Switzerland Champions Disclosure Requirement In Patents, Counters US Interpretation 15/09/2016 by Catherine Saez, Intellectual Property Watch 1 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)The government of Switzerland has issued a defence of its national law on disclosure of origin of genetic resources in patent applications, finding fault with a critical interpretation of its law by the United States. The Swiss response comes on the eve of a World Intellectual Property Organization meeting on related issues. alpen_edelweis_leontopodium_alpinum Should sources of genetic resources be included in patent applications? Most developing countries agree, since they see it as a protection against biopiracy, but some developed countries oppose it. Last June, the United States delivered an analysis of the Swiss legislation on disclosure of origin without consulting Switzerland, a proponent of disclosure, underlining what the US saw as potential hurdles for innovators. Switzerland has issued a reply, along with a detailed presentation of its law, and the reason why the World Intellectual Property Organization should adopt an international disclosure requirement. The disclosure of generic resources in patent applications is discussed in a number of fora. At WIPO, this issue is addressed in the Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC). The IGC is meeting next week. Following the one-sided US analysis [pdf] of its law on disclosure of the source of genetic resources and traditional knowledge at the last session of the IGC in June, Switzerland tabled a document [pdf] to be presented next week at the IGC, explaining its law and responding to points made by the US analysis, which they found were erroneous. The US document analysed Switzerland’s Federal Act on the Protection of Nature and Cultural Heritage, and the Federal Act on Patents for Inventions, and applying those laws hypothetically to a US patent. According to the Swiss document, “The US document was prepared without consulting Switzerland, and without verifying the accuracy of the content with any competent Swiss authorities. In addition, the document contains a number of serious shortcomings and errors.” In particular, the Swiss document points out that the US analysis “confuses (1) the disclosure of the source requirement as stipulated in the Swiss Federal Act on Patents for Inventions (PatA); (2) the notification of the due diligence obligation according to the Swiss Federal Act on the Protection of Nature and Cultural Heritage (NCHA), which implements the provisions of the Nagoya Protocol (NP)[The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity]; and (3) the product marketing approval procedures.” The US document, said Switzerland, “does not take into account several important provisions of these Acts, and completely ignores the Ordinances that implement them,” and the hypothetical example used is outdated. Swiss Laws Rationale In 2010, Switzerland submitted a document [pdf] to the IGC entitled, “Declaration of the Source of Genetic Resources and Traditional Knowledge in Patent Applications: Provisions of the Swiss Patent Act” which summarised and explained the relevant provisions of the PatA on the disclosure of the source. The document to be presented next week further explains the legislation and its policy objectives. For example, the declaration of the source requirement was introduced to increase transparency about the specific genetic resource(s) and the traditional knowledge related to genetic resources, on which an invention is directly based on. The disclosure of source should also strengthen mutual trust between users and providers of such resources or knowledge, enhance the traceability of these resources and knowledge, and facilitate the establishment of technical prior art, the document said. However, “it is crucial to keep in mind that the disclosure of source requirement will, by itself, not be sufficient to resolve all issues arising in the context of access and benefit-sharing.” Many genetic resources are used in the context of non-commercial research projects, and may result in commercial products not protected by patents, the document said, adding that in line with the provisions of the Nagoya Protocol, additional measures have to be taken outside of the patent system in other fields of law. The document adds: “The disclosure requirement in the PatA is based on the following key principles: a) it is flexible enough to cope with the wide range of circumstances related to genetic resources and traditional knowledge associated with genetic resources, b) it has a clear scope in order to easily determine whether the disclosure requirement will be triggered, c) it includes effective and proportionate sanctions in order to ensure legal certainty for both users and providers of genetic resources and associated traditional knowledge, and d) it has to be understood in the broader context of measures to implement the international regime on access and benefit-sharing at the national level.” The provisions of the PatA on the disclosure requirement are based on the concept of “source”, which takes into account the diversity of: sourcing locations, legal situations, types of genetic resources, sectorial approaches, and traditional knowledge associated with genetic resources. The Edelweiss Example The Swiss document illustrates the concept of source with the Alpine Edelweiss, a plant species which contains pharmaceutical and cosmetic properties and can be sourced in situ in alpine countries that are the countries of origin of the plant. Countries include Austria, France, Germany, Italy, and Switzerland. The plant can also be sourced in situ in countries of the Carpathians, such as Romania, and some Balkan countries, which are also countries of origin. To complicate matters, the plant is also grown in ex situ conditions, explains the document, and may be sourced in botanical gardens, not located in a country of origin, such as the Netherlands or the United Kingdom. That gives way to different disclosure as primary source, for example, if the plant was sourced either in Austria, France, Germany, Italy, Romania or Switzerland, the respective country would need to be disclosed as the primary source, the document says. However, “if the plant was sourced from the ex-situ collection in the Netherlands, the primary source would be Germany, if the plant was initially sourced in Germany. In contrast, the primary source would be France, if the plant was initially sourced in France, and obtained by the ex-situ collection in the Netherlands through another ex-situ collection in the UK.” Nagoya Protocol, International Harmonisation According to the Swiss document, several countries, following the provision of the Nagoya Protocol, have introduced disclosure requirements in their national patent system, “or are likely to do it in the near future.” Adopting a disclosure requirement at the international level would foster the international harmonisation of disclosure requirements within the patent system, and increase legal certainty, support innovation on products based on genetic resources, and/or associated traditional knowledge at the global level, it says. “An international disclosure requirement established under WIPO would increase WIPO’s role and credibility in governing issues related to intellectual property, genetic resources and/or associated traditional knowledge, which would be to the benefit of the patent system in the long term,” says the document. However, Switzerland advises to establish minimum standards for this requirement. US Analysis Called Erroneous In a detailed comment to the June US document, in Appendix II of their document, the Swiss point out several flaws they found with the US analysis. For example, they say that the US ignored relevant articles in the Swiss laws that they examined, along with ordinances. Furthermore, the US patent used to illustrate how the Swiss laws would have applied was filed in February 1990, and thus considered as outdated to be used for the analysis of the Swiss legislation on genetic resources which entered into force “many years later.” The genetic resources used in the research leading to the patent were accessed “even before the CBD entered into force.” Switzerland also remarks that “the description of the US patent already contains the source of the genetic resources, including the precise coordinates of the access locations. This even goes beyond the information that a patent applicant would need to disclose according to the PatA in Switzerland.” The Swiss document also says that the US overlooked possible sanctions in the context of the due diligence requirement. In June, the US indicated that their analysis of the Swiss legislation was to be followed by analysis of other countries’ legislation on disclosure. The 31st session of the IGC is taking place from 19-23 September. The documents for the session are here. 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