipla USA, Inc.

    Infringement of U.S. Patent Nos. 6,995,186 ("Olopatadine Formulations for Topical Administration," issued on February 7, 2006) and 7,402,609 (same title, issued July 22, 2008) following a Paragraph IV certification as part of Cipla's filing of an ANDA to manufacture a generic version of Alcon's Pataday® (olopatadine hydrochloride ophthalmic solution, used to treat ocular itching associated with allergic conjunctivitis).  View the complaint here.

    Eli Lilly and Company et al. v. Par Pharmaceutical Companies, Inc. et al.
    2:14-cv-00508; filed January 24, 2014 in the District Court of New Jersey

    • Plaintiffs:  Eli Lilly and Company; Diichi Sankyo Co., Ltd.; Daiichi Sanyko, Inc.; UBE Industries, Ltd.
    • Defendants:  Par Pharmaceutical Companies, Inc.; Par Pharmaceutical, Inc.

    Infringement of U.S. Patent Nos. 8,404,703 ("Medicinal Compositions Containing Aspirin," issued March 26, 2013) and 8,569,325 ("Method of Treatment with Coadministration of Aspirin and Prasugrel," issued October 29, 2013) following a Paragraph IV certification as part of Par's amendment of its ANDA to manufacture a generic version of Lilly's Effient® (prasugrel hydrochloride, to be used in combination with aspirin for the reduction of thrombotic cardiovascular events in certain patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention).  View the complaint here.

    Cadence Pharmaceuticals, Inc. et al. v. Wockhardt Ltd. et al.
    1:14-cv-00485; filed January 23, 2014 in the District Court of New Jersey

    • Plaintiffs:  Cadence Pharmaceuticals, Inc.; SCR Pharmatop
    • Defendants:  Wockhardt Ltd.; Wockhardt Bio AG; Wockhardt USA LLC

    Infringement of U.S. Patent Nos. 6,028,222 ("Stable Liquid Paracetamol Compositions, and Method for Preparing the Same," issued February 22, 2000) and 6,992,218 ("Method for Obtaining Aqueous Formulations of Oxidation-Sensitive Active Principles," issued January 31, 2006), both licensed to Cadence, following a Paragraph IV certification as part of Wockhardt's filing of an ANDA to manufacture a generic version of Cadence's Ofirmev® (acetaminophen injection, used for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fevers).  View the complaint here.