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Gilead Competitor Applies to Make Generic Hepsera

From Associated Press (August 20, 2010)

FOSTER CITY, Calif. -- Biotech drug maker Gilead Sciences Inc. said Thursday that it was notified that Sigmapharm Laboratories LLC sent an application to the U.S. Food and Drug Administration asking it to allow the company to make and market a generic version of hepatitis B drug Hepsera.

Gilead said in a statement that in the notification Sigmapharm alleged that two of Gilead's Hepsera patents are "invalid, unenforceable and/or will not be infringed" by Sigmapharm making, using or selling a generic version of the drug.

Gilead said it is reviewing the notification and has 45 days to file a patent infringement suit against Sigmapharm. If it does file a suit, the FDA would be prevented from approving Hepsera's request for 30 months or, if it happens sooner, until a court rules against Gilead.

Posted: August 2010