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II. Patentable Subject-Matter: Medical Procedure
The TRIPS Agreement allows the Members to exclude certain inventions from pa-
tentability. In art. 27.3 it gives the Members the discretion to exclude diagnostic,
therapeutic and surgical methods for the treatment of humans or animals.29 Most
countries recognize the flexibility and do not allow patents for such inventions – more
than 80 countries have so far banned patents for medical procedure.30 Some other
countries, such as New Zealand, do not exclude the patentability of treatment meth-
ods statutorily, but their case law rejects such claims.31 Only three countries allow
patentability of medical procedure – the US, Australia and to some extent Canada.
In Canada, patents are available only for diagnostic methods. On the other hand,
Australian case law suggests that all medical procedures are patentable. This is a para-
dox, given that Australia maintained its discretion to exclude the procedures from pa-
tentability in US-Australia FTA but chose to patent the medical procedures anyway.32
The flexibility to exclude medical procedures from patentability is important for
moral and ethical reasons. It protects medical practitioners from the monopoly privi-
leges and allows for healthy competition, which is beneficial for public well-being.
Providing patents to medical procedures raises the costs of healthcare and exposes
doctors to liability for using methods to treat their patients.33 The patentability would
mean that healthcare providers would be charged royalties for every time they practice
a patented method. Whereas a normal product is a subject to a patent exhaustion once
placed on the market, the medical procedure would be subject to royalties for each and
every time it is used by the doctor. These prices would likely be paid by the patients.
For example, whereas a patient in the US is billed about 2000 USD per stent in a coro-
nary angioplasty surgery, the actual cost of the stent is 15 USD.34
As was mentioned, only the US, Australia, and partially Canada allow patentability
of medical procedures – no other legal system requires this. However, during the ne-
gotiations of the US-Thailand FTA, US demanded from Thailand patent protection
for medical procedures. However, the US-Thailand FTA negotiations were suspended
in 2006.35 A similar provision to this one is included in the Morocco-US FTA, which
29 TRIPS supra note 14 art. 27.3(a).
30 “Medical Procedure Patents in the TPP” Public Citizen (13 March 2013) online .
org/documents/MedicalProceduresMemo_final%20draft1.pdf> [Medical Procedure].
31 Adriana Lee Benedict, “Is the USTR Trading Away Doctors’ Rights to Freely Perform Medical
Procedures?” Harvard Law Petrie-Flom Center (8 September 2012) online
billofhealth/2012/09/08/is-the-ustr-trading-away-doctors-rights-to-freely-perform-medical-procedures/>.
32 “Dangers for Access to Medicines in the Trans-Pacific Partnership Agreement: Comparative Analysis of
the U.S. Intellectual Property Proposal and Australian Law,“ Public Citizen (29 August 2011) online
[Public Citizen, “Australia”].
33 Medical Procedure supra note 38.
34 Ibid.
35 US-Thailand FTA, on hold: since 2006, online
ic/Thailand>.