TERM Act Would Presume All Patents Covering a Branded Pharmaceutical Product Are Not Patentably Distinct

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 [...]

P.T.A.B. Assumes Nothing Based on Tradenames

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 […]

Court Requires the FDA to Reassess Decisions Rendered Under its Old Interpretation of Five-Year NCE Exclusivity

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 […]

“Consisting Essentially Of” Preamble Indefinite Because the “Basic and Novel Properties” of the Invention Were Not Reasonably Clear

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 […]

No Personal Jurisdiction over Foreign Patentee in Benicar® Saga

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 […]

Supreme Court Upholds “Broadest Reasonable” Claim Construction Standard; Confirms Decision to Institute IPRs Remains “Unappealable”

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 […]

No Sale Required for 102(b) On-Sale Bar

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 […]