Narinder Banait, a partner in the Life Sciences Group with Fenwick & West, was recently quoted in the Pharmawire article, "Gilead's Hypertension Drug Darusentan Will Likely Receive Patent Extension, Attorneys Say."
Gilead delivered news on April 2, 2009 that darusentan, a selective endothelin A (ETA) receptor antagonist used to treat resistant hypertension, has received positive results from its Phase III DORADO trial. With darusentan's patent expiring in 2015, Gilead plans to file a new drug application in the fourth quarter of 2010.
Banait said that a patent extension is typical but not guaranteed after a drug receives approval from the FDA. "To get an extension, the patent cannot have expired before the FDA grants approval. If the FDA grants approval in 2015, then Gilead might not receive an extension."
Banait noted that if Gilead is not granted a patent extension, darusentan will receive protection from test data exclusivity, a system that would prevent the FDA from approving generic drugs with Gilead's data but does not prevent generic drug companies from using the data in their own studies. Without a patent, generic companies may go as far as to conduct clinical trials with the other drug's data, which is why "patent protection was ultimately preferred" by Gilead, Banait concluded.