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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Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.