A federal judge in Texas on Monday ruled that four patents for Allergan's best-selling eye drug Restasis are invalid—opening up the possibility that drugmakers could create generic versions of Restasis.
Background: Restasis patents face legal challenges
Allergan in a case before the U.S. District Court in Texas has argued that Restasis' six patents should not expire until 2024, while generic drugmakers Akorn, InnoPharma, Mylan, and Teva Pharmaceuticals in the case have argued Allergan should not have been granted the patents in the first place, and that the patents therefore should be ruled invalid. According to Reuters, Allergan last week reached a settlement with InnoPharma in the case, leaving Akorn, Mylan, and Teva to contest Allergan's patents.
Separately, Akorn, Mylan, and Teva have sought to invalidate Allergan's patents for Restasis through the U.S. Patent and Trademark Office's inter partes review process (IPR). IPR was created about six years ago as a faster, low-cost alternative to determining patent validity through the federal courts. Some stakeholders have criticized the process, including some pharmaceutical companies, and the Supreme Court is considering the constitutionality of the process in a separate case.
Allergan in September announced that it had transferred patents for Restasis to the Saint Regis Mohawk Tribe—a move that some legal experts say could give pharmaceutical companies a new avenue to block patent disputes from generic drug companies. Under the arrangement, Allergan will pay the tribe $13.75 million, and the tribe will claim sovereign immunity as grounds to dismiss the IPR challenge. The tribe will lease the patent to Allergan and receive $15 million in annual royalties until the patents expire or are no longer valid.
According to the Times, Allergan's deal with the Saint Regis Mohawk Tribe does not affect the case in the U.S. District Court in Texas. However, a ruling in the case ultimately could affect the U.S. Patent and Trademark Office's review of Allergan's deal with the Saint Regis Mohawk Tribe, because federal court rulings typically supersede administrative reviews. Michael Carrier, a professor at Rutgers Law School who studies patent law, said, "If a court overturns the patent, then that is game over for the patent."
Judge rules Restasis patents are invalid
According to Reuters, U.S. Circuit Judge William Bryson on Monday ruled that four of Allergan's patents for Restasis are invalid. Bryson said the patents should not have been granted to Allergan because they cover treatment methods that were obvious when considering earlier patents that Allergan had been granted.
Bryson in his ruling also criticized Allergan's agreement with the Saint Regis Mohawk Tribe, even though the agreement does not affect the Texas case. Bryson said such arrangements could harm the United States' patent process. He 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."
Allergan, tribe react
Allegan has said it will appeal the ruling, which could block drugmakers from launching generic versions of Restasis until the appeal is resolved. According to the Journal, some drugmakers, including Mylan and Teva, are working on generic versions of the drug, but so far none have received approval for a generic form of Restasis.
Brendan White, a spokesperson for the tribe, said it is "in the process of reviewing the decision and its impact on [the tribe's] patent business" (Thomas, New York Times, 10/16; Erman, Reuters, 10/12; Wolfe/Erman, Reuters, 10/16; Moise, Wall Street Journal, 10/16).
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