The 14th round of negotiations for the Trans-Pacific Partnership Agreement (TPPA, a multilateral trade agreement currently being negotiated by the USTR and 10 other countries) is currently underway in Leesburg, VA. Last month, KEI posted a brief video blog about an interesting provision (Article 8.2) of the TTPA’s leaked draft IP chapter calling for patentability of diagnostic, therapeutic and surgical methods. Critically, KEI pointed out that current US law (35 U.S.C. 287(c))—which was amended after widespread concern from physicians’ associations regarding the adverse public health effects of medical method patent liability were brought to light with Pallin v. Singer, 36 U.S.P.Q.2d (BNA) 1050 (D. Vt. 1995)—immunizes medical practitioners from patent infringement suits concerning medical methods, although the draft TPPA provision makes no such exception. The proposed provision is also contrary to Article 27(3) of TRIPS and Article 1709(3)(a) of NAFTA, all of which allow countries to exclude such medical methods from patentability, as well as Rule 39.1 of the 1970 PCT, which exempts International Searching Authorities from having to conduct patent searches relating to medical methods.
Medical professional societies, including the WMA, AMA, AAOS, ACOG and ASRC, have also opposed medical procedure patents on ethical grounds. The WMA has explained that patents are not necessary to incentivize innovation in medical procedures: “Unlike device development, which requires investment in engineers, production processes, and factories, development of medical procedures consists of physicians attaining and perfecting manual and intellectual skills… physicians already have both obligations to engage in these professional activities as well as rewards for doing so.” The WMA has also noted a number of adverse effects on access to medical care resulting from medical procedure patents, including higher costs, fewer physicians available and/or willing to perform patented procedure, and less innovation in medical procedures.
So what does this mean for the TPPA negotiating parties? More than 80 countries, including most TPP negotiating parties, exclude medical procedures from patentability. Medical methods are expressly excluded from patentability in Brunei Darussalam (Section 16 of the new Patents Act (2011)), Chile (Article 37 of Chilean Law No. 19.039 on Industrial Property), Malaysia (Section 13 of the Malaysia Patents Act (291 of 1983)), Mexico (Article 19 (VII) of the Industrial Property Law), Peru, (Article 20 of Andean Community Decision 486 “Common Intellectual Property Regime” , as authorized by Article 16.9.2 of the US-Peru TPA), Singapore, (Section 16(2) of the Patents Act (No. 24 of 2001, as amended by Act No. 2 of 2007), as authorized by Article 16.7.1 of the US-Singapore FTA), and Vietnam (Vietnamese Law on Intellectual Property (50/2005)). In Canada, Section 2(d) of the Canadian Patent Act does not exclude medical procedures from patentability, but case law prohibits patents on surgical and therapeutic methods, while allowing patents on diagnostic methods. In New Zealand, while medical procedures are not statutorily excluded from patentability, case law has generally rejected such patents. Only Australia—even though it maintained the flexibility to do so in the AUSFTA (Article 17.9.2)—the Patents Act of 1990 doesn’t specifically exclude medical procedures from patentability, and case law suggests that they are in fact patentable. [See Public Citizen’s website for more comparisons between domestic laws and proposed TPPA provisions.]
In the US, case law is swinging the pendulum even further away from broad medical procedure patents. Earlier this year, the Supreme Court reaffirmed the importance of limiting the adverse effects of diagnostic method patents, which remain among the most contentious of the medical procedure trio. In Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. — (2012), the Court invalidated Prometheus’s patent on a diagnostic method that involved administering thiopurines and observing chemical reactions in the body as a basis for dosing advice, stating that the patent improperly claimed a natural law.
If only Australia allows for fully enforceable medical procedure patents, why would the USTR want to provide for them in the draft TPPA? The KEI video blog noted that USTR officials suggested draft article 8.2 may be a negotiating chip. If this is the case, then negotiating countries must be cautious of making any trade concessions with respect to any USTR proposals that exceed democratically established laws not only in their own countries, but also in the US.