Teva Wins Ruling on Patents for Bendeka Cancer Drug

(Bloomberg) -- Teva Pharmaceutical Industries Ltd. won a ruling that could keep its cancer drug Bendeka free from generic competition for more than a decade.

A federal judge in Delaware on Monday ruled that proposed generic versions of Bendeka by Mylan NV, Fresenius SE’s Fresenius Kabi, closely held Apotex Inc. and Slayback Pharma LLC infringe as many as four Teva patents on the drug, which has generated more than $2 billion in sales since its 2016 launch.

U.S. District Judge Colm Connolly also rejected the generic-drug makers’ contentions that Teva’s patents are invalid.

“Although the evidence of commercial success does not support a finding of nonobviousness, I still find that defendants have not shown by clear and convincing evidence that the prior art they cited would have motivated a person of skill in the art to reach the claimed formulations,” Connolly wrote in his opinion.

“Teva is very pleased that the court has ruled to uphold the validity of the patents and looks forward to continuing to provide bendamustine therapy to patients who need it,” said spokesperson Kelley Dougherty.

A spokesperson for Fresenius Kabi declined to comment, while representatives of the other companies didn’t respond to requests for comment.

In a 2017 lawsuit, Teva accused the four generic-drug makers of infringing as many as four patents for Bendeka, an improved version of its injectable Treanda cancer treatment with the same active ingredient, bendamustine, but a faster infusion time. The non-jury trial before Connolly ended in September.

Two of the patents cover the drug’s formulation, and three others cover methods of administering the drug. The formulation patents expire in January 2031, according to the U.S. Food and Drug Administration’s registry of information on approved drugs; the method patents expire in March 2033.

Bendeka has a 10-minute infusion time, which Teva said helps it compete against more convenient oral treatments. Before its launch, sales of Treanda, which has infusion times as long as an hour, were declining.

Bendeka and Treanda had combined North America sales of $496 million in 2019, down from $642 million in 2018, according to data compiled by Bloomberg. In its court filings, Teva said Bendeka now accounts for 90% of the market for bendamustine.

Teva licenses the Bendeka patents from Eagle Pharmaceuticals Inc., which is a co-plaintiff in the case. An appeals court in March said Eagle was entitled to seven years of marketing exclusivity for Bendeka when it received regulatory approval in 2015.

Eagle also sells its own bendamustine drug, Belrapzo, which has a different infusion protocol.

The case is Cephalon Inc. v. Slayback Pharma LLC, 17-cv-1154, U.S. District Court, District of Delaware (Wilmington).

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