The Federal Court of Appeal (“FCA”) upheld the validity of Canadian Patent 2,436,668 (“668 Patent”) which covers Form I ODV succinate (marketed as PRISTIQ) in two separate appeals by Apotex Inc. (“Apotex”) and Teva Canada Ltd (“Teva”), finding that the claims were novel and inventive. Obviousness The FCA began be reiterating key points of the obviousness analysis: The Sanofi test is flexible and expansive and can include consideration of the invention story as a whole;…

The Federal Court of Appeal (“FCA”) confirmed that in assessing the availability of a non-infringing alternative (“NIA”) defence, the NIA must be legal and cannot infringe any patent, and its economic viability must be considered objectively. The FCA upheld an award for damages for patent infringement by the Federal Court (“FC”) but remitted the issue of prejudgment interest back for redetermination. Background This case arises from a dispute between Apotex Inc. (“Apotex”) and Eli Lilly…

This decision of the Ontario Court of Appeal (ONCA) arises in the context of a novel action brought by Apotex seeking damages for the delayed market entry of its generic version of Sanofi’s blockbuster ramipril drug. Apotex’s claims in this action are linked to the invalidity of Canadian Patent No. 1,341,206 (206 Patent). The 206 Patent had previously been invalidated  based on the application of the “promise doctrine”. In June 2017, the Supreme Court of…

The Ontario Superior Court of Justice (ONSC) recently denied Apotex’s attempt to repackage the now defunct “promise of the patent” doctrine (the Promise Doctrine).  Apotex sought to amend its pleadings to reintroduce the Promise Doctrine under the guise of invalidity allegations of over-breadth, insufficiency, and willful misrepresentation pursuant to sections 27 and 53 of the Patent Act. The motion was heard in the broader context of the quantum phase of an action for damages by…

The Federal Court dismissed an application by Eli Lilly Canada Inc., Ube Industries, Ltd., and Daiichi Sankyo Company, Limited (the Applicants) seeking a prohibition order regarding Apotex’s generic version of Lilly’s EFFIENT® (prasugrel hydrochloride). While the Court rejected Apotex’s allegations of overbreadth, insufficiency, and non-patentable subject matter, it held that the claims were obvious. Background The claims of Canadian Patent No. 2,432,644 (the 644 Patent) relate to pharmaceutical compositions comprising prasugrel and aspirin. Prasugrel is…

As we reported, Abbott Laboratories Limited, Takeda Pharmaceuticals Company Limited and Takeda Pharmaceuticals America Inc. sought dismissal of Apotex’s action for s. 8 damages in the Ontario Superior Court by summary judgment. The Ontario Court of Appeal (ONCA) affirmed the lower court’s finding that a real-world notice of non-compliance – withdrawal (NON-W) issued by Health Canada did not operate to void the patent hold letter ab initio. The ONCA held it was open to…

The Federal Court of Appeal (FCA) has refused to apply the “special circumstances” exception to issue estoppel in view of a change in law arising from the rejection of the “promise doctrine” in AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 (NEXIUM, reported here). Noting any injustice to Lilly is “entirely commercial in nature” as well as a concern of Teva being ‟twice vexed,” the court rejected Lilly’s argument that the NEXIUM decision…