In Amerigen Pharmaceuticals v. UCB Pharmaceuticals, the Federal Circuit held that a generic Abbreviated New Drug Application (“ANDA”) filer with a Paragraph III certification to an Orange Book-listed patent has standing to appeal decisions from the Patent Trial and Appeal Board (“the Board”). Case No. 17-2529, Doc. 54, January 11, 2019 (the “Decision”). In this case, Amerigen was a Petitioner in inter partes review proceedings involving U.S. Patent No. 6,858,650 (“the ’650 patent”). The Board found the challenged claims not unpatentable, and Amerigen appealed. On appeal, UCB argued that Amerigen lacked standing to appeal because Amerigen had filed a Paragraph III certification with its ANDA. The Federal Circuit disagreed.
By way of background, when a brand company brings a drug to market, it can submit to the Food and Drug Administration (“FDA”) a list of any patents that the brand company reasonably could assert in a patent infringement action against a company that later wants to make a generic version of the same drug. The FDA then lists these patents in the publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations (known as the “Orange Book”). When a generic-drug company later files an ANDA requesting approval to market and sell a generic version of the brand drug, the generic-drug company provides one of several certifications to the FDA for each patent listed in the Orange Book for that drug. Those certifications inform the FDA whether, for example, the ANDA filer will wait to market and sell its drug until after the expiration of the patents the brand company has listed in the FDA’s Orange Book. If the ANDA filer intends to wait, it files a “Paragraph III” certification. In contrast, if the ANDA filer believes that any Orange Book-listed patent is invalid or unenforceable, or that the proposed generic product will not infringe the listed patent, the ANDA filer can file a “Paragraph IV” certification. Under the Hatch-Waxman act, the filing of a Paragraph IV certification allows the patent owner to sue the ANDA filer for infringement in District Court under the Hatch-Waxman Act. In contrast, the filing of a Paragraph III certification does not provide grounds for the patent owner to sue the ANDA filer for infringement in District Court.
In this case, Amerigen had filed a Paragraph III certification to the ’650 patent. UCB argued therefore that Amerigen had no standing to appeal the Board’s decision holding the ’650 patent not unpatentable as obvious. The Federal Circuit disagreed with UCB, finding that Amerigen did have standing.
The Federal Circuit noted that it has “previously recognized a patent in the Orange Book may create a cognizable injury independent of the prospect of infringement liability” because the listing of a patent in the Orange Book affects the timing of approval of generic drugs by the FDA. Decision at 13-14. Here, the Federal Circuit reasoned that the listing of the ’650 patent is delaying generic entry. Id. at 15. Notably, Amerigen represented to the Federal Circuit that it had received tentative approval of its ANDA from the FDA and would be able to launch its product in 2019 if the ’650 patent is invalidated. Id. at 12.
The Federal Circuit further stated that the America Invents Act and the provisions governing IPRs provided “broad access to challenge patents through the IPR procedure” in stating that “[a]ny ‘person who is not the owner of a patent may file with the Office a petition,’” and moreover that “any ‘party dissatisfied with the final written decision . . . may appeal the decision.” Id. at 15. The Federal Circuit therefore held that the listing of the ’650 patent in the Orange Book, which was delaying Amerigen’s ability to launch its product was sufficient to support standing.