WIPO Seminar: Experts Discuss IP Protection Of Genetic Resources 31/05/2016 by Catherine Saez, Intellectual Property Watch Leave a Comment Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window)Last week, the World Intellectual Property Organization held a seminar on intellectual property and genetic resources. For over a decade, WIPO members have been discussing ways to protect genetic resources and associated traditional knowledge from misappropriation. The seminar allowed speakers from different regions and interests to offer their views on the topic. WIPO Seminar on IP and Genetic Resources The seminar was held from 26-27 May, and the programme [pdf] was divided into four roundtables: relationship with relevant international instruments; policy objectives relating to IP and genetic resources (GRs); disclosure requirements relating to GRs and associated traditional knowledge; and databases and other defensive measures relating to GRs and associated TK. The 30th session of the IGC is taking place from 30 May to 3 June (IPW, WIPO, 30 May 2016). Disclosure requirement is a prickly issue in the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). Speakers from China, Brazil and Romania presented how their national laws tackle the issue of disclosure requirement, while a representative of industry warned against increasing costs, and an academic said the patent system needs reforms. Felix Addor, deputy director general of the Swiss Federal Institute of Intellectual Property Felix Addor, deputy director general of the Swiss Federal Institute of Intellectual Property, moderating the panel on disclosure requirements relating to GRs and associated TK, said a major objective of disclosure requirements should be to enhance transparency in the patent system. Disclosure would ease patent examiners’ search for prior art and would allow verifying if prior informed consent was obtained from the GR providers, he said. However, this is a complex issue and views differ considerably, he said. “Let us briefly assume for arguments sake that we all agree on the necessity of a disclosure requirement,” he speculated, “Even so, we would still have to find agreement on several outstanding issues.” Addor cited for example the object of disclosure, the source or country of origin, what should be covered by this requirement, which mechanism triggering the disclosure requirement, what forms of IP should be covered by the disclosure requirement, what sanctions for violating the disclosure requirement, and is the revocation of granted patents suggested by some appropriate. Although those issues are currently unresolved in the IGC, he said they are bridgeable. “To achieve this, however, all member states will need to collaborate in a constructive manner and refrain from positional bargaining,” he said. Not achieving an international solution might be in the short-term interest “of those parties who perceive themselves to gain benefits from the current legal situation,” he said, “Yet it is risky for all parties in the long term.” Addor’s remarks are available here [pdf]. New Brazilian Legislation: More Carrot, Less Stick Daniel Pinto, counselor and head of the Intellectual Property Division of the Brazilian Foreign Ministry, provided an overview of recent developments in the Brazilian biodiversity legislation. Daniel Pinto, Counselor and head of the Intellectual Property Division of the Brazilian Foreign Ministry Brazil’s provisional Act 2186-16 of 1986 was the country’s first legislative attempt to address biopiracy. “It was a very reactive legislation,” he said. “Very punitive as well.” However, Pinto said, the legislation had unintended consequences. The legislation was so punitive that eventually most traditional knowledge holders were not attained, and the overly complex and lengthy process deterred even “legitimate researchers” from accessing resources, he explained. As a consequence, in 14 years, “we had only 136 contracts approved,” he said. There was no synergy with the Brazilian innovation system, he said. In 2010, it was estimated that due to this legislation, Brazils failed to generate US$5 billion annually for not taking fuller advantage of its biodiversity, he said. In 2015, Brazil developed a new biodiversity law, which won the support of the vast majority of the Brazilian congress even in a climate of political polarisation, he said. The law entered into force in November, and the rules of application released on 11 May, he said. The access to GRs or to associated TK and the shipping of sample of GRs abroad have to be registered online under the new law, in a much swifter manner than under the previous legislation, literally in minutes, Pinto said. Such registration has to occur prior to requesting any IP rights, he added. In terms of IP rights, he said, the new legislation is based on incentives rather than penalties. It encourages compliance, research and development (R&D) and innovation, he said. Pinto’s presentation is here [pdf]. China: Disclosure and Balance of Interests Hong ju Yang, director of the Legal Affairs Department of the China State Intellectual Property Office, underlined the importance of the protection and management of biological GRs for China, which she said has a very diverse biodiversity. Hong JuYang, director of the Legal Affairs Department of the China State Intellectual Property Office A number of laws have been promulgated in this area, involving many government agencies, she said. In 2008, China put forward specific policy objectives in its Outline of the National Intellectual Property Strategy, according to Yang’s presentation. In particular, she said, those policy objectives include strengthening protection, and developing systems for genetic resources to prevent their inappropriate use and loss. “Firstly we encourage the utilisation [of genetic resources], secondly we should prevent the abuse, and thirdly we should balance different interests,” she said. “Those are the settings of our IP protection,” she said. The IP system can be used to encourage innovation, she said, but also to prevent undue granting of IP rights, in particular in bettering the examination capacities, and applying higher criteria for granting rights. Defensive measures such as databases can help examiners in their work, said Yang, “but the sole establishment of databases without the other elements … might not be a good thing.” A disclosure requirement creates more work for the applicant, she said, but it helps the patent examiners search for information. In China, disclosure requirement applies to genetic resources, but not yet to traditional knowledge, she said. According to Yang, failure to fill out a disclosure form by the applicant can lead to patent examiners to refuse to consider the patent application. For patents already granted, failure to disclose may result in an invalidation of the patent, she said. Note: Yang presented her comments in Chinese. Yang’s presentation is available here [pdf]. Romania: No Disclosure Requirement Mirela Georgescu, head of the Chemistry and Pharmaceutical Examining Division at the State Office for Inventions and Trademarks of Romania said there is currently no mandatory disclosure of origin under the Romanian patent law. Romania transposed the European Directive 98/44/EC on biotechnologial inventions, she said. Mirela Goergescu, head of the Chemistry and Pharmaceutical Examining Division at the State Office for Inventions and Trademarks of Romania In line with the EU Directive, indication of the geographical origin is made on a voluntary basis, she said. The Romanian legislation provides for no stringent obligation on the applicant to acknowledge prior art known to him, she said. “Applicants are encouraged to provide information on prior art related to the claimed invention, but they are not obliged to do it.” The burden to find the relevant prior art for challenging novelty or inventive step is in principle on the Romanian patent office, in particular patent examiners, she added. On prior art, there is no sanction if the patent applicant holds back his knowledge of prior art, she said, adding that there is currently no requirement regarding prior informed consent in the Romanian legislation with respect to GRs and associated TK. She remarked that access of examiners to prior art information on GRs and associated TK “is a huge challenge as associated TK tends not to be documented, or if it is, it is not easy for a patent examiner to find it.” Romania has an important tradition in phytotherapy, and use of medicinal plants, she said. “We receive quite a lot of patent applications regarding medicinal plants filed by companies of private inventors,” she said, but applicants rarely indicate the geographical origin or the traditional knowledge. The full disclosure of the invention is the basic principle of patent law, she said, and GRs have the potential of being translated into substantial commercial benefits through patent protection, she said. A mandatory disclosure requirement would bring more consistency, transparency, and uniformity in the system, she said. Georgescu’s presentation is available here [pdf]. Industry Warns against Higher Transaction Costs Dominic Muyldermans, senior legal consultant for industry group CropLife International, said there is no need to develop a new access and benefit-sharing system (ABS) as it already exists, citing the Nagoya Protocol, which is currently being implemented in some countries, and was not in existence at the beginning of the discussions in the IGC. Dominic Muyldermans, senior legal consultant for CropLife International “It is not always a good idea to link compliance to the IP system because it might have adverse effects,” and might even create issues as to whether this would be compliant with principles of patent law, he said. ABS compliance is not needed, he said, particularly because the Nagoya Protocol requires countries to implement an effective compliance system, he said. Moreover, disclosure and transparency are already addressed in the patent system. Patents are not granted on the genetic resource itself, he said, “it always has to be an invention,..” Introducing further obligations would lead to higher transaction costs, he said. It would bring additional complexity and legal uncertainty to the patent system, he added. According to Muyldermans, if there are higher transaction costs and is a lower incentive to innovate, there will be less benefits to be shared as well, which will have a negative impact on the ABS objective. Muyldermans’s presentation is available here [pdf]. Patent Offices as Gatekeepers, Patent System Reform, Academic Says Ruth Okediji, law professor at the University of Minnesota Law School and Harvard University, said most of the discussions in the IGC tend to focus on the design of a disclosure system, and the impact of the implementation of such a system. But “unless we actually focus on why we need an international disclosure system, I think we get lost in the challenges of creating the optimum design and the possibilities that the implementation may be hard,” she said. Ruth Okediji, professor of Law at the University of Minnesota Law School, and at Harvard University Knowledge diffusion is global, she said, and “no longer can we hide behind national boundaries,” scientists are no longer isolated in labs and in firms, nor are academic publications available to a limited few, and cross-border innovation is increasingly the norm. It makes sense that patent offices act as gatekeepers because patent rules and patent offices were not created for patent applicants, said Okediji. “Patent rules and patent offices were created for the public, and the public is also a stakeholder,” she added. “Why do we need a rule?” she asked, because rules reflect values, regulate behaviour, and shapes expectations, and these rules need to be efficient and simple, she answered. The patent system is not always pro-innovation, and imposes social costs, Okediji said. It requires regular oversight, upgrading and always requires adjustments, she added, first starting at the national level, and then at the international level which creates a global minimum base line for rules “that all of us need to abide by.” There are pros and cons to the disclosure requirement, she said, in particular, are the costs worth it. If disclosure adds a burden to the patent system, maybe the problem is not coming from the disclosure requirement but might be a sign that the patent system is in need of a fundamental reform, she said. Okediji’s presentation is available here [pdf]. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at csaez@ip-watch.ch."WIPO Seminar: Experts Discuss IP Protection Of Genetic Resources" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.