LexisNexis® Legal Newsroom
Sunstein Kann Murphy & Timbers LLP: Pharmaceutical Companies Take Heed — Compulsory Patent License Is Awarded in India

By Thomas Carey and Nancy C. Wilker, Ph.D. As part of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), a signatory country can allow someone to produce a patented product or process without the patent owner's consent. The grounds for justifying a grant of a compulsory...

Sheppard Mullin Richter & Hampton LLP: Section viii Statements -- Still A Viable Route to Generic Approval Where the Application Is Not Claimed in an Orange Book Patent

By Nagendra Setty and Mark E. McGrath In its recent decision in AstraZeneca Pharmaceuticals LP v. Apotex Corp ., Nos. 2011-1182 - 2011-1190 (Fed. Cir. Feb. 9, 2012) (hereinafter the " AstraZeneca Decision") (Rader*, Bryson & Linn), the Federal Circuit affirmed a District of Delaware...

Supreme Court confirms that generic drug manufacturers can challenge brand-name use-code descriptions in patent litigation

Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S 566 U.S. ___, 132 S. Ct. 1670 (Apr. 17, 2012) By Nagendra Setty and Bill Blonigan The Hatch-Waxman Act Congress designed the Hatch-Waxman Act (codified at 21 U.S.C. § 355 (b), (j), (l) and 35 U.S.C. §§ 156 , 271 , and 282...

Brinks Hofer Gilson & Lione: Third Circuit Issues Key Ruling Regarding "Reverse Payment" Settlement Agreements

On July 16, 2012, the Third Circuit issued a key ruling in In re K-Dur Antitrust Litigation [ enhanced version available to lexis.com subscribers ] regarding so-called "reverse payment" settlement agreements, which are not uncommon in the pharmaceutical industry. In these types of agreements...

Duane Morris LLP: FTC Proposes New HSR Rules for Exclusive Patent Licenses in the Pharmaceutical Industry

On August 13, 2012, the U.S. Federal Trade Commission (FTC) announced it is seeking public comment to proposed changes to the premerger notification rules under the Hart Scott Rodino Act (HSR) relating to acquisitions of exclusive patent rights in the pharmaceutical industry. Background HSR requires...

Generic Pharma Leverages PTAB

IPRs and Drug Litigation Since Post Grant Review (PGR) is designed to challenge patents on 112 and 101 grounds not available in Inter Partes Review (IPR), it is often assumed that Bio/Pharma is somewhat unconcerned with the growing trend to challenge patents in IPR at the PTAB . Today, my partner...

Pharmaceutical Claims Found Unpatentable

by Michael K. Levy On June 20, 2014, the Patent Trial and Appeal Board (PTAB) issued the first inter partes review (IPR) decisions reaching pharmaceutically-related subject matter, which in this case constituted dietary supplement and vitamin products. Four separate final written decisions, addressing...

Will Government Efforts to Derail Patentable Subject Matter Status Quo Derail Its Efforts to Promote Personalized Medicine?

by Dov Greenbaum President Obama -- in his January 20, 2015 State of the Union address -- declared Personalized Medicine as a technology he would like to pursue. Here we examine developments in the Federal Circuit (which ruled in a related Myriad case in December 2014), the Supreme Court and the Executive...