PATENTS
Infringement
Applicants seek order prohibiting Minister from issuing to Pharmascience notice of compliance (NOC) for clarithromycin tablets until expiry of patent 2261732 ('732 patent)—Application filed under Patented Medicines (Notice of Compliance) Regulations, s. 6 in response to notice of allegation (NOA) served by Pharmascience on Abbott Canada under Regulations, s. 5—Pharmascience alleges its version of drug produced by process not infringing patent or that patent’s claims broader than invention disclosed so patent invalid—Prothonotary granted 105-day extension of 24-month period set by Regulations, s. 7(1)(e) during which Minister prohibited from issuing NOC—Appeal against that order denied—Prohibition remains in force—Drug in question is antibiotic Biaxin BID ®, made in Canada by Abbott Canada with permission of Abbott U.S.—Pharmascience generic drug company which markets drugs without having to independently establish safety, effectiveness of drug—Patent at issue contained 44 claims—Claimed invention summarized—Pharmascience intends to purchase clarithromycin II form off-shore supplier, says supplier’s process outside applicants’ patent as not involving crystallization or recrystallization but “solid-state transformation” accomplished by slurrying in water—But supplier also makes clarithromycin II by a second process which does fall within applicants’ patent—Pharmascience would only acquire product made by “slurrying” method—Preliminary issues: (1) whether NOA deficient on its face; (2) whether respondent’s reliance on evidence alleged to be hearsay adequate for allegation evaluation—Substantive issues: non-infringement of '732 patent and, if infringement is found, whether patent invalid as claims broader than invention made, disclosed—As to validity of NOA, evidence that, at date of NOA, respondent aware (or unaware) suppliers acknowledged used two processes, only one of which involved slurrying—Insufficient evidence to evaluate allegation—Factual basis in NOA read together with further disclosure when confidentiality order in place were insufficient to support NOA—NOA approached abuse of process of Court, NOC Regulations scheme—Impossible for Court to conclude if NOC issued, respondent’s drug would be produced by non-infringing process—While that conclusion dispositive of matter, Court went on to consider allegations of non-infringement, whether patent invalid for over breadth—Resolution of those issues turned on credibility of expert witnesses—Principles of patent claims construction reviewed—For purposes of this application, person “skilled in the art to which the invention relates” is one with undergraduate chemistry or chemical engineering degree, having two to five years’ experience, including graduate work, in pharmaceutical process development—Effective date for interpretation of '732 patent was February 5, 1998, date “laid open” or “published”—Construction of word “treating”— “Treating” covers any method of crystallization of clarithromycin involving dissolution in solvents or solvent systems listed in '732 patent—Extends to slurrying whereby clarithromycin form II is resultant crystalline form— Construction of starting compound, solvent systems— Legal, evidential burdens on infringement allegation—Where, as here, patent in issue is product-by-process patent, Regulations, s. 6(6) created presumption patent infringed in absence of proof to contrary—Assuming NOA adequate, Pharmascience put non-infringement, overbreadth issues “in play”; applicants’ expert evidence met “persuasive burden”—So “evidential burden” shifts back to respondent and not met— Outcome of infringement issue, against Court’s interpretation of '732 patent, depends entirely on conflicting expert evidence—Suggestion by Pharmascience supplier’s transformation does not take place in solvent or solvent system disclosed in '732 patent non-sustainable—Non-infringement allegation involving solid state or solid-to-solid transformation rather than crystallization or recrystallization within scope of '732 patent not made out—As for allegation of invalidity for over-breadth, interpretation of disclosure of '732 patent as extending to process utilized by respondent’s supplier reasonably open, does not result in patent claims exceeding disclosure—Pharmascience failed to discharge evidentiary burden to justify invalidity allegation—Applicants entirely successful herein—Order to go prohibiting Health Minister from issuing NOC until patent expires—Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, ss. 5 (as am. by SOR/98-1066, s. 4; 99-379, s. 2), 6 (as am. by SOR/98-166, s. 5; 99-379, s. 3), 7(1)(e) (as am. by SOR/98-166, s. 6).
Abbott Laboratories v. Canada (Minister of Health) (T-1035-02, 2004 FC 1349, Gibson J., order dated 1/10/04, 58 pp.)