Time To Remove Patent Barriers To US Drug Manufacturing

By Frederick Rein, Aviv Zalcenstein and Ilana Saltz (August 6, 2018, 12:19 PM EDT) -- We have written a few articles for Law360 about the interplay between patent law and U.S.-based manufacturing of pharmaceuticals.[1] One outstanding issue concerns the role played by patent term extension, pursuant to 35 U.S.C. §156, in determining where to manufacture a generic product. The PTE period is not as restrictive as the regular patent term in several important ways (for example, a compound approved as a pharmaceutical may be able to be manufactured during the PTE for use as a detergent). However, the PTE period currently still poses problems for U.S.-based generic manufacturing. Right now, a generic manufacturer can manufacture and...

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