Supreme Court to Weigh-in on Amgen, Sandoz Neupogen® Biosimilars Battle


On January 13, 2017 the U.S. Supreme Court granted certiorari in Amgen v. Sandoz. The case involves interpretation of key provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), including (1) the effect of a biosimilar applicant’s failure to provide a sponsor with a copy of its FDA application and related manufacturing information; (2) whether an applicant’s notice of marketing to a biologic sponsor prior to FDA approval is effective; and (3) whether the Federal Circuit’s interpretation of the BPCIA effectively granting the sponsor an additional 180 days of exclusivity is improper.


In 2010, as part of the Patient Protection and Affordable Care Act, Congress enacted the BPCIA to provide faster FDA approval of follow-on biologics (i.e., “biosimilars”) that are highly similar to biologic products that were previously approved under the traditional FDA approval process for biologics. Examples of such biologic products (and follow-on biosimilars) include therapeutic serums, antitoxins, vaccines, blood components or derivatives, allergenic products, or other analogous products applicable to the prevention, treatment, or cure of a disease or condition of human beings. See 42 U.S.C. 262(i)(1).


In the present case, Amgen (here the biologic sponsor) had sold its biologic filgrastim product under the brand name Neupogen® for over 20 years. In 2014, Novartis unit Sandoz (here the biosimilar applicant) filed a biosimilar application for approval of its own filgrastim product.


Pursuant to the BPCIA, FDA’s acceptance of the Sandoz application triggered a process in which Sandoz would share its FDA biologics license application and related manufacturing information with Amgen; both parties would work to resolve any patent disputes; and Sandoz would provide notice to Amgen at least 180 days prior to the time Sandoz began its commercial marketing of its biosimilar product. However, Sandoz declined to share its application with Amgen, and purported to give notice of commercial marketing both while its application was pending, and on the date of approval.


Amgen contended that these actions violated the BPCIA and sued Sandoz in the U.S. District Court for the Northern District of California asserting patent infringement and state law claims for unfair competition and conversion (based on Sandoz’s conduct relating to its alleged violations of the BPCIA). In March 2015, the district court dismissed Amgen’s state law claims, finding that Sandoz’s failure to share its application with Amgen was permissible; that such failure did not offer a basis for the relief sought by Amgen; and that the Sandoz notice of commercial marketing prior to approval was permissible.


On appeal, the U.S. Court of Appeals for the Federal Circuit held that (1) Sandoz’s failure to provide Amgen with its FDA application and manufacturing information was proper and expressly contemplated by the statute, giving rise to Amgen’s sole remedy being based on patent infringement; (2) Sandoz’s notice of marketing to Amgen prior to FDA approval of Sandoz’s biosimilar application was premature and ineffective since notice is only effective after FDA approval; and (3) because Sandoz failed to provide Amgen with the FDA application and manufacturing information, Sandoz is precluded from marketing its biosimilar product for 180 days after the effective date of notice—here effectively granting another 6 months of exclusivity to Amgen. The Court also affirmed dismissal of the state law claims for reasons as stated in the opinion as can be found here: http://www.cafc.uscourts.gov/sites/default/files/s15-1499.pdf.


As indicated above, the issues raised in the parties’ certiorari petitions involve whether notice of commercial marketing given before FDA approval can be effective; whether the Federal Circuit’s interpretation that under the present circumstances the BPCIA delays commercial marketing of biosimilars by 180 days after approval is improper; whether applicant is required to provide the sponsor with a copy of its biologics license application and related manufacturing information, and whether, in the absence of such production, sponsor’s sole recourse is a declaratory judgment action or patent infringement action.No hearing date has been set to date.


A link to the Supreme Court’s docket for this case can be found here: https://www.supremecourt.gov/Search.aspx?FileName=/docketfiles/15-1195.htm


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