Setterwalls has successfully represented a client in a case of invalidation of a patent on sleep medicine

Setterwalls has once again successfully represented a pharmaceutical company in a patent dispute, this time regarding a patent on a sleep medicine. The ruling from the Swedish Patent and Market Court clarifies, among other things, the conditions for declaring a patent invalid on based on lack of sufficiency and the plausibility requirement imposed under Swedish law.

In January 2020, the pharmaceutical company represented by Setterwalls was sued for alleged infringement of a European patent. The patent concerned the use of the active substance melatonin in the treatment of certain types of insomnia. As Setterwalls reported earlier (see here and here), the Patent and Market Court rejected the patent holder’s interim injunction claims , and the Patent and Market Court of Appeal chose not to grant leave to appeal. In connection with the patent subsequently being finally revoked at the EPO, meaning that the question of the patent’s validity was finally settled also for Sweden, the client company withdrew its action, and the court ordered the patent holder to reimburse the client company for its legal costs, in accordance with current practice.

In the summer of 2021, the patent holder was granted a new patent, based on a divisional patent application derived from the patent that had previously been examined.  The divisional also considered the use of melatonin for the treatment of certain types of insomnia. The patent holder, citing the divisional, sued the client company for alleged patent infringement once again. The patent holder also sought compensation for the infringement. The client company, in turn, sued the patent holder, claiming that the divisional should also be revoked for lack of sufficiency, lack of novelty or under all circumstances lack of inventive step. In parallel with the Swedish cases, opposition proceedings at the European Patent Office has been ongoing.  However, the European Patent Office has not yet announced a decision in the parallel opposition proceedings.

After a main hearing in January 2023, the Patent and Market Court has now issued its ruling, whereby the court invalidates the divisional with respect to Sweden.

In past court rulings, the bar for a patent holder to overcome an invalidity attack based on lack of sufficiency has been low. Despite this, the divisional in suit was declared invalid due to lack of sufficiency.

In the reasons for its decision, the court concludes that, based on the description and examples in the patent, the skilled person would have had serious doubts about the effect of the melatonin formulation for patients younger than 55 years of age.  According to the patent, the alleged invention covered all patients suffering from the type of sleep disorder in question, regardless of the patient’s age. These serious doubts could not be overcome by the patent holder, even when considering post-published evidence submitted and relied upon by the patent holder in the case. Against this background, the Court found that the patent had not made it likely that the technical effect of the alleged invention would be achieved for the entire patient population claimed. Accordingly, the Court found that the alleged invention under the patent was sufficiently disclosed.

As the Court annulled the patent based on lack of sufficiency, there was no need to examine the other grounds for invalidity raised in the case as well. The client company was also fully reimbursed for its legal costs in the invalidity case.

Since the patent was declared invalid, there was also no need for the Court to consider the issues in the infringement case, other than the question of infringement itself under the assumption that the patent would be valid. That issue was not contentious between the parties, but was for procedural reasons subject to an intermediate ruling pending the final outcome of the case concerning the validity of the patent.

In summary, the Patent and Market Court has in a clear and welcome way clarified the conditions for applying lack of sufficiency under Swedish law. The court’s clarifications regarding which plausibility requirement should be applied under Swedish law when it comes to lack of exercise instructions are also welcomed.

See PMD’s judgment of 8 March 2023 in case no. PMT 14011-21 and PMT 2895-22.