Posts Tagged: "Sandoz v. Amgen"

42 U.S.C. § 262(l) of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) regulates “biosimilars,” biological products that are highly similar to FDA-approved biological products. Section 262(l) has two notification requirements that are important to this case… The second question addressed by the Court was whether the applicant must provide notice after the FDA licenses its biosimilar, or if it may provide notice before the FDA licenses its biosimilar. The Court concluded that an applicant might, but does not have to, provide notice to the manufacturer of the biologic before obtaining a license from the FDA.

The Court’s Sandoz v. Amgen decision gutted a statute that had been carefully crafted to facilitate timely resolution of patent disputes and avoid delaying market entry of biosimilar products. In holding that a biosimilar applicant cannot be compelled through federal law to engage in the patent dance, the Court effectively gave biosimilar applicants a license to hide the ball. Given the complexity of biologics and biosimilars, it can be very difficult for an innovator company to reasonably determine which of its patents might be infringed by the biosimilar. Now, potentially meritorious patent infringement questions could be kicked far down the road. This could lead to delayed launch of the biosimilar product, possibly through a decision not to launch at risk or possibly by way of injunctive relief outside the BPCIA.