On June 28, 2012, the Supreme Court issued a 5-4 decision upholding the constitutionality of the Affordable Care Act (ACA). Most of the publicity surrounding the ACA has focused on its provisions for health care reform, such as the individual mandate for health care coverage and its proposed expansion of Medicaid. However, the ACA also created a new regulatory pathway and patent litigation framework for biosimilars, which are biologic products that reference an FDA-approved product. 42 U.S.C. § 262. The Supreme Court’s ruling means that the Biologics Price Competition and Innovation Act of the ACA remains in full force and effect.
A product qualifies as a biosimilar if it is highly similar to and has no clinically meaningful differences from a previously approved product in terms of safety, purity, and potency. Approved biosimilars outside of the U.S. include recombinant proteins that have been used in a variety of therapeutic areas, such as treatment for cancer, anemia, and kidney failure.
The statute creates specific periods of data and market exclusivity for previously-approved biologic products. A Reference Product Sponsor with an FDA-approved biologic receives a 4-year period of data exclusivity during which no biosimilar applications can be filed against its approved product. In addition, the Reference Product Sponsor receives a market exclusivity period of 12 years during which no biosimilar can enter the U.S. market.
The statute also requires Biosimilar Applicants to notify the Reference Product Sponsor when the FDA accepts a biosimilar application for review. This notification triggers a series of expedited patent exchanges in which both the Reference Product Sponsor and Biosimilar Applicant identify patents to be litigated, exchange infringement and invalidity positions, and negotiate over which patents will be litigated prior to launch of the biosimilar. The Reference Product Sponsor can also seek an injunction against the Biosimilar Applicant in advance of any product launch.
Because of the complexity and compressed time frames of these pre-litigation procedures, it is important to prepare in advance for this patent exchange. Reference Product Sponsors can prepare by reviewing and categorizing their existing patent portfolios, developing claim strategies to potentially cover biosimilar products, acquiring additional technology to assert in litigation, determining the analysis and testing required for infringement, and evaluating invalidity risks. Biosimilar Applicants can also prepare in advance by proactively developing their own patent portfolio, licensing in technology, searching for and evaluating the portfolio of the Reference Product Sponsor, developing non-infringement positions, and identifying relevant prior art.
For more information on preparing for biosimilars patent enforcement, please contact Knobbe Martens.
Additional resources on our Biosimilars Practice can also be found on our website.