FDA head Janet Wood­cock rais­es patent-re­lat­ed con­cerns to PTO di­rec­tor

While mat­ters of drug pric­ing may not fall square­ly un­der the FDA’s purview, act­ing FDA com­mis­sion­er Janet Wood­cock made clear the agency’s con­cerns around patents and com­pe­ti­tion, ac­cord­ing to a let­ter sent Fri­day to the US Patent and Trade­mark Of­fice.

The let­ter, ad­dressed to An­drew Hir­sh­field, un­der sec­re­tary of com­merce for in­tel­lec­tu­al prop­er­ty and di­rec­tor of the US PTO, said the FDA is con­cerned that some com­pa­nies are fil­ing so-called “con­tin­u­a­tion” patent ap­pli­ca­tions, which can al­low a fil­er to pile on fol­low-on patents on one drug, cre­at­ing a thick­et of patents to block or in­tim­i­date the com­pe­ti­tion. While Wood­cock did not men­tion Ab­b­Vie by name, the term patent thick­et is of­ten used in as­so­ci­a­tion with the com­pa­ny’s dozens of patents cov­er­ing its block­buster rheuma­toid arthri­tis drug Hu­mi­ra.

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