Timothy J. Shea, Jr. discusses with Law360 the implications of the U.S. Federal Circuit's ruling in Amgen Inc. v. Sandoz Inc., the Court's first interpretation of key provisions of the Biologics Price Competition and Innovation Act (BPCIA).
Discussing the rulings impact on the 180-day notice period and the patent dance mandate, Shea told Law360, "It does seem that the court is at least leaving open the question of whether it is mandatory if [the] patent dance is initiated." Shea noted that while the Amgen ruling that the patent dance is optional is a victory for biosimilar makers, its significance will fade as biosimilar applications are increasingly filed long before brand-name exclusivity lapses. "In that [scenario], it might be more advantageous for the biosimilar maker to use the patent dance to vet all patent issues, knowing that there's no urgency to get to market," Shea told Law360.
Discussing a footnote in the opinion suggesting that infringement suits brought under the BPCIA could be premised on process patents, Shea remarked, "The court here concludes that [the patent infringement statute] eliminates that concern and specifically allows the [branded manufacturer] to assert such process patents."