The Directive on the legal protection of biotechnological inventions (98/44/EC) was implemented in Swedish law in 2004. The legislative amendments resulting from the implementation did not entail any extension of patent protection for biotechnological inventions but rather constituted a clarification of the practice already applied. When the Directive was implemented, the Government noted that there was broad consensus that the availability of effective patent protection in the biotechnology area constituted an important incentive, for example for developing new and improved medicines. At the same time the Government noted that there were fears that patent protection, if it became too extensive and strong, would risk counteracting its purpose. In the light of this, the Government stated that there was a need to follow the case law developments as regards the application of both the fundamental patentability conditions and the limitations of the extent of protection. The Government also stated that special measures for coordinating and facilitating licence agreements should be considered in order to encourage access to diagnostic tests on reasonable terms. Moreover, the Government stated that the effects of the development of the patent system for research should be followed closely. For this reason, in 2005 the Government decided to set up a committee, the report of which has now been published (SOU 2008:20).
Fundamental patentability conditions: The committee has found that the EPO case law in the biotechnology area in recent years has taken a restrictive course as regards the application of the patentability requirements of inventive step and industrial applicability. On several occasions the EPO has stated that vague indications of possible medical use for a chemical substance did not meet the industrial applicability requirement. In the opinion of the Committee, the application of the fundamental patentability requirements in both the EPO and the Swedish Patent and Registration Office (PRV) is appropriate. Accordingly, no changes to the Swedish Patent Act were proposed.
Extent of protection: Absolute product protection implies that all use of a chemical substance falls within the patent’s scope of protection. Absolute product protection constitutes a central issue with regard to the scope of patent protection for gene sequences and the fear that protection in this area may be too wide and strong. Sweden applies absolute product protection for gene sequences and micro-organisms (unlike e.g. France and Germany). The Committee has concluded that Sweden should not aim for a transition to use-bound product protection for patents on gene sequences.
Access to diagnostic tests: The Committee found that on the whole, access to patented genetic and diagnostic tests in the health and medical care sector can be regarded as satisfactory. If issues were to arise, the Committee deemed that such situations can be dealt with firstly by competition law measures and possibly by means of the compulsory licencing regime.
Research: With regard to the experimental use exemption, the Committee found that the present Swedish regulation is satisfactory. The right to make experiments on but not with a patented invention is an appropriate allocation of rights that allows for continued research on the patented product while protecting the justifiable interests of those who develop new and improved research tools. At a more general level, the Committee noted that the access to patented biotechnological inventions for research purposes seems to be satisfied by way of licensing. The Committee gave credit to the 2006 OECD Guidelines for the Licensing of Genetic Inventions and recommended that at a European level, efforts should be made to create a standard agreement for biological material transfers.
Ethical issues: The Committee noted that as a result of the implementation of the Biotech Directive, the limitations and borders circumventing patents on inventions involving human biological material have been made clearer. Although The Committee found that such patents are still an ethically sensitive issue for many people, in light of the restrictive practice of EPO, there is no need for additional changes to the Patent Act. The Government however is recommended to monitor the outcome of an embryonic stem cell technology patent case pending before the EPO Enlarged Board of Appeal (G 2/06).
In summary, the Committee has made no proposals for introducing changes to the Swedish Patent Act in relation to biotechnological inventions. Although slightly outside the scope of its remit, the Committee has proposed that the Government should amend the Patent Act to make it clearer that the first, second and following medical indications are patentable in accordance with Article 54.4 and 54.5 of the EPC 2000. Such amendment, if eventually proposed by the Government, would only be a matter of clarification and not a change of law.