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…
The Patent Trial and Appeal Board recently denied institution of inter partes review of two Allergan patents directed to a hyaluronic acid-based gel containing lidocaine. Teoxane S.A. v. Allergan, PLC, IPR2017-01906, Paper 15 (P.T.A.B. March 9, 2018); Teoxane S.A. v. Allergan, PLC, IPR2017-02002, Paper 14 (P.T.A.B. March 9, 2018). The patents at issue, U.S. Patent…
U.S. District Judge Rudolph Contreras found that the FDA’s prior interpretation of the Federal Food, Drug, and Cosmetics Act’s (“FDCA”) five-year exclusivity provision was arbitrary and capricious. Ferring Pharm., Inc. v. Burwell, No. 15-0802 (D.D.C. Sep. 9, 2016). This provision—known as NCE exclusivity—provides a five-year period of marketing exclusivity for drugs in which “no active…
A U.S. federal district court judged the transitional phrase “consisting essentially of” to be indefinite in view of the Supreme Court’s ruling in Nautilus. Horizon Pharma Ireland Ltd. et al. v. Actavis Laboratories UT Inc., Case no. 1:14-cv-07992, in the U.S.D.C., District of New Jersey. Background. As we wrote about here, in its 2014 Nautilus…
Last week the Northern District of Illinois found it lacked personal jurisdiction over foreign patentee Daiichi Sankyo Co., Ltd. and its U.S. subsidiary, Daiichi Sankyo, Inc.. Torrent Pharma. Ltd. v. Daiichi Sankyo Co., Ltd., No. 16-C-2988 (N.D. Ill. July 25, 2016). The First Benicar® Case. Daiichi holds the NDA for Benicar® and markets the blood…
A recent order from the Federal Circuit serves as a good reminder that a party’s statements in its ANDA may be used against the party in litigation. Intendis GmbH v. Glenmark Pharms. Inc., 822 F.3d 1355 (Fed. Cir. 2016). The Court relied on statements in the ANDA about the function of the claimed excipients to…
Yesterday in Cuozzo Speed Techs., LLC v Lee, the Supreme Court clarified two aspects of inter partes review procedure: (1) the Patent Trial and Appeal Board (PTAB) may continue to use the broadest reasonable claim construction standard for construing the claims of unexpired patents; and (2) the PTAB’s decision to institute (or not institute) an…
The Patent Trial and Appeal Board (PTAB) recently denied motions by Teva to amend the filing dates of two petitions to institute IPRs related to patents covering Suboxone, a drug used to help patients suffering from opioid addiction. Teva’s deadline for filing these petitions was December 3, 2016, but due to technical difficulties in filing,…
In Merck & CIE v. Watson Laboratories, Inc., No. 2015-2063, 2016 U.S. App. LEXIS 8782 (Fed. Cir. May 13, 2016), the Federal Circuit reversed a District of Delaware Paragraph IV decision, and held that the patent-in-suit was invalid under the on-sale bar of pre-AIA Section 102(b). The sole asserted claim was directed to crystalline calcium…
A recent order the District of New Jersey highlights the importance of diligence in establishing good cause to amend a party’s contentions, and that a claim construction ruling is a not a free pass to amend infringement contentions. Takeda Pharmaceutical Co. Ltd., et al. v. Sun Pharma Global FZE et al., Case No. 14-cv-4616 (D.N.J.)…