Native American tribe hits back at Mylan in PTAB filing

The Saint Regis Mohawk Tribe, the owner of dry eye disease treatment Restasis (cyclosporine ophthalmic emulsion), has hit back at Mylan for questioning its sovereign immunity.

On Friday, October 20, the tribe responded to Mylan’s opposition to the tribe’s bid to have a number of inter partes reviews (IPRs) dismissed.

In September, LSIPR reported that Allergan had transferred its patent rights for the dry eye treatment to the tribe.

Allergan paid the tribe $13.75 million and the tribe granted the pharmaceutical company an exclusive licence to the treatment.

A few days later, the tribe attempted to dismiss IPRs brought by Mylan based on sovereign immunity.

Mylan claimed the deal was a “desperate” and “transparent” delay tactic, in a filing at the US District Court for the Eastern District of Texas, Marshall Division.

Then, last week, the court invalidated several Allergan patent claims at the centre of dispute, and Circuit Judge William Bryson claimed that Allergan’s licensing deal could spell the end for IPRs.

Bryson ruled against Allergan in the infringement suit, but in a separate order he granted a request to add the tribe to the case.

Just days later, on Thursday, October 18, San Diego-based Imprimis Pharmaceuticals announced plans to launch a generic version of Restasis.

Now, the Native American tribe has responded to Mylan’s attempts to stop dismissal of the IPRs, claiming that Mylan has not “articulated any coherent legal theory to support their oft repeated allegation that this transaction is a sham”.

The response, filed at the Patent Trial and Appeal Board (PTAB), went on to claim that Mylan’s argument lacks “substance” and that the company has relied on “liberal citations to news articles rather than law”.

“A refusal to recognise the tribe’s sovereignty here not only violates binding US Supreme Court precedent, it also would not solve the problem articulated by petitioners since state universities would still be able to use their immunity to avoid IPRs,” claimed the tribe.

According to the tribe, there is no basis for the PTAB to declare the assignment of patents void “simply because the tribe is invoking sovereign immunity in a commercial context”.

“Petitioners ask the board to give generic drug manufacturers more rights than state governments when it comes to protecting their business interests against those of a tribe,” concluded the tribe.

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