The case involving a Children's Hospital of Eastern Ontario
("CHEO") challenge to an isolated gene patent has
settled1. For background on the case and issues around
isolated gene patenting, see our prior articles
here. It is important to note that Canadian gene patents cover
the chemical sequence of an isolated gene as it would exist, for
example, in a test tube on a lab bench, but not the gene as it
exists in a person's body. It is not possible to patent a gene
in a human body.
CHEO has been granted a license by the patent owner,
Transgenomic, Inc. ("Transgenomic"), to use the genes for
non-profit diagnostic testing (click here for settlement agreement). The patent owners also
agreed to grant licenses to other non-profit public sectorusers
(click here for standard license agreement). Transgenomic has
not issued a press release about the case, and is keeping its version of the diagnostic test using the
genes available to Canadians.
The patents in question remain valid and enforceable against
commercial use of the isolated genes in Canada, because the case
settled without a determination of the subject matter
patent-eligibility of genes ("subject-matter patent
eligibility" refers to whether genes are a patentable category
of invention - for example, abstract ideas, pure business methods
and laws of nature are not patentable subject matter). Isolated
gene patents remain available through the Canadian Intellectual
Property Office, which considers isolated genes to be a patentable
category of invention. As well, in a case involving isolated plant
genes and methods of their use to make genetically modified plants,
the Supreme Court of Canada held the patent valid and infringed by
someone that produced the plants without permission2.
The subject matter-eligibility of isolated genes and their methods
of use was not in issue in that case. Since the CHEO case has
petered out short of trial, there is no such subject-matter
eligibility case on the horizon to revisit patenting of isolated
genes. Those with patents on isolated genes and their methods of
use should still expect to be able to fully enforce their patent
rights in Canada, as in the prior Supreme Court case.
The settlement is being billed as a win for patients in
CHEO's media release. It is a short term win for
the pockets of governments and any consumers that would have
otherwise paid Transgenomic more money for the test. For those that
would like to incentivize companies to do R&D to develop new,
better diagnostics, trying to undermine patents on legitimate
inventions is not a win in the long term. As noted above, the CHEO
challenge was unsuccessful in the broader sense that Canadian gene
patents are still generally valid and enforceable following this
settlement. Due to recent actions by the Canadian Intellectual
Property Office, there are potential issues on the horizon for our
courts involving patentability of certain types of diagnostic
methods discussed generally
here.If theCanadian patent system is not effectively protecting
gene and diagnostic-related inventions, multinational companies
will still do their R&D - Canada is a small part of the global
market - they may just not bother to promote and sell innovative
diagnostics here. We all have an interest in getting the best
diagnostic tests available in Canada asap. This should be the
unifying goal, rather than than scoring short-term savings and
short-sighted PR victories against gene-based diagnostics and those
companies that spend millions to invent them.
1 Children's Hospital of Eastern Ontario v
Transgenomic, Inc et al. (14 May 2015) T-2249-14.
2 Monsanto Canada Inc v Schmeiser,  1 S.C.R.
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