Bridges Trade BioRes • Volume 7 • Number 7 • 13th April 2007
BIOTECH COMPANIES WANT SWITZERLAND ON IP WATCHLIST
BIOTECH COMPANIES WANT SWITZERLAND ON IP WATCHLISTIn a move some observers find surprising, the Biotechnology Industry Organisation (BIO) is requesting that Switzerland be placed on a "Watchlist" due to its new draft rules on biotechnology inventions. In a letter to the US Trade Representative’s office, BIO expressed concern that the revised Swiss Patent Act could undermine property rights associated with patents, and signalled uncertainty with regard to how some of the provisions may play out in practice.
Switzerland itself is one of the largest exporters of pharmaceuticals and biotechnology-based products, with high stakes in facilitating and supporting biotechnology industry.
BIO concerns over patentability
BIO expressed particular concern with regard to a proposal to patent DNA fragments only if their function is clearly disclosed. BIO is of the opinion that this criteria would amount to an additional technology-specific disclosure requirement, which would be in violation of trade-related intellectual property right (TRIPS) patent rules. In addition, the Swiss proposal provides that protection would only be granted to the part of the DNA sequence that is responsible for the described function. BIO believes this requirement would lead to uncertainty in the enforcement of patents.
The draft Swiss Patent Act does not provide for patent protection for a mere presentation of a fragment of a gene. Only when a useful function of the gene is provided will protection be granted.
Swiss authorities were surprised by the request made by BIO and considered the concerns unfounded. They argue that the proposal is TRIPS compliant and mirrors the EU Biotech Directive. According to the Swiss authorities, the disclosure of "function" is a basic principle of patent law (similar to the utility requirement under US law) and in this case was adjusted to meet the specificities of the field of biotechnology. Further, the draft Patent Act would prioritise invention rather than mere discoveries.
The Swiss authorities argue that the provision aims at preventing overly broad patents. They note that the French and German patent laws are stricter than the Swiss proposed amendment, as in France and Germany only the functions disclosed in the patent application are protected, whereas in Switzerland all functions would be protected.
Disclosure issues underlined
The draft Patent Law contains an amendment that requires patent applicants to supply available information with regard to genetic resources and traditional knowledge — aiming to increase transparency in the context of access and benefit sharing. Swiss rules refer to disclosure of the ’source’ rather than ‘origin’ of genetic material. Source, in its broadest sense, refers to genetic resources and associated traditional knowledge. The Swiss amendment does not deal with the Convention on Biological Diversity (CBD) issues of access and benefit-sharing and prior informed consent. However, the disclosure of source requirement would leave the door open to address these issues. In comparison, the EU Biotech Directive refers to disclosure of origin, which does not necessarily refer to pre-existing rights that holders of traditional knowledge might have over the genetic resources.
Overall, the Swiss draft amendment is more comprehensive than the EU Biotech Directive. First, it requires the disclosure not only of resources related to plants and animals, but also to microorganisms as well as traditional knowledge of indigenous and local communities associated with an invention. Second, if the source is not declared, this can result in the patent not being granted. Third, an intentional false declaration will be subject to criminal sanctions.
Background
Switzerland has been active in international deliberations on disclosure issues, including at the World Intellectual Property Organisation Working Group of the Patent Cooperation Treaty, the WTO TRIPS Council and the Convention on Biological Diversity, promoting the view that including the disclosure of the source of genetic resources and traditional knowledge in patent applications would enhance transparency, traceability, technical prior art and mutual trust.
During the drafting of the revised Swiss Patent Act, the Swiss authorities held stakeholders consultations, including with the Swiss pharmaceutical and biotechnology industries, as well as formal public consultations.
Additional resources
The BIO letter is available athttp://www.ustr.gov/assets/Document_Library/Reports_Publications/2007/2007_Special_301/asset_upload_file765_10561.pdf
ICTSD reporting.