- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Public Health, Innovation, Intellectual Property and Trade > Intellectual Property (IP) and Trade
(2002; 131 pages)
The universal novelty requirement, as applied in most countries, prevents the patenting of information in the “prior art”, that is, information that has been published in a written form or has otherwise been made available to the public, for instance, through public use, in any country before the date of filing of a patent.
The novelty requirement will generally impede the patenting of TRM knowledge that has been published or openly used before the filing date of the patent application.94 Hence, a large portion of TRM held by local/indigenous communities, and codified TRM, is likely to be deemed not to be novel and therefore not patentable.
94 In the Delgamuukw case (December 1997) the Supreme Court of Canada rejected the court’s usual approach of attributing little if any weight to the oral evidence of elders. That is, oral testimony was given status as legal evidence. Presumably, in Canada at least, this precedent provides an argument for non-written knowledge (oral history) to invalidate novelty on a patent claim (personal communication from K. Bannister, 22.8.01). See also Gupta, 2002b.
In order to destroy novelty, however, the prior use must generally be such that access to the information would have allowed a third party to execute the invention, without significant further research. Thus, there may be situations in which novelty may not be lost, despite the relevant TRM knowledge having been previously used, even for long periods. An example would be the case of TRM knowledge used in a small community, when the information has not diffused beyond the community’s members. Cases in which the traditional healers have kept confidential95 certain aspects of their treatment and associated medicines may be another example. In short, it would be incorrect to assume that all TMR, because it may be old and previously used, has necessarily lost its novelty for the purposes of patent law.
95 In the Mobil case, for instance, the Enlarged Board of Appeal of the European Patent Office decided that the word “available” carries with it the idea that, for lack of novelty to be found, all the technical features of the claimed invention in combination must have been communicated to the public, or laid open for inspection. Under the European Patent Convention, a hidden or secret use, because it has not been made available to the public, is not a ground for objection to validity of a European patent (Mobil/Friction-Reducing Additive, 1990) (see Koon, 1999, p. 166).
An important issue is whether novelty should be deemed to exist in cases where the chemical structure of the active substance responsible for the therapeutic effect of an openly used product was not known. For instance, a UK court held in the case Merrill Dow Pharmaceuticals v. Norton & Co. (1996) that it was not necessary for an active substance to be identifiable or reproducible for it to have been made available to the public.96 Applied in the context of TRM, this doctrine would mean that the fact that local/indigenous communities were unable to scientifically describe the structure of a useful compound, would not prevent it from entering the public domain. Further, disclosure in a non-written form may not be an obstacle to obtain patents on TRM in countries where a relative novelty standard is applied. In the United States, for instance, according to article 102 of the Patent Law (35 United States Code),
“A person shall be entitled to a patent unless the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States...”
96 Lord Hoffmann explained this situation by reference to the case of Amazonian Indians, who believed that the effect of the cinchona bark on malaria was due to “the spirit of the bark”. The Indians, however, should be said to have known about quinine even though they did not know its chemical structure (Koon, 1999, p. 166).
This means that TRM knowledge that has been published in a written form in the United States or in any other country is not patentable. However, if such knowledge was publicly used but not documented in a foreign country, novelty is not lost and patenting remains a possibility.
As a result of the relative novelty requirement of the U.S., as mentioned above, several patents relating to or consisting of genetic materials or traditional knowledge acquired in developing countries, have been granted to researchers or firms by the US Patent and Trademark Office (Correa, 1999; The Crucible Group, 2000).