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 stockpile drugs abroad in a country with no PTE period, or a shortened PTE period relative to the United States, and then ship those drugs to the U.S. on the day that the PTE expires in this country, rather than waiting for PTE expiry to start manufacturing a pharmaceutical product for ultimate sale in the U.S. If a company is able to manufacture the pharmaceutical product in say, Canada, for sale in the U.S. immediately after PTE expiry, why can't that company do the same in New Jersey?...

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