About | HeinOnline Law Journal Library | HeinOnline Law Journal Library | HeinOnline
LOG IN
LOG IN

4 U. Ottawa L. & Tech. J. 1 (2007)

handle is hein.journals/uoltj4 and id is 1 raw text is: Living Separate and Apart is Never Easy: Inventive Capacity of the PHOSITA as the Tie That Binds Obviousness and Inventiveness in Pharmaceutical Litigation Ron A. Bouchard* THE PURPOSE OF THIS ARTICLE IS TO GAIN INSIGHT INTO THE RELATIONSHIP between obviousness and inventiveness in pharmaceutical litigation. Canadian jurisprudence and legal commentary stipulate that persons having ordinary skills in the art (PHOSITA) of pharmaceutical drug development possess not even a mere scintilla of inventiveness even though the global pharmaceutical industry is one of the most sophisticated, research-intensive and profitable in the world. Because a person lacking in right brain functions would not contemplate, let alone conduct, research during the lead-up to invention, the result is that patentees need only demonstrate a de minimus level of testing in order to automatically vitiate a finding of obviousness. Therefore, the current test for obviousness constitutes a binary assessment, with little regard for the realities of contemporary drug development. As such, the identity and inventive capacity of the PHOSITA is critical to the outcome of pharmaceutical litigation. A social sciences construction of the normative identity and inventive capacity of the PHOSITA was undertaken using the tacit and focal knowledge framework of Polanyi and actor- network theory of Latour. Both analyses underscored the inherent creativity and inventiveness of the normative PHOSITA and the ability of the PHOSITA to work under conditions of uncertainty and ambiguity. The normative PHOSITA exists in a milieu that is at once indeterminate and determinate, indicating that the push-pull of obviousness and inventiveness cannot be legitimately explained using binary terminology alone. Consequently, the normative PHOSITA supports a flexible rather than stringent standard for obviousness. The legal nexus between the normative PHOSITA and obviousness is provided by a purposive construction, which focuses on the essence of an invention rather than on binary distinctions and provides a contextual yet objective and evidence-driven framework for obviousness. Finally, the suggested purposive approach is conducive to a patent policy which facilitates rather than impedes strong innovation in the pharmaceutical sector. AVEC CET ARTICLE, ON CHERCHE A COMPRENDRE LES LIENS QUI PEUVENT EXSTER entre I'Nvidence et l'inventivit6 dans le contexte des litiges en mati~re pharmaceutique. La jurisprudence canadienne et la doctrine juridique s'accordent pour dire que les personnes versdes dans 'art (ou ( PHOSITA o pour ( persons having ordinary skills in the art )) de I'6laboration des drogues pharmaceutiques ne possbdent m~me pas une ( simple parcelle d'inventivitd o bien que I'industrie pharmaceutique soit I'une des plus 6labordes, des plus axdes sur la recherche et des plus rentables du monde. Etant donn6 qu'une personne d~pourvue des fonctions propres 6 la partie droite du cerveau ne pourrait envisager, et encore moins diriger, des projets de recherche, 6 partir de I'6tape de la mise en route jusqu'6 celle de I'invention, il suffit par consequent aux titulaires de brevet de satisfaire le test minimum pour automatiquement vicier une conclusion d'6vidence. Par consdquent, le crit~re actuel pour conclure h I'dvidence consiste en une dvaluation binaire, qui accorde peu d'importance aux rdalitds du ddveloppement moderne de la pharmacopde. Dans cette optique, l'identitd et la capacitd inventive des PHOSITA sont cruciales pour I'issue des litiges en mati~re pharmaceutique. Une construction de l'identit6 normative et de la capacit6 inventive des PHOSITA, sous I'angle des sciences sociales, a W 6labor~e I'aide du cadre des connaissances tacites et focales de Polanyi et de la th~orie du r~seau d'acteurs (actor-network theory ou ANT) de Latour. Les deux analyses ont montr6 la crdativit6 et l'inventivitd inhdrentes des PHOSITA normatifs et la capacit6 de ces derniers de travailler dans des conditions d'incertitude et d'ambigOitd. Les PHOSITA normatifs vivent dans un milieu qui est h la fois inddtermind et ddtermin6, ce qui incite A conclure que le rapport entre I'6vidence et l'inventivit6 ne peut I6gitimement s'expliquer 6 I'aide de la seule terminologie binaire. Par consequent, les PHOSITA normatifs suivent un critbre souple, et non pas rigoureux, en ce qui a trait Sl'vidence. Le lien juridique entre les PHOSITA normatifs et I'6vidence d~coule d'une e interpretation utilitaire ) qui met I'accent sur I'essence d'une invention plut6t que sur des distinctions binaires et qui fournit un cadre A la fois contextuel et objectif, fond6 sur la recherche, pour prouver I'4vidence. Enfin, l'interpr6tation utilitaire proposde aboutirait A une politique en matibre de brevets qui favoriserait, plut6t qu'elle n'empdcherait, un solide lan d'innovation dans le secteur pharmaceutique. Copyright © 2007 by Ron A. Bouchard. Associate Professor, Faculties of Law and Medicine & Dentistry, University of Alberta, Canada, PhD, LLB, LLM. In addition to the comments of an anonymous reviewer, I am grateful to Trudo Lemmens and Alex Stack (Toronto), Mark Lemley (Stanford), Leigh Martinson of McDermott, Will, & Emery LLP (Boston), and Harry Radomski of Goodmans LLP and Kevin Zive of Hazzard & Hore (Toronto) for valuable comments at varying stages. This work was supported by grants from the CIHR Health Law & Policy Program, Genome Canada, through its Ontario Genomics Institute, and the Lupina Foundation Comparative Program in Health and Society Fellowship at the Munk Centre for International Studies, University of Toronto.

What Is HeinOnline?

HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.



Short-term subscription options include 24 hours, 48 hours, or 1 week to HeinOnline.

Purchase Access

Contact us for annual subscription options:

Contact Us

Already a HeinOnline Subscriber?

Log In

profiles profiles most