PATENTS |
Infringement |
AB Hassle v. Apotex Inc.
T-470-02
2004 FC 379, Lemieux J.
16/3/04
59 pp.
Application for order prohibiting Minister of Health (Minister) from issuing notice of compliance (NOC) to Apotex until expiry of 688 and 762 patents--Both patents claim new uses for well-known medicinal compound, omeprazole or its pharmaceutically acceptable salts (omeprazole)--Field of invention of 688 patent new use of omeprazole as antimicrobial agent for treatment of infectious diseases, especially infections caused by bacterium H. pylori--Invention of 762 patent, combination of gastric acid inhibitor (such as omeprazole) and acid degradable antibiotic (such as penicillin)--New use is in treatment of gastritis or peptic ulcer diseases caused by H. pylori--AstraZeneca holds NOC for omeprazole tablets, capsules marketed under name "Losec"--This proceeding initiated after Apotex Inc. (Apotex) served AstraZeneca Canada Inc. with notice of allegation (NOA) advising it had filed with Minister new drug submission for Apo-Omeprazole tablets for oral administration in strengths of 10 mg, 20 mg and 40 mg--AstraZeneca submitting allegations of non-infringement not justified-- Review of case law, in context of NOC proceedings, on scope, circumstances where indirect infringement by pharmacists, patients may be sufficient to lead to finding allegation of non-infringement by generic drug manufacturer not justified--Vast differences in evidence led resulting in different conclusions, even where same patents but different parties involved--As to whether Apotex's NOA defective, Apotex stated as fact Apo-Omeprazole tablets not combination product because comprise only omeprazole as sole active ingredient--Applicants arguing AstraZeneca misconstrued patent, i.e. claims not limited to single product, because combination could be produced in separate tablets-- Court disagreed--Novelty or discovery disclosed in 762 patent produced by combining omeprazole and antibiotic in order to make more potent antibiotic in order to eradicate bacteria H. pylori--Clear from 762 patent use essential feature in all claims--Whether either 688 or 762 patents infringed by patient use--Answer to this question involving consideration of Rothstein J.A.'s decision in Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2003] 1 F.C. 402 (C.A.) (Genpharm case)-- Rothstein J.A. held issuance of NOC to generic drug manufacturer prohibited where demonstrating infringement will occur by patients consuming patented drug--Theory behind indirect infringement of patent by patient necessarily involves consideration of how prescription drug market operates in Canada--Operation of regulated prescription drug marketplace focusses on behaviour of doctors, pharmacists and drug manufacturers and on laws regulating federal approvals authorizing marketing of drugs and provincial laws relating to Formulary requirements--At level of physician, operation of prescription drug marketplace involves consideration of how doctors prescribe drug to patients, for which illnesses, how they choose to prescribe one of two competing drugs, their knowledge of approved indications and extent to which they may be involved in prescribing non-approved drugs--At level of pharmacist, similar questions arise--Operation of prescription drug marketplace in Canada matter of evidence and drawing reasonable conclusions from that evidence--Evidence herein leading to conclusion applicants led insufficient evidence to show either patent will be infringed should Apotex receive from Minister NOC for Apo-Omeprazole tablets--Evidence led by applicants would deny Apotex its NOC by merely selling Apo-Omeprazole tablets--Law requires something more by Apotex--As applicants led no evidence from doctor, no evidence on what factors drive Canadian doctors' prescribing behaviour--Gap in evidence significant because operation of prescription drug market and findings of indirect patent infringement through use dependent on how doctors prescribe drugs--Pharmacist's evidence of insufficient strength to make out applicants' case of indirect patient infringement through use should Apo-Omeprazole come on marketplace--Apotex confirmed no documents distributed or intended for distribution to public touching on treatment of H. Pylori or Campylobacter or relating to peptic ulcers--Also confirmed no internal Apotex documents, memos or anything touching in any way on marketing plans or strategies with respect to Apo-Omeprazole tablets--Evidence not showing Apotex's NOA not justified-- Application for prohibition order dismissed--Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.