Baker Donelson - USA
On March 23 2010, as part of the Patient Protection and Affordable Care Act, Congress enacted the Biologics Price Competition and Innovation Act. The term ‘biological product’ or ‘biologics’ is defined to mean:
"a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings".
The act establishes a regulatory pathway for obtaining Food and Drug Administration (FDA) approval for biological products that are found to be ‘biosimilar‘ to an FDA-approved biologic (reference product). According to the act, a biosimilar product is a biological product that is approved based on its close similarity to a reference product, and has no clinically meaningful differences from the reference product in terms of safety and effectiveness. A biological product can also be ‘interchangeable’ with a reference product. The act provides that an interchangeable product may be substituted for the reference product by a pharmacist without intervention from the prescriber of the reference product.
The regulatory pathway for biosimilar products entering the market, abbreviated by the act, is also referred to as the ‘patent dance’. The ‘patent dance’ is the statutory framework for the exchange of patent and related information between the biosimilar applicant and the reference product sponsor. The act provides that a biosimilar applicant "shall provide to the reference product sponsor a copy of the application" and other information that "describes the process or processes used to manufacture the biological product". The act further provides that a biosimilar applicant should give notice of the biosimilar product to the reference product sponsor "not later than 180 days before the date of the first commercial marketing" (42 USC Section 262(I)).
A recent decision by the Supreme Court in Sandoz Inc v Amgen Inc (15-1039) illustrated the high court's interpretation of the act’s ‘patent dance’ provisions. In 2014, Sandoz filed an abbreviated biologics application and sought approval under the act for a biosimilar product, filgrastim-sndz, using the brand name Zarxio. The reference product was Amgen's leukocyte growth factor, filgrastim, under the brand name Neupogen. However, the biosimilar applicant, Sandoz, refused to disclose its confidential application and manufacturing trade secrets information to Amgen within 20 days of the FDA notice of acceptance under the act. In addition, Sandoz informed Amgen that it intended to market Zarxio immediately on receipt of FDA approval. Amgen sued Sandoz for patent infringement and violation of the act. Amgen sought an injunction against Sandoz, alleging that Sandoz had violated the act by:
- failing to disclose the biosimilar's application and manufacturing information; and
- providing a premature notice of the commercial marketing but failing to give notice of first commercial marketing upon FDA approval, according to the act’s provisions.
On June 12 2017 the Supreme Court decided this landmark case and interpreted the meaning of the act. The court ruled in favour of Sandoz and held that under federal law, federal injunctive relief is not available to a reference product sponsor for a biosimilar applicant's failure to provide application and manufacturing information during the ‘patent dance’ contemplated by the act. Therefore, the ‘patent dance’ information exchange is optional under the act. The court further held that under the act, a biosimilar applicant may provide 180-day pre-launch notice of commercial marketing before the biosimilar product is licensed by the FDA.
The high court's decision is welcomed by biosimilar companies as it gives biosimilar products more certainty and flexibility. Based on this decision, biosimilar companies can bring biosimilar products to the market without waiting for 180 days after FDA approval. However, because this is the first case in which the court has interpreted key provisions of the act, its impact on other ongoing and future disputes involving the act remains to be seen.
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