Justice O'Reilly of the Federal Court has rejected
Teva's allegations of invalidity regarding Novartis's
patent1 covering its iron chelator product EXJADE
(deferasirox) (2015 FC 770, attached here). Novartis was successful in showing that
Teva's allegations of lack of utility (with respect to the
compound claims), obviousness, and insufficiency were
Utility – The Utility of Compound Claims Differed from
the Utility of Use Claims
On the issue of utility, O'Reilly J. applied the principles
set out by the FCA in Celebrex2 and by Snider J. in
Gleevec3, including the principle of claim
differentiation, to find that the utility of the novel compound
claims (claims 5-37) differed from the utility of the use
O'Reilly J. rejected Teva's argument that the 951 Patent
contained an "explicit and overarching promise" that
applies across all of the patent's claims, including the claims
for novel compounds. He held that the statements in the 951
Patent's disclosure cited by Teva merely provide support for
the patent's use claims.
O'Reilly J. recognized that the compound claims made no
explicit promise of a specific result, while the use claims
contained an explicit promise of use for treatment of an excess of
iron in a human or animal body. He thus found that the 951 Patent
did not promise that the claimed novel compounds would be valuable
in treating iron overload disease in humans.
Applying the above construction, the utility of the novel
compounds that were tested, including claim 32 to deferasirox, was
held to be "clearly demonstrated". The utility of the
claimed compounds that were not specifically tested was held to be
However, O'Reilly J. held that Teva's utility allegation
with respect to the use claims had merit. In this respect, he
relied on Teva's allegation that the compounds must be
non-toxic, even though toxicity is nowhere discussed in the 951
Obviousness – s. 28.3 Does Not Expand the Scope of the
Skilled Person's Common General Knowledge
O'Reilly J. had "considerable doubt" that some of
the key references that Teva sought to rely on formed part of the
relevant prior art and dismissed Teva's argument that s. 28.3
of the Patent Act only requires relevant prior art to be
"publicly available" instead of the usual criterion of
"discoverable on a reasonably diligent search" (applying
Dow Chemical Company v NOVA Chemicals Corporation, 2014 FC 844 at
paras 232-236; Eurocopter v Bell Helicopter Textron Canada
Limitée, 2012 FC 113 at para 80, aff'd 2013 FCA 219; Eli
Lilly and Company v Apotex Inc, 2009 FC 991 at para 532; Takeda
Canada Inc v Canada (Minister of Health), 2015 FC 570 at paras
Even if the disputed art was considered, O'Reilly J. found
that a significant gap existed between the inventive concept and
the skilled person's common general knowledge.
Sufficiency – Distinguishing Viagra, the Invention was
the Class of Compounds
Teva argued that the true invention was deferasirox, and that
the 951 Patent should be invalidated for failing to disclose this
fact. O'Reilly J. rejected this allegation and held that the
true invention was the novel class of compounds that bind markedly
to iron, are soluble in vivo, and induce excretion of the resulting
Unlike in Viagra4, where the true invention was found to be the
one claimed compound that the inventors knew to be useful in
treating ED, in this case all thirty individually claimed compounds
were found to possess the above properties. O'Reilly J. also
found that the patent describes how to make the compounds, thus
providing the skilled person with the information necessary to put
the invention into practice.
The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.
From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
Health Canada is proposing to change the way that it regulates non-prescription drugs, natural health products and cosmetics in Canada, which will now be referred to collectively as "self-care products."
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).