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Biotech patents: Norway’s government issues consultation paper on amendments to the Patents Act
Eight years after Norway implemented the Patent Directive (Directive 98/44/EC), and four years after the Patents Act underwent some further changes when Norway acceded to the EPC, the Norwegian Ministry of Justice (MoJ) has issued a consultation paper in which some of the implemented measures are reviewed and some amendments and adjustments are proposed.
A heated public debate preceded Norway’s implementation of the Patent Directive effective 1st January 2004. As a result of a political compromise to have the bill approved, certain special measures were put in place. When accession to the EPC came on the agenda in 2006-2007, and the EPO was to be empowered to grant patents with effect in Norway, there was again a heated debate. Some further special measures were implemented, such as the availability, through the term of the patent, of administrative re-examinations of any patent, be it granted by the EPO or by the Norwegian Patent Office.
The special measures that are now being assessed are:
1. Measures intended to secure that the requirements for granting patents on inventions that relate to naturally occurring biological material are applied strictly, and that if granted, their scope should be construed narrowly:
a) patent applications concerning naturally occurring biological material must set out clearly how the material can be industrially utilized – no intention on the part of the MoJ to materially change this requirement
b) an amendment is proposed to make it clear that failure to comply with the requirement in a) can lead to invalidation of the patent, in an administrative re-examination proceedings or in an invalidity action before the courts
c) guidelines in the preparatory works to the effect that Norwegian patent authorities and courts should apply the law in the strictest way both when deciding if an invention relating to or using biological material has inventive step and when determining its scope of protection – will continue to apply
d) should additional special restrictions in the scope of protection for certain biotechnological inventions, be introduced, as in Germany or France? The MoJ asks for comments and observations on a proposal to limit the scope of protection afforded to inventions that concern sequences or a partial sequences of a gene occurring in nature to such industrial applications as are clearly set out in the patent application
2. Since 2004 it has been possible to obtain a compulsory licence by an administrative procedure, and the Norwegian Competition Authority became the authority that could grant it. The Oslo District Court remained competent to grant compulsory licenses. In the 8 years that have passed since the administrative option became available, it has been tried only once. No changes are being proposed but the MoJ expresses some doubts as to whether the administrative route is practical.
3. Proposal that information mandatorily disclosed in the patent application about the country of origin of the biological matter that the invention concerns or uses will be part of the record and thereby become accessible to the public.
4. An obligation to disclose in the patent application whether a consent has been obtained for the use of the human material that the invention concerns or uses. The MoJ does not propose amendments.
5. The MoJ proposes that the special extended three year opposition term that applies to oppositions based on the patent being in conflict with public order or morality should be repealed. Patents can now be challenged throughout their term in administrative re-examinations on these grounds, so there is no need for the extended opposition term.
6. Under the current Patents Act the Patent Office is to consult with a permanent Ethics Committee comprised of members appointed by the government in cases where it is uncertain whether a patent application should be refused on account of being contrary to public order or morality. The MoJ expresses some doubts as to the actual need for the Ethics Committee, in view of the fact that only once since 2004 has the Patent Office felt it should consult with the Ethics Committee. Nevertheless, it bodes ill that the MoJ invites comments on three possible alternative amendments: a) the Patent Office should consult with the Ethics Committee in all cases where there could conceivably be a public order or morality issue, even if the Patent Office harbours no doubt about the answer; b) all patent applications should be submitted to the Ethics Committee; and c) submission of a patent application to the Ethics Committee should occur at the request of any person.
7. The farmer’s exemption, which allows farmers to use patented formation material from animals and plants for their own agricultural purposes will not be amended.
The consultations will end on 1st September 2012. The government will then have a bill prepared that will be put before the Storting (parliament). The amendments proposed could come into effect within one to two years.
Two comments appear relevant:
The first one concerns the proposal to limit the scope of protection of inventions concerning sequences of naturally occurring genes to industrial applications set out in the patent application. If this amendment is introduced it would apply both to national and European patents in Norway. Hence, the scope of protection of a European patent could be more limited in Norway than in other designated EPC countries. The legislative technique proposed by the MoJ is devised to achieve a more limited scope of protection independently of the patent claims, by stating that the patent application shall be determining for the scope. This could be said to be a departure from the principle of Art. 69 EPC (and section 39 Norwegian Patents Act) that the scope of protection shall be determined by the patent claims and that for interpreting the patent claims the description and drawings are to be referred to. In Norway the prosecution history is a relevant factor when construing patent claims, so it is perhaps not so surprising that such a proposal could be put forward. However, it goes further than using the prosecution file as a factor when construing the claims, in that it elevates the patent application to primary source of information for the purpose of claim construction. The disadvantages are multiple. Firstly, anyone applying for a European patent concerned with sequences or partial sequences of a gene occurring in nature would risk ending up with a lot less in Norway than elsewhere. Secondly, it is a disadvantage for third parties that reading the patent claims and the specification would not be sufficient to establish the scope of the patent.
The second comment that appears appropriate concerns a procedural point among the proposed amendments. It is the widening of the basis for “post grant, post opposition” administrative invalidation of patents. Currently only the basic patentability requirements (patentable subject matter, novelty and inventive step) can be reviewed in administrative re-examinations of patents, as opposed to oppositions and invalidity actions before the courts, in which inventorship, insufficiency, claims’ lack of support in the description and added subject-matter are also admissible grounds for revocation or invalidation. If enacted, the MoJ proposal will add insufficiency (lack of enablement) to the list of grounds for invalidation that can be relied upon in administrative re-examinations. Importantly, this will apply not just to patents that relate to biological material, but to any patent. The change is intended to make it easier to challenge patents. The administrative route, though less costly than a court action, is at least as time consuming. It will take between one and two years to get a decision. An appeal is available.
It is not easy to predict the precise effects of the proposed amendments, especially since the number of cases concerning any of the measures reviewed and discussed has been very limited. However, the number of patent applications concerned with naturally occurring biological material and human material will increase, and the restrictive legislation in this area will become much more practically important.