Apotex asks Supreme Court to overturn Teva ‘Bendeka’ ruling

Apotex has asked the US Supreme Court to reconsider a US Court of Appeals for the Federal Circuit ruling upholding four of Teva Pharmaceutical’s cancer drug patents.

The generic drugmaker submitted a petition for a  writ of  certiorari on Tuesday, December 14, urging the US’ highest court to overturn the Federal Circuit ruling.

The decision to uphold the validity of Teva’s “weak” patents “impedes innovation”, Apotex claims.

In August, the Federal Circuit issued a short opinion upholding four of Teva Pharmaceutical’s Bendeka (bendamustine HCl) patents, preventing several generic manufacturers from selling their version of the drug until 2033.

Teva and co-plaintiff Eagle Pharmaceuticals had sued Apotex, Mylan, and others in the US District Court for the District of Delaware to stop their attempts to manufacture a generic version of Bendeka prior to the expiration of patents.

The court ruled that the generics companies infringed four key patents in separate suits, rejecting the arguments that the four patents were invalid for obviousness.

Apotex and Mylan 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.

Now, Apotex’s petition to the US Supreme court claims that the Federal Circuit “strayed from the [US Supreme] Court’s guidance” in applying its “overly rigid and formulaic obviousness test”.

Apotex asks the Supreme Court whether, “claimed inventions involving reformulating and administering an old drug in ways that are no better than prior techniques, and which had been taught and suggested in the prior art, are nevertheless patentable”.

The petition invokes the Supreme Court’s ruling in KSR v Teleflex (2007) which reversed a Federal Circuit judgment that upheld the validity of a vehicle control pedal patent.

This decision looked to “restore the proper balance” between patentable “real innovation” and “minor manipulations of prior art”. The petition claims that the Federal Circuit disregarded this case law in upholding Teva’s Bendeka patents.

“Our submission is… that this court should use its supervisory power to direct the court of appeals to apply with integrity KSR and its holding that what is obvious to-try and hence unpatentable,” concludes the petition.

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