Decision from the Norwegian Supreme Court concerning equivalence for a pharmaceutical patent
The recent decision HR-2009-1735-A from the Supreme Court concerns the interpretation of Section 39 of the Patents Act and in particular the doctrine of equivalence in relation to an analogy method patent.
Up to 1 January 1992 it was not possible to obtain a patent on a new pharmaceutical product explicitly by claiming the product, as claiming the product itself was prohibited by law. Instead, a method for production of this new pharmaceutical product was used to obtain patent protection (analogy method). This production method itself did not need to be inventive.
In this case, the alleged infringer, Krka Sverige AB, had developed an alternative method for production of a generic product of the pharmaceutical in Eisai Co. Ltd's patent. This alternative method was in principle a technically different method. The Borgarting Court of Appeal held that using the doctrine of equivalence did not widen the scope of protection conferred by the claims to technically different methods for the production of the pharmaceutical, even though it would be obvious for a person skilled in the art to find and use these methods, when the pharmaceutical itself was known.
The patentee disagreed with this view, and claimed that the correct starting point was if a skilled person having knowledge of the patent in suit would try the method of the generic producer with a reasonable chance of success.
The Supreme Court confirms the view of the Borgarting Court of Appeal. Based on normal principles of interpretation, the starting point for claim interpretation is the wording of the claims. It is also referred to Article 69 EPC concerning the interpretation of the claims. The decision uses the three principles of equivalence: 1) solve the same problem, 2) obvious for a skilled person, and 3) method must not belong to the prior art, as an adequate starting point.
This decision confirms that it is the method according to the claims that is protected also for analogy method patents. The teaching of equivalence is an aid to widen the scope of protection to methods which are fairly identical, and which represent modifications of the method according to the claims. The assessment as to whether a method is sufficiently close to be characterized as fairly identical, are specific considerations that must be made in each specific case.
By Kristine Rekdal, M.Sc. Physics, Bryn Aarflot AS
Published in Managing Intellectual Property, October Edition 2009
