At the beginning of 2016, Canadians were looking forward with
great anticipation to a Federal Court challenge launched by The
Children's Hospital of Eastern Ontario (CHEO) against a suite
of five patents pertaining to methods of genetic testing. However,
in March of 2016, the challenge settled with the negotiation of a
royalty-free license agreement between CHEO and the patentee:
Transgenomic, Inc. of Omaha Nebraska.
The subject patents claim methods for identifying genetic
mutations associated with Long QT Syndrome, a disorder of the
heart's electrical activity. CHEO wishes to offer whole genome
testing for Ontario children on a not-for-profit basis and wants to
include analysis for all validated mutations, including those
associated with Long QT syndrome. As the subject patents seemed to
present a barrier, the challenge by CHEO sought to invalidate the
patents or certain patent claims on a number of grounds including
the ineligibility of gene-related subject matter for patenting.
In a press release dated March 9, 2016, CHEO announced the
settlement stating that these patents "will no longer
stand in the way of diagnosing a life threatening
disease". The agreement between CHEO and Transgenomic
Inc., as well as a template agreement that Transgenomic Inc. now
offers to other Canadian not-for-profit entities wishing to conduct
Long QT testing, can be found on the CHEO website (www.cheo.on.ca).
The agreement is reminiscent of the non-exclusive licensing model
established in the late 1980's and early 1990's for
gene-related patents directed to CFTR mutations in cystic fibrosis,
which permitted genetic testing to be widely accessible to patients
by offering reasonable licensing terms to those wishing to conduct
laboratory-developed tests. See: Minear et al., Cystic Fibrosis
Patents: A Case Study of Successful Licensing. LES Nouv. 2013
The CHEO press release states: "While CHEO and Transgenomic
were originally going to look to the courts for a resolution on
this important health care issue, they were both committed to
finding a solution to the issue without the expense and delay of a
prolonged court case." While gene-related subject matter is
not excluded from patentability under Canadian law, a Court
challenge to gene-related patents would have presented an
opportunity to either affirm the status quo or to define
gene-related subject matter as falling outside of the definition of
invention. Absent a Court challenge, there is no change to the law
regarding patent eligibility of gene-related subject matter in
It is worth noting that while gene-related subject matter is not
excluded from patent eligibility, the Canadian Patent Office
released guidelines in 2015 for examination of diagnostic methods.
These guidelines currently impede proper examination of diagnostic
inventions. In practical terms, this means that gene-related
subject matter presented in diagnostic method claims will be
blocked from patentability at the examination level for the
foreseeable future, until the examination guidelines can be
challenged in court. Had the Court challenge to the Long QT patents
proceeded, it may have affirmed the patent-eligibility of
diagnostic method claims, whether gene-related or not.
Bringing a gene-related diagnostic technology to market extends
well beyond the initial research and discovery stage, requiring
years of commercialization efforts. A Court decision to invalidate
gene-related patent claims would have called into question the
value of the ongoing commercialization efforts taken by publically
funded research institutions across the country, typically built on
a foundation of patent protection. Would a chill in private
investment have been the ultimate result?
Seeking commercialization funding is difficult at the best of
times for even the most accomplished of institutional researchers.
With the chronic reduction of public funds available for research,
institutional researchers often turn to industry partners and
investors to help commercialize their products or tests. Without a
proprietary position, an investor has little basis to believe that
the investment needed for development, validation, and approval of
a gene-related technology can be recouped. The choice of whether to
offer a patented technology on reasonable terms, such as
royalty-free not-for-profit access, resides with the patent holder.
Without any patent position, the choice is unlikely to arise for
new gene-related technologies: the investment needed to bring such
technologies from proof-ofconcept to regulatory approval is
unlikely to come knocking.
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
Last year we saw the Canadian Courts release trademark decisions that granted a rare interlocutory injunction, issued jailed sentences for failure to comply with injunctive relief, grappled with trademark and internet issues...
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).