- Traditional Medicine > Traditional, Complementary and Herbal Medicine
- Public Health, Innovation, Intellectual Property and Trade > Intellectual Property (IP) and Trade
(2002; 131 pages)
G. Misappropriation Regime
Despite wide agreement among developing countries about the importance of obtaining recognition for traditional knowldege, the main concern of some countries has been to avoid the “bio-piracy” of traditional knowledge, rather than the creation of positive rights for their potential benefits. A misappropriation regime aimed at avoiding the monopolization of TRM and related biological materials may be based on a number of measures (legal and otherwise), not requiring the granting of exclusive rights. The adoption of some elements of an international misappropriation system seems more feasible to achieve in the short term than an internationally accepted sui generis regime providing for positive protection.
Possible measures include changes in some key elements of the patent laws (of developed and developing countries), such as applying a consistent novelty requirement that ensures non-written disclosure outside the country of registration is deemed destructive of novelty.
Patent laws may also be amended in order to introduce an obligation to disclose the origin of resources covered by IPRs claims, as well as compliance with access legislation, where appropriate.
The disclosure of the country of origin of a biological product may facilitate claims of benefit sharing by these countries, as well as challenges to the validity of wrongly granted IPRs. This goal may be better achieved if the country where the application was made, notified the country of origin of the material as to the existence of such an application.
Some national laws have already taken some steps in relation to this matter (see Box 2). The European Directive on Biotechnological Inventions165 also refers to the disclosure of information as to the origin of biological materials, but within preambular provision rather than as a substantive obligation.
165 No 96/9/EC of 11 March 1996.
The proposal for the implementation of the European Directive in Belgium stipulates in Article 4(3) that the exploitation of an invention is contrary to ordre public and morality, when an invention was developed on the basis of human tissue removal without the consent of the donor, or when an invention is developed on the basis of plant or animal material which was imported in violation of the law of the country of origin of these materials. In these cases, a patent could be revoked on the basis of Art. 49(1)(1) of the Belgian Patent Act 1984 (Van Overwalle, 2000, p. 282).
The disclosure obligation, as illustrated by the above mentioned legislation, may refer to the country where the applicant has obtained the material, and also require information about compliance with national access laws, if in existence and applicable166, in that country.
166 It is to be noted that only a few countries have so far adopted access legislation (Petit et al, 2000) and, therefore, there are no mechanisms in place in most countries to determine conditions for access. This is quite paradoxical in view of the importance attributed by developing countries to the principles of the CBD, and of their demand in WTO to reconcile the TRIPS Agreement with said Convention. See para. 19 of the WTO Doha Ministerial Declaration (WT/MIN(01)/DEC/1).
Disclosure Obligations Under National Laws
Pursuant to Biodiversity Law 7788, Article 80, both the National Seed Office and the Registers of Intellectual and Industrial Property are obliged to consult with the Technical Office of the Commission before granting intellectual or industrial property protection to innovations involving components of biodiversity. They must always provide the certificate of origin issued by the Technical Office of the Commission and the prior informed consent. Justified opposition from the Technical Office would prevent granting of a patent. Failure to provide the necessary information could lead to the rejection of the application or revocation of the patent.
The Patents Second Amendment Act (adopted in 2002) provides that the applicant must disclose in their patent application the source of origin of the biological material used in the invention (section 10). It also allows for opposition to be filed on the ground that the complete specification does not disclose or wrongly mentions the source or geographical origin of biological material used in the invention. The grounds for rejection of the patent application, as well as revocation of the patent, include non-disclosure or wrongful disclosure of the source of origin of biological resource or knowledge in the patent application, and prior disclosure of knowledge, oral otherwise.
In addition, according to section 6 of the Indian Biodiversity Bill, anybody seeking any kind of intellectual property rights on a biological resource or knowledge obtained from India, needs to obtain prior approval of the NBA. The NBA will determine benefit-sharing conditions. Section 18 (iv) stipulates that one of the functions of NBA is to take measures to oppose the grant of IPRs in any country outside India on any biological resource obtained from India or knowledge associated with such biological resource.
The Andean Group Decision 391 establishes that any IPRs or other claims to biological resources shall not be considered valid, if they were obtained or used in violation of the conditions for access to biological resources residing in any of the Andean countries, as regulated under that Decision.
Andean Decision 486 provides in Article 26 (h) that applications for patents shall be filed with the competent national office and shall contain a copy of the contract for access, if the products or processes for which a patent application is being filed, were obtained or developed from genetic resources or by products originating in one of the Member Countries. If appropriate, the applicant shall also submit a copy of the document that certifies the authorization to use the traditional knowledge by indigenous, African American, or local communities in the Member country where the products or processes whose protection is being requested were obtained or developed.
The possible establishment of a disclosure obligation has been controversial. Certain governments and experts suggest it would impose an additional requirement, inconsistent with article 27.1 of the TRIPS Agreement which lays down the three requirements for patentability (novelty, inventive step, industrial applicability), and with article 29 that provides for the conditions to obtain a patent grant. It has also been argued that applicants may lack the information necessary to comply with such an obligation, and that it would increase the costs of patent applications.
The disclosure obligation would not create an additional patentability requirement. As a matter of principle, a patent should not be granted to a person who has not made an “inventive contribution”. Inventorship is a basic element in patent law and there are no limitations under the TRIPS Agreement with regard to the means to determine it.167 Applicants may be required to summarily show, in the case of inventions relating to the use of plants, etc., whether they have effectively arrived at the invention. Such an obligation would permit patent offices to obtain better information on the “prior art”, which may be deemed as inclusive of precedents that have not been divulged before the filing date, but that demonstrate that somebody has previously arrived at the same invention.168
167 See the Report of the WTO case United States-Section 211 Omnibus Appropriations Act of 1998 (WT/DS176/AB/R) where the Appellate Body (supporting the panel’s view) held that neither the TRIPS Agreement nor the Paris Convention addresses the question how the ownership of a trademark is determined, and that is an issue to be determined by national law (para. 188-189). The same doctrine is arguably valid for patents and other IPRs.
168 This concept was applied in some US decisions, based on Corona Cord Tire Co. vs. Dovan Chem. Corp. (US Supreme Court, 1928), where a prior invention of another party, not publicly known, was deemed as destructive of the novelty of a second invention (Merges, 1992, p.504).
The applicant may be obliged to submit, on a bona fide basis, whatever information he or she has obtained without necessarily obliging him or her to make a costly and time consuming search of information not available or difficult to obtain. He or she should certainly be in a position to inform whether he/she has complied with existing access legislation.
The consequences of the failure to disclose the origin of material (and compliance with access legislation) may include invalidation of the grant, if the applicant is unable to prove inventorship. A lack of candor in providing information may also be deemed to have occurred and may be sanctioned with the non-enforceability of the granted rights,169 as practised under US law.170
169 See, e.g., Pires de Carvalho, 2000, p. 394.
170 The US Supreme Court has declared that “A court of equity acts only when and as conscience commands; and if the conduct of the plaintiff be offensive to the dictates of natural justice, then, whatever may be the rights he possesses, and whatever use he may make of them in a court of law, he will be held remediless in a court of equity” (290 US 240 quoting Deweese v. Reinhard 165 US 386).