LexisNexis® Legal Newsroom
Brinks Hofer Gilson & Lione: Supreme Court Issues Key Ruling Regarding Pharmaceutical Litigation

On April 17, 2012, the Supreme Court issued a unanimous decision favorable to generic pharmaceutical companies in Caraco Pharmaceuticals, Ltd. v. Novo Nordisk , No. 10-844 [ enhanced version available to lexis.com subscribers ]. The Court held that a generic pharmaceutical company may pursue a counterclaim...

Duane Morris LLP: U.S. Supreme Court Restores Generic Pharma's Ability to Challenge Orange Book Use Code Information

The U.S. Supreme Court's unanimous ruling on April 17, 2012, in Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S was a resounding win for both Caraco and the generic pharmaceutical industry as a whole. Specifically, the Court held that a generic manufacturer may employ the counterclaim...

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...

Reverse Payments by Drug Companies: The Supreme Court Declines to Adopt a Bright-Line Test

by Thomas Carey and Nancy Chiu Wilker Ph.D. Excerpt: The Federal Trade Commission has long opposed "reverse payments," the practice by which a pioneer drug company selling a brand-name drug pays a generic drug company to not enter the market. These payments arise in connection with the...