AMERIGEN PHARMACEUTICALS v. UCB PHARMA GMBH

Summary: A generic pharmaceutical company had standing to appeal the Board’s decision in an IPR that claims of a patent were not obvious even though it may be incapable of maintaining a parallel Hatch-Waxman suit because it demonstrated a controversy traceable to the patent and redressable by the Court.  

Mylan Pharmaceuticals sought inter partes review of claims in a patent owned by UCB Pharma GmbH (“UCB”) which relates to a compound called fesoterodine.  Fesoterodine is an antimuscarinic drug marketed as Toviaz® to treat urinary incontinence.  Mylan alleged that the claims were obvious based on prior art.  After institution, Amerigen and two other companies joined as parties to the proceeding.  The Board held that the claims were patentable, and Amerigen alone appealed to the Federal Circuit. UCB moved to dismiss for lack of standing.

Although the Federal Circuit has jurisdiction to review a final decision of the PTAB, an appellant must meet “the irreducible constitutional minimum of standing” even if there is no such requirement to appear before the administrative agency being reviewed.  The Federal Circuit found that Amerigen had standing because the invalidation of UCB’s patent would advance the final approval and launch of Amerigen’s product.  

UCB argued that Amerigen lacked standing to appeal because the FDA would not approve Amerigen’s ANDA until the expiration of UCB’s patent in 2022, which was previously upheld in a separate suit in the District of Delaware.  Amerigen had initially filed a Paragraph IV certification against the patent, and Pfizer and UCB sued Amerigen for patent infringement in the District of Delaware.  In that case, Amerigen stipulated to infringement, and the district court held the patent was valid.  Amerigen waived its right to appeal, and the district court’s holding resulted in the conversion of Amerigen’s Paragraph IV certification to a Paragraph III.  Thus, the FDA will only approve Amerigen’s ANDA after the patent has expired, and UCB contended that Amerigen was foreclosed from infringing the patent. 

Amerigen responded that it had secured tentative approval from the FDA, that the patent delays entry of its competing product, and invalidating the claims of the patent would advance the launch of its product.  If the patent was held unpatentable through reversal of the Board’s decision, then UCB would have to notify the FDA that the patent may no longer be listed in the FDA’s Orange Book entry for Toviaz®.  The FDA would then remove the patent from the list “if there is no first applicant eligible for 180 day exclusivity based on Paragraph IV or after the 180 day exclusivity period of a first applicant based on that patent has expired or been extinguished.”  Amerigen represented that its ANDA had received tentative approval, and it would be able to obtain final approval for launch in 2019 if the patent was invalidated.  Thus, there was a three year period where Amerigen’s sales would be blocked by the patent.  The Federal Circuit agreed that Amerigen had a concrete economic interest in the sales of its tentatively approved drug being obstructed by the patent and demonstrated a controversy of sufficient immediacy and reality for Article III. 

UCB’s argument that Amerigen lacked standing was premised on the Hatch-Waxman Act because under the Hatch-Waxman Act a Paragraph IV certification is the fundamental jurisdictional basis for enabling parties to litigate Orange Book listed patents in Article III courts and without that basis there can be no injury in fact.  However, this case did not arise under the Hatch-Waxman Act.  Amerigen did not rely on a risk of infringement liability as a basis for injury.  Instead, it contended that the mere listing of the patent in the Orange Book inflicts concrete commercial injury redressable by the Court.   While the Federal Circuit found that Amerigen had standing, the Federal Circuit affirmed the Board’s finding that the claims were not obvious.