Ramipril Section 8

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.

Justice Hughes and Justice Snider jointly heard arguments on the validity of Section 8 of the PM(NOC) Regulations. In Justice Snider’s decisions Teva Canada v. Sanofi-Aventis; Apotex v. Sanofi-Aventis, 2012 FC 551 (ramipril), she found that none of the validity arguments should succeed. Justice Hughes released his decision on the validity of Section 8 earlier in Apotex v. Astrazeneca Canada, 2012 FC 559 (omeprazole).

In Teva Canada v. Sanofi-Aventis Canada, 2012 FC 552, Justice Snider considered that during the relevant period, an authorized generic and Apotex would have entered the market and Sanofi’s decision to cease advertising would have decreased the size of the market. The relevant period was limited by the expiry of a patent Teva indicated it would not address. The onus was on Sanofi to adduce evidence of the entry of other generics while Teva had the overall legal burden to prove its losses. No amounts were awarded for lost future business as of the final day of the relevant period but amounts were awarded for off-label uses.

In Apotex v. Sanofi Aventis Canada, 2012 FC 553, Justice Snider similarly considered a hypothetical world with both an authorized generic and Teva.

These decisions were released to the parties on May 11th, released publicly on May 23rd and should be posted on the Federal Court website shortly. In the mean time, they are available in PDF format:

Teva Canada has filed an appeal to the Federal Court of Appeal (A-147-12).

[Updated May 25 to include file numbers and appeal.]