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O’Connor, Sean --- "Enabling Research or Unfair Competition? De Jure and De Facto Research Use Exceptions in Major Technology Countries" [2009] ELECD 254; in Takenka, Toshiko (ed), "Patent Law and Theory" (Edward Elgar Publishing, 2009)

Book Title: Patent Law and Theory

Editor(s): Takenka, Toshiko

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781845424138

Section: Chapter 19

Section Title: Enabling Research or Unfair Competition? De Jure and De Facto Research Use Exceptions in Major Technology Countries

Author(s): O’Connor, Sean

Number of pages: 38

Extract:

19 Enabling research or unfair competition?
De jure and de facto research use exceptions
in major technology countries
Sean O'Connor*



Introduction
To start with the basics, the unauthorized making, using, or selling of patented
inventions is normally an infringement of exclusive patent rights. Further, in
many countries, the unauthorized import of products embodying the patented
invention, or resulting from the patented process, is also an infringement of
exclusive patent rights. Thus, absent an exception, all research which either
experiments on or with patented inventions ­ including both non-commercial
research by universities or non-profits and product-oriented research and
development (R&D) by commercial firms ­ constitutes patent infringement.
However, rigid enforcement of patent rights without any exception for
research activities may hinder basic science research as well as socially useful
follow-on innovation in any given industry. In some cases, the absence of a
research exception may give the pioneer patent holder a de facto patent term
extension as his competitors will not be able to engage in the pre-market R&D
often required to create a saleable product that can be brought to market as
soon as the pioneer patent expires. This is most apparent in the case of phar-
maceutical regulatory regimes where generic or follow-on drug manufacturers
cannot even begin research to satisfy a regulatory agency's approval process
until the pioneer patent expires: the pioneer manufacturer then gets a de facto
patent term extension for the time it takes the generic manufacturer to ...