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Articles

Reissue Patents and the Orange Book: A New Wrinkle

March 1, 2006

Articles

Reissue Patents and the Orange Book: A New Wrinkle

March 1, 2006

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Terry Mahn article

BNA’s Pharmaceutical Law & Industry Report, March 2006

Terry G. Mahn, Fish & Richardson

The Food and Drug Administration has always taken the position that it possesses no patent expertise. When forced to deal with patents—Orange Book (OB) listings for example—it maintains that its function is solely ministerial. It would dutifully list those patents that NDA applicants said claimed their drug or method of using their drug, and then would stay out of any listing disputes raised by generics. This ‘‘see no evil’’ attitude toward OB listing gave a decided advantage to the pioneers because a listed patent can force the FDA to suspend a generic approval for up to 30 months. Critics complained that the listing process was being ruthlessly exploited by pioneer drug companies to keep generics off the market.

In 2003, the FDA began to cave in to the critics. That year it adopted new OB listing procedures that now require the FDA staff to actually read the claims of patents an NDA holder submits for listing, and make a reasoned determination as to whether they should, in fact, be listed. Thus, nearly 20 years after Hatch-Waxman Act adoption, the FDA has finally begun to learn the rudiments of patent law—and each year it finds itself being forced to learn a little bit more.

A recent exercise that has occupied FDA thinking involves OB patents that are ‘‘reissued’’ by the U.S. Patent and Trademark Office and how the patent reissue process potentially affects the rights of generic drug applicants.

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