Laura Gordon

The Federal Circuit Deals Another Blow to Diagnostic Method Patents

By Laura Gordon on April 11, 2019 Posted in Patent

In another setback for diagnostic method patents, the Federal Circuit rejected efforts by patent owner/appellant Cleveland Clinic[1] to avoid 35 U.S.C. § 101 by restyling diagnostic method claims as “techniques” for detecting a correlation between protein levels and a disease state. Cleveland Clinic Found. v. True Health Diagnostics LLC, No. 2018-1218, 2019 WL 1452697, at … Continue Reading

The Federal Circuit Reverses a Hindsight Reconstruction of An Important Pharmaceutical Invention

By Allen Sokal, Stephanie Lodise, Ph.D. and Laura Gordon on July 20, 2017 Posted in Patent

In Millennium Pharmaceuticals v. Sandoz,[1] the Federal Circuit reversed the district court’s holding of obviousness of certain claims of Millennium-owned U.S. Patent No. 6,713,446 (the ‘446 patent), finding that the district court improperly applied the lead compound analysis and the inherency doctrine and clearly erred by rejecting objective indicia of non-obviousness. The disputed claims of … Continue Reading

The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

By Laura Gordon on June 28, 2017 Posted in Biosimilars

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers (applicants).[1] In particular, the Court held that (1) a federal injunction is not available to compel biosimilar applicants to disclose application and manufacturing … Continue Reading

Filing an ANDA May Expose Generic Manufacturers to Nationwide Personal Jurisdiction in Patent Infringement Suits

By Laura Gordon on April 4, 2016 Posted in Patent

On March 18, 2016, the Federal Circuit affirmed the District of Delaware’s ruling in two companion cases that West Virginia-based defendant Mylan Pharmaceuticals is subject to specific personal jurisdiction in Delaware. Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 2015-1456 (Fed. Cir. Mar. 18, 2016); AstraZeneca AB v. Mylan Pharm. Inc., 2015-1460 (Fed. Cir. Mar. 18, … Continue Reading

Petitioners Beware: Improper Incorporation by Reference May Result in Truncated Petition

By Laura Gordon on March 3, 2016 Posted in Patent

On February 16, 2016, the Patent Trial and Appeal Board (“the Board”) partially denied institution of inter partes review (“IPR”) of claims 1-26 of U.S. Patent No. 8,338,724, citing petitioner’s improper use of incorporation by reference.[1] Shenzhen Huiding Technology Co., Ltd. v. Synaptics Incorporated, IPR2015-01741, Paper 8 at 29-31 (PTAB Aug. 7, 2015) (“Shenzhen”). As … Continue Reading

As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials

By Laura Gordon on January 27, 2016 Posted in Uncategorized

Pharmaceutical companies have reason to be pleased with the Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle K. Lee, Under Secretary of Commerce for Intellectual Property and Director, Patent and Trademark Office, No. 15-446 (Cuozzo). The Supreme Court has agreed to review the … Continue Reading

Patent Trial and Appeal Board Denies Inter Partes Review of Patent Claiming the Deuterated Form of a Known Compound

By Laura Gordon and Stephanie Lodise, Ph.D. on January 5, 2016 Posted in Uncategorized

In Neptune Generics, LLC v. Auspex Pharmaceuticals, Inc., IPR2015-01313, Paper No. 25 (PTAB Dec. 9, 2015) (“Neptune”), the Patent Trial and Appeal Board (“the Board”) issued an opinion denying institution of inter partes review of U.S. Patent No. 7,456,317 B2 (“the ’317 patent”). The ’317 patent claims an analog of venlafaxine (Effexor®) in which nine … Continue Reading

The USPTO Global Dossier Service Is Scheduled to Go Live in Mid-November

By Laura Gordon on November 11, 2015 Posted in Uncategorized

The Global Dossier is a project stemming from a collaboration between the European Patent Office (EPO), the Japan Patent Office (JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People’s Republic of China (SIPO), and the United States Patent and Trademark Office (USPTO) (collectively, the IP5 Offices). As envisioned by … Continue Reading