Supreme Court Grants Certiorari in Patent Dispute over Hatch-Waxman Provision

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court will review the Federal Circuit U.S. Court of Appeals' ruling [ enhanced version available to lexis.com subscribers / unenhanced version available from lexisONE Free Case Law ], in a case of first impression, that the counterclaim provision...

Hatch-Waxman Provision Debated Before Supreme Court In Patent Dispute

WASHINGTON, D.C. - (Mealey's) An attorney for the federal government told the U.S. Supreme Court yesterday that the U.S. Food and Drug Administration's role in patent labeling should remain ministerial, warning the high court of a "slippery slope" should it hold otherwise ( Caraco...

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...

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...

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...