Posts Tagged: "hatch-waxman"

The PTAB Puts Hatch-Waxman Defendants on Notice: File IPRs Early or Risk Fintiv Discretionary Denial

On September 16, 2020, the Patent Trial and Appeal Board (PTAB) denied institution of Mylan Labs Ltd.’s petition for IPR of U.S. Patent No. 9,439,906 (“the ’906 patent”) in IPR2020-00440.  In doing so, the PTAB exercised discretion to deny institution based on the six factors set forth in its precedential order in Apple Inc. v Fintiv Inc. For Hatch-Waxman Defendants interested in challenging the validity of Orange Book-listed patents at the PTAB, IPR petitions should be filed as early as possible in order to avoid this same result.

Federal Circuit Says Teva Induced Infringement of GSK Patent on Congestive Heart Failure Drug

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the United States Court of Appeals for the Federal Circuit (CAFC) on Friday reversed a district court’s motion for judgment as a matter of law (JMOL) for Teva, finding that Teva was liable for induced infringement of GlaxoSmithKline’s (GSK’s) patent directed to a method of treating Congestive Heart Failure (CHF) using carvedilol….. Chief Judge Prost authored a dissenting opinion, wherein she expressed the majority’s opinion undermined a critical balance between patent protection and public access once a patent expires “by allowing a drug marketed for unpatented uses to give rise to liability for inducement and by permitting an award of patent damages where causation has not been shown.”

Federal Circuit Decision Delays Generic Osteoarthritis Drug

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the U.S. District Court for the District of New Jersey’s findings of invalidity and noninfringement of certain claims of some of the asserted HZNP (Horizon) patents, as well as the district court’s finding of nonobviousness of one claim of another Horizon patent. The finding of nonobviousness means that Actavis, owned by generic drug maker Teva Pharmaceuticals, is enjoined from engaging in the commercial use, offer for sale, or sale of its product covered in its Abbreviated New Drug Application (ANDA) until the expiration of U.S. Patent No. 9,066,913 (the ‘913 patent) in 2027.

Bipartisan Agreement That Drug Prices Are a Problem (and Patents are Complicated) Could Mean Changes for Pharma

During a hearing of the Senate Committee on the Judiciary on Tuesday titled, “Intellectual Property and the Price of Prescription Drugs: Balancing Innovation and Competition,” senators heard from five witnesses about proposals to lower drug prices for Americans and what role the patent system plays in the high cost of prescription drugs. The witnesses included two professors, a patient advocate, the Director of South Carolina’s Department of Health and Human Services, and the Executive Vice President and General Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA). The hearing is one of several so far this term on the topic. Judiciary Committee Chair, Lindsey Graham (R-SC), opened the hearing by summing up the problem they faced in a question: essentially, how do we make sure that America continues to be the most innovative place on the planet and avoid killing the “goose that laid the golden egg,” without having a system that drives up cost for the consumer? Graham said he expects the committee will move on legislation related to patents and prescription drug pricing this year, and there seemed to be broad agreement on at least one bill currently under consideration—the CREATES Act of 2019, which has been floating around Congress since 2016.

Filer of an ANDA Paragraph III Certification has Standing to Appeal from PTAB in IPR

The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of the ‘650 patent alleging certain claims were obvious. After institution of the IPR, Amerigen and two other companies joined as parties to the proceeding. After the PTAB’s finding that the challenged claims were not unpatentable, Amerigen—but not Mylan—appealed the decision.

On appeal, UCB asserted Amerigen lacked standing. Specifically, UCB argued that, based on the Paragraph III certification accompanying Amerigen’s abbreviated new drug application (ANDA), the FDA will not approve Amerigen’s ANDA until the expiration of the ‘650 patent, previously upheld in a separate suit in the District of Delaware, in 2022. Consequently, UCB contends Amerigen is foreclosed from infringing the ‘650 patent, and without a possibility of infringement there can be no justiciable dispute.

The Federal Circuit rejected UCB’s argument for several reasons. First, this case did not arise under the Hatch-Waxman Act. Second, Amerigen did not rely a risk of infringement liability as a basis for injury. Rather, Amerigen pointed to a concrete commercial injury that it incurred from the listing of the ’650 patent in the Orange Book, which was only possible so long as the ’650 patent was not found invalid. Specifically, the listing of the ‘650 patent blocked the launch of Amerigen’s tentatively approved ANDA, and invalidation of the patent would advance its drug’s launch.