Hatch-Waxman and Biologics Litigation

Intellectual Property Litigation

Key Contacts

Experience

  • Won a major, complete victory for Bristol-Myers Squibb and Pfizer in one of the largest Hatch-Waxman cases ever filed. A district judge found the patents covering our clients’ blockbuster drug Eliquis® were valid and infringed by all generics challenging them. This case covered 25 generic companies and likely protects Eliquis® until at least 2031. 
  • Achieved a significant victory for Shionogi when its motion for preliminary injunction was granted, preventing defendant Lupin Limited from further importation and sale of its generic copy of Shionogi's diabetes drug, Fortamet®. 
  • Obtained an important victory for Braintree Laboratories, when the Federal Circuit reversed a district court's grant of summary judgment of noninfringement for Breckenridge Pharmaceutical and remanded with instructions to enter judgment in Braintree's favor. This matter involved a patent owned by Braintree pertaining to its product Suprep®, a highly successful product designed to cleanse the colon safely before a colonoscopy.
  • Achieved a significant victory for Takeda’s wholly owned subsidiary, Millennium Pharmaceuticals, at the Federal Circuit, when the appeals court reversed a district court finding of patent invalidity and remanded the case with instructions to enter judgment in favor of Takeda. This matter involved a patent owned by the US government and exclusively licensed to Takeda covering the latter’s blockbuster oncology drug Velcade®.
  • Represented Gilead in defending the patentability of several patents related to its blockbuster Hepatitis C drugs Sovaldi® and Harvoni®. Together with co-counsel Fish & Richardson, we successfully defended all of Gilead’s challenged patents, obtaining denials of each of I-MAK’s 10 IPR petitions at the institution stage.
  • Achieved a significant victory for GlaxoSmithKline when the Federal Circuit affirmed a district judgment finding that the patent covering dutasteride, the active ingredient in GSK’s Avodart and Jalyn products, was not invalid. After a three-day bench trial, the district court had concluded that the defendants failed to prove the asserted claims invalid under any theory.

Hatch-Waxman and Biologics Litigation