and
Beverley Moore
Actions
Motion for Additional Rebuttal Witnesses in Re-opened Trial Denied
Varco Canada Limited v. Pason Systems Corp.
The Defendants brought a motion seeking to call rebuttal witnesses in a trial that has been re-opened to allow evidence that may contradict the evidence given at trial. The Court dismissed the motion, finding it to be premature on the basis that additional evidence must be relevant to the specific issue for which the trial was re-opened, which is to allow the corrected evidence and testimony. It is not clear what, if any, additional evidence will be relevant at this stage.
NOC Cases
Prohibition Order Granted
Allergan v. Sandoz Canada Inc.
Drug: COMBIGAN brimonidine tartrate
The Court considered arguments that one patent was invalid on
the basis of obviousness and that a second patent was not
infringed, and invalid on the basis of inutility. The Court issued
a prohibition order, preventing Sandoz from coming to market with
its generic brimonidine tartrate product, until the expiry of the
first patent. However, the Court held that the second patent was
not infringed.
The first patent claimed the use of timolol and brimonidine in a
particular combination, with a particular carrier, to treat
glaucoma. The Court considered the test for obviousness and held
that in the absence of prior art which demonstrated a safety
profile for concomitant therapy comparable to that reported in the
patent, it is entirely appropriate to recognize that superior
safety profile as being one of the differences that distinguish the
patent from the prior art. The Court held that while it may have
been worthwhile to pursue, it was not self-evident that formulating
brimonidine and timolol into a chemically stable drug would work,
let alone have a superior safety profile to brimonidine, or permit
BID dosing without an afternoon reduction in efficiency. Thus, the
Court held that the allegation as to obviousness was not
justified.
The second patent claimed the use of brimonidine for
neuroprotection. The Court first considered whether Sandoz's
allegations of non-infringement were justified on the basis of the
test for induced infringement with respect to the product
monograph. The Court held that the generic product was likely to
infringe the patent. However, the Court also held that as the
innovator product is not indicated for neuroprotection, despite
neuroprotective information in Sandoz' product monograph, the
test was not met for inducement of infringement.
With respect to direct infringement, the Court held that an
allegation of non-infringement cannot be justified solely on the
basis that the product monograph does not mention the particular
use claimed in a patent. The Court then considered the evidence and
held that the allegations of non-infringement were not justified.
Finally, with respect to the allegations as to inutility, the Court
held that they were not justified, as the evidence demonstrated a
neuroprotective effect. Furthermore, Sandoz had not raised the
issue of sound prediction properly in its NOA. Thus, the Court held
it should not be considered. The Court did, nonetheless, consider
the issue, and held that the allegations as to a lack of sound
prediction were not justified as there was both a factual basis and
a sound line of reasoning for the prediction and both were
disclosed in the patent.
Appeal is Neither Stayed nor Expedited
Mylan Pharmaceuticals ULC v. AstraZeneca
Canada, Inc.
Drug: ARIMIDEX anastrozole
The Court of Appeal was considering two motions, one motion by
Mylan seeking to expedite the appeal, and one motion by AstraZeneca
seeking to stay the appeal until the decision of the Supreme Court
of Canada (SCC) in Teva Canada Limited v. Pfizer Canada Inc.
(Teva).
The Court of Appeal first considered the motion by AstraZeneca to
stay the appeal. In respect of the test to be applied on such a
motion, the Court of Appeal distinguished a motion asking the Court
to enjoin another body from exercising its jurisdiction, in which
the test set out in RJR-MacDonald applies, and a motion
asking the Court not to exercise its jurisdiction until a later
date. This motion requires the Court to consider whether the stay
is in the interests of justice.
The Court of Appeal declined to stay the appeal, on the basis that
the length of delay will be significant and there is not a very
direct nexus between the issues in Teva and the within
appeal. The Court of Appeal held that there are mechanisms to
address AstraZeneca's concerns of a decision in the appeal that
is wrong in light of the later decision of the SCC in
Teva.
With respect to Mylan's motion to expedite the appeal, the
Court of Appeal dismissed the motion and noted that Mylan has not
acted expeditiously in moving the appeal forward.
Other Cases of Interest
No Vested Interest in NOC While on Patent
Hold
Apotex Inc. v. Canada (Health)
Drug: omeprazole
Apotex brought a judicial review application, challenging three
decisions made by the Minister of Health (Minister) with respect to
Apotex' submission for approval of its Apo-omeprazole
product.
The Court found that Apotex' application did not meet the
timing requirements for filing pursuant to section 18.1(2) of the
Federal Courts Act. Apotex argued that the Minister has
shown a "pattern of misconduct", such that it was not
required to meet the 30 day timeline for filing its application.
The Court rejected this argument and found that the filing
requirement did apply to the application and it was therefore
necessary for Apotex to succeed in respect of its motion for an
extension of time to file the application. The Court found that
Apotex' motion for an extension of time failed to provide a
reasonable explanation for the delay, and accordingly dismissed
this motion.
The Court did not need to deal with the substantive issues, other
than the issue of a vested right in the issuance of a Notice of
Compliance (NOC), as a result of the dismissal of the motion for an
extension of time. With respect to the vesting issue, Apotex argued
that it had a vested right to a NOC when the Minister indicated
that its review was complete but for the requirements under the
NOC Regulations. The Court did not accept Apotex'
argument that it had a vested right, and the application was
accordingly dismissed.
Court of Appeal Requires Commissioner of Patents to
Re-examine Patent
Canada (Attorney General and Commissioner of Patents) v.
Amazon
On November 24, 2011, the Court of Appeal released its decision
relating to Amazon's "one-click method of internet
shopping." The Court had allowed Amazon's appeal and
ordered the Commissioner of Patents (Commissioner) to expedite
re-examination of the patent application and undertake this
re-examination in light of the Court's direction that the
claims constitute patent subject matter. The Court of Appeal
allowed the Commissioner's appeal to the extent that it amended
the direction from the Court to re-examine the patent application
in accordance with the reasons of the Court of Appeal.
BLG will be releasing an Alert shortly that provides an in-depth
analysis of the Court of Appeals Judgment and Reasons.
Other Industry News
Health Canada has published a web info sheet on drug shortages.
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.
