Notice By Biosimilar Maker To Biologic Originator Is Always Required

July 6th, 2016
Life Sciences/Pharma

By Mary An Merchant, PhD & Richard Timmer

The Court of Appeals for the Federal Circuit (“CAFC”) issued an important ruling today in the ongoing evolution of biosimilar product regulation.  In the ruling today, the CAFC in Amgen Inc., Amgen Manufacturing Limited v. Apotex Inc., Apotex Corp. (CAFC Case No. 2016-1308) affirmed the district court ruling and held that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A) is mandatory and enforceable by injunction, even where the biosimilar applicant has triggered the “patent dance” provisions of the BCPOA by providing its application and information to the reference product sponsor under paragraph (l)(2)(A). That is, under the Biologics Price Competition and Innovation Act (“BCPIA”), a biosimilar applicant must provide a maker of a reference product a 180-day notice prior to commercial marketing of the biosimilar product. 

The ruling is a significant win for the brand companies who originally developed a biologic molecule. The requirement for a biosimilar applicant to provide a 180-day notice following marketing approval by the FDA potentially allows the brand company to continue to derive significant revenues from its product due the 6-month delay provided by the notice provision. In the present case, which involves Amgen’s anti-infective biologic, Neulasta®, an additional six-month of sales translates to about $1.8 billion based on sales in 2015.

Importantly, the CAFC had held in Amgen v. Sandoz that the commercial marketing provision, i.e., the 180-day notice prior to marketing, was mandatory when the biosimilar applicant had not triggered the “patent dance” provisions of the BCPIA. At the present time, these two rulings appear suggest that the commercial marketing provision of the BCPIA is required, regardless of whether or not the biosimilar applicant has triggered the “patent dance” provisions. 

However, the understanding of the marketing approval notice provision of the BCPIA remains in flux. Sandoz filed a petition to the Supreme Court for a writ of certiorari following the CAFC decision in Amgen v. Sandoz and the CAFC’s refusal to hear the case en banc. On June 20, 2016, the Supreme Court invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Thus, the Supreme Court, at this point, has not denied the petitions for certiorari, and a request such as this to the Solicitor General typically indicates that the Supreme Court has a substantial degree of interest in hearing the case. If accepted, this would be the first BCPIA case to be heard by the Supreme Court. It is a reasonable possibility that Apotex will appeal the ruling in the present case.

Although the present ruling appears to provide much-needed clarification to a key provision of the BCPIA, there remains a lack of certainty until all appeals are completed. The MMM Life Sciences team will continue to follow developments in this area and provide alerts as the law develops further. In addition, we are available to discuss your concerns regarding biosimilar products, review your technology and claims, and provide strategic advice for navigating the uncertain waters of biosimilar regulation.

The information presented is for educational and informational purposes and is not intended to constitute legal advice. Readers should consult their professional advisor.  Any opinions expressed within this article are solely the opinion of the featured author and not of Morris, Manning & Martin, LLP.