Published: Wed, October 18, 2017
Health | By Jay Jacobs

Judge invalidates Allergan's key patents for dry-eye treatment Restasis

Judge invalidates Allergan's key patents for dry-eye treatment Restasis

A judge in Texas Monday invalidated those patents for the popular dry-eye drug, Restasis.

Allergan said it planned to appeal the decision. The 135-page decision found that Allergan's patent protection for the drug ended in 2014, and that "Allergan is not entitled to renewed patent rights for Restasis in the form of the second wave of patent protection".

The lawmakers requested correspondence between the drugmaker and tribe, market share analyses, Restasis sales figures and more.

Allergan transferred its Orange Book-listed patents for Restasis to the tribe, describing it as a "sophisticated opportunity to strengthen the defense of our Restasis intellectual property in the upcoming IPR proceedings before the PTAB".

For the St. Regis Mohawk Tribe, it could mean big hurdles, or even the end, of what tribal leaders hoped would be a lucrative new business for the Akwesasne economy - protecting patents for a range of companies. Allergan's CEO said defending the patents in a court as well as before a review board amounted to "double jeopardy". It was in federal court, where Allergan had said at the time of the deal it wouldn't try to use the Mohawks' sovereign immunity.

But after Bryson's ruling, other patent owners will be less likely to transfer such patents to tribes to shield them from review, said Rachel Sachs, a professor of patent law at Washington University in St. Louis.

Because of the outcome of the case, however, the benefits of having sovereign immunity from certain patent challenges might be moot.

The deal has faced criticism from senators and drug manufacturers who claimed the move was anti-competitive. "Because that is in essence is [sic] what the agreement between Allergan and the Tribe does, the Court has serious reservations about whether the contract between Allergan and the Tribe should be recognised as valid, rather than being held void as being contrary to public policy".

Some legal experts said it is too early to declare Allergan's patent gambit a failure.

Bryson's decision "will make patent owners question the arrangement, but I don't know if the ruling will prevent it entirely", Landau said.

Allergan noted that it will appeal the ruling.

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