[Ip-health] Compulsory licensing of Pharmaceutical patents

Alfred Engelberg aengelberg at nglbrg.com
Fri Aug 22 12:54:40 PDT 2014

The Hatch-Waxman Act prohibits the FDA from accepting  an Abbreviated New Drug Application for 5 years (4 years in the case of a paragraph IV Patent Certification of non-infringement) following the approval of a pharmaceutical product containing a new chemical entity (NCE). Given current FDA backlogs, it would probably take at least 6 years for a generic version of a new drug to reach the market even if  the US, which clearly possesses sovereign immunity under 28 USC 1498, exercised that right by authorizing a generic company to produce product for sale to the United States.  In the case of biologic drugs the non-patent exclusivity period is 12 years before a biosimilar application can be approved.

In short, a compulsory patent license will not produce generic competition for a new drug in the near term. The situation is not like CIPRO where the competitive generic products actually had tentative FDA approval at the time the US undertook its price negotiations with Bayer.

Alfred Engelberg
aengelberg at nglbrg.com

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