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.
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
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
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)
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.
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