Recently, in a 135-page opinion, Judge William C. Bryson (left), sitting by designation as a trial judge for the United States Federal District Court for the Eastern District of Texas, found that Allergan’s RESTASIS patents were infringed by Teva Pharmaceuticals USA, but that Teva had demonstrated invalidity of those RESTASIS patents by clear and convincing evidence.
“We are disappointed by the Federal District Court’s decision on the RESTASIS® patents. We are carefully reviewing the decision and are considering all options,” said Robert D. Bailey, Chief Legal Officer for Allergan. “Allergan remains committed to vigorously defending the intellectual property of our products, which allows us to continue to invest in developing and bringing forward new medicines for millions of patients.”
The patents include United States Patent Nos. 8,629,111; 8,648,048; 8,685,930 and 9,248,191. These patents, along with United States Patent Nos. 8,633,162 and 8,642,556, are listed in the Orange Book for RESTASIS® and expire on August 27, 2024.
In a separate Order dealing with the issue of whether the Saint Regis Mohawk Tribe should be joined as co-plaintiff, Judge Bryson acknowledged that “the sovereign immunity issue is not presented in this case,” but nevertheless went to great lengths in dicta to express his opinion on the matter anyway.
“The Court has serious concerns about the legitimacy of the tactic that Allergan and the Tribe have employed. The essence of the matter is this: Allergan purports to have sold the patents to the Tribe, but in reality it has paid the Tribe to allow Allergan to purchase—or perhaps more precisely, to rent—the Tribe’s sovereign immunity in order to defeat the pending IPR proceedings in the PTO. This is not a situation in which the patentee was entitled to sovereign immunity in the first instance. Rather, Allergan, which does not enjoy sovereign immunity, has invoked the benefits of the patent system and has obtained valuable patent protection for its product, Restasis. But when faced with the possibility that the PTO would determine that those patents should not have been issued, Allergan has sought to prevent the PTO from reconsidering its original issuance decision. What Allergan seeks is the right to continue to enjoy the considerable benefits of the U.S. patent system without accepting the limits that Congress has placed on those benefits through the administrative mechanism for canceling invalid patents.
If that ploy succeeds, any patentee facing IPR proceedings would presumably be able to defeat those proceedings by employing the same artifice. In short, Allergan’s tactic, if successful, could spell the end of the PTO’s IPR program, which was a central component of the America Invents Act of 2011.”
Despite the foregoing, Judge Bryson acknowledged that the validity of the assignment and exclusive license transaction “may be dispositive in the IPR proceedings” and that there was consideration given by the Saint Regis Mohawk Tribe in exchange for the RESTASIS patents.
To date, none of the proposed generic versions of RESTASIS have received approval and none of these products would be able to launch in the market.
Tags: Allergan, Eastern District of Texas, EDTX, Judge Bryson, patent, Patent Litigation, patents
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