PATENTS |
Novartis AG v. Apotex Inc.
T-1266-99
2001 FCT 1129, Blais J.
18/10/01
77 pp.
Application for order under Patented Medicines (Notice of Compliance) Regulations, s. 6(1) to prohibit Minister of Health from issuing notice of compliance (NOC) to respondent Apotex Inc. in connection with Apotex' version of drug cyclosporin until after expiration of Canadian Letters Patent 1332150--Novartis owner of Canadian Letters Patent 1332150 (150 patent)--By letter dated May 28, 1999, Apotex provided notice of allegation to Novartis, alleging claims 1, 6-12, 15-17, 27 of 150 patent invalid on grounds of anticipation, obviousness, being overly broad--Apotex alleging for third time 150 patent invalid, relying on same prior art document, namely Canadian Patent 1339667 (667 patent)--Major point of difference between Apotex, Novartis concerning correct definition of microemulsion--That Apotex withdrew notice of allegation because of problems regarding compliance with Food and Drug Regulations reasonable explanation--Apotex' notice of allegation not abuse of process--Court rendered interlocutory decision on November 17, 1999, months before F.C.A. decision in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.)--Not reasonable for Court to allow applicants to raise that question now when decision already rendered in regard to exact question by Court two years ago--Request presented by Novartis that Court should not consider Apotex's additional references dismissed--File wrapper estoppel, also called prosecution history or extrinsic evidence, doctrine that developed in U.S.A.--Specific purpose for use of file wrapper herein to clarify prior art so as to tender to look at earlier patent (307 patent) to determine if it anticipates later patent (150 patent)--File wrapper should not be admitted since earlier patent should be able to clarify prior art--No need to consult other material, namely file wrapper from U.S. patent office--Key to purposive construction identification by court, with assistance of skilled reader, of particular words, phrases in claims that describe what inventor considered to be "essential" elements of invention--Court should construe patents from perspective of average person skilled in particular art--Should consider what person skilled in art, upon reading claims in light of common general knowledge available at date of patent, would have considered to be invention claimed--Presumption of validity in favour of applicants--Whether formulator skilled in art would be aware smaller droplets size, higher surface area of contact between oil and water enhance, thus better drug blood levels that result--667, 307 patents not describing emulsions formed by compositions disclosed other than being emulsion--Claim 1 of 150 patent anticipated by 667, 307 patents--Person skilled in art, on basis of prior art namely 667, 307 patents and existing common knowledge at relevant time, would in every case and without possibility of error have arrived at formulation claimed in claim 1 of 150 patent--Claims 6-12, 15-17, 27 dependent on claim 1, therefore anticipated by 667, 307 patents--Test for obviousness difficult to meet--Cyclosporin presented problems in administration with regard to bioavailability, uniformness of dose, palatability, potential for toxicity--State of art showing emulsion, microemulsion systems developed as means to increase mass transfer rate of drug to aqueous phase--General formulation specified in claim 1 of 150 patent, benefits would have been obvious to skilled formulator as of date of invention (September 1988)--Claims 6-12, 15-17, 27 dependent upon claim 1 of 150 patent, therefore obvious to skilled formulator as of date of invention (September 1988)--Claims overly broad--Application dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6 (as am. by SOR/98-166, s. 5; 99-379, s. 3)--Food and Drug Regulations, C.R.C., c. 870.