PATENTS
Infringement
Abbott Laboratories seeking order prohibiting Minister from issuing notice of compliance (NOC) to ratiopharm for production of Clarithromycin 250, 500 mg as infringing ′732 patent—(1) Construction of claims 15, 20 of ′732 patent— This is process patent, disclosure reveals has known therapeutic effect as antibacterial treatment of upper respiratory tract infections—While Court to look at disclosure to understand patent, disclosure not to be used to enlarge, contract scope of claim: Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, paragraph 52—(2) Ratiopharm alleging patent invalid for lack of utility—Asserting Claim 15 is “Markush Claim”, therefore applies to all members of genus and cannot claim utility for just one member—Markush claim defined in Manual of Patent Office Practice, c. 11: “In chemical cases, a claim directed to a genus expressed as a group consisting of certain specified materials is allowable (ex parte Markush 1925, 340 U.S.O.G. 839) provided it is clear from the known nature of the alternative materials or from the prior art that the materials in the group possess at least one property in common which is mainly responsible for their function in the claimed relationship”—Manual, c. 14, further explains that “Markush claim is a claim which covers selected members of a genus as contrasted to all the members of a genus, so as to exclude inoperative members of the group. Markush groupings will be considered to be directed to one invention when all of the members of the group have a common basic structure and/or common property or activity is present. In those cases where a common property or activity is present, all of the members are expected to behave in the same way in the context of the claimed invention”— “Markush” of American origin but following textbook definition recently cited with approval in Abbott Labs. v. Baxter Pharm. Prods., 334 F.3d 1274 (Fed. Cir. 2003) at p. 1280: “A Markush group is a sort of homemade generic expression covering a group of two or more different materials (elements, radicals, compounds etc.), mechanical elements, or process steps, any one of which would work in the combination claimed”—Markush claims intended to reduce number of claims, costs given limitation on number of claims that could be made in a patent and fee per claim under American law—Concept adopted in Canadian practice— Given Commissioner’s guidance, above-cited definition, fact claim 15 uses phrase “selected from the group consisting of”, use of word “and”, not “or” before enumerating last solvent, no doubt claim 15 is Markush claim—Key to Markush claim that it defines homemade genus, all members of which can be used interchangeably—In claiming solvent selected from group consisting of: “acetone . . . . and methanol-ethanol”, only conclusion that any one of these solvents can be used to obtain desired result—It is claim to group of solvents, not to each in alternative—Court accepting neither listed solvents meant as alternatives nor Patent Act, s. 27(5) applicable— Drafter clearly asserted use of all specified solvents would produce desired result—Review of conflicting expert opinions on claim 15—On balance of probabilities, ratiopharm proving claim 15 without utility as to 3 of 17 solvents claimed —Abbott not disproving allegation claim 15 invalid for want of utility—(3) Ratiopharm alleging invalidity due to anticipation by prior use, sale of Biaxin—Abbott selling Biaxin since 1989—In Hoffman-La Roche v. Commissioner of Patents, 1955 S.C.R. 414, at p. 415 Kerwin C.J. stating “There being nothing new about the product, an appellant is not entitled to obtain a patent therefor even on the basis of a process dependent product claim”—That case decided under former Act and must be translated into current Act, s. 28.2(1)(a), (b) applied—Must apply s. 28(5) as interpreted in Baker Petrolite Corp. v. Canwell Enviro-Industries Ltd., [2003] 1 F.C. 49 (C.A.)—Must be evidence on any analysis “which would make such composition or internal structure available to the public”—Ratiopharm not explaining in notice of allegation (NOA) how prior Biaxin sale would permit one skilled in art to somehow obtain knowledge in accordance with known analytical techniques available at time in such manner that subject-matter of ′732 patent would become available to public in Canada—Argument on Biaxin developed only in memorandum of fact and law—Standard for sufficiency of NOAs established in AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.)—NOA deficient, not meeting AB Hassle standards regarding prior sale of Biaxin so Abbott need not disprove allegation—(4) Ratiopharm alleging invention in ′732 patent anticipated by article by I. I. Salem published by Academic Press at San Diego sometime in 1996—′732 patent application filed in Canada on July 28, 1997 but had priority date, thus claim date of July 29, 1996—Ratiopharm having to establish Salem article available to public prior to July 29, 1996—Evidence University of Missouri not placing volume in library before August 19, 1996 and, as had standing order, would have received copy as fast as any other library—Lux Traffic Controls Ltd. v. Pike Signals Ltd. and Faronwise Ltd., [1993] R.P.C. 107 (H.L.), holding if book on shelf of library open to public, even if in dark, dusty corner, need not be proven anyone actually read book—Ratiopharm not meeting standard established by case law regarding Salem article—(5) Ratiopharm also alleged anticipation by Iwasaki article published June 15, 1993, which clearly predated ′732 patent claim, but it described molecular structure of a solvate and nothing in ′732 indicates it is solvate—Expert evidence that customary for chemists to indicate in formula, text if dealing with solvate preferred to that of Ratiopharm’s expert—′732 not including solvates so could not have been anticipated by Iwasaki paper—(6) As to non-infringement, Ratiopharm omitting step in process for reasons of confidentiality— Ratiopharm should have alerted Abbott step in patent not used in manufacturing process once confidentiality order issued— In result, no expert evidence on point adduced by either side —Issue of fundamental importance, could be dispositive of case and ratiopharm breached s. 5(3)(a) of Patented Medicines (Notice of Compliance) Regulations, A.B. Hassle standard— Abbott not required to disprove this portion of allegations— Non-infringement also alleged on basis final step in ratiopharm’s process not producing Clarithromycin Form II from solvent A but from solvent X, not substance claimed in ′732—Abbott insisted patent infringed as steps involve dissolving in solvent A—Conflict in expert evidence not resolved—Abbott’s experts only giving evidence of possibility of infringement and insufficient as applicant bearing burden of proof to disprove non-infringement allegations—(7) Final issue whether Notice of Compliance Regulations apply to intermediates—Settled law that intermediates without therapeutic value fall outside Regulations but intermediate produced at stage 4 very medicine covered by ′732 patent, so question becoming whether Regulations cover intermediate having therapeutic value but used only as intermediate —Unnecessary to decide point as Abbott not proving it was produced at stage 4—Application denied—Patent Act, S.C. 1935, c. 32, ss. 26(1)(a)—Patent Act, R.S.C., 1985, c. P-4, ss. 27(5) (as enacted by S.C. 1993, c. 15, s. 31), 28(5), 28.2(1) (as enacted idem, s. 33)—Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 5(1)(b)(iv) (as am. by SOR/99-379, s. 2), 5(3)(a) (as am. idem).
Abbott Laboratories v. Canada (Minister of Health) (T-1847-02, 2005 FC 1095, von Finckenstein J., order dated 10/8/05, 43 pp.)