Pharmaceutical inventions have been the subject of special provisions in the past, the likes of which have not been applied to other inventions. Furthermore, pharmaceuticals are the subject of much government regulation outside of the patent system.
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September 2, 2015
September 2, 2015
AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322 - Claim 1 was worded general enough to capture Apotex’s subcoating layer even though Apotex’s subcoating layer was generated by an in situ chemical reaction, a process that the patentee had not contemplated.
May 21, 2015
May 21, 2015
ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93 - The FCA confirmed that paragraph 4(2)(a) of the Patented Medicines (Notice of Compliance Regulations) requires that a patent listed on the register requires an “exacting threshold of specificity” between what is claimed in the patent and what has been approved in the Notice of Compliance. However, proposed amendments to the PM(NOC) Regulations would reverse this holding.
May 20, 2015
May 20, 2015
The proposed amendments would dispose of the product specificity requirement that was interpreted by the Federal Court of Appeal in paragraphs 4(2)(a) and 4(2)(b) of the PM(NOC) Regulations.
May 13, 2015
May 13, 2015
Lundbeck Canada Inc v Canada (Health), 2014 FC 1049 - How should overlapping expert costs be allocated? Three parties each sought a Notice of Compliance (NOC) for the same drug, and the innovator relied on much the same expert evidence in each proceeding but costs were not precisely allocated among the three proceedings.
March 24, 2015
March 24, 2015
Eli Lilly Inc v Mylan Pharmaceuticals ULC, 2015 FC 178 - Mylan did not infringe the ‘948 Patent because the Mylan’s tadalafil compound did not have the claimed particle size distribution and the formulation did not contain the claimed concentration of hydrophilic binder. The Court rejected two purposive arguments by Eli Lilly in favour of a more literal reading of the patent.
March 3, 2015
March 3, 2015
Alcon Canada Inc v Cobalt Pharmaceuticals Company, 2014 FC 149 - The Court examined in detail a number of experiments disclosed in the patent that were said to establish the claimed utility, but the experiments did not demonstrate or soundly predict utility for the broad ranges of molecular weight and chemical concentration claimed.
February 25, 2015
February 25, 2015
Eli Lilly Canada v Canada (Attorney General), 2014 FC 152 - This decision clearly states that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction.
February 5, 2015
February 5, 2015
AbbVie Biotechnology Ltd v Canada (Attorney General), 2014 FC 1251 - The core of the Commissioner’s argument was that Janssen Inc v Mylan Pharmaceuticals ULC, 2010 FC 1123, broadened the prohibition against patents on methods of medical treatment to include generally claims which restrict the “how and when” a physician could administer a particular drug. The Court found that the Commissioner had misread Janssen.
January 23, 2015
January 23, 2015
Commissioner’s Decision # 1371 - The Commissioner refused to grant GlaxoSmithKline’s patent application for an “influenza vaccine formulation for intradermal delivery” due to obviousness since there was always a motivation to use the ID route, but it had always been impractical until the advent of a short needle device.
December 22, 2014
December 22, 2014
The proposed amendments are said to clarify the patent listing requirements as they relate to single medicinal ingredients found in combination drugs and confirm Health Canada’s established practices which, in light of recent Federal Court and Federal Court of Appeal decisions, may need to change.
November 21, 2014
November 21, 2014
Apotex Inc v Pfizer Canada Inc, 2014 FCA 250 - The Court rejected Apotex’s sweeping argument that any given promise in the patent must be construed as overarching to all of the patent’s claims.
July 31, 2014
July 31, 2014
Allergan Inc v Apotex Inc, 2014 FC 567 - In terms of claim construction, this case shows the tension between construing claims based solely on the wording of the claims versus peering beyond the wording of the claims to distill an underlying invention.
July 3, 2014
July 3, 2014
Hospira Healthcare Corporation v Canada (Health), 2014 FC 179 - The Court determined that a pharmaceutical innovator benefiting from data protection has standing where that data protection is challenged.
May 26, 2014
May 26, 2014
Apotex Inc v Pfizer Canada Inc, 2014 FC 159 - The Court confirmed that bifurcation of a PM(NOC) proceeding is not limited to liability/damages, and held that “[i]t is open to the Court to bifurcate any issue which will result in the saving of time, cost and judicial resources.” The issue need not be a threshold issue determinative of the proceedings.
March 21, 2014
March 21, 2014
Sanofi-Aventis Canada Inc v Teva Canada Limited - 2014 FCA 69 - The Court stated that whether there can be recovery for unauthorized indications under section 8 of the PM(NOC) Regulations is a question of fact, and that the purpose of section 8 damages is to compensate generics for a delay caused by NOC Proceedings.
March 21, 2014
March 21, 2014
Sanofi-Aventis Canada Inc v Teva Canada Limited - 2014 FCA 65 - The Court dismissed Sanofi’s appeal to amend its statement of defence in a PM(NOC) proceeding. It is not sufficient that allowing the amendment would not be unjust. What is required is that any injustice to the other party is capable of being compensated by an award of costs and the interest of justice must be served.
March 10, 2014
March 10, 2014
Pfizer Canada Inc v Apotex Inc, 2014 FCA 54 - The Court rejected Pfizer's argument that the trial judge did not properly apply the R. v. J.-L.J., 2000 SCC 51 case when assessing the admissibility of what Pfizer alleged were novel scientific theories put forth by Apotex’s expert.
March 10, 2014
March 10, 2014
Valeant Canada LP v Canada (Health), 2014 FCA 50 - The Court dismissed an appeal from the Federal Court’s decision to grant Valeant’s motion to disqualify Cobalt’s in-house lawyer from any further involvement in the application before the Court on the ground that he could be presumed to have Valeant’s confidential information.
February 18, 2014
February 18, 2014
Valeant Canada LP v. Cobalt Pharmaceuticals – 2013 FC 1254 Cobalt moved, pursuant to s. 6(5)(b) of the PM(NOC) Regulations, to dismiss as an abuse of […]
February 11, 2014
February 11, 2014
Pfizer Canada Inc. v. Mylan Pharmaceuticals ULC – 2014 FC 38 In this case Pfizer brought a prohibition application under the PM(NOC) Regulations to prevent the […]