Decisions were released publicly yesterday in two PM(NOC) Section 8 proceedings. After a joint hearing with Justice Hughes, Justice Snider upheld the validity of Section 8 of the Regulations (in 2012 FC 551). She awarded the recovery of losses to Teva (in 2012 FC 552) and Apotex (in 2012 FC 553) on the assumption that an authorized generic and another generic would have enter the market.
Tag Archives: PM(NOC)
SCC adjourns Sildenafil hearing
The Supreme Court has adjourned the hearing in the appeal of the sildenafil PM(NOC) application on the sufficiency of disclosure. The hearing had been scheduled for tomorrow but is now tentatively scheduled for April 20, 2012.
SCC denies leave on selection patent proceedings
Update: The Supreme Court has denied the leave applications.
On Thursday, the Supreme Court of Canada denied leave will be announcing whether it will grant leave in three related proceedings primarily relating to the validity of a selection patent. Apotex (SCC #34067), Genpharm (#34068) and Cobalt (#34066) are seeking leave to appeal the decision of the Federal Court of Appeal in 2010 FCA 320. That decision held that Lundbeck’s patent CA1,339,452 was a valid patent for the purposes of a PM(NOC) prohibition order. Continue reading SCC denies leave on selection patent proceedings
FCA allows appeal on lack of sound prediction (Latanoprost)
In a decision released yesterday, the Federal Court of Appeal has allowed Apotex’s appeal and held that Pfizer’s 132 Patent relating to latanoprost “fails to meet the requirements for sound prediction.”
Continue reading FCA allows appeal on lack of sound prediction (Latanoprost)
Proposed revisions to PM(NOC) Guidance Document
The Office of Patented Medicines and Liaison (OPML) within Health Canada released proposed revisions to its PM(NOC) Guidance Document relating to administrative new drug submissions and administrative abbreviated new drug submissions.
Continue reading Proposed revisions to PM(NOC) Guidance Document
Interlocutory injunction denied in Esomeprazole-Apotex
In a decision published yesterday, Justice Crampton of the Federal Court denied Astrazeneca’s request for an interlocutory injunction against Apotex. The decision is Astrazeneca Canada Inc. v. Apotex Inc., 2011 FC 505 (Esomeprazole) in T-1668-10 and follows a PM(NOC) proceeding in which Apotex’s allegations of invalidity against at least some of the patents were found justified (T-371-08). The decision has already been appealed and the appeal dismissed by the Federal Court of Appeal (A-180-11).
Professor Norman Siebrasse of University of New Brunswick and author of the Sufficient Description blog, has an interesting discussion of the test for an interlocutory injunction in the context of this decision.