
NEJM Interview: Prof. Arti Rai on U.S. legal regimes governing access to biomedical innovation.
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The Implications of Intellectual Property Protection for Biologics
There are real problems of, I think, excessive incentive laring in the IP protections for biologics. A lot of these patents are patents on the manufacturing process. The FDA is tougher on you when you try to get a biosemolar through. And as an originator manufacturer, you have 12 years of data exclusivity over your original clinical trial data.
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