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.

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