142.173e-ast

BEWARE OF OVERCLAIMING, FEDERAL COURT OF CANADA WARNS Alexandra Steele* LEGER ROBIC RICHARD, Lawyers ROBIC, Patent & Trademark Agents Centre CDP Capital 1001 Square-Victoria – Bloc E – 8th Floor Montréal, Québec, Canada H2Z 2B7 Tel.: (514) 987-6242 - Fax (514) 845-7874 [email protected] –www.robic.ca INTRODUCTION The Applicant's application for a writ of prohibition preventing the Canadian Minister of National Health and Welfare from issuing a Notice of Compliance to the Respondent in respect of anti-depression medication was denied, the Court having ruled that the Respondent's al egations that the proposed drug would not infringe the Applicant's patents were sufficient. [Biovail Pharmaceuticals Inc. et al v. Minister of National Health and Welfare at al, [2005] F.C.J. No. 7, Harrington J., January 6, 2005] BACKGROUND This case relates to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 ("NOC Regulations"). When a generic drug manufacturer wishes to obtain a Notice of Compliance ("NOC"), it can, instead of filing a New Drug Submission, compare its proposed drug to an existing drug. In the present case, the Applicant, Biovail, had obtained a NOC for its anti-depression drug Wel butrin® SR and the Respondent, Novopharm, compared its proposed drug, also for the treatment of depression, to Biovail's Wel butrin® SR drug. Biovail had previously filed a list of its patents relating to Wel butrin® SR pursuant to the NOC Regulations. In accordance with said NOC Regulations, Novopharm had no alternative but to file a Notice of Al egation ("NOA") in respect of al of Biovail's disclosed patents, failing which the Minister of National Health and Welfare ("Minister") would not issue a NOC. In its NOA, LEGER ROBIC RICHARD / ROBIC, 2005. * Lawyer with the law firm LEGER ROBIC RICHARD, g.p. and of the patent and trademark agency firm ROBIC, g.p. Publication 142.173. Novopharm al eged, in respect of Biovail's patents, that its proposed drug did not infringe said patents, and that the patents were not valid. Biovail in turn filed an application to the Federal Court of Canada for a writ of prohibition to prevent the Minister from issuing a NOC to Novopharm. As in al cases relating to patents, the Court must first interpret the patent(s) in suit to determine the scope of the invention. The Court wil then decide whether the first drug manufacturer's application for a writ of prohibition is substantiated. It should be noted that in such NOC proceedings, the Court's finding of infringement and/or invalidity does not constitute res judicata. A patentee is therefore always free to litigate a "regular" patent infringement action against the generic drug maker if the latter is al owed to commercialize the generic drug. Biovail's drug contains an ingredient, HPMC, which serves in the release of the medicine; Novopharm's proposed drug contains a different ingredient, HPC, a derivative of HPMC that serves the same purpose. In its application for a writ of prohibition, Biovail argued that Novopharm's NOA was insufficient and that the proposed generic drug would infringe its patents. Novopharm in addition al eged that Biovail's patents were invalid. The Court therefore had to decide the fol owing: "The only question is whether the Court should grant an order prohibiting the Minister from issuing Novopharm a NOC until after the expiration of one or both of the two underlying patents". In other words, if the Court found the patents to be valid and infringed, then a NOC cannot issue. However, if the Court found that the patents are not infringed or invalid, then a NOC may be issued to Novopharm. THE FEDERAL COURT JUDGEMENT Justice Harrington began his analysis by interpreting the patents in suit, in accordance with the teachings of the Supreme Court of Canada concerning the proper way to construe patent claims (Free World Trust v. Électro-Santé Inc., [2000] 2 S.C.R. 1024 and Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067). In respect of the first patent, the Court was asked to determine whether HPMC, the substance used by Biovail for the control ed release of the medicine, was essential to the working of the invention, or if a variant could be substituted without making any material difference. After hearing the expert evidence of the parties, the Court concluded that HPMC, the substance described in Biovail's first patent, was an essential element of the invention and that no variant, such as HPC used in Novapharm's drug, had been contemplated by the inventor. The Court ruled that a literal interpretation of the claims excluded HPC as a permissible variant, and in addition, the intent of the inventor showed that HPMC was essential and therefore, al variants would fal outside of the claims. The Court ruled that the first Biovail patent would not be infringed if a NOC was issued to Novopharm. Justice Harrington therefore concluded that Biovail's assertion that the al egations of Novopharm's NOA in respect of that patent were insufficient should fail. In respect of the second patent, which related general y to a chemical composition al owing the release of the active ingredients of the drug, Novopharm had al eged in its NOA that not only was this patent not infringed, but also that the patent was so broad in scope that it was invalid. The Court, in order to construe the claims in an informed and purposive way, referred to the disclosure. Justice Harrington, with the assistance of the expert evidence, concluded hat the inventor intended only one means of release of the medicine, namely through "an osmotic pressure system". The process described in Novopharm's drug submission was a "hydrogel process" which, according to Justice Harrington, and al of the experts, was a completely different system than the one described in the patent and therefore, Biovail's second patent was not infringed. However, the Court also ruled that if the claims were to be interpreted more broadly, i.e. that Novopharm's "hydrogel process" could be included in Biovail's "osmotic process", then Biovail's second patent would be invalid for "covetous claiming". Justice Harrington writes: "If the inventor claims more than he should, he loses everything. His fences must be clearly placed in order to give the necessary warning and he must not fence in any property that is not his own. […] The disclosure teaches us nothing about sustained release through a hydrogel process, the process to be used by Novopharm." In light of its findings, the Court dismissed Biovail's application for a writ of prohibition, with costs. Although this decision relates to the particulars of a NOC proceeding, the Court's thorough application of the Supreme Court teachings is of much interest to patent agents and attorneys alike. Patent construction is of the utmost importance and the Courts wil not hesitate to consider a patent unenforceable if its claims are too broad in scope. As stated by the Supreme Court of Canada: "The claims are to be read in an informed and purposive way to permit a fairness and predictability and to define the limits of the monopoly. Ingenuity of the patent lies not in the identification of the desired result but in teaching one particular means to achieve it. The claims cannot be stretched to al ow the patentee to monopolize anything that achieves the desired result" (Free World Trust v. Électro-Santé Inc., [2000] 2 S.C.R. 1024, paragraphs 31-32). ROBIC, un groupe d'avocats et d'agents de brevets et de marques de commerce voué depuis 1892 à la protection et à la valorisation de la propriété intel ectuel e dans tous les domaines: brevets, dessins industriels et modèles utilitaires; marques de commerce, marques de certification et appel ations d'origine; droits d'auteur, propriété littéraire et artistique, droits voisins et de l'artiste interprète; informatique, logiciels et circuits intégrés; biotechnologies, pharmaceutiques et obtentions végétales; secrets de commerce, know-how et concurrence; licences, franchises et transferts de technologies; commerce électronique, distribution et droit des affaires; marquage, publicité et étiquetage; poursuite, litige et arbitrage; vérification diligente et audit; et ce, tant au Canada qu'ail eurs dans le monde. La maîtrise des intangibles. ROBIC, a group of lawyers and of patent and trademark agents dedicated since 1892 to the protection and the valorization of al fields of intel ectual property: patents, industrial designs and utility patents; trademarks, certification marks and indications of origin; copyright and entertainment law, artists and performers, neighbouring rights; computer, software and integrated circuits; biotechnologies, pharmaceuticals and plant breeders; trade secrets, know-how, competition and anti-trust; licensing, franchising and technology transfers; e-commerce, distribution and business law; marketing, publicity and label ing; prosecution litigation and arbitration; due diligence; in Canada and throughout the world. Ideas live here. COPYRIGHTER IDEAS LIVE HERE IL A TOUT DE MÊME FALLU L'INVENTER! LA MAÎTRISE DES INTANGIBLES LEGER ROBIC RICHARD NOS FENÊTRES GRANDES OUVERTES SUR LE MONDE DES AFFAIRES PATENTER R ROBIC ROBIC + DROIT +AFFAIRES +SCIENCES +ARTS ROBIC ++++ ROBIC +LAW +BUSINESS +SCIENCE +ART THE TRADEMARKER GROUP TRADEMARKER VOS IDÉES À LA PORTÉE DU MONDE , DES AFFAIRES À LA GRANDEUR DE LA PLANÈTE YOUR BUSINESS IS THE WORLD OF IDEAS; OUR BUSINESS BRINGS YOUR IDEAS TO THE WORLD

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Sonderdruck Nr. 1501 aus gwa 3/2007 des Schweizerischen Vereins des Gas- und Wasserfaches (SVGW), Zürich Irene Hanke, Eawag Umweltchemie Heinz Singer, Eawag Umweltchemie Christa McArdell-Buergisser, Eawag Umweltchemie Matthias Brennwald, Eawag Wasserressourcen und Trinkwasser Daniel Traber, Bundesamt für Umwelt (BAFU), Gruppe NAQUA Reto Muralt, Bundesamt für Umwelt (BAFU), Gruppe NAQUA Thilo Herold, Bundesamt für Umwelt (BAFU), Gruppe NAQUA Rahel Oechslin, Amt für Lebensmittelkontrolle und Umweltschutz des Kantons Schaffhausen Rolf Kipfer, ETH Zürich, Institut für Isotopengeologie und mineralische Rohstoffe