Patents on Surgical Methods
An interesting example of how the US seeks to change national and global norms are the provisions in the TPP over patents on surgical methods. The WTO permits countries to exclude “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.” The US wants to flip this provision, so that “may also exclude from patentability” becomes “shall make patents available.” However, when a version of the IP Chapter was leaked in 2011, the US trade negotiators were criticized for ignoring the provisions in 28 USC 287 that eliminated remedies for infringement involving the “medical activity” of a “medical practitioner.” The exception in US law covered ”the performance of a medical or surgical procedure on a body.” The US trade negotiators then proposed adding language that would permit an exception for surgery, but only “if they cover a method of using a machine, manufacture, or composition of matter.” The US proposal, crafted in consultation with the medical devices lobby, but secret from the general public, was similar, but different from the U.S. statute, which narrowed the exception in cases involving “the use of a patented machine, manufacture, or composition of matter in violation of such patent.” How different? As Public Citizen’s Burcu Kilic puts it, under the US proposal in the TPP, the exception would only apply to “surgical methods you can perform with your bare hands.”
Why is the United States putting so much effort into narrowing if not eliminating the flexibility in the WTO agreement to provide exceptions for patents on “diagnostic, therapeutic, and surgical methods for the treatment of humans or animals”? It did not hurt that AdvaMed, the trade association for the medical device manufacturers, hired Ralph F. Ives as Executive Vice President for Global Strategy & Analysis. Before becoming a lobbyist for the medical device industry, Ives was the head of pharmaceutical policy for USTR. And Ives is just one of an army of lobbyists (including former Senator Evan Bayh) representing the medical devices industry. ITAC3, the USTR advisory board for Chemicals, Pharmaceuticals, Health/Science Products And Services, includes not only Ralph Ives, but also representatives from Medronic, Abbott, Johnson and Johnson, DemeTech, North Coast Medical and Airmed Biotech -- all companies involved in the medical device business. All are considered “cleared advisors” to USTR and have access to the TPP text.
