From our friend Sidsel Hauge (Partner and European Patent Attorney, Awapatent A/S, Copenhagen) comes news of the Danish Patent Office's new guidelines on the interpretation of "identified/specified" after Medeva. The following is Sidsel's unofficial translation:
Protection by a basic patent, particularly for combination products (Last update: 17‐12‐2012)
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Before a product which consists of a composition of two or more active ingredients, known as a combination product, can be considered to be protected by a basic patent according to the Regulation, the combination of the active ingredients must be specified by the wording of the claims of the basic patent in accordance with the judgment of 24 November 2011 in Case C‐322/10 (Medeva) of Court of Justice of the European Union.
For example, a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent, if the combination A and B appear in the wording of the claims.
The product is considered to be specified in the wording of the claims when the product is described by a chemical name or a structural formula, i.e. specifically mentioned or being comprised by a Markush formula.
A product may in some cases be considered to be specified in the wording of the claims of the basic patent, if the product is specified by functional terms. The actual protection will always be decided from case to case on a case by case basis.
If the basic patent in an administrative re‐examination could be limited so that the combination of the active ingredients remains in wording of the claims of the basic patent, we also consider the combination product to be protected by the basic patent and thus Article 3, point a, to be fulfilled.
You can read more about the effects of the foregoing for applications for a certificate for combination products under Combination products.
3 comments:
"A product may in some cases be considered to be specified in the wording of the claims of the basic patent, if the product is specified by functional terms. The actual protection will always be decided from case to case on a case by case basis."
From case to case on a case by case basis. Sounds like a recipe for disaster to me. It will lead to inconsistency of approach, and thus uncertainty for both patentees and third parties.
If the CJEU had simply been clearer in Medeva (by saying that specified in the wording of the claim means that you have have to write the name of the INN or its IUPAC name) then we would have a system that was simple and easy to apply.
Simple and easy maybe, but grossly unfair to innovators and therefore contrary to the aims of the Regulation. INN names are assigned years after an active ingredient is first described - how can the INN be included in the initial patent application? Even IUPAC names will only be known if the particular active ingredient was described by the time the patent application was filed - many applications claim active ingredients generically (e.g. by Markush formulae) because it takes further research to identify the best compound for clinical development.
Let's hope the CJEU understands the patent system enough to get it right this time.
"...many applications claim active ingredients generically (e.g. by Markush formulae) because it takes further research to identify the best compound for clinical development".
In that case, perhaps that patent application / patent is not the most appropriate basis for an SPC..?
Why not file a selection patent as soon as you have indeed identified the compound that does in fact have some clinical benefit, and use that as the basis for your SPC.
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