Cyclosporine – USA

On Nov. 13, 2018, Federal Circuit affirmed (Rule 36 judgment) Texas judge’s decision that patents covering Allergan’s Restasis® are invalid.

Previously, on Oct. 16, 2017, Judge Bryson of Eastern District of Texas issued an opinion & found patents [U.S. Patent Nos. 8,629,111; 8,633,162; 8,642,556; 8,648,048; 8,685,930 and 9,248,191] invalid as obvious (reported here on this blog).  In short, the obviousness dispute in this case centered on Allergan’s assertion that the Restasis formulation exhibited unexpected results compared to the prior art. Allergan stated that the prior art patent discloses ranges of amounts of cyclosporin (0.05% to 0.40%) and castor oil (0.625% to 5.0%) that cover Restasis. Allergan argued however, that the particular combination in Restasis of 0.05% cyclosporin and 1.25% castor oil is a critical value that produces unexpected results far better than would be expected for the range of values disclosed in prior arts. For that reason, Allergan contended that the critical value of 0.05% cyclosporin with 1.25% castor oil is patentable, even though it falls within the ranges disclosed and claimed in prior art patent. Court, however, found that a person of skill reviewing prior arts & the underlying Phase 2 data, would not conclude that the 0.1% cyclosporine /1.25% castor oil formulation was more effective than the 0.05% cyclosporin/0.625% castor oil formulation. A person of skill reviewing those papers would come to the conclusion that neither formulation was more effective than the other in Phase 2. That person of skill would reach the same conclusion for Phase 3. The court finally held that based on the extensive amount of pertinent prior art, Allergan is not entitled to renewed patent rights for Restasis in the form of a second wave of patent protection. The Court therefore held that while Allergan has proved by a preponderance of the evidence that the defendants have infringed the asserted claims of the Restasis patents, the defendants have proved by clear and convincing evidence that the asserted claims of the Restasis patents are invalid for obviousness.