Fed­er­al claims court rules in fa­vor of Gilead in CDC Tru­va­da patent case

Gilead pulled a win last week in its on­go­ing patent bat­tle with the CDC over the HIV drug Tru­va­da for pre-ex­po­sure pro­phy­lax­is (PrEP).

The US Court of Fed­er­al Claims ruled on Nov. 21 that the gov­ern­ment breached cer­tain agree­ments with Gilead by fail­ing to prompt­ly no­ti­fy the com­pa­ny of its patent ap­pli­ca­tions for Tru­va­da for PrEP, ac­cord­ing to doc­u­ments un­sealed on Wednes­day.

The is­sue traces back to around 2004 when Tru­va­da won an ac­cel­er­at­ed ap­proval to treat HIV. Be­cause HIV is known to de­vel­op re­sis­tance to ther­a­py, pa­tients at the time were of­ten re­quired to take more than one drug at a time. Tru­va­da com­bines Gilead’s pri­or HIV drugs, Emtri­va and Viread, mak­ing life eas­i­er for pa­tients who were tak­ing sep­a­rate pills dai­ly. Short­ly af­ter, the CDC and Gilead struck up a part­ner­ship to re­search Tru­va­da’s use as a pre­ven­ta­tive mea­sure pri­or to ex­po­sure.

The duo inked mul­ti­ple ma­te­r­i­al trans­fer and clin­i­cal tri­al agree­ments, re­ferred to as MTAs and CTAs in the court doc­u­ments.

Tru­va­da won a la­bel ex­pan­sion in 2012 for PrEP, al­low­ing in­di­vid­u­als at high risk for HIV to take med­i­cine dai­ly to low­er their chances of con­tract­ing HIV. In 2016, the gov­ern­ment no­ti­fied Gilead that it had ac­quired patents for Tru­va­da’s use in PrEP, and three years lat­er, it sued Gilead in Delaware court for in­fring­ing on those patents by mar­ket­ing Tru­va­da and its fol­low-on drug, De­scovy, for PrEP. The Yale Glob­al Health Jus­tice Part­ner­ship pub­lished a re­port that year find­ing that CDC sci­en­tists were the first to de­ter­mine that the drugs com­pris­ing Gilead’s Tru­va­da could be used to pre­vent HIV trans­mis­sion.

Gilead CEO Daniel O’Day has re­fut­ed those claims, ar­gu­ing be­fore the House Over­sight Com­mit­tee in May 2019 that the patents are in­valid “be­cause the use of Tru­va­da as pro­phy­lax­is was wide­ly known at the time the CDC sought these patents.”

In ad­di­tion to chal­leng­ing the va­lid­i­ty of the patents, Gilead took the is­sue to fed­er­al claims court in 2020, al­leg­ing that the gov­ern­ment breached its MTAs and CTAs with Gilead.

The court sided with Gilead last week, find­ing that the gov­ern­ment failed to no­ti­fy Gilead of its patent ap­pli­ca­tions in a time­ly man­ner. The email no­ti­fi­ca­tion in 2016 came a year af­ter the first patent was grant­ed.

“To be able to ex­er­cise its rights un­der the MTAs, Gilead would need to know about the gov­ern­ment’s patent ap­pli­ca­tion,” the court said. Un­der the MTAs, the gov­ern­ment must give Gilead “se­ri­ous and rea­son­able con­sid­er­a­tion to [a] re­quest for a . . . li­cense,” the opin­ion states. “Gilead’s abil­i­ty to ex­er­cise this right is fore­stalled if it does not know a patent ap­pli­ca­tion ex­ists, es­pe­cial­ly in a time­ly man­ner.”

The Delaware case is set to go to tri­al in May 2023. The fed­er­al claims court did not come to a de­ci­sion on whether the CTAs were breached.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

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I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.