For the First Time PTAB Upholds Validity of Pharma Patents
On December 9, 2014, the Patent Trial and Appeal Board (“PTAB”) upheld the validity of three Supernus Pharmaceutical’s patents relating to once-daily formulations of doxycycline. The trio of decisions is significant because one of the three patents had been at issue in a Hatch Waxman litigation. The PTAB’s decision with respect to this patent marks the first time the Board has reached a final decision regarding the validity of a patent first put at issue in litigation filed under the Hatch-Waxman Act.
The patents at issue in the three decisions – U.S. Patent Nos. 8,206,740 (“the ‘740 patent”), 8,394,405 (“the ‘405 patent”), and 8,394,406 (“the ‘406 patent”) – all related to Oracea®, an antibiotic used to treat the chronic skin disease rosacea. The ‘740 patent was originally asserted in a Hatch Waxman proceeding in the U.S. District Court for the District of Delaware (Case No. 1:11-cv-01106-LPS). Eleven months after plaintiffs in that action amended their complaint to assert infringement of the ‘740 patent (which issued subsequent to the filing of the initial action), Amneal filed a petition seeking inter partes review (“IPR”) of the ‘740 patent, thus challenging the validity of that patent simultaneously before the district court and before the PTAB.
On the eve of trial, nearly two and a half years into the litigation, Amneal amended the patent certification in its ANDA with respect to the ‘740 patent to include a paragraph III certification that it would not seek approval prior to the patent’s expiration. The parties then filed a stipulation of dismissal without prejudice, terminating the district court litigation.
At the same time Amneal filed its petition seeking inter partes review of the ‘740 patent, it also filed two additional petitions seeking review of the related ‘405 and ‘406 patents. The ‘405 and 406 patents were continuations of the ‘740 patent. Both issued well after the Hatch Waxman litigation began. Neither the ‘405 nor the ‘406 patents were the subject of Hatch Waxman litigation, suggesting that Amneal may have also provided paragraph III certifications for those patents.
Amneal thus appears to have employed a deliberate strategy to proceed before the PTAB rather than the district court. Amneal’s decision-making demonstrates how IPRs are increasingly being used by defendants involved in Hatch-Waxman litigation. In this case, Amneal’s strategy was unsuccessful, as the PTAB upheld the validity of all three patents. Whether future ANDA applicants will be more successful before the Board remains to be seen.