FLH NEWS HEADLINES


FLH WINS AFFIRMANCE OF MARKET EXCLUSIVITY AWARD
FOR PHARMACEUTICAL COMPANY


On January 20, the U.S. Court of Appeals for the District of Columbia Circuit issued a 22-page decision that preserves the 180-day market exclusivity award to FLH client Purepac Pharmaceutical Co. for Purepac's generic formulation of the widely-prescribed anti-epilepsy drug Neurontin (gabapentin).

Affirming two lower court rulings, the D.C. Circuit:

  • Upheld Purepac's right to file with the U.S. Food and Drug Administration a statement of inapplicable use for a patent claiming a unapproved use of gabapentin; and
  • Upheld Purepac's award of market exclusivity for generic gabapentin based on the company's status as the first generic drug company to file a certification of invalidity or non-infringement against an additional composition patent claiming the drug.
Partner Charles Raubicheck, the lead attorney on the case, argued the appeal on behalf of Purepac. Also actively involved in the case were partners Ed Haug and Steven Amundson, and associates John Taylor, Terri Lee Young Nataline, Pearl Teng Ling Siew, and Wendy Stein. The case has been reported as Purepac Pharmaceutical Co. v. Tommy G. Thompson, et al., 2004 WL 76594 (D.C. Cir. No. 02-5410, Jan. 20, 2004).

For more information about this case and about FLH's Regulatory Practice Group, contact Charles Raubicheck at (212) 863-2167


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