The recently obtained US draft text [1] for the intellectual property rights chapter for the Trans-Pacific Partnership Agreement (TPP) contains provisions that go far beyond the requirements of international agreements as well as the standards of US law itself. One particular area of concern involves the broad definition of patent eligible subject matter that fails to provide for any exception from patentability for surgical methods or procedures. Nor does the draft language contain any exception for the enforcement of surgical method patents. This failure to include such exceptions not only implicates significant ethical problems for surgeons, but is inconsistent with US law.
Under US patent law, certain exclusions apply limiting enforcement of particular patents.
35 U.S.C. 287 [2]. Limitation on damages and other remedies; marking and notice.
(c)(1) With respect to a medical practitioner’s performance of a medical activity that constitutes an infringement under section 271(a) or (b) of this title, the provisions of sections 281, 283, 284, and 285 of this title shall not apply against the medical practitioner or against a related health care entity with respect to such medical activity.
While the US does not provide an exception for the patent eligibility of a surgical method, patent law does limit enforcement of these patents against medical practitioners who perform medical or surgical procedures. Surgeons who perform patented surgical methods are therefore not liable for patent infringement on these activities.
Consistent with this exception, the Australia-United States Free Trade Agreement (AUSFTA) allows for a surgical method exclusion from patentability. The text of the AUSFTA allows for:
2. Each Party may only exclude from patentability: (a) inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law; and (b) diagnostic, therapeutic, and surgical methods for the treatment of humans and animals.
Although the AUSFTA provided for an surgical method exclusion from patentability, no similar provision exists within the USTR’s proposed TPP text. In fact, draft Article 8.2(b) apparently requires that patents be made available for surgical methods:
Each Party shall make patents available for inventions for the following:
(a) plants and animals, and
(b) diagnostic, therapeutic, and surgical methods for the treatment of humans or animals.
The US draft TPP language on patentability provides a narrow exclusion that does not explicitly cover surgical methods. Draft Article 8.3 reads:
Each Party may only exclude from patentability inventions, the prevention within its territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal, or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by law.
The TPP draft also fails to exclude surgical methods from patent enforcement, thus opening surgeons who use patented surgical methods up to patent infringement liability. This lack of exception for surgical methods creates ethical problems for surgeons treating patients best served by a patented technology.
The USTR’s draft provisions in the TPP are therefore inconsistent with US law. Both US patent law and the AUSFTA contain provisions allowing for exceptions from patentability or patent infringement for surgical methods. The lack of a similar provision in the TPP text effectively ignores current, applicable US law.
As KEI has noted repeatedly, when the USTR keeps the draft text of these trade agreements secret, the public is prevented from giving policy makers informed and effective feedback on the flaws of various proposals. The lack of surgical methods exception is an example of how the policy of secrecy can create problems.