Setterwalls has successfully represented two pharmaceutical companies in defence against claims for preliminary injunctions

Setterwalls has successfully represented two pharmaceutical companies in defending themselves against claims for preliminary injunctions before the Patent and Market Court (“PMC”). The PMC held that the presumption of validity had been overcome.

As Setterwalls previously reported here, the PMC decided on August 23 this year not to issue a preliminary injunction based on a yet-to-be-granted patent application. The patent applicant chose to appeal the PMC’s decision to the Patent and Market Court of Appeal (“PMCA”) but withdrew the appeal when it became clear that the EPO would soon grant the patent. The applicant then again filed claims for preliminary injunctions, with a request that the PMC would examine the claims as soon as the patent in question took effect in Sweden.

The PMC began its reasons for the decision by concluding that there was reason to apply a presumption of validity because of the thorough examination of the patent in the context of the EPO administrative procedure. However, the presumption of validity may be overcome if it appears likely that the patent will be invalidated at a final examination. The PMC also noted that previous practice by the Patent and Market Courts was applicable in that the preliminary assessment, in the context of the preliminary examination, should be cursory and thus should not pre-empt the final examination of the patent’s validity.

The two pharmaceutical companies represented by Setterwalls have consistently argued that the patent lacks support in the application as filed, that the patent did not sufficiently disclose the alleged invention and that the patent was not new in relation to the prior art on the day of priority. The PMC briefly noted that it was not possible to establish with a predominant probability that the patent had such defects in the preliminary and cursory assessment to be made by the court. The preliminary review instead came to focus on the companies’ fourth invalidity ground: that the patent lacked an inventive step.

As to whether the patent was likely to lack an inventive step, the PMC found that the two documents from the prior art cited by the defendants as the closest prior art both supported the fact that the alleged invention was obvious to the skilled person on the day of priority. In the examination before the EPO’s grant of the patent, the patent holder had successfully argued that the skilled person would not have had an expectation of reaching the alleged invention due to the existence of a so-called technical prejudice. The PMC noted that the more extensive investigation in the Swedish case showed that it was unlikely that such a technical prejudice existed.

Overall, the PMC concluded that the patent holder had not made probable the existence of an exclusive right and decided not to grant the patent holder’s claims for preliminary injunctions. The decisions may be appealed to the PMCA within 3 weeks. It is required that the PMCA grants leave to appeal.

We believe that the PMC’s decisions not to issue preliminary injunctions are well balanced and are based on thorough reasoning that is well in line with the practice of both the Swedish patent and market courts and the EPO. The decisions also show that it is possible to break the presumption that granted patents are valid in situations where the EPO has based its decision to grant the patent on deficient or one-sided materials.

See PMC decisions of 8 November 2022 in case no. PMT 9389-22 and PMT 7797-22.