Generics Behaving Badly: Carve Outs, Off-Label Uses

Law360 (March 24, 2009, 12:00 AM EDT) -- Patents have long been the crown jewels of the pharma industry. They protect pioneer therapies from generic competition and underwrite the enormous investment required for new drug research and development.

However, with an estimated $65 billion of drugs coming off patent protection in the next five years, generics stand ready to cash in on this bonanza. As the competitive landscape undergoes enormous changes, pioneers need to coordinate their IP and regulatory strategies to protect new investments in old drugs.

Hatch-Waxman: Then and Now

For the past 20 years, what made drug patents so valuable was the Orange Book (OB) patent listing...

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