Fed Circuit refuses to rehear Allergan and tribe Restasis ruling

The US Court of Appeals for the Federal Circuit yesterday, March 6, refused to rehear a decision which found  Allergan and the  Saint Regis Mohawk Tribe’s patents for dry-eye treatment Restasis (cyclosporine ophthalmic emulsion) are invalid.

Yesterday, the Federal Circuit rejected the petition for a panel rehearing and a rehearing en banc.

Back in October 2017, Judge William Bryson of the US District Court for the Eastern District of Texas  concluded that although Allergan’s Restasis patents were infringed by generic drugmaker Teva, Teva had demonstrated the patents were invalid.

In November 2018, the Federal Circuit affirmed the district court’s ruling without issuing a formal opinion.

The following month, Allergan and the tribe requested a rehearing.

According to their submission, while the district court acknowledged that Restasis was a commercial success and met a long-felt need, it disregarded this evidence “based principally on the presence of the blocking patents that suppressed any competition in cyclosporin/glyceride emulsion formulations”.

Allergan and the tribe claimed that the Federal Circuit should rehear the case because of the “strong evidence” that there was no blocking, to correct the expansion of the “blocking patent” doctrine, and to reaffirm that any analysis of blocking must be case and fact specific.

Linked with this case, is the closely-followed dispute centring on the application of tribal sovereign immunity in inter partes reviews (IPRs).

One month before Bryson’s ruling, in September 2017, Allergan  transferred its Orange Book-listed patents for the dry eye treatment to the tribe, a move that sparked much debate.

Bryson, at the same time as his patent ruling and in a separate decision, said that Allergan’s controversial patent licensing deal with the tribe could spell the end for IPRs.

Last March, the Patent Trial and Appeal Board  rejected the tribe’s claims of tribal sovereign immunity and determined that the proceedings could continue without the tribe’s participation. The decision was  affirmed by the Federal Circuit in July 2018,

In a petition filed with the US Supreme Court in December last year, the Saint Regis Mohawk Tribe and Allergan have asked the court to hear their immunity case.

Restasis generates more than $1 billion in annual sales for Allergan.

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