By Emily M. Wessels. Full text here.
The patent safe harbor, 35 U.S.C. § 271(e)(1), codifies an exception to the general concept of patent exclusivity that excuses entities from infringement liability for activities reasonably related to submitting information under federal laws that regulate drugs. For the past three decades, this provision has operated in a pharmaceutical industry dominated by small molecule drugs to balance the benefits of price reduction from generic competition with the costs of competition’s potentially stifling effects on innovation. Unfortunately, evolution of the industry toward complex biopharmaceuticals—coupled with the Federal Circuit’s recent decision in Momenta Pharmaceuticals, Inc. v. Sandoz, Inc., extending safe harbor protection to activities occurring after FDA approvalhas upset this equilibrium. This Note explores the underlying factors contributing to the upset and proposes a solution for restoring balance in anticipation of the advent of follow-on biologic competition. Specifically, the Note rejects a bright-line application of the safe harbor along the pre- and post-FDA approval threshold that was the focus of Momenta and its predecessor, Classen Immunotherapies, Inc. v. Biogen IDEC. The Note instead advocates for a temporally unrestricted safe harbor that includes provisions for minimizing patentees’ market harm using notification, exclusivity, and compensation mechanisms. These mechanisms work to protect the value of the manufacturing method patents threatened by Momenta, increasing the chances for attaining a successful follow-on biologic regime.