Judge Invalidates Allergan's Patent With SRMT

Four of the company’s patents covering its blockbuster eye drug Restasis were ruled invalid on Monday, October 16, 2017, by the US District Court for the Eastern District of Texas.

According to NPR, in the order on the agreement between Allergan and the Saint Regis Mohawk Tribe, US Circuit Judge William Bryson wrote: “Sovereign immunity should not be treated as a monetizable commodity that can be purchased by private entities as part of a scheme to evade their legal responsibilities.”

In an 11-page order separate from the one invalidating the Restasis patents for obviousness, Judge Bryson wrote that 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.

“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,” Bryson added.

He did not rule directly on whether the transfer was legal, however, because that question was not before him. According to some, the judge’s decision on Monday rendered Allergan’s move largely meaningless, since he invalidated the Restasis patents himself instead of waiting for the patent office to rule. While other suggest the rebuke from a prominent judge will make other patent owners reluctant to copy Allergan’s maneuver.

According to Regulatory Affairs Professional Society, Rachel Sachs, an assistant professor of law at Washington University in St. Louis, stated that the order does not mean that other companies cannot attempt these types of patent transfers with Native American tribes, “but it expresses reservations that should make companies nervous.”

Allergan said the move was justified because the same patents were already being reviewed in federal court, but critics said it was a cynical attempt to prolong the company’s monopoly on Restasis. Allergan said it was disappointed by Bryson’s decision to invalidate the patents and vowed to appeal.

In a direct statement from Allergan; “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, 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.”

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. 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.

Indian Time received this statement from the SRMT:

“The Tribe is in the process of reviewing the federal judge’s 135-page opinion and determining its impact on our patent business.”