In our previous article of 5 October 2017, we described Allergan’s novel strategy to shield valuable patents covering blockbuster dry-eye drug, Restasis®, from IPRs at the PTAB: The global pharmaceutical company took the eyebrow-raising step of transferring these patents to the Native American St. Regis Mohawk Tribe, who benefit from “sovereign immunity” status.
The US Court of Appeals for the Federal Circuit has since rejected the legitimacy of Allergan’s patent shield and said the PTAB does indeed have authority to review the validity of patents covering Restasis®. The decision, which Allergan have appealed against, can be found here.
Allergan said this manoeuvre was to protect itself from the PTAB, which it claimed to be a flawed and biased forum, and also said it did not object to the validity of its patents being reviewed by federal judges. Subsequently, and rightfully some have argued, one such federal judge in Texas invalidated Allergan’s Restasis® patents on grounds that the patents cover ideas that are obvious, rendering Allergan’s strategy largely meaningless. Allergan have also appealed against this decision.
Despite these setbacks, the St. Regis Mohawk Tribe and Allergan issued generic drug manufacturer Amneal Pharmaceuticals with a patent infringement suit over Restasis® last month.
The saga continues…
For more information or advice, please contact Gavin Wai or your usual Kilburn & Strode advisor.