Everolimus - USA

On Mar 28, 2017, Delaware court issued trial opinion in Everolimus (ZORTRESS) case.

Plaintiffs Novartis brought the patent infringement actions against Breckenridge Pharmaceutical, Inc., Roxane Laboratories, Inc. and Par Pharmaceutical, Inc. in 2014.  Breckenridge, Roxane, and Par each filed an Abbreviated New Drug Application ("ANDA"), seeking to engage in the commercial manufacture, use, and sale of generic versions of Novartis's Zortress product. Plaintiffs allege that these ANDAs infringe U.S. Patent No. 5,665,772 ("the '772 patent"). Plaintiffs further allege that by filing these ANDAs, Roxane and Breckenridge induced infringement of U.S. Patent No. 6,239,124 ("the '124 patent") and Roxane and Par induced infringement of U.S. Patent No. 6,455,518 ("the '518 patent").

The Court held a bench trial on August 29-September 1, 2016. Defendants concede that their proposed products meet all limitations of the '772 patent.  Defendants argue that Plaintiffs have not proven by a preponderance of evidence that Defendants induced infringement of the '124 and '518 patents. Defendants further argue that the '772, '124, and '518 patents are invalid as obvious and for obviousness-type double patenting.

CONCLUSION: Defendants proved that the asserted claims of the '772 patent are invalid for obviousness type double patenting. Defendants failed to prove by clear and convincing evidence that the asserted claims of the '124 and '518 patents are invalid. Plaintiffs proved by a preponderance of the evidence that Defendants Roxane and Breckenridge induced infringement of claim 7 of the '124 patent and Defendants Roxane and Par induced infringement of claim 7 of the '518 patent.