[Ip-health] Professor Carlos Correa: Patent protection of the new use of a medicine under the TPP

Thiru Balasubramaniam thiru at keionline.org
Wed Aug 12 03:03:21 PDT 2015

Patent protection of the new use of a medicine under the TPP

Some of the changes observed in the last leaked text of the intellectual
property chapter of the TPP are positive from a public health perspective,
but many problematic clauses remain. While the USA has apparently abandoned
a text aimed at neutralizing provisions like section 3(d) of the Indian
Patent Act, it has introduced a carefully drafted provision that, if not
correctly interpreted, may give the false impression that the target of
forcing the recognition of patents on the new use of known medicines has
been abandoned as well.

Article QQ.E.1(2) states :

 [US/NZ/SG/AU/JP/CA/PE/MX/BN/VN propose; CL oppose: Subject to
paragraphs 3 and 4 and consistent with paragraph 1, each Party confirms
patents are available for inventions claimed as at least one of the
new uses of a known product, new methods of using a known product, or new
processes of using a known product. A Party may limit such processes to
those that do not claim the use of the product as such.]

This provision would leave TPP parties the option to choose whether to
patents on ‘new uses’, ‘new methods’ or ‘new processes’ of using a known
However, unless it is clarified that such methods or processes should be of
technical nature, they may be understood as encompassing patent claims
how a medicine may be used to address a particular disease.  This is the
interpretation that will probably be given by the USA, where the new use of
medicine is not patentable as such, but admissible as
process-of-use-claims. This
means that as long as the claim is on a process for use rather than use, it
admissible as subject matter of a patent. This is precisely what the USA is
likely to
aim at with the proposed text in the TPP chapter.

In accordance with article QQ.E1(3) of the draft TPP, parties may exclude
patentability therapeutic methods for the treatment of humans and animals.
It may be
argued that a claim on the use of a medicine is equivalent to a therapeutic
and that, therefore, that exception would allow TPP parties to exclude
patents on the
new use of a medicine. This reading, however, may be deemed unviable under
interpretation principle of ‘effet utile’, which means that amongst several
interpretations the one will prevail which best guarantees the practical
effect of all
provisions in the treaty, including article QQ.E.1(2).

Moreover, article QQ.E.1(2) refers to ‘inventions claimed as’ a new use,
or process. This seems to exclude the possibility of considering that, in
essence, a
claimed new use invention is a therapeutic method, if the claim is drafted
in the form
of a method or process. Typically claims on the new use of a medicine are
drafted in
the USA as ‘"A method of treating XX in a patient, comprising
administration of a
therapeutically effective amount of compound Y to the patient."

This analysis suggests that US still pursues the target of obliging TPP
parties to
grant patents on the new uses of a medicine, one of the main strategies
used for ‘evergreening’ pharmaceutical patents. The intention to achieve
this target is actually
confirmed by the plain language of article QQ.E.17.1(b)(ii) which refers to
‘a product
for an approved use, during the term of a patent identified as claiming
that approved
use’ (emphasis added).

Carlos Correa

August 12, 2015

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