[Ip-health] Patents and Doctors, and the USTR TPP text
krista.cox at keionline.org
Mon Mar 14 16:47:29 PDT 2011
*Patents and Doctors, and the USTR TPP text*
Submitted by Krista Cox
The recently obtained US draft text 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
35 U.S.C. 287. 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. The US draft TPP language on patentability provides a narrow exclusion
that does not explicitly cover diagnostic, therapeutic and 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
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
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