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Orifarm Generics AS et al. v. Mundipharma AS, Oslo District Court, Norway, Joint cases 16-135025TVI-OTIR/01 and 16-141308TVI-OTIR/01, 8. September 2017

On 8 September 2017, Oslo District Court rendered its decision in a case uniting two separate cases between Orifarm and Mundipharma (patentee) regarding claims of infringement and invalidity of Mundipharma’s patents NO 334290, 332248 and 333139.

The relevant patent claims were formulated as a transdermal patch for use in the treatment of chronic pain by administration of the opioid buprenorphine over a period of 5 or 7 days. The court found all patent claims to be invalid due to lack of inventive step and revoked the preliminary injunction.

Prior to the judgement Mundipharma had obtained an ex parte injunction prohibiting Orifarm’s sale of its buprenorphine patch product Buprefarm in Norway. Orifarm chose not to contest the injunction, but initiated legal proceedings before the Oslo District Court claiming that the patents were invalid due to lack of inventive step. Mundipharma subsequently initiated an infringement proceeding claiming that Orifarm’s Buprefarm product infringed Mundipharma’s patents. The two cases were joined and heard by the Oslo District Court in March 2017.

In its decision on invalidity the court referred to the so called Swingball Doctrine established by the Norwegian Supreme Court (Rt-1975-603) according to which the courts should show restraint in disregarding the discretionary assessments of the Norwegian Patent Office (NIPO) in granting the patent, and thus in invalidating granted patents.

The court, however, held that the threshold for reviewing the assessments of NIPO will be lowered in cases where it is evidenced that NIPO did not take into consideration all relevant information at the time of the patent application. On the basis of a review of the correspondence between NIPO and the applicant during the application process the court found that NIPO had not taken all relevant factors into account when assessing patentability.

NIPO had initially been of the opinion that the patents lacked novelty and/or inventive step, but changed its mind. The District Court found that NIPO did not sufficiently explain this change of mind. Consequently, the court did not find reason to give any weight to NIPO’s assessment of the patentability. The conclusion seems to be that the principles laid down by the Supreme Court in Swingball, and upheld in the Supreme Court’s decision in Biomar (Rt-2008-1555) are respected, but is of limited help for the patentee considering the quality demanded by the courts for the NIPO decisions in order not to overrule them. It will be the normality that the courts will have the possibility of a much more in-depth analysis of the patentability than NIPO, which inter alia does not have the advantage of a process respecting the principles of contradiction.

The court further stated that Norwegian patent law is considered to be completely in line with the rules of the European Patent Convention (EPC), which was ratified by Norway in 2007 (The principle was laid down by the Supreme Court in Donepezil (Rt-2009-1055)) . Thus cases from the European Patent Office (EPO) (mainly the Board of Appeal) is relevant and has significant weight when interpreting Norwegian patent law. The court based its decision of invalidity on the problem-solution approach as applied by the EPO and NIPO was criticized also for not applying the problem-solution approach.

The use of transdermal patches for administration of buprenorphine was known from the prior art. The parties agreed that the dosing interval of 5 and 7 days constituted the invention in all of the patents. Due to the substantial amounts of claims in the patents, the analysis of obviousness for the person skilled in the art took on different connotations to some extent. The court stated that the requirement for inventive step is stricter when the patent claims are wide and cover a large range of possible technical solutions, and pointed out that this was relevant for the widest claims of the patents.

Based on the prior art the court found that it was obvious to solve the problem of finding a more effective and suitable transdermal administration of buprenorphine by choosing the dosing intervals described in the patents, and thus found the patents to be invalid. Consequently, there was no need to consider the infringement issues. Mundipharma did not appeal the judgement and the decision is thus final. At the time of publication of this article, the issue of damages has not yet been assessed by the court.

A copy of the decision (in English) can be found here.

A copy of the decision (in Norwegian) can be found here.

Headnote: Håkon Bleken and Vebjørn Krag Iversen, Advokatfirmaet Haavind