Fed Circ upholds Teva cancer drug patents

The US Court of Appeals for the Federal Circuit has affirmed a Delaware court ruling upholding the validity of cancer drug patents owned by Teva Pharmaceuticals.

The decision handed down on Friday, August 13, will prevent generics of the drug from being released until 2033.

Teva and co-plaintiff Eagle pharmaceuticals had sued several generics manufacturers, including Apotex and Mylan Laboratories, to stop their attempts to manufacture a generic version of Bendeka prior to the expiration of patents.

The US District Court for the District of Delaware ruled that Mylan, Apotex, Fresenius and Slayback Pharma infringed four key patents in separate suits, rejecting the generic’s arguments that the four patents were invalid for obviousness.

Mylan, Apotex, Fresenius SE challenged the rulings in a consolidated Federal Circuit appeal but Slayback chose not to join.

In a short opinion Circuit judges Pauline Newman, Raymond Clevenger, and Richard Taranto upheld the district court’s ruling.

Treanda and Bendeka

Teva’s first bendamustine cancer treatment was Treanda, a freeze-dried formula that received FDA approval in 2008.

Eagle sought to develop a follow-on product of Treanda, filing its own Abbreviated New Drug Application (ANDA) to develop Bendeka.

Teva sued Eagle in 2017 for infringing the four patents, but the companies settled out of court, with Teva acquiring the rights to Bendeka.

The patents in dispute comprise two formulation patents set to expire in January 2031 and two method patents expiring in March 2033.

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