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8 July 2022Americas

Federal Circuit rejects ADHD generic drug challenge

A major generic pharma company has failed to undo patents related to the oral suspension Quillivant XR.

Teva Pharmaceuticals-owned Actavis Laboratories has failed to convince the US Court of Appeals for the Federal Circuit to overturn a finding that Tris Pharma’s innovations for an attention-deficit hyperactivity disorder (ADHD) drug are patentable.

In a decision handed down yesterday, July 7, the Federal Circuit affirmed a decision by the US District Court for the District of Delaware which found that Tris’ innovations were patentable and not obvious.

Tris owns US patent numbers 8,465,765; 8,563,033; and 8,778,390, all of which relate to a liquid methylphenidate (MPH) oral suspension with certain pharmacodynamic and pharmacokinetic properties.

Tris’ ADHD drug Quillivant XR (methylphenidate) is an extended-release liquid product which contains the same active ingredient as Novartis’ Ritalin.

Back in 2014, Tris sued Actavis after the generic maker revealed plans to launch its own generic version of the drug.

In 2017, the Delaware court ruled that the asserted patents were invalid as obvious. While this was an early win for Actavis, it was subsequently overturned by the Federal Circuit which, in November 2018, held that the Delaware court’s “obviousness decision lack[ed] the requisite fact-finding”.

The suit was remanded back to the Delaware court for further proceedings and, in November 2020, the court ruled that all of Tris’ asserted patent claims were valid and infringed by Actavis.

In yesterday’s decision, Circuit Judge Chen—on behalf of the court—said: “Because the district court’s conclusions are not clearly erroneous, we affirm.”

Before the Federal Circuit, Actavis had again argued that a skilled artisan would have been motivated to combine prior art references (including disclosing certain subsets of the claimed features with a reasonable expectation of success.

“However, the district court’s findings are supported by the record and Actavis has failed to show any clear error by the district court,” said Chen.

The court added that it had considered Actavis’ remaining arguments but did not find them “persuasive”, before affirming the Delaware court’s decision.

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More on this story

Americas
10 December 2020   New Jersey-based Tris Pharma has won a ruling blocking Teva-owned Actavis from launching a generic version of attention deficit and hyperactivity disorder drug Quillivant XR.

More on this story

Americas
10 December 2020   New Jersey-based Tris Pharma has won a ruling blocking Teva-owned Actavis from launching a generic version of attention deficit and hyperactivity disorder drug Quillivant XR.

More on this story

Americas
10 December 2020   New Jersey-based Tris Pharma has won a ruling blocking Teva-owned Actavis from launching a generic version of attention deficit and hyperactivity disorder drug Quillivant XR.