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LEO Pharma v. Sandoz, District Court The Hague (PI Proceedings), the Netherlands, 11 May 2016,  ECLI:NLRBDHA:2016:5093

LEO Pharma is the proprietor of EP 2 455 083 B1 for a “Pharmaceutical composition for dermal use comprising calcipotriol and betamethasone”, which claims (in claim 1, a combination preparation consisting of calcipotriol, betamethasone and a solvent, used for the treatment of psoriasis. EP 083 is a divisional application of EP 1 178 808. LEO Pharma has commenced preliminary injunction proceedings against Sandoz in the Netherlands, claiming that Sandoz’ launch of a generic product comprising calcipotriol, betamethasone and a solvent infringes EP 083.

The Provisions Judge has rejected Sandoz’ claims as he considers there to be a serious chance that LEO Pharma’s patent would be found invalid in proceedings on the merits for lack of novelty and inventive step.

Re inventive step: the closest prior art disclosed that calcipotriol and betamethasone were administered separately.  The benefit of the use of the combination preparation in accordance with EP 083 was that it improved patient compliance. The Provisions Judge found that it was obvious (and even common general knowledge, according to the Opposition Division) to combine both substances in one preparation.

The Judge rejected LEO Pharma’s argument that an additional benefit of the invention was that the combination created a synergistic effect, since such effect was not mentioned in EP 083. The study by Van den Kerkhof submitted by LEO Pharma may not be taken into account as it was published well after the priority date of EP 083, and moreover it did not constitute convincing evidence of the synergistic effect.

LEO Pharma’s also argued that it had overcome a technical prejudice against the use of a combination preparation, based on three publications disclosing that the two substances are stable at different pH values and they are therefore incompatible. The Judge also rejected this argument, inter alia because three publications are insufficient to meet the high threshold for proof of a technical prejudice.

Re novelty: Sandoz had argued that the priority for claims 1 and 2 was invalid because the priority application discloses application of a solvent selected from a specific group of solvents, whereas claims 1 and 2 of EP 083 comprise all possible solvents. Since the priority application, the parent application for EP 083 (WO 450) and the divisional EP 808 all disclose an Example 1 in which the specific solvent Arlamol-E is used, the priority claim would be valid for this divisional insofar as Example 1 is concerned. This would mean that the parent application WO 450 would in that case be a prior right in the sense of article 54(3) EPC and destroy the novelty of EP 083.

The Judge points out that this issue of ‘poisonous priority’ is currently subject to review by the Enlarged Board of Appeal as different Technical Boards of Appeal have ruled different differently on this subject.  As this issue has not yet been decided, the uncertainty contributes to the chance that EP 083 will be held to be invalid in proceedings on the merits.

A copy of the judgment can be found here.

Headnote: Jaap Bremer, BarentsKrans