OFAC revokes so-called U-turn authorization for Cuba-related financial transactions
OFAC published a final rule that modifies the Cuban Assets Control Regulations to revoke the so-called "U-turn" authorization.
Case: Apotex Inc v Eli Lilly Canada Inc, et al (SCC Docket 37368)
Drug: CIALIS® (tadalafil)
Nature of case: Application for leave to appeal decision upholding prohibition order granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)
Successful party: Eli Lilly Canada Inc. and ICOS Corporation (collectively Eli Lilly)
Date of decision: April 27, 2017
On April 27 the Supreme Court dismissed Apotex Inc.’s (Apotex) application for leave to appeal the Federal Court of Appeal (FCA) decision upholding the order prohibiting the minister of health from granting a notice of compliance to Apotex for its generic version of tadalafil under section 6 of the Regulations.
As we reported, the FCA dismissed Apotex’s appeal of the lower court’s decision on obviousness-type double patenting and insufficiency, and rejected Apotex’s argument that obviousness-type double patenting is assessed as of the publication date of the later patent. The FCA declined to specify the relevant date for this analysis, holding that “[t]his remains an open question.”
Eli Lilly was also successful in overcoming a double patenting attack in another s. 6 proceeding relating to the same patent against Mylan. Mylan also appealed and in that case the FCA declined to choose between the priority dates of the two patents, but did reject Mylan’s assertion of the publication date of the second patent as the appropriate date.
FCA Decision: Apotex Inc v Eli Lilly Canada Inc, 2016 FCA 267
Trial Decision: Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875
On 5 September 2019, Professor John McMillan AO’s Final Report (Report) on the operation of the Narcotic Drugs Act 1967 (ND Act) was tabled in Parliament. Section 26A of the ND Act required the Minster to cause a review of the operation of the ND Act to be undertaken.