On Tuesday, July 5th the Federal Circuit Court announced the final decision in the case of Amgen v. Apotex, ruling that manufacturers of biosimilar products must notify their brand-name competitors at least six months prior to launching their product. The decision, which is the second decision involving the interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), marks a major milestone for biosimilar products as it could cause further delays in development and availability of lower-cost versions of notoriously expensive biologics.
According to a recent article from Law360, the court’s unanimous ruling states that the 180-day notice provision included in the BPCIA requires biosimilar makers to participate in a “so-called patent dance – an exchange of intellectual property information meant to streamline patent litigation.”
Amgen v. Sandoz
According to the BPCIA, in accordance with the patent dance, biosimilar applicants must:
- Provide a copy of the biosimilar application as well as any applicable information about the product’s manufacturing – under section 262(/)(2)(A).
- Provide the manufacturer of the brand-name product with a notice at least 180 days notice before the product enters the market – under section 262(/)(8)(A).
In a previous case regarding biosimilar products involving Amgen v. Sandoz, the Federal Circuit Court ruled that (2)(A) was optional. However, in the same ruling the court held that the requirements under section (8)(A) were mandatory and could only be provided after receiving FDA approval.
Agmen v. Apotex
Apotex Inc. recently developed a biosimilar version of Amgen’s Neulasta®, “indicated to decrease the incidence of infection, as manifested by febrile neutropenia.” In the recent case between Apotex and Amgen, Apotex argued that “because notice can only be given after a product is approved, and approval has been expected to only occur after exclusivity expires for a brand-name biologic,” the initial 12-year exclusivity timeframe is being extended by another six months. Despite Apotex’s argument, the Federal Court suggested that there may be a loophole to avoid the extension in exclusivity. As such, the court upheld its previous ruling, stating that the commercial marketing provision (as stated in section 262(/)8(A) of the BPCIA) continues to be mandatory and enforceable.
This decision marks a big event for current and upcoming biosimilar products, and it will be interesting to see what the future hold for these products and their manufacturers.
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