We recently reported on the Federal Circuit’s holdings in Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. and AstraZeneca AB v. Mylan Pharm., Inc., where it held that Mylan was subject to jurisdiction in Delaware because “Mylan’s ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs.” Earlier this month, the first decision from the District of New Jersey District applying the Federal Circuits ruling was rendered. In Helsinn Healthcare S.A., et al. v. Hospira, Inc., No. 15-2077 (MLC), 2016 U.S. Dist. LEXIS 45826 (D.N.J. April 5, 2016), Judge Mary L. Cooper held that sufficient minimum contacts is to find specific jurisdiction is established by the fact that Hospira filed an ANDA seeking to market a generic version of Helsinn’s Aloxi® product that if approved, the marketing of will take place in New Jersey.
Last week the Federal Circuit handed down one of its more anticipated decisions regarding jurisdiction in cases brought under 35 U.S.C. § 271(e)(2) (aka Hatch-Waxman or ANDA litigation). In its holding, the Federal Circuit stated that a “[defendant’s] ANDA filings and its distribution channels” are enough to “establish that [the defendant’s] plans to market its proposed [ANDA product in the forum state]” are enough to meet the minimum-contacts requirement to establish jurisdiction. It further held “there is no substantial argument that considerations of unfairness override the minimum-contacts basis for [the forum state’s] exercise of specific personal jurisdiction over” the defendants. This holding is much broader than the underlying district court rulings and limited the analysis to specific jurisdiction without addressing the underlying general jurisdictional questions.
In 2005, the Federal Circuit established the framework for the construction of patent claim terms. In its landmark holding in Philips v. AWH Corp., the Federal Circuit stated that “words of a claim ‘are generally given their ordinary and customary meaning . . . [and] that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art . . . .”
Offering Compassionate Care While Alleviating Ethical Concerns: How Some Pharmaceutical Companies Are Meeting Both Demands
In recent years, families and friends of terminally ill patients have launched highly visible social media campaigns to secure access to potentially life-saving medicine, before those experimental drugs are approved. Pharmaceutical companies that are developing these investigational medicines often face difficult ethical and business relations dilemmas: there are limited exceptions for non-approved drug dissemination and the costs and consequences attendant on the exceptions can make either choice unpalatable. Companies and caregivers alike have struggled with how to fairly provide access to experimental drugs without negatively impacting long term drug development or approval.
Federal Appeals Court Directs FDA to Treat Reissue Patents as Separate and Distinct When Determining Eligibility for Pre-MMA 180-Day Exclusivity
In Mylan Pharm., Inc. v. FDA, generic drug manufacturer Mylan Pharmaceuticals, Inc. (“Mylan”) challenged an FDA letter decision describing the agency’s treatment of original and reissue patents as “a single bundle of patent rights” when determining eligibility for 180-day exclusivity under the Hatch Waxman Act (pre-MMA). The United States District Court for the Northern District of West Virginia deferred to the FDA’s interpretation of the statute under step 2 of Chevron U.S.A. Inc. v. Natural Res. Def. Council, Inc..
In Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms Inc., the Federal Circuit followed previous precedent in holding that the combination of compounds is not “obvious to try” if unexpected properties are supported by evidence. The patent-at-issue was directed to an antihypertension drug, Tarka®, which is the combination of an angiotension-converting enzyme inhibitor (such as trandolapril or quinapril, both double-ring compounds) and a calcium channel blocker. The jury found that the patent had not been proven invalid and defendant, on appeal, argued that “if a combination of classes of components is already known, all selections within such classes are obvious to try . . . .” The Federal Circuit found that there was substantial evidence supporting the jury’s verdict that obviousness had not been proved by clear and convincing evidence because of the unpredicted “longer-lasting effectiveness” achieved with the drug.
Takeda Part Two: Destroy Evidence, Pay the Price — Eli Lilly and Takeda Pharmaceutical Co. Get Hit For $9 Billion Punitive Damages Verdict
Recently, in In re Actos (Pioglitazone) Products Liability Litigation, MDL No. 11-2299, a Louisiana federal jury awarded $9 billion in punitive damages against Takeda Pharmaceutical Co. (“Takeda”) and Eli Lilly & Co. (“Lilly”). The verdict was delivered on the heels of Judge Rebecca Doherty’s January opinion, which lambasted Takeda for failing to (1) enforce its own litigation hold and (2) follow its document retention procedures, which led to the destruction of relevant evidence that Judge Doherty found would have likely been beneficial for the plaintiffs’ case.
An opinion from Judge Rebecca Doherty in In re Actos (Pioglitazone) Products Liability Litigation, MDL No. 11-2299, provides valuable lessons on the consequences of drafting overly-broad litigation hold notices, as well as the importance of providing evidence from knowledgeable witnesses in defense of document retention procedures.
On Wednesday, December 11, the New Jersey Intellectual Property Association will host the 27th Annual Pharmaceutical / Chemical Patent Practice Update at the Woodbridge Hilton in Iselin, NJ. This seminar will cover a range of important topics pertaining to arising pharmaceutical patent matters. This seminar will cover a range of important topics pertaining to arising pharmaceutical patent matters such as: Impact of Erosion of IP Rights on the Pharmaceutical Industry; Maximizing the Probability of Success in Post-Grant Proceedings for Pharmaceutical Patents; Patent Term Adjustment Strategies; The Bolar Exemption in the EU and UK; Claiming Functionally-Defined Biologics; Self-Colliding” Co-Pending Applications at the EPO; Recent Developments in Hatch-Waxman Litigation: (1) Impact of FTC v. Actavis on Pharmaceutical Patent Settlements; and (2) NCE Exclusivity for Enantiomers and Combination Products; and USPTO Ethics Horror Stories – Tales from the OED Crypt.
Rutgers Business School’s MBA in Pharmaceutical Management was recently ranked as one of the top 10 MBA programs for Health Care/Pharmaceuticals/Biotechnology in the world, based on a survey done by Find-MBA.com. According to a press release from Rutgers, the program earned its ranking due to its success in assisting MBA grads to earn internships and jobs focused in the health care, pharmaceuticals and biotechnology industries. This was a function of the quality of the program, complemented by Rutgers Business School’s proximity to, and relationship with, top tier pharmaceutical companies and several large hospitals in the region.