Last month, the Federal Circuit affirmed per curium U.S. District Judge Colm F. Connolly’s order denying Genentech’s request for either a temporary restraining order or a preliminary injunction. Genentech sought a preliminary injunction to prevent Amgen from selling a generic version of Genentech’s blockbuster cancer drug, Herceptin®. Amgen launched on the same day the district court […]
Recently, the PTAB denied Gilead Sciences, Inc.’s (Gilead) request to institute an inter partes review of two patents relating to HIV-prevention, U.S. Patent No. 9,044,509 (the ’509 patent) and U.S. Patent No. 9,579,333 (the ’333 patent). One key reason for the denial was because Gilead failed to adequately address unexpected results in its Petition. The […]
Just before the New Year, the Federal Circuit affirmed a decision from the District of Delaware finding patent claims related to using Zohydro ER in patients having hepatic impairment (liver disfunction) invalid as obvious. Persion Pharm. LLC v. Alvogen Malta Oper. Ltd. Some of the claims at issue included pharmacokinetic limitations requiring that the serum […]
Part of the ACA’s sweeping healthcare reform was the Biologics Price Competition and Innovation (BCPI) Act of 2009, which re-classified certain drugs that had previously been regulated under the Food, Drug and Cosmetic Act. Insulin, for example, has historically been treated as a drug product, but will be classified as a biological product (and, therefore, […]
In a recent opinion, the District Court of New Jersey held that a decision in a parallel proceeding at the Patent and Trademark Appeal Board (PTAB) does not give rise to collateral estoppel in the court proceeding. The case concerns Sanofi Aventis’s (“Sanofi”) LANTUS® injectable insulin drug, indicated for the treatment of diabetes mellitus. After […]
In a recent decision, the Federal Circuit held that the district court lacked authority to “disinter” and declare claims invalid where the patent owner had statutorily disclaimed the claims. Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., 933 F.3d 1367 (Fed. Cir. 2019). The case concerns the drug cabazitaxel, marketed as Jevtanta®, which is used […]
On June 18, 2019, the FDA announced plans to expand its Paragraph IV Patent Certifications List, a database used to list information about applications for generic drug approval. The changes are part of the FDA’s on-going efforts “to provide the industry with greater transparency in order to provide greater certainty around timing of market entry […]
In a recent decision, the Federal Circuit reversed the District of New Jersey’s final judgment that two patents directed to methods of administering NSAIDs were adequately described under § 112. Nuvo Pharm. (Ir.) Designated Activity Co. v. Dr. Reddy’s Labs. Inc., 2019 U.S. App. LEXIS 14345 (Fed. Cir. 2019). Both of the asserted patents are […]
Recently, the Federal Circuit affirmed a decision from the United States Patent and Trademark Office Patent Trial and Appeal Board (“the Board”) finding claims of Purdue’s latest abuse deterrent, extended release oxycodone patent, U.S. Patent No. 9,034,376 (“the ’376 patent”), obvious over reference combinations including Pub. No. US 2002/0187192 A1 (“Joshi”). Purdue Pharma L.P., et […]