Note: An Unacceptable Exception: The Ramifications of Physician Immunity from Medical Procedure Patent Infringement Liability

By Emily C. Melvin. Full text here.

Medical procedures present a unique challenge to the patent system. Without patents, investors may be unwilling to commit resources to the costly development of new procedures. However, patents on these procedures may decrease public access to the procedures, which may harm society’s interest in accessible medical care. In response to these concerns, Congress enacted 35 U.S.C. § 287(c), which does not prohibit patents on medical procedures, but instead makes them unenforceable against physicians and their associated healthcare entities. This legislation is problematic because it violates the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The United States’ violation of this agreement sends a message to other countries to do the same and weakens the ability to strengthen intellectual property protection abroad.

To cure this violation, Congress should enact a TRIPS-compliant compulsory licensing system. Fully enforceable medical procedure patents are not advisable because of the unique ethical considerations that these patents present. However, eliminating medical procedures from patentability reduces the incentives both to innovate and to disclose, and creates the additional risk that costly procedures will go undeveloped. Compulsory licensing balances these interests by ensuring that medical procedures are widely available to the public, while providing financial remuneration for inventors and investors.