NOC Proceedings
Prohibition Granted on Basis of Comity
Allergan Inc. v. Canada
(Health)
Drug: COMBIGAN® (brimonidine-timolol)
The Court granted an Order of Prohibition to Allergan in the face
of a Notice of Allegation from Apotex.
The Court found the allegations of anticipation unjustified. The
Court spent considerable time discussing comity and the effect of a
previous decision in a proceeding between Allergan and Sandoz that
dealt with allegations of obviousness (found here, summarized here). The Court then considered the evidence
of obviousness in this proceeding and indicated it would have found
the allegations as to obviousness justified. However, the Court
held that if it dismissed the application for prohibition then
there would be no appeal and there was conflicting jurisprudence on
the effect that should be given to matters of comity in NOC
proceedings. Thus, the Court granted the Order for Prohibition,
with the likely expectation that Apotex will appeal, in order to
place the issue of comity squarely before the Court of
Appeal.
Prohibition Not Granted as Non-Infringement Allegation
held Justified
Fournier Pharma Inc. v. Canada
(Health)
Drug: LIPIDIL EZ® (fenofibrate)
The Court heard this application and the next application
consecutively and issued decisions on the same day, however,
indicated that each was considered separately. The Court dismissed
the application for a prohibition order.
As a preliminary consideration, the Court examined challenges made
to the expert evidence. The majority of these were either dismissed
or said to go to weight. However, in one case, the expert was found
not to possess the necessary expertise of a person skilled in the
art. Thus whenever his evidence was in conflict with another expert
or not supported by other evidence, his evidence was
disregarded.
The Court considered the evidence relating to the allegation of
non-infringement and held that on the balance of probabilities,
there was no evidence from which the Court could conclude that the
particle size of the fenofibrate particles in the Sandoz tablet
infringed the patent. Although this finding was dispositive of the
application, the Court went on to consider the validity allegations
raised. The allegation of anticipation was found not to be
justified; as were the allegations obviousness, overbreadth, lack
of utility, lack of sound prediction, insufficiency and
ambiguity.
Prohibition Not Granted as Non-Infringement Allegation
held Justified
Fournier Pharma Inc. v. Canada
(Health)
In the second application, the Court considered allegations of
non-infringement and validity of a second patent relating to
fenofibrate. The Court dismissed the application for a prohibition
order.
Again, the credibility of witnesses and their admissibility as
experts was challenged. The challenges as to impartiality were
dismissed. As in the case above, one of the witness' testimony
was given little weight as he did not have the credentials of a
person skilled in the art.
In this case, after considering the evidence of non-infringement,
the Court found the allegations as to non-infringement justified.
Again, it went on to consider the validity issues raised. The
allegations as to anticipation, obviousness, claims broader,
inutility, lack of sound prediction and insufficiency were all
found to not be justified.
Other Cases of Interest
Copyright Infringement Found for Broadcast; Technical
Means to Relay Work Excluded
Leuthold v. Canadian Broadcasting
Corporation
This is a copyright dispute. Ms. Leuthold sued the CBC and an
individual for copyright infringement of photographs she took on
September 11, 2001. The CBC was made a documentary to show how the
September 11 attacks unfolded through the reaction of journalists,
cameramen and photographers who were on the scene that day. They
negotiated two licences with Ms. Leuthold for use of her
photographs. The correct interpretation of those licences as
compared with the number of broadcasts was at issue in this
proceeding.
The Court held that the first licence was unrestricted, except for
use of the images in promotional materials, and thus permitted the
first broadcast. The second licence, signed after the second
broadcast, permitted the second broadcast. However, the Court held
that on six (6) separate occasions, the Plaintiff's photographs
were shown to Canadians without her authorization, thus
compensation for each of those communications would be
awarded.
There was a dispute over whether a broadcast included more than
one time zone, and whether it also included the Newsworld
broadcasts. Furthermore, there was a dispute over whether the
technical means used to transmit the documentary across Canada
consisted of additional broadcasts that deserved compensation. The
Court held that one broadcast to a Canadian network includes all
time zones. In addition, the licence to the one broadcast was held
to include Newsworld. Furthermore, the Court did not accept the
principle that compensation should be awarded on the basis of each
technical act of infringement as this would be contrary to the
reading of the Broadcasting Act with the Copyright Act. The
technical means used to relay the infringing work has no bearing on
the amount of compensation owed. Finally, the Court refused to
order exemplary damages as the six (6) unauthorized communications
resulted from an honest mistake which was admitted quite candidly
in testimony. The individual Defendant was held not be personally
liable as the Court found that the unauthorized communications were
not the result of a deliberate act or gross negligence.
SCC Releases Five Decisions relating to Copyright tariffs
On Thursday, July 12, the Supreme Court of Canada (SCC) released
5 decisions, providing guidance with respect to a number of
tariffs. Please read BLG's Intellectual Property Alert for summaries of
each of the decisions.
Entertainment Software Association v. Society
of Composers, Authors and Music Publishers of
Canada
Rogers Communications Inc. v. Society of
Composers, Authors and Music Publishers of
Canada
Society of Composers, Authors and Music
Publishers of Canada et al v. Bell Canada
Alberta (Education) v. Canadian Copyright
Licensing Agency (Access Copyright)
Re:Sound v. Motion Picture Theatre Associations
of Canada
Leave Applications Denied
The SCC denied leave applications in two IP cases. In
Schering v. Apotex, the FCA upheld the decision of the Trial Judge
finding the patent invalid for lack of utility. Our summary of the
decision can be found here. In Apotex v. Merck, the FCA upheld the Trial Judge's findings of
infringement of the patent at issue. Our summary of the decision
can be found here.
Other Industry News
Health Canada's Therapeutic Products Directorate has published
its Statistical Report for 2011 for the Patented
Medicines (Notice of Compliance) Regulations and Data
Protection.
Regulations Amending the Food and Drug Regulations
(Positron-Emitting Radiopharmaceuticals) have been enacted
through the Canada Gazette Part II.
Health Canada has published a website (Health Products and Food Regulatory
Modernization) designed to provide information on the
Regulatory Roadmap for Health Products and Food.
Health Canada has released an Updated Guidance Document: Bulk Forming Laxatives – Labelling
Standard.
Health Canada has indicated that it is determining how it will implement the new ICH E2F
Guidance, and will publish a Notice when the strategy is
determined.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
