Bayer Inc. v. Canada ( Minister of National Health and Welfare )
T-1596-95
Lutfy J.
20/7/98
22 pp.
Application pursuant to Patented Medicines (Notice of Compliance) Regulations for order prohibiting Minister from issuing Notice of Compliance (NOC) to respondent Apotex in respect of ciprofloxacin hydrochloride (cipro) until after expiration of Canadian Patent No. 1,322,334 (334)-Application brought in response to 1995 notice of allegation (NOA) by Apotex alleging invalidity of 334 patent on basis disclosing no invention beyond what claimed in patent 1,218,067 (067)-Bayer characterizing third of six NOAs as abuse of process on basis prohibition order concerning 334 patent which now final decision and lack of significant progress in appeal from prohibition order concerning 067 patent-Also, arguing eventual adjudication of applications for prohibition orders concerning fourth and fifth NOAs and statement of claim render proceeding moot and waste of effort for all concerned-Bringing of more than one NOA before Court, provided separate and distinct from others, cannot be seen as abuse of process-On basis of F.C.A. decision in Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.), there could have been no suggestion of abuse of process at time this NOA issued-No evidence in this proceeding concerning substantive issues in applications concerning fourth and fifth NOAs and statement of claim-Cursory review of fourth and fifth NOAs and Bayer's statement of claim, with no other evidence, not sufficient basis upon which to determine in serious way this proceeding moot-Assertion of mootness not establishing abuse of process-Mootness one thing, abuse of process another-If proceedings concerning third, fourth and fifth NOAs so related as to make proceeding moot, may have been open to either party for reasons of efficiency or otherwise to take up suggestion of Strayer J.A. in Bayer AG v. Canada (Minister of National Health and Welfare) (1995), 60 C.P.R. (3d) 129 (F.C.A.) that with modicum of cooperation and good sense of parties, trial judge might in appropriate case order evidence and argument of all such matters be dealt with in same prohibition proceeding or at same time-On main issue, Bayer has failed to establish that Apotex allegation of invalidity of 334 patent not justified-Accordingly, application for prohibition order dismissed-Bayer relying on statutory presumption of validity in Patent Act, s. 43-On evidence, both patents concern same compound cipro-First claim in 334 patent for composition comprising as active ingredient pharmaceutically effective amount of cipro with pharmaceutically acceptable diluent or carrier-Bayer has acknowledged no new inventiveness in 334 patent other than in compound itself-Application of Commissioner of Patents v. Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] S.C.R 49 wherein S.C.C. held addition of inert carrier to original compound nothing more than dilution and did not result in further invention over and above that of compound itself-In Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536, S.C.C. reiterated principle that in absence of any inventive ingenuity other than original patent, no invention in composition-Therefore, whether compound is medicine or not or regardless of whether Act, s. 41 in play or not, must be inventive ingenuity other than that in compound itself if separate patent to issue for composition-Patent Rules, ss. 58-60, routinely applied by Patent Office to require applicants to file divisional applications in respect of different embodiments when no unity of invention, cannot be used to extend patentee's monopoly rights as would create serious anomaly in law-Patent Act as interpreted by judicial pronouncements must prevail over administrative practice-In conclusion, evidence, when assessed in light of Farbwerke Hoescht, sufficient to rebut presumption of validity in Act, s. 43, at least for purposes of this summary proceeding-Patent Act, R.S.C. 1970, c. P-4, ss. 41, 43-Patent Rules, C.R.C., c. 1250, ss. 58, 59, 60-Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.