Fed Circuit refuses to revive Parkinson’s disease patent

Precedential decision upholds lower court’s earlier finding | Patent at heart of the dispute covers treatment patch for Parkinson’s.

The US Court of Appeals for the Federal Circuit has rejected pharmaceutical company’s  UCB bid to overturn a lower court’s finding of patent invalidity.

In a p recedential decision handed down yesterday, April 12, the Federal Circuit refused to revive US patent number 10,130,589, directed to transdermal rotigotine patches. Rotigotine is used to treat Parkinson’s disease.

The ruling—which affirmed the US District Court for the District of Delaware’s finding that the patent was invalid for anticipation and obviousness—clears the way for  Teva’s unit  Actavis and  Mylan to sell generic versions of the drug.

If the court had sided with UCB, this would have delayed  US Food and Drug Administration approval of a generic for nine additional years, until the ‘589 patent expired in 2030.

UCB asserted the ’589 patent, which would delay FDA approval of a generic until the ’589 patent expired in 2030.

Earlier  litigation on a related patent between UCB and Teva resulted in proposed generic versions being blocked until 2021. While the first case was on appeal, UCB filed the patent application that matured into the patent-in-suit.

About a year before the injunction expired, UCB again sued Teva, accusing the company of infringing the newly-registered ‘589 patent.

And, when Mylan submitted an Abbreviated New Drug Application to launch a generic version, UCB also took Mylan to court for infringement of the ‘589 patent and another patent. As part of this, the parties stipulated to adopt, and the US District Court of the District of Vermont adopted, the Delaware judgment, opinion, and trial record.

The Delaware court, when dealing with the Teva dispute, concluded that the Muller patents (two patents that covered the original version of UCB’s rotigotine patch Neupro) anticipated all asserted claims and that the claims would have been obvious in light of multiple prior art references.

On appeal, the Federal Circuit said: “Because the district court’s fact findings on overlapping ranges, teaching away, unexpected results, and commercial success are not clearly erroneous, we affirm the judgment of invalidity.”

While the Federal Circuit agreed with UCB that the district court had erred by ignoring the appeals court’s case law regarding overlapping ranges, it affirmed the court’s finding of obviousness.

“In light of the evidentiary record, we do not see any error with the court’s conclusion of obviousness based on the Muller patents,” concluded the court.