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Adam Houldsworth, featuring work by Jonathan Darrow
IAM Media
October 1, 2018

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From the article:

Further data has emerged showing that the Patent Trial and Appeal Board (PTAB) is far from the “death squad” that many in the US life sciences industries fear that it may be becoming.

A recent study by Harvard University’s Jonathan J Darrow and Aaron Kesselheim, and the University of Calgary’s Reed F. Beall - The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents – analyses data on inter partes review proceedings since their inception, as well as information from the FDA’s Orange Book about the drugs whose patents have been the subject to administrative challenges.While highlighting the increasing popularity of IPRs among generic drug companies, the research refutes the idea that the proceedings have treated US patents in the pharma sector harshly. Instead, it reveals a high patent claim survival rate – even when petitions reach a final written decision – and shows that administrative challenges seldom invalidate (or even target) all-important active ingredient patents. The study’s findings also suggest that only a tiny number of drugs’ entire patent protection has been wiped out by the PTAB.

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fda   pharmaceuticals   regulation