- 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]
VI.1 Options - Disclosure
A possible provision in national laws may include the elements indicated in model option in the next page.
The three first paragraphs of the proposed language contain the general rules, while the three remaining paragraphs relate to the specific case of biological inventions.
The implications of the concept contained in the third paragraph need to be carefully considered. Its purpose is to ensure that patents are granted in inventions that can be actually executed in practice, and that do not contain purely speculative statements. For instance, when an application includes a group or family of elements, the granting of the patent should not be based on the possibility of executing some of those elements. Under the proposed Option, the claims would be limited to what is really enabled by the invention.
a) The invention shall be disclosed in a manner sufficiently clear and complete for the invention to be carried out by a person possessing ordinary skill in the art to which the invention pertains.
b) The applicant shall disclose the best mode known, at the date of the application or prioritya), for the execution of the invention.
c) The description shall enable the execution of all embodiments of the invention.
d) In the case of inventions related to microorganisms, the applicant shall deposit a culture thereof not later than the date of filing of the application. After the publication of the application, any interested party shall have access to a sample of the deposited culture, subject to the obligation by said party to use said sample for experimental purposes only until such time as the patent application is refused or withdrawn, or up to the date of granting of the patent.b)
e) In the case where the description is supplemented by the deposit of a microorganism, the scope of the claim shall be determined on the basis of the material deposited.
f) The applicant shall disclose the place wherefrom any claimed biological material was obtained and, where appropriate, shall demonstrate compliance with the access and export regulations applicable in the country from which that material was obtained.
The last paragraph makes it clear that the obligation to demonstrate prior informed consent would only apply in cases where there are access (or equivalent) regulations in force in the country from which the material was obtained. The inclusion of this requirement may be important to avoid cases of “bio-piracy” and to provide a basis for the sharing of benefits with the supplier of the material, when appropriate.