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…
On June 11, a bipartisan group of Representatives including Hakeem Jeffries (D-N.Y.), Doug Collins (R-Ga.), Ben Cline (R-Va.), and Debbie Mucarsel-Powell (D-Fla.) introduced a new bill to address the rising cost of branded prescription drugs. The Terminating the Extension of Rights Misappropriated (TERM) Act of 2019, H.R. 3199, 116th Cong. (2019), aims to prevent pharmaceutical…
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…
The District of Delaware recently weighed in on the scope of IPR estoppel in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical, Inc., 14-cv-01289 (D. Del. Apr. 11, 2019). Describing the issue before it as a matter of first impression, the Court held that “IPR estoppel will still apply post-trial where the Court has not entered a…
Last week the Patent Trial and Appeal Board invalidated Concert Pharmaceuticals’ patent covering modified ruxolitinib compounds in a final inter partes review decision, despite having initially denied institution of the underlying petition. The Board found all claims of U.S. Patent No. 9,249,149 obvious over the prior art. Ruxolitinib is the active ingredient in Concert’s Jakafi®…
Last week, the Federal Circuit reversed a decision from the District of Delaware that held that a method of treatment patent invalid under 35 U.S.C. § 101. Endo Pharms. Inc. et al. v. Teva Pharms. USA et al. The claim at issue recited: A method of treating pain in a renally impaired patient, comprising the steps…