A shift in the Canadian law of obviousness: a comment on Sanofi-Synthelabo Canada Inc. v. Apotex Inc.

• Author: Moeser, Andrew

Abstract

The Supreme Court of Canada's 2008 decision in Sanofi-Synthelabo Canada Inc. v. Apotex Inc. is significant for patent law generally because it modified the legal tests for two of the three fundamental requirements for patentability: novelty and non-obviousness. This comment focuses on the changes the Court made to the law of obviousness.

This comment argues that Sanofi represents a subtle, but important shift in the law of obviousness, and will trace four of Sanofi's contributions to the jurisprudence. First, the Court emphasizes that the test must be functional and flexible. Second, the Court adopts a formal framework--the "Windsurfing questions"--drawn from the UK law of obviousness. Although the Windsurfing questions largely deal with the same issues that were present in the Beloit test, the new framework permits the obviousness inquiry to be divided into discrete issues as opposed to the Beloit test, which condensed these issues into a single question. Third, the Court adopts an "obvious to try" approach that brings Canadian law closer to the UK and US law of obviousness. Fourth, the Sanofi decision appears to change our conception of the person having ordinary skills in the art (PHOSITA). A natural extension of a functional approach to obviousness is the construction of a PHOSITA with an ordinary level of creativity, as opposed to one with no creativity.

This comment argues that this shift is a positive development because it is commensurate with a purposive approach to patent law. The purpose of the obviousness test is to filter out those inventions that do not appreciably add to the store of public knowledge from those that are truly inventive. The emphasis on a functional and flexible approach should assist courts in undertaking a purposive analysis of obviousness, as opposed to placing undue emphasis on a particular phrase or legal formulation. Moreover, the flexibility in the new test should permit the law of obviousness to be better calibrated according to industry-specific differences in innovation.

The comment concludes with a discussion of the interaction between selection patents and obviousness. Aside from reiterating that selection patents are valid in principle, the Sanofi decision does little to clarify this interaction. Nevertheless, this comment argues that the decision of the Federal Court in BMS v. Apotex, released three months after Sanofi, is a coherent interpretation of the Supreme Court's pronouncements on selection patents. Specifically, this approach involves treating selection patents similarly to other patents and using the framework of the Sanofi test to address the issues that selection patents raise.

Resume

La decision de la Cour Supreme du Canada, en 2008, dans l'arret Sanofi-Synthelabo Canada Inc. c. Apotex Inc. est importante pour le droit des brevets parce qu'elle a modifie le test pour deux des trois exigences fondamentales de la brevetabilite : la nouveaute et la non-evidence. Ce commentaire portera sur les changements faits a la loi de la non-evidence.

Ce commentaire soutiendra que Sanofi represente un changement de la loi de la non-evidence, a la fois subtil et important, et il tracera quatre contributions de Sanofi a la jurisprudence. Premierement, la Cour a souligne que le test devrait etre fonctionnel et flexible. Deuxiemement, la Cour adopte un cadre formel--les Questions > --developpees dans la loi de la non-evidence du Royaume-Uni. Malgre que les questions > impliquent largement les memes questions qui etaient presentes dans le test Beloit, le nouveau cadre permet que l'enquete quant a la non-evidence soit divise en causes distinctes, ce qui est different du test dans Beloit qui a condense tout les causes en une seule question. Troisiemement, le Cour adopte une notion > qui rapproche la loi canadienne, quant a la non-evidence, a celle du Royaume Uni et des Etats-Unis. Quatriemement, la decision dans Sanofi semble changer notre conception de la personne possedant des habiletes ordinaires dans l'art (PPHOA). Une extension naturelle d'une approche fonctionnelle quant a la non-evidence est la construction d'un PPHOA avec un niveau ordinaire de creativite au lieu d'un PPHOA sans creativite.

Ce commentaire soutiendra que ce changement constitue une evolution positive parce qu'il est proportionnel a une interpretation utile du droit des brevets. Le but du test de la non-evidence est de filtrer les inventions qui n'ajoutent pas appreciablement a la connaissance du public de celles qui sont reellement inventives. L 'accent sur un test qui est fonctionnel et flexible aidera les cours a entreprendre une analyse utile de la non-evidence, au lieu de trop mettre l' accent sur une phrase ou une formulation particuliere. De plus, la flexibilite du nouveau test devrait permettre a la loi de la non-evidence de mieux se calibrer aux differences en innovation parmi les differentes industries.

Ce commentaire conclura avec une discussion de l'interaction entre les brevets de selection et la non-evidence. Mis a part la repetition que les brevets de selection sont en principe valables, la decision dans Sanofi ne clarifie guere cette interaction. Neanmoins, ce commentaire soutiendra que la decision de la Cour Federale dans BMS v. Apotex, annoncee trois mois apres celle dans Sanofi, est une interpretation coherente des declarations de la Cour Supreme sur les brevets de selection. En particulier, cette methode consiste a traiter les brevets de selection de la meme facon que les autres brevets, et a utiliser le cadre du test dans Sanofi pour aborder les questions concernant les brevets de selection.

I INTRODUCTION II BACKGROUND: PATENT LAW AND THE OBVIOUSNESS STANDARD The Purpose of the Patent Act and the Patent Bargain Requirements for a Valid Patent Law of Obviousness--Relationship to the Patent Bargain Canadian Obviousness Standard Prior to Sanofi III SANOFI v. APOTEX Facts and Lower Court Decisions The Supreme Court of Canada's Decision IV SHIFT IN THE LAW OF OBVIOUSNESS Emphasis on Functional Approach Formal Structure of Restated Windsurfing Questions Obvious to Try Approach Obvious to Try Factors Pfizer v. Apotex: Sanofi Interpreted (Part 1) Does Sanofi Change Our Conception of the PHOSITA? V SANOFI TEST, POLICY LEVERS, AND THE PATENT BARGAIN VI SELECTION PATENTS AND OBVIOUSNESS Unresolved Issues BMS v. Apotex: Sanofi Interpreted (Part 2) VII CONCLUSION I INTRODUCTION

On November 6th, 2008, the Supreme Court of Canada released its decision in Sanofi-Synthelabo Canada Inc. v. Apotex Inc. (1) The case involved a dispute between a brand drug manufacturer, Sanofi-Synthelabo Canada Inc. ("Sanofi"), and a generic drug manufacturer, Apotex Inc. ("Apotex"). At issue was the validity of Sanofi's patent covering the compound clopidogrel bisulfate ("clopidogrel"), which is marketed as a blood clot inhibitor in Canada by Sanofi under the trade name Plavix. Although the Court rejected all of Apotex's grounds of appeal, finding the patent to be valid, the Sanofi decision is significant for patent law generally because it modified the legal tests for two of the three fundamental requirements for patentability: novelty and non-obviousness. (The third, utility, was not at issue in the case.) This comment will focus on the changes the Court made to the law of obviousness. (2)

The patent system is commonly understood as a notional bargain; in return for disclosure of the invention to the public, the inventor is granted a time-limited monopoly to exploit the invention--a patent. The law of obviousness precludes the grant of patents for inventions that are obvious extensions of existing public knowledge. Prior to the decision in Sanofi, the leading test for obviousness from Beloit Canada Ltd. v. Valmet Oy held that an invention was obvious if a person having ordinary skills in the art ("PHOSITA") (3) "would ... have come directly and without difficulty to the solution taught by the patent". (4) In Sanofi, the Court explicitly reformulated the law of obviousness by adopting a more flexible standard that incorporates an "obvious to try" approach, which means that an invention may be obvious if it was obvious to the PHOSITA to try the solution taught by the patent.

Despite the Court's attempt to put forth a definitive statement on the law of obviousness, Sanofi has given rise to surprisingly divergent interpretations. At one extreme, Sanofi has been interpreted as radically lowering the bar for invalidating patents on the grounds of obviousness, such that any invention is obvious if it was "worth a try". (5) At the other extreme, Sanofi has been described as a mere "refinement" of the Beloit test, (6) and some commentators have argued that there was no substantive change in the law. (7) Part of this variation in interpretation may be due to the highly polarized nature of pharmaceutical litigation. The pharmaceutical industry forms an important part of the Canadian economy, and pharmaceutical drugs are one of the fastest growing sectors of health care expenditures. (8) Patent law plays a critical role in drug development and marketing. Generic drug manufacturers uniformly seek to lower the bar for invalidating patents as obvious, and brand manufacturers uniformly seek to strengthen patent protection. Part of the variation in interpretation, however, may be due to genuine confusion relating to the vagueness of the phrase "obvious to try" and to the state of the law prior to Sanofi. Accordingly, the first aim of this comment is to explore the impact of Sanofi on the law of obviousness. The second aim of this comment is to argue that this shift is a positive development because it is commensurate with a purposive approach to patent law.

This comment will argue that Sanofi represents a subtle, but important shift in the law of obviousness. It is neither a radical reorientation, nor a mere restatement of the law. The decision shifts the law of obviousness in at least four ways. First, the...