Setterwalls has successfully represented a pharmaceutical company in a patent dispute before the Patent and Market Court

Setterwalls has successfully represented a major pharmaceutical company in a patent dispute before the Patent and Market Court. In its decision rendered on 25 January 2024, the Patent and Market Court found the relevant patent for the specific salt of a cancer drug to be invalid – over one year after the expiry of the patent in question.

On 28 October 2022, while the patent was still in force, the patent holder filed a lawsuit due to alleged infringement of the relevant patent. The alleged infringement specifically concerned a claim which claimed a specific salt (the tosylate salt) of a known cancer agent. The patent holder requested the Patent and Market Court to issue preliminary and final injunctions. The claimed infringement was contested on the basis that the patent was invalid and a request for revocation of the Swedish portion of the patent on the grounds that the alleged invention lacked support in the application as filed as well as inventive step was submitted.

On 28 November, the Patent and Market Court issued a preliminary injunction and on 3 December 2022, the patent expired, meaning that the preliminary injunction no longer was in force.

In the spring of 2023, the patent holder submitted two auxiliary requests, in case the Patent and Market Court would find the relevant claim as granted to be invalid, namely:

1. The specific salt for oral administration, and
2. The specific salt for use in the treatment of cancer by oral administration.

The Patent and Market Court issued its judgment on 25 January 2024. In brief, the Court concluded that the claim lacked inventive step. The Court considered that it would have been obvious for the skilled person to undertake a salt screen, and that it would have been obvious to include the tosylate salt in such test. Already on this basis, the skilled person would have arrived at the claimed invention, rendering it obvious for the skilled person.

The Court found the same to apply for the claim as amended according to the first auxiliary request, i.e. the salt in question for oral administration. The addition of “for oral administration” did not change the Courts considerations, as the claim still concerned the salt per se and not a composition or preparation of it. Therefore, the first auxiliary request was also found to lack inventive step on the same basis as the claim as originally granted.

In regard to the claim according to the second auxiliary request, i.e., the salt in question for use in the treatment of cancer by oral administration, the Court concluded that the claim lacked support in the application as filed. Based on the fact that the application as filed in its’ entirety was related to the combination treatment, the mono treatment of cancer through oral administration was considered falling outside its scope and the claim as amended was considered as an unallowed intermediate generalisation.

The judgment brings clarity to a number of different patent law questions, including the assessment when it comes to inventive step in relation to routine pre-formulation tests of a known drug substance, as well as the criterions which are applied by Swedish courts for determining whether a claimed invention lacks support in the application as filed when it comes to intermediate generalisations.

As the patent was found to be invalid, the infringement claims were dismissed. The decisions of the Patent and Market Court  may be appealed. Leave for appeal is however necessary.

[See PMD’s decision of 25 January 2024 in cases PMT 15942-22 and PMT 17040-22]