A fed­er­al judge in­val­i­dat­ed four of Van­da Phar­ma­ceu­ti­cals’ patents for sleep med Het­lioz on Tues­day, ef­fec­tive­ly open­ing the door to gener­ic tasimelteon com­pe­ti­tion from Te­va, Apo­tex and oth­ers. Van­da plans to ap­peal and is ask­ing for a stay against the com­pe­ti­tion in the mean­time.

“Van­da in­tends to ap­peal the de­ci­sion to the Unit­ed States Court of Ap­peals for the Fed­er­al Cir­cuit and to re­quest a stay of mar­ket en­try by Te­va and Apo­tex while the ap­peal is pend­ing,” the com­pa­ny said in a state­ment.

Mean­while, a Te­va spokesper­son said in an email to End­points News that it is “pleased by the de­ci­sion,” but de­clined fur­ther com­ment as Van­da’s new ap­peal is pend­ing.

US dis­trict court judge Colm Con­nol­ly’s straight­for­ward de­ci­sion found that the de­fen­dants Te­va and Apo­tex’s pro­posed prod­ucts do not in­fringe on Van­da’s RE604 patent, and ad­di­tion­al­ly found Van­da’s four as­sert­ed patents “in­valid for ob­vi­ous­ness.”

Van­da had al­ready set­tled with a third pos­si­ble gener­ic tasimelteon from MSN Labs and Im­pax al­most a year ago, ink­ing a non-ex­clu­sive li­cens­ing agree­ment that would go in­to ef­fect in 2035. How­ev­er, the terms of the deal stip­u­late that MSN and Im­pax would be able to en­ter the mar­ket ear­li­er if re­lat­ed to the patent lit­i­ga­tion there would be sub­se­quent mar­ket en­try “of cer­tain oth­er third-par­ty gener­ic ver­sions.”

The rul­ing caused Van­da stock $VN­DA to tum­ble by about 30%, from $11 be­fore the rul­ing on Tues­day morn­ing to around $7.50 in Wednes­day mid­day trad­ing.

The loss comes as Van­da is em­broiled in a sep­a­rate Het­lioz is­sue with the FDA. In No­vem­ber, Van­da wrote a let­ter to the FDA de­mand­ing a hear­ing for its sN­DA on Het­lioz for the treat­ment of jet lag. Van­da at­tor­ney Paul Hugh­es gave the FDA a Christ­mas Eve dead­line to set it up.

The lat­est Van­da let­ter fol­lowed a let­ter in Oc­to­ber from CDER di­rec­tor Pa­trizia Cavaz­zoni to Van­da not­ing the sN­DA would not be ap­proved be­cause of a lack of sub­stan­tial ev­i­dence as had been laid out in a CRL in 2019. Cavaz­zoni said in the Oc­to­ber let­ter that Van­da could file for a hear­ing if it can show “gen­uine and sub­stan­tial is­sue of fact that re­quires a hear­ing to re­solve.”

President Joe Biden made clear in his “finish the job” State of the Union address last night that one of those jobs to be finished is insulin prices.

Biden’s push again to tackle insulin prices, after Republicans rebuffed the idea last summer and just after Biden won Medicare drug price negotiations/caps via the Inflation Reduction Act, shows how heavily he’s leaning into this work.

Six weeks into his new role at the helm of Teva Pharmaceutical, Richard Francis said it’s time to “get back to growth,” starting with a good look at the company’s priorities.

The chief executive has kicked off a strategic review, he announced during Teva’s quarterly call, which will continue over the next several months and produce results sometime in the middle of 2023. That means some pipeline cuts may be in store, he told Endpoints News, while declining to offer much more detail.

We now know where Roche’s ex-pharma chief Bill Anderson is going.

German pharma giant Bayer announced Wednesday that Anderson will be taking on the role as CEO, less than six weeks after Anderson stepped down from his perch at Roche as head of the group’s pharmaceutical division.

Roche announced back in December that Anderson would depart on Dec. 31 to “pursue opportunities outside of Roche.” His replacement, Genentech vet and Roche’s current head of global product strategy, Teresa Graham, will start her role in March.

The DC Circuit Court has struck a blow against the pharmaceutical lobbying group PhRMA and other plaintiffs’ attempt to stop states from importing drugs from Canada.

Joined alongside public health group Partnership for Safe Medicines and advocacy group Council for Affordable Health Coverage, PhRMA was rebuffed by Judge Timothy Kelly on Monday, who dismissed the civil suit due to a lack of standing.