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JP Russel Science Ltd. v. Innovet Italia S.r.l., District Court of The Hague, the Netherlands, 30 March 2016, Case number 481573 / HA ZA 15-111

JP Russel develops and markets nutricial supplements and dietetics for medical use. One of the products sold by JP Russel on the Dutch market is PEAPURE, a product that includes N-palmitoylethanolamide or PEA. PEA works as an analgesic and anti-inflammatory.  Innovet is the holder of the European patent with number 1 207 870. Claim 3 of EP ‘870 claims a pharmaceutical composition containing PEA in micronized form or co-micronized with an excipient, together with pharmaceutically acceptable excipients. Claims 4 – 6 claim further embodiments of the composition of claim 3.

JP Russel argues that claims 3 – 6 of the Dutch part of EP ‘870 are invalid for lack of sufficiency, novelty and inventive step. In the alternative JP Russel claims a declaratory decision of non-infringement, arguing that its PEAPURE product does not infringe claims 3 – 6 of EP ‘870 as the PEA in PEAPURE is not micronized.

The parties agree that the skilled person is a team including a pharmacologist and a formulation expert. According to the Court, the skilled person on the priority date was familiar with the concept of micronisation and how to perform micronisation. The skilled person was not familiar with the specific particle size resulting from micronisation. Micronised PEA is nevertheless to be distinguished over raw PEA, as it was not in dispute that micronisation would lead to a significant reduction of the known particle size of raw PEA. Example 1 of the patent shows that the prior art synthesis of raw PEA would typically lead to a particle size of 50 – 100 microns.

Claims 3 – 6 are found novel, as compositions including micronized PEA are found not to be clearly and unambiguously disclosed in any of the prior art submitted by JP Russel. Prior art document EP 0 550 006 discloses many possible formulations including aerosols. EP 006 however does not disclose concrete examples of such formulations. Even if the skilled person knew that PEA particles should be reduced prior to formulation, this according to the Court does not mean that the skilled person would necessarily choose micronisation.

JP Russel’s public prior use argument was dismissed as JP Russel had not sufficiently proven that the prior art drug sample on which it relied was available before the priority date of the patent.
In relation to inventive step, EP 006 was found to be the closest prior art.

The only difference between EP 006 and the claimed composition is the use of micronized PEA. It was not in dispute that this difference leads to an improved therapeutic effect for the treatment of certain skin diseases in cats. The Court found it likely that this effect was to be extrapolated at least in some way. But even if this would turn out incorrect, the effect is to be included in the problem to be solved by the skilled person.

The objective technical problem is formulated by the Court as: how to improve the therapeutic effect of PEA, in any event for the treatment of the skin diseases mentioned in the patent. As JP Russel had not disputed the fact that the skilled person had no reason to expect an improvement from micronisation and had not disputed that micronisation of lipid substances could lead to adverse effect, the court found that there was no reason to conclude that the skilled person would solve the objective technical problem by micronising PEA. Accordingly the court found claims 3 – 6 of PE ‘870 also inventive.

With regard to JP Russel’s alternative claim for a declaratory decision of non-infringement, there was doubt as to whether or not PEA in PEAPURE is micronized. JP Russel argued that it was not, but its website at least at some point said otherwise. The court allows JP Russel to provide additional evidence to substantiate its alternative claim.

Read the judgment (in Dutch) here.

Head note: Mattie de Koning, Simmons&Simmons LLP