A Handbook of Contemporary Research
Edited by Toshiko Takenka
Chapter 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 pharmaceutical 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 obtain regulatory approval to market its version of the drug. Even outside of this scenario, pioneer patents often give their holders a substantial head start in the...
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