Respondent prevented from getting into market because of appellant’s prohibition application

PATENTS

Respondent prevented from getting into market because of appellant’s prohibition application

Appellant’s application for prohibition prevented respondent from marketing Apo-Norfloxacin for over five years. Relying on s. 8 of the Patented Medicines (Notices of Compliances) Regulations (Can.), respondent sued appellant for damages. Federal Court awarded respondent damages. Federal Court ruled in favour of respondent’s action against appellant under s. 8 of Regulations. In course of its reasons, Federal Court ruled that 1998 version of s. 8 of Regulations (“1998 Regulations”) applied to this case, and not 1993 version of s. 8 of Regulations (“1993 Regulations”). Appellant appealed from that ruling. Appellant also submitted that Federal Court erred in fact and law in concluding that respondent suffered loss as result of appellant’s prohibition application. Appellant’s appeal was dismissed. Appellant’s application for prohibition was “pending” when 1998 Regulations came into force. Therefore, by operation of transitional provision in 1998 Regulations, 1998 Regulations applied in this case. 1998 Regulations could not be said to be retroactive or retrospective or interfere with any vested rights of appellant. Federal Court Judge correctly held that 1998 Regulations were authorized by s. 55.2(4) of Patent Act (Can.), were valid, and applied in this case. Federal Court found that respondent suffered loss as result of appellant’s prohibition application. Respondent established, to satisfaction of Federal Court, that it was prevented from getting into norfloxacin market because of appellant’s prohibition application. In establishing this, respondent satisfied Federal Court that, on balance of probabilities, it would have had access to available supply of non-infringing norfloxacin. There was sufficient evidence upon which Federal Court could have made factual findings it did, and those findings were not susceptible to review in appellate court.

Apotex Inc. v. Merck & Co. (Nov. 25, 2011, F.C.A., Sexton, Layden-Stevenson and Stratas JJ.A., File No. A-154-10) Decision at 186 A.C.W.S. (3d) 1115 was affirmed. 210 A.C.W.S. (3d) 224 (32 pp.).