Obviousness or Inventive Step as Applied to Nucleic Acid Molecules: A Global Perspective

June 16, 2012

Obviousness, or inventive step, has been called the ultimate bar to patentability. The purpose of the nonobviousness requirement is to complement the novelty requirement and to extend the scope of the relevant prior art beyond anticipatory prior art. This ensures that an invention constitutes a sufficient advance in technology to warrant an exclusive right. Adoption of an obviousness standard is a balancing act that requires weighing the inventor’s right to exclude and the public’s need to gain useful technological knowledge in exchange for that patent right. As a consequence of its interpretive flexibility, the application of obviousness has varied greatly among nations. This is particularly true for its application to nucleic acid molecules.
The Agreement on Trade-Related Intellectual Property Rights (“TRIPS”) has attempted to bring some international uniformity to the application of obviousness or inventive step rules. TRIPS, however, only sets the minimum patentability standards with which signatories must comply.13 National patentability rules may vary beyond the minimum, and member states are free to set their own intellectual property laws. To the extent that different countries have differing patentability standards, those differences in national laws may be significant. As a result, TRIPS allows for differing standards of inventive step or obviousness under different national laws. In recent years, there has been an explosion of patent applications in biotechnology, particularly applications directed to nucleic acid molecules. TRIPS countries, however, have adopted a variety of standards for determining obviousness or inventive step for nucleic acid molecules. Part II discusses legal standards as applied in the United States, Australia, Europe, and Japan, with particular emphasis on the distinctions between U.S. laws and those of other countries. Part III discusses the implications of having different legal standards in different countries.