On February 2, 2015 Justice de Montigny of the Federal Court
released his judgment and reasons in Eli Lilly Canada Inc. v.
Mylan Pharmaceuticals ULC, 2015 FC 125, dismissing Lilly's
application for an order prohibiting the Minister of Health from
issuing a Notice of Compliance to Mylan until the expiry of
Canadian Patent No. 2,371,684 (the "'684 Patent").
The '684 Patent claims a dosage form of tadalafil and its use
to treat erectile dysfunction ("ED"). This decision is
the second in a series of three prohibition applications by Lilly
relating to its tadalafil patents.
The use of tadalafil for the treatment of ED was claimed in the
earlier '784 Patent which was the subject of a prohibition
application summarized in a
January 26, 2015 post on snIP/ITs. In contrast to that
decision, Justice de Montigny took a harder stance on the promised
utility of the '684 Patent. He noted that the patent made
several explicit statements promising particular results, and that
this promised utility was neither disclosed nor soundly predicted
on the filing date. Justice de Montigny ultimately found that
Mylan's allegations of invalidity on the basis of lack of
utility, anticipation and obviousness were justified.
Lilly submitted that the '684 Patent promises that the
claimed dosage forms will be effective in the treatment of ED and
will have a better side effect profile than sildenafil, an earlier
ED drug. Mylan argued that the '684 Patent goes far beyond
Lilly's construction and promises that the claimed doses will
minimize three specific side effects to insignificant levels.
Justice de Montigny preferred Mylan's construction, noting
that the ambitious and explicit statements throughout the patent
promise much more than a marginal improvement over sildenafil. He
observed that reading down the promise in accordance with
Lilly's construction would "fly in the face of the clear
language of the '648 Patent".
Justice de Montigny further held that, as of the filing date,
this promised utility had not been demonstrated. He noted that the
only study comparing the occurrence of one of the side effects
showed no difference between the compounds. He also rejected
Lilly's assertion that the promised utility could be predicted,
noting that the patent's disclosure of a study comparing the
two compounds was "very sketchy" because it failed to
refer to or explain the results of the head-to-head testing in the
"This failure is clearly unacceptable in a Patent that
promises not only efficacy in treating ED, but also a better side
effect profile [...] and a patentee should not be able to benefit
from a partial, if not misleading, disclosure."
Anticipation & Obviousness
Justice de Montigny held that the '684 Patent is not a
selection patent because the special advantage is not peculiar to
the particular dosage range claimed. On this basis, he held that
the '684 Patent is anticipated by the '784 Patent because
the claimed invention was disclosed and enabled by the '784
Patent. He explained that:
"When a second patent is not interpreted as a selection
patent, its advantages do not factor into the inquiry of
anticipation and need not be disclosed in a previous patent to be
Justice de Montigny also held that it was obvious that the lower
and narrower doses claimed in the '684 Patent would be
effective in treating ED and would lead to fewer side effects. He
noted that knowledge about the efficacy and side effects of an
earlier, similar ED drug would have guided the inventors'
choice of dose, and that lowering dosage is a standard way to
reduce side effects.
A recent Saskatchewan Court of Queen's Bench decision allowed a court-appointed receiver to sell and transfer intellectual property rights free and clear of encumbrances, finding that a license to use improvements of an invention was a contractual interest and not a property interest.
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).