세계지식재산기구 정부간위원회의 유전자원 및 연관 전통지식 관련 지식재산권 협상쟁점과 나고야의정서에 대한 시사점

Despite its ongoing negotiation status, the IGC Chair’s A mended Draft(hereinafter, the Chair’s Draft) could make a great contribution to the practical implementation of the intellectual property-related issues under Nagoya Protocol. Especially, The definitions which have not previously been defined at the multilateral level, source of genetic resources, and source of traditional knowledge associated with genetic resources materially/directly based on may make a great contribution to enhance the legal certainty and clarity. The IGC Chair’s Draft defines the source of genetic resources as referring to any source from which the applicant has obtained the genetic resources, such as the country of origin, indigenous peoples and local communities, a research centre, gene bank, the Multilateral System of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), or any other ex situ collection or depository of genetic resources, which is expected to provide the limited scope of their source. This Draft also defines the “Source of Traditional Knowledge Associated with Genetic Resources” as meaning any source from which the applicant has obtained the traditiona l k nowledge associated with genetic resources, such as indigenous peoples or local communities, scientific literature, publicly accessible databases, patent applications and patent publications, which indicates that there could be other source of traditional knowledge of genetic resources in addition to IPLC. The “materially/directly based on” specifies the particular relationship between the claimed invention and the genetic resources and Associated Traditional knowledge which activates the obligation to disclose (referred to in the IGC discussions as the “trigger”), and provides important guidance and direction to the patent applicant as well as patent offices. The definition of “[materially/directly] based on” is found in Article 2 of the Chair’s Draft, which reads “[Materially/Directly] based on” means that the genetic resources and/or Associated traditional knowledge must have been necessary or material to the development of the claimed invention, and that the claimed invention must depend on the specific properties of the genetic resources and/or Associated traditional knowledge, and reveals its quite strict “disclosure requirement. Therefore, this definition clarifies the causal relationship between the claimed invention and genetic resou rces and/or Associated traditiona l k nowledge which must be necessary or material to the claimed invention, not to the development of the claimed invention. What could most attract the attention of patent applicant and patent offices wil l be related to the provisions regarding the limitations and sanctions for the non-compliance with disclosure requirement obligations. The Draft requires each Contracting Party to put in place appropriate, effective and proportionate legal, administrative, and/ or policy measures to address an applicant’s failure to disclose the information specified in disclosure requirement clause. However, it leaves to the national patent offices what constitutes appropriate, ef fec tive a nd propor tionate lega l, a d m i n is t rative, a nd/or pol ic y measures. These measures could include pre-grant sanctions, such as suspending the further processing of a patent application until the disclosure requirement is satisfied, or withdrawing/lapsing the application if the applicant fails or refuses to provide the information specified in the disclosure requirement clause within a time period as determined at the national level. These measures could also contain post-grant sanctions, such as fines for wilfully failing to disclose the specified information or intentionally providing incorrect information as well as the publication of judicial rulings. In addition, the Draft requires each Contracting Party to provide an applicant an opportunity to rectify an unintentional failure to disclose the information specified in Article 3 before implementing pre grant sanctions or directing remedies. Furthermore, the Draft places a ceiling for non-compliance with the disclosure obligations. The inclusion of this provision is intended to ensure that no patents will be revoked or rendered unenforceable based solely on an applicant’s failure to provide the information specified unless this deficiency comes from the willful or fraudulent intent. This provision appears to try to maintain the balance between the positions of the user countries and the providing countries by providing that while it opens the possibility of revoking or rendering the claimed patent, on one hand, it also prohibits them solely on the basis of an applicant’s failure to disclose the information specified in the disclosure requirement clause. Finally, the most crucial and important element in the disclosure requirement regime would be the legal status of the claimed invention. In this regard, the Draft requires each Contracting Party to provide for post grant sanctions or remedies where an applicant, either willfully or with fraudulent intent, failed to disclose the information specified in the disclosure requirement clause, in accordance with its national law. Therefore, the revocation or sanctions will not automatically and immediately apply for non-compliance with the disclosure requirement obligations. Instead, it demands the a micable dispute settlements between the parties concerned. This concerns are explicitly Finally, the Draft require Contracting Parties to put in place adequate dispute mechanisms that allow all parties, including indigenous and local communities, to reach timely and mutually satisfactory solutions, in accordance with national law.