Who Will Be Left Standing? The Constitutional Requirements for IPR Appeals
As we have previously discussed, some petitioners for IPR are not able to appeal an adverse decision by the PTAB because they lack constitutional standing. Though Article III standing is not required to file an IPR petition, because it does not apply to administrative proceedings, standing is required to bring a case in Federal court—including an appeal to the Federal Circuit. Several recent decisions have further clarified this standing requirement and give good reason to continue to follow the issue.
Petitioners that have not suffered any “injury” from the patent (e.g., harm to their business) may not be able to appeal an adverse IPR decision. The Federal Circuit’s decision last year in Phigenix, Inc. v. ImmunoGen, Inc. first explained this. There, the Court dismissed the appeal because the petitioner had failed to establish the requisite injury. Notably, the Court rejected the argument that the estoppel effect of an adverse IPR decision was sufficient to establish injury in fact.
The Federal Circuit has further refined this standing requirement in several recent cases. In JTEKT Corp. v. GKN Automotive Ltd., the Court again dismissed the petitioner’s appeal because of a lack of the requisite injury. The Court explained that although it is not necessary for a petitioner to have a product on the market that is accused of infringement, there must be some concrete plan that would create a risk of future infringement. Because the petitioner was still developing its product, it could not definitely compare the product’s features to the claims of the patent.
On the other hand, the petitioner in E.I. Dupont De Nemours & Co. v. Synvina C.V. was able to appeal because it demonstrated concrete plans for future activity that risked infringement. The petitioner filed an IPR petition before it had sold any products made by the patented process, and before the patent owner had alleged infringement, but after it had built a facility capable of infringing the patent. The court also noted that the patent owner both refused to grant a covenant not to sue and alleged before the Board that the petitioner had copied its process. On that basis, the Federal Circuit found the risk of infringement sufficient to give the petitioner standing to appeal.
Takeaways
Petitioners need to be mindful that the ability to appeal an adverse decision from the PTAB will require some form of concrete injury connected to the challenged patent. And because of the IPR-estoppel provisions, an unsuccessful petitioner may be precluded from again challenging the patent in certain ways, either before the Board or in district court.
Although Dupont provides one circumstance where the petitioner has standing, many questions remain to be addressed. For example, the Federal Circuit is currently considering the Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company case in which a biosimilar manufacturer is appealing an adverse Board decision before it files its application with the FDA. In addition, the Supreme Court is currently considering a petition challenging the Federal Circuit’s rule that the statute does not itself give petitioners standing – and indeed recently requested the Solicitor General’s views on the topic, which often suggests that the Justices are considering the issue closely. These cases will likely provide further clarity on the contours of the standing requirement.