In Norway there is a fear that the dangerous patent creature shall play with the even more dangerous biotechnology creature. This fear is prominent among some groups of politicians and within some NGOs. After prolonged public debate, Norway implemented the biopatent directive 1st January 2004. However, special means should ensure that the adverse effects of the directive were not too large. One of these means was that the patentability requirements should be practiced so strictly that Norway would be among the strictest European countries.
The parliament has requested a review of the measures to find out whether the measures work as intended. The Ministry of Justice has, in continuation of this, proposed amendments to the Patents Act.
Of the more important suggested amendments is that absolute product protection shall no longer be available for gene sequences. The proposed new paragraph is intended to apply also to EP-patents in Norway. According to the proposal, the scope of protection shall be limited to the industrial application which is clearly described in the patent application. Did anyone mention the rule in the TRIPS agreement about discrimination as to technological fields?
It is also thought provoking that if the amendment goes through, absolute product protection will be available for both microorganisms and for proteins, but not for the genes in the organisms encoding the proteins.
The proposal departs from the well established view that the primary source for finding the scope of protection is the patent claims. In fact, the Norwegian Patents Act explicitly states that the scope of protection is determined by the patent claims. Contrary to this, according to the proposal the use covered by a gene patent is limited to the use clearly described in the description. If the industrial application is not stated with sufficient clarity and completeness, there will be no protection, and such patents should not be granted. However, it is very unclear how detailed the industrial application must be stated, and at what level of detailing the addition of more details may not limit the scope of the patent.
If the proposal goes through, writing biotech patent descriptions for Norway will become quite an art. However, the outcome with respect to actual protective scope will be highly uncertain.
The requirement that there be a clear description of how a biotech invention can be used industrially is not new. Norway has had this special rule for patents on naturally occurring biological material for some time. The Norwegian Intellectual Property Office has been enforcing this rule rigidly, often refusing to grant a patent due to lack of experimental evidence for industrial application. According to the proposal, the described industrial application will not only be limiting for the scope of the patent as I have already described. A granted patent, whether it is granted by EPO or is strictly national, may be invalidated due to failure to fulfill the requirement. The Ministry says that this is not a new invalidating factor, since it is comprised by the rule stating that patents may be invalidated if the description is not sufficiently clear for a skilled person to work the invention. The Ministry argues that for the same reason the proposed new basis for invalidity does not violate EPC article 138, which lists the allowed grounds for revoking a patent.
This seems to raise a dilemma. If the explicit requirement for a clear description of industrial application in the patent document is fully comprised by the general rule that the description shall be sufficient for the skilled person to work the invention, then the specific requirement regarding biotech inventions is just an empty rule, which might as well have been removed from the Patents Act. The same goes for the proposed new corresponding invalidity reason. However, if the requirement has substance of its own, then we do have a new invalidity reason, and Norway would be in breach with EPC article 138.
Maybe Norway has to go through a transition period where we have confusing, but empty, rules regarding biotech patenting. Maybe we can remove these rules entirely in the next amendment of the Patents Act, so that we become more harmonized with the rest of Europe.
Some Norwegian peculiarities may disappear already in this round. That is the three year opposition period for oppositions based on that the patent is against public order and morality, and the Ethical committee that shall advise the Norwegian Intellectual Property Office.
About the author:
Inga Kaasen is an attorney-at-law and partner at the Norwegian law firm Grette. She also holds a PhD. in biotechnology. She is the leader of Grette's Life Sciences team, and has extensive experience with patent disputes, pharmaceutical law, IP transactions and R&D agreements.
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