[2012] 1 F.C.R. D-11
Patents
Practice
Appeal from Federal Court (F.C.) decision (2010 FC 287) in favour of respondent (Apotex Inc.) under Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 8 wherein F.C. ruling that 1998 version of s. 8 applying, not 1993 version—Appellant (Merck & Co., Inc.) listing norfloxacin on patent list under 1993 Regulations—Minister prohibited from issuing notice of compliance (NOC) concerning respondent’s Apo-Norfloxacin until expiry of appellant’s patent—Respondent marketing Apo-Norfloxacin in 1998 following Supreme Court of Canada (S.C.C.) decision dismissing appellant’s application for prohibition—Respondent suing appellant for damages pursuant to 1998 Regulations, s. 8—Principal issues whether (1) 1993 or 1998 Regulations applying herein; (2) 1998 Regulations causing retroactive or retrospective effects, or interfering with vested rights, without authorization in Patent Act, R.S.C., 1985, c. P-4—Issue 1: Transitional provision stating that 1998 Regulations, s. 8 applying to application pending on coming into force of 1998 Regulations—Appellant’s application pending before S.C.C. at time of coming into force—Transitional provision broad, not referring to specific court—1998 Regulations therefore applying herein by operation of transitional provision—Issue 2: 1998 Regulations making aspects of 1993 Regulations, s. 8 clearer by declaring bases of liability for damages—Legislation declaring state of earlier, uncertain law not retrospective—Unfair if 1998 Regulations purporting to change rules when appellant planning affairs in reliance upon definite, concrete set of rules set out in 1993 Regulations, s. 8—However, 1998 Regulations not pulling rug out from under appellant—When bringing application, appellant’s legal situation fundamentally uncertain, acquiring “black box” of potential liability—1998 Regulations authorized by Patent Act, s. 55.2(4)—Appeal dismissed.
Apotex Inc. v. Merck & Co., Inc. (A-154-10, 2011 FCA 329, Stratas J.A., judgment dated November 25, 2011, 30 pp.)