Janet Woodcock, acting FDA commissioner (Bill Clark/CQ Roll Call via AP Images)

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.

“The ex­is­tence of mul­ti­ple patents in­creas­es lit­i­ga­tion bur­dens and po­ten­tial­ly de­lays the ap­proval of gener­ics and the launch of gener­ics and biosim­i­lar and in­ter­change­able bi­o­log­i­cal prod­ucts,” she wrote.

The prac­tice of patent­ing slight tweaks to a new drug, such as for­mu­la­tion changes, new de­liv­ery sys­tems, or patents claim­ing ad­di­tion­al meth­ods of use should al­so come un­der scruti­ny, wrote Wood­cock, who’s like­ly to de­part the FDA’s act­ing com­mis­sion­er role in about two months.

She point­ed to a study, pub­lished in the Jour­nal of Law and the Bio­sciences in 2018, that found 78% of drugs for which new patents were list­ed in the Or­ange Book from 2005-2015 were for ex­ist­ing drugs, not new drugs.

Prod­uct hop­ping was her third con­cern, and Wood­cock point­ed to the way that some com­pa­nies ef­fec­tive­ly switched one drug’s en­tire mar­ket to a new dos­ing reg­i­men (e.g. twice dai­ly to once per day) and then cor­doned off their mo­nop­o­lies with new patents.

In the case of the Alzheimer’s drug Na­men­da, Ac­tavis (now owned by Te­va Phar­ma­ceu­ti­cals) and its sub­sidiary, For­est Lab­o­ra­to­ries, were found to have an­ti-com­pet­i­tive­ly launched an ex­tend­ed-re­lease ver­sion of its block­buster drug and delist­ed the im­me­di­ate-re­lease ver­sion, ef­fec­tive­ly block­ing any in­com­ing gener­ic com­pe­ti­tion. The Sec­ond Cir­cuit said in its de­ci­sion, “when a mo­nop­o­list com­bines prod­uct with­draw­al with some oth­er con­duct, the over­all ef­fect of which is to co­erce con­sumers rather than per­suade them on the mer­its, and to im­pede com­pe­ti­tion, its ac­tions are an­ti­com­pet­i­tive un­der the Sher­man Act.”

Wood­cock said prod­uct hop­ping “has the prac­ti­cal ef­fect of fore­stalling com­pe­ti­tion notwith­stand­ing the fact that the pri­or prod­uct (for which gener­ic, biosim­i­lar, or in­ter­change­able com­pe­ti­tion has be­come avail­able) re­mains safe and ef­fec­tive.”

As far as what’s ex­pect­ed for FDA and US PTO re­la­tions mov­ing for­ward, Wood­cock of­fered up op­por­tu­ni­ties for PTO ex­am­in­ers and staffers to learn the ways of the FDA’s data­bas­es and oth­er ex­per­tise to sup­port their “abil­i­ty to ac­cu­rate­ly and fair­ly grant patent term ex­ten­sions.”

She al­so ques­tioned whether patent ex­am­in­ers might need more time to re­view phar­ma­ceu­ti­cal patents, due to their com­plex na­ture, and she sought fur­ther in­for­ma­tion on the Patent Tri­al and Ap­peal Board, es­pe­cial­ly when it comes to da­ta on post grant re­views and in­ter partes re­views.

“In par­tic­u­lar, we would be in­ter­est­ed in da­ta re­gard­ing the im­pact of PGR and IPR pro­ceed­ings, if any, on Or­ange Book-list­ed patents and/or patents cov­er­ing bi­o­log­i­cal prod­ucts,” Wood­cock wrote.

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