Moderna’s COVID-19 Vaccine May Infringe Valid Patent

After holding Moderna has standing to appeal an adverse Inter Partes Review decision, Federal Circuit upholds patent over Moderna’s challenge. Concerning another adverse decision in an IPR against a different patent, Moderna found not to have standing to appeal.

In decisions issued simultaneously, the Federal Circuit held Moderna had standing to appeal an adverse decision in an IPR challenging one patent but did not have standing to appeal an adverse decision concerning another patent.

During the appeals. Moderna supplemented the record to establish standing, which is a requirement for appeals before the Federal Circuit but not a requirement for IPRs before the USPTO. In the appeal where standing was established, the decision implies that Moderna’s COVID-19 vaccine relies on a lipid nanoparticle (“LNP”) delivery system and states that the patent owner claimed its patents covered “virtually all” LNP delivery systems and that the patent owner and its affiliates “have consistently taken the position” that Moderna requires a requires a license to the patent and did not provide a covenant not to sue.

Based on those facts, the Federal Circuit found standing to appeal, stating “Moderna has demonstrated enough of a risk that it will be faced with an infringement suit based on the combination of its own activities in developing the COVID-19 vaccine,” the patent owner’s “broad public statements about its extensive patent coverage in this area,” and the “refusal to grant a covenant not to sue.” Moderna’s victory was short-lived, however, as on the merits, the Federal Circuit affirmed the IPR decision finding the patent valid.

In contrast, in the appeal where standing was not established, Moderna did “not base its Article III standing on the threat of an impending infringement suit” or accusations of infringement. Instead, Moderna relied a portfolio license agreement covering a number of patents, and one where Moderna’s viral targets covered under the license were not being pursued to further phases but not fully abandoned, without providing an approximate date of termination or any concrete plans to further pursue development programs for any of the viral targets. The Federal Circuit found these facts too speculative to establish standing, and discounted the relevance of the portfolio license.