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: Federal Circuit Addresses Infringement of Method-of-Use Patents by Generics in Yasmin® Case

The U.S. Court of Appeals for the Federal Circuit on April 16, 2012, in Bayer Schering Pharma AG v. Sandoz, Inc. , Nos. 2011-1143, -1228 (YASMIN®), affirmed a district court's holding that as a matter of law, generic drug makers could not infringe patent claims reciting a method of use of an...

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...

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...

Generics May Seek Correction Of Overly Broad Use Codes

In Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S , 132 S. Ct. 1670 (April 17, 2012) [ enhanced version available to lexis.com subscribers ], the Supreme Court unanimously held that a generic drug company may use a counterclaim provision of the Hatch-Waxman Act to seek correction of an overly broad use...

Trips and Bits: An Essay on Compulsory Licenses, Expropriation, and International Arbitration

By Peter B. Rutledge * * Professor of Law, University of Georgia School of Law. Excerpt from Trips and Bits: An Essay on Compulsory Licenses, Expropriation, and International Arbitration , 13 N.C. J.L. & Tech. On. 149 (June, 2012) In the early 1980s, the World Bank forecast that more than 1...

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...

Sunstein Kann Murphy & Timbers LLP: Generic Drugmakers Gain Safe Harbor Protection For Compliance Activities That Occur After FDA Approval

By Isabelle Blundell , a member of our Life Sciences Practice Group E ver since the Hatch-Waxman Act became law in 1984, generic-drug manufacturers have had increasing success in lowering barriers to entry in the marketplace. The Act created a streamlined process, the Abbreviated New Drug Application...