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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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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