Allergan documents due to address patent ‘sham’ question
Allergan has until tomorrow, Friday October 13, to address the question of whether its patent licensing deal with a Native American tribe was a sham.
The order was made on September 6 by Judge William Bryson at the US District Court for the Eastern District of Texas, where Allergan sued Teva, Mylan and other generic drug makers for patent infringement in 2015.
Bryson’s order came after Allergan notified the court that it had licensed rights to a number of patents, including those in this case, to the Saint Regis Mohawk Tribe. Allergan paid the tribe $13.75 million.
That deal has sparked a backlash, including from Congress, and the defendants in the case have called it a sham.
The agreement itself was made after Mylan had filed six inter partes reviews (IPRs) against Allergan patents covering Restasis (cyclosporine ophthalmic emulsion), a dry eye treatment. Following the deal, the Saint Regis Mohawk Tribe has attempted to dismiss the IPRs brought by Mylan.
In the court case, in which Allergan sued the generic producers for patent infringement covering Restasis, Bryson is nearly ready to issue his findings from the already completed trial.
In September, following that trial, Allergan notified the court of the patent licensing deal. The company said it would add the tribe as a co-plaintiff in the dispute, even though it didn’t believe the move would have any impact on the litigation.
According to the court, Mylan responded saying Allergan is attempting to misuse Native American sovereignty to shield invalid patents from cancellation.
Bryson said that since Allergan’s letter, there has been no motion to add the tribe as a plaintiff, and with the court expecting to issue a ruling soon, he ordered the parties to file briefs by October 13.
These must address the question of whether the tribe should be added or whether the patent assignment should be “disregarded as a sham”, as the defendants have claimed.
Allergan said in a previous filing that it will comply with the request.
There has been criticism since the deal was announced, with commentators questioning whether it was a misuse of sovereign immunity.
Senator Claire McCaskill has proposed a bill that says tribal sovereign immunity cannot be used to block patent review by the US Patent and Trademark Office.
The Saint Regis Mohawk Tribe has said it is “outraged” by the proposed legislation.
McCaskill said that Congress “never imagined tribes would allow themselves to be used by pharmaceutical companies to avoid challenges to patents, and this bill will shut the practice down before others follow suit”.
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
