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Generic Makers to Challenge Ruling Upholding Teva Cancer Drug

Aug. 2, 2021, 9:03 AM

Teva Pharmaceutical Industries Inc.‘s patents for cancer drug Bendeka are invalid, three companies seeking to sell generic versions of the drug will tell the Federal Circuit at argument Tuesday.

Mylan NV, Fresenius SE, and Apotex Inc. are appealing a U.S. District Court for the District of Delaware ruling that their proposed generics infringe four Teva patents on the drug.

Bendeka’s active ingredient “is an old drug used to treat cancer since the early 1970s,” Mylan and Fresenius argued in their opening brief. “Only incremental changes have been made since the early days of bendamustine usage, and plaintiffs’ asserted patents are no more than that: incremental change already taught and supported by the prior art.”

“This had all been done before,” Apotex argued in its separate opening brief.

If the U.S. Court of Appeals for the Federal Circuit upholds the ruling, Teva’s drug could remain free from generic competition for more than a decade.

Defendant ‘Amnesia’

In 2017, Teva sued the generic drugmakers for infringing two formulation patents and two method patents for Bendeka.

Bendeka is an improved version of its injectable Treanda cancer treatment with the same active ingredient, bendamustine, but a faster infusion time.

Cephalon Inc., later acquired by Teva, licenses the Bendeka patents from Eagle Pharmaceuticals Inc., which was a co-plaintiff in the case. The formulation patents expire in January 2031 and the method patents expire in March 2033, according to the U.S. Food and Drug Administration’s registry of information on approved drugs.

The trial court found Mylan, Fresenius, and Apotex—as well as Slayback Pharma LLC, which isn’t involved in the appeal—infringed the patents. The court rejected their arguments that the patents were invalid as obvious, indefinite, and lacking enough detail to enable a skilled artisan to replicate the drug.

Teva defended the trial court’s ruling on appeal, arguing that Bendeka improved upon a “notoriously unstable” drug that “caused dangerous toxicities.”

The generic companies suffer from “amnesia,” Teva said in its response brief.

“Relying on tendentiously-selected excerpts, defendants endeavor to prove that the record could have supported a determination of invalidity—in so doing, seeking to reframe their disagreements with the district court’s factual findings as ‘legal errors,’” Teva said. “These attempts fail.”

Steven Feldman of Hahn Loeser & Parks LLP in Chicago will argue for Apotex. Imron Ally of Schiff Hardin LLP in Chicago will argue for Fresenius and Mylan. David Berl of Williams & Connolly LLP in Washington will argue for Teva, Cephalon, and Eagle.

The case is Cephalon, Inc. v. Slayback Pharma Ltd., Fed. Cir., No. 20-2134, argument 8/3/21.

To contact the reporter on this story: Perry Cooper in Washington at pcooper@bloomberglaw.com

To contact the editor responsible for this story: Keith Perine at kperine@bloomberglaw.com

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