Bayer AG v. Apotex Inc.
T-35-96 / T-591-96
Gibson J.
3/11/98
30 pp.
Notice of motion to prohibit Minister of National Health and Welfare from issuing notice of compliance to respondent Apotex Inc. in respect of medicine ciprofloxacin hydrochloride until after expiration of Canadian patents Nos. 1,218,067 (067 patent) and 1,322,334 (334 patent)-Notice of motion filed on January 8, 1996 in response to notice of allegation sent by Apotex on November 24, 1995 alleging such patents invalid-Bayer Germany owner of 067, 334 patents-Bayer Canada licensee of Bayer Germany in respect of both patents, selling ciprofloxacin as medicine in Canada under notices of compliance granted by Minister-Apotex "generic drug company" seeking notice of compliance from Minister to enable it to market ciprofloxacin-Ciprofloxacin drug used as antibiotic-Bayer Germany filing in number of countries "two families of patents"-Both Canadian patents derived from application in "family II" class with actual filing date in Canada of August 13, 1982-Initial "persuasive", "legal" burden of proof falling on Bayer to establish Bayer Germany entitled to grant of Canadian patents, patents not invalid-Bayer entitled to rely on presumption of validity in Patent Act, s. 47-Apotex having adduced sufficient evidence of existence of issue on record to pass threshold for that particular issue-"Initial burden of proof" restored, lying upon Bayer-Act, s. 55(1) providing patent void if material allegation in petition of applicant in respect of patent untrue-No allegation with respect to German application, Chilean application, patent, Spanish application, patent made on face of petition giving rise to Canadian patents-Failure to disclose not explicit allegation-Canadian patents not void by reason of untrue material allegation in petition giving rise to them-No fraud on Patent Office established-Notices of allegations giving rise to applications fourth, fifth notices of allegations made by Apotex in respect of ciprofloxacin-Fifth notice of allegation provided by Apotex to Bayer not separate, distinct from fourth notice of allegation-Constituting abuse of process, not of process of Court since not document in proceeding in Court other than as evidence, but rather of regulatory scheme established by Regulations-On or about September 8, 1998, counsel for Bayer filed reply memorandum of fact and law extending on file T-591 to 146 paragraphs and listing 43 new authorities, including significant number of American authorities-R. 1608 not authorizing additional legal argument to be filed, but meant to permit party to file additional factual evidence to meet respondent's case-Reply memorandum filed on behalf on Bayer including extensive additional legal argument-No reason to discount weight to be given to expert evidence tendered by parties-Application giving rise to Canadian patents filed on August 13, 1982-Bayer filing application in Chile for "family I" patent on August 12, 1981-Chilean patent "conceded", "issued" before filing of application in Canada-Whether conceding, "issuing" of Chilean patent on either March 16 or May 27, 1982 constituted issuing of patent for purposes of Act, s. 28(2)(a), (b)-Before patent can be said to have issued within meaning of Act, s. 28(2), following criteria must be satisfied: public must have been given notice of grant of patent, public must be able to inspect specification of patent and copy it, application must have reached stage in prosecution such that owner able to enforce rights to invention-Evidence failing to establish Chilean patent "issued" before filing of application in Canada that gave rise to Canadian patents-Concept of "issue" consistent with degree of openness urged on behalf of Bayer-Under Act, s. 28(2), Chilean patent had not "issued" when application giving rise to Canadian patents filed-"Foreign patent bar" provided by s. 28(2) not disentitling Bayer from obtaining Canadian patents-Act, ss. 28(2), 29(1) should be read together in such way references to "filing" of application in Canada in s. 28(2) not simply to actual filing but to any effective, priority filing date to which applicant entitled by virtue of s. 29(1)-Foreign patent bar provided by s. 28(2) not applying to filing by Bayer of application giving rise to Canadian patents-Chilean patent containing no claim similar to claims of 334 Canadian patent-Not for same invention as invention claimed in either of Canadian patents-Motion allowed-Patent Act, R.S.C. 1970, c. P-4, ss. 28, 29, 47, 55-Federal Court Rules, C.R.C., c. 663, R. 1608.