- Keywords > compulsory licences
- Keywords > intellectual property laws
- Keywords > intellectual property protection (IPP)
- Keywords > parallel importation
- Keywords > patentability criteria - policy options
- Keywords > patents
- Keywords > pharmaceutical legislation
- Keywords > public health
- Keywords > Trade Related Aspects of the Intellectual Property Rights (TRIPS)
- Keywords > TRIPS flexibilities
(2000; 140 pages) [French] [Spanish]
Patents grant temporary monopolies to inventors in exchange for public disclosure of the invention. The full disclosure of the invention is a basic principle of patent law. Access to the information on the invention is one of the traditional justifications for the granting of temporary exclusivity to the inventor. Though relevant to health-related inventions, the problem of assuring adequate disclosure is of a general nature.
In order to perform its informative function, invention disclosures should at minimum be such that the invention can be understood and executed by an expert with average skills in the discipline concerned. This test should be applied at the national level, i.e. the description should be sufficient to teach the invention to a local expert114.
114 See, e.g., UNCTAD, 1996, p. 33.
The law should require that the disclosure be sufficient so that a person of ordinary skill could reproduce the invention. A strict rule would require patent applicants to provide sufficient information to enable the reproduction of each embodiment of the invention for which they seek patent protection. If several embodiments are claimed, an “enablement” requirement would mandate disclosure of each embodiment115. This approach would prevent excessively broad claims covering embodiments of the invention that have not been described by the applicant in a form that allows their reproduction by a third party.
115 However, some patent offices, such as the European Patent Office, accept that, in order to be valid, the disclosure need not include specific instructions as to how all possible variants within the claim definition can be obtained. See, e.g., Cook, Doyle and Jabbari, 1991, p. 80.
Another possible approach, applied by some patent offices, is to permit more generalized claims for those inventions constituting a substantial technical contribution. Thus, “pioneer” inventions - those that open a whole new technical field - may be entitled more generality in their claims than mere “follow-up” inventions - those that only constitute improvements or “minor” innovations.
Article 29 of the TRIPs Agreement covers disclosure obligations. According to this article, Members may require the applicant to indicate the best mode for carrying out the invention known to the inventor at the filing or at the priority date of the application. This standard only requires the applicant to submit the best mode known at the date of the application or priority. This information rarely includes the actual know-how for the execution of the invention, since production has seldom started at that date.
One important issue - not addressed by the TRIPs Agreement - relates to the disclosure of inventions relating to microorganisms, since access to the relevant knowledge is only possible through access to the biological material itself. Such access may be made available to third parties with the publication of the patent application (as provided under European law)116. However, in order to protect the legitimate interests of the applicant, this access is for experimental purposes only117.
116 In the case of the United States, access to a deposited sample is possible after granting of the patent.
117 The Budapest Treaty (1977) has created a system for the international recognition of the deposit of microorganisms, that facilitates the tasks of patent offices and provides adequate guarantees to the applicants/patent holders.
It is important to ensure that the scope of protection for biological material patents corresponds to the material actually deposited. If there is no correspondence between the description and the deposited material, the patent (or claim) may be deemed void.
Finally, national laws may require that biological material patent applicants inform the country of origin of the biological material, and to demonstrate that he/she has complied with the relevant rules with regard to access to the material. This requirement118 will help to ensure that the provisions of the Convention on Biological Diversity and of related national implementing legislation are complied with.
118 An obligation of this type was incorporated in the draft of the European Union Directive relating to patents on biotechnology, as recommended by the European Parliament in July 1997. Though it was removed from the finally approved text, Recital 27 of the Directive mentions an obligation to provide information as to geographical origin of biological material where this is known, without prejudice to patent validity.