Fed Circuit rules against Mylan in patent dispute over epilepsy drug

Generic-drug manufacturers Mylan Pharmaceuticals, Breckenridge Pharmaceutical and Alembin Pharmaceuticals have lost their bid to prove that claims in a patent owned by US company Research Corporation Technologies, were invalid on the grounds of obviousness.

In a precedential ruling on Friday, February 1, the US Court of Appeals for the Federal Circuit affirmed a decision by the US Patent Trial and Appeal Board which upheld Research Corp’s patent.

The patent (US number 38,551) is for the anti-epileptic drug Vimpat (lacosamide), which Research Corp licenses to biopharmaceutical company UCB.

Mylan and the generic-drug makers had argued that the invention in the patent was an obvious modification of an existing compound.

In its ruling, the Federal Circuit court agreed with the PTAB’s determination that the group had failed to establish that a person of ordinary skill in the art would have been motivated to modify the compound.

“We agree with the Board that appellants failed to meet their burden to establish a motivation,” the court said.

The ruling is the latest decision in an on-going dispute since 2013, when Mylan, Breckenridge, Alembin and another company, Argentum Pharmaceuticals, were accused of infringing the 551 patent.

The companies denied infringement, and in 2015, Argentum sought inter partes review—a review of the patentability of one or more claims in a patent—of 13 claims of the patent.

After the PTAB agreed to review the patent, Mylan, Breckenridge and Alembic joined the proceedings.

In a decision in March 2017, the PTAB upheld the patent and said Argentum had not given sufficient evidence that the claims of the patent-in-suit were unpatentable for obviousness.

Following the decision, Mylan, Breckenridge and Alembic appealed. Argentum is not named in the latest appeal to the Federal Circuit.

Mylan, Breckenridge and Alembic also challenged aspects of the PTAB’s legal analysis.

The companies argued that the PTAB “improperly” negated their proposed motivation argument “without finding that the prior art taught away” from their proposed modification.

However, the Federal Circuit said that this argument had no merit, concluding that it was “merely an attack on factual findings under the guise of a challenge to [the] PTAB’s legal analysis”.

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