The filer of a tentatively-approved ANDA with a Paragraph III certification has standing to appeal an IPR decision to the CAFC if the listing of the challenged patent in the Orange Book delays the final approval of the ANDA.
The Federal Circuit affirmed a decision of the PTAB holding that claims 1-5 and 21-24 of U.S. Patent No. 6,858,650 to UCB Pharma GmbH (the ’650 patent) were not unpatentable as obvious on January 11. See Amerigen Pharmaceuticals Ltd. v. UCB Pharma GmbH No. 2017-2596 (Fed. Cir. January 11, 2019).
The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of the ‘650 patent alleging certain claims were obvious. After institution of the IPR, Amerigen and two other companies joined as parties to the proceeding. After the PTAB’s finding that the challenged claims were not unpatentable, Amerigen—but not Mylan—appealed the decision.
On appeal, UCB asserted Amerigen lacked standing. Specifically, UCB argued that, based on the Paragraph III certification accompanying Amerigen’s abbreviated new drug application (ANDA), the FDA will not approve Amerigen’s ANDA until the expiration of the ‘650 patent, previously upheld in a separate suit in the District of Delaware, in 2022. Consequently, UCB contends Amerigen is foreclosed from infringing the ‘650 patent, and without a possibility of infringement there can be no justiciable dispute.
Standing requires a claimant to have “(1) suffered an injury in fact, (2) that is fairly traceable to the challenged conduct of the defendant, and (3) that is likely to be redressed by a favorable judicial decision.” Spokeo, Inc v. Robins, 136 S. Ct. 1540, 1547 (2016). UCB further argued that under the Hatch-Waxman Act “Paragraph IV certification is the fundamental, jurisdictional basis enabling parties to litigate Orange Book- listed patents in Article III courts,” and without that basis there can be no injury in fact.
The Federal Circuit rejected UCB’s argument for several reasons. First, this case did not arise under the Hatch-Waxman Act. Second, Amerigen did not rely a risk of infringement liability as a basis for injury. Rather, Amerigen pointed to a concrete commercial injury that it incurred from the listing of the ’650 patent in the Orange Book, which was only possible so long as the ’650 patent was not found invalid. Specifically, the listing of the ‘650 patent blocked the launch of Amerigen’s tentatively approved ANDA, and invalidation of the patent would advance its drug’s launch.
“We have previously recognized that listing a patent in the Orange Book may create a cognizable injury independent of the prospect of infringement liability,” wrote Judge Alan Lourie for a unanimous panel of the Federal Circuit. “ If Amerigen succeeds in invalidating the ‘650 patent here and having the patent delisted, then it… could launch its proposed drug substantially earlier than it otherwise could. Consequently, by any common-sense measure, Amerigen has a substantial, concrete stake in whether it succeeds in proving the invalidity of the ‘650 patent.” (internal quotations omitted).
Thus, the Federal Circuit concluded that Amerigen had standing to appeal from the PTAB’s decision and proceeded to the merits.
Regarding the merits of Amerigen’s obviousness arguments, the Federal Circuit found no error in the PTAB’s decision. Judge Lourie explained that is was reasonable, based on the dearth of testimony, to weigh the appellee’s expert testimony over the appellant’s expert testimony. Further, even assuming a person skilled in the art would be motivated to modify one of the key compounds of the ‘650 patent, the petitioners failed to prove a skilled person would have made the specific modifications leading to the claimed compounds. Thus, the PTAB finding that the petitioners did not sustain their burden of proof was supported by substantial evidence.
Ultimately, the Federal Circuit affirmed the PTAB’s decision to confirm the patentability of the claims of the ‘650 patent.
Image Source: Gene Quinn © 2015
Judge Alan Lourie speaking at the AIPLA Annual meeting, October 2015.