- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Public Health, Innovation, Intellectual Property and Trade > Intellectual Property (IP) and Trade
(2002; 131 pages)
A.2. Inventive step
When certain TRM knowledge has remained undisclosed - and, thus, the novelty of the information preserved - an additional standard of patentability must be met in order to acquire patent rights: “inventive-step” or “non-obviousnness”. This standard requires that the claimed invention be non-obvious for a person with ordinary skills in a given technical field. Even if novel, knowledge will not be patentable if it is proven obvious or lacking an inventive step.
“A person with ordinary skills” is a legal fiction. Patent offices and courts may apply different standards, according to the technical field concerned.97 Thus, something that may be obvious to a healer or professional trained in TRM may not be so for somebody trained in the Western medical tradition (the reverse may also be true, of course), thereby allowing for the granting of a patent (assuming other standards are met). It is likely that patents and courts tend to assess obviousness under the crystal of Western knowledge, as long as they do not recognize TRM as a valid system of knowledge. Hence, uses of plants and other knowledge that may be obvious within a TRM system may be deemed “inventive” and patentable.98
97 See, e.g. Reid, 1999, p. 42-50.
98 This increases the possibility of TK holders obtaining patents but, given their limited resources and lack of familiarity with the patent system, it is likely that others (researchers and companies) will benefit the most from this limitation in the examination process.
Non-obviousness is judged in the United States on the basis of the determination of a) the scope and content of the “prior art”; b) the differences between the claimed invention versus the prior art; and c) the level of ordinary skill in the relevant field of technology (Wegner, 1994, p. 224). Under the US standards, inventions may result from painstaking research, slow trial and error, or serendipity.99 In Europe and other countries, emphasis is given to the extent that the invention solves a technical problem. This “problem-and-solution” approach makes the inquiry on inventive step more objective than in the United States (Merges, 1992, p. 505). In some cases, commercial success where others have failed is regarded as an indicator of inventive step.100 Thousands of patents are granted each year in the major countries for minor, sometimes trivial developments (Barton, 2000, p. 1933). In 1999, for instance, the United States Patent Office granted over 160 000 patents, twice the number granted ten years before. This is probably the combined result of the quite broad non-obviousness and utility standard applied, as well as of shortcomings in the examination procedures.101
99See, e.g., Dratler., 1999, §2.03.
100 See, e.g. Reid, 1999, p. 53.
101 For example, less than 50% of the examinations conducted by the Office refer to the relevant background bibliography; the examination is by and large limited to analyzing previous patents. See, e.g. Aharonian, 2000.
In this context, the patentability of TRM knowledge, or minor variants around it, may be more likely than expected by many, as illustrated by the already referred to cases of several questionable patents based on traditional knowledge. Whether this is the right policy or not in the case of TRM depends on the philosophy underpinning the patent system in each country, and on the objectives pursued.
Quite clearly, the loose application of the inventive step/non-obviousness standard allows for the patenting of minor advancements, if any, in relation to previously available information.102 This is clearly undesirable from the point of view of public policy and the preservation of the freedom to use knowledge within the public domain. There is little society may gain by extending legal monopolies to holders of TRM, or to those that obtained knowledge from them, where no genuine invention can be claimed.
102 See, e.g. Correa, 2001.