Posted by Laura Ercoli on Friday October 11th, 2024

A close look at the competence over pharmaceuticals of Milan’s UPC Central Division

The areas of competence of the Milan section of the Unified Patent Court’s Central Division have been established by a specific amendment of UPC law; as far as pharma patents are concerned, Milan’s competences may be broader than they appear at first glance, depending on how the wording of relevant UPC laws and rules of procedure is interpreted.

The Milan section ofthe Central Division of the Unified Patent Court (UPC) opened its doors on 27 June 2024. At long last, the three sections of the UPC’s Central Division are now operational, the other two based in Paris and Munich respectively.

The delay was caused by difficulties in reassigning the central division seat originally based in London; these were overcome, after much discussion, by amending the UPC’s fundamental law: the Unified Patent Court Agreement, hereinafter UPCA.

Which cases will the Milan Central Division be dealing with?

According to the amended version of the UPCA, the competences between the Central Division sections in Milan, Paris and Munich are shared as follows according to the International Patent Classification (IPC) sections to which the patent is assigned:

Milan: IPC section A (human necessities, without Supplementary Protection Certificates – hereinafter SPCs).
Paris: IPC sections B (performing operations, transporting), D (textiles, paper), E (fixed constructions), G (physics), H (electricity), and all SPCs, regardless of whether the relevant medicinal product falls under section A or section C.
Munich: IPC sections C (chemistry, metallurgy, excluding SPCs) and F (mechanical engineering, lighting, heating, weapons, blasting).

Therefore, Milan is competent for patents pertaining to section A (“Human necessities”) of the IPC, excluding SPCs, which remain under the competence of Paris.

It should be noted that section A is not limited to pharmaceutical patents but encompasses rights related to additional and diverse sectors, including agriculture, food products, tobacco, sanitary and medical-veterinary articles, household items, sports, and toys.

This varied range of subjects offers Milan a unique opportunity to consolidate its leadership position in various industrial sectors on one hand, and to venture into partially unexplored patent sectors on the other, becoming a reference point for disputes involving new technologies. Milan could attract cases related to innovative food products and processes, such as those connected to the production of synthetic meat, disputes concerning medical devices, or technologies for household cleaning, which are increasingly being entrusted to advanced devices.

So far, Paris appears to have been busier than Munich, receiving 37 revocation actions, 1 infringement action and 1 action for a declaration of non-infringement, while Munich has only received 5 revocation actions. Newly opened Milan has already received 3 revocation actions, 1 infringement action and 1 application for provisional measures (see Case Load of the UPC up to end September 2024).

Interestingly, figures show that the vast majority of revocation (i.e. validity) actions – for which the Central Division is indeed competent – involve patents falling under section A of the IPC, which are to now in the domain of Milan.

Pharma Patents with no SPCs: the issue of interpretation

Although Milan is now competent for patents classified under IPC Section A, including pharmaceuticals and medical devices, jurisdiction over patents with SPCs remains with Paris.

Since most marketed pharmaceuticals do have SPCs, a crucial issue turns on the interpretation of the wording used in amended Annex II of the UPCA for the reallocation of the competences to Milan i.e. “Human necessities, without Supplementary protection certificates”.

Will all the patents with a pending or granted SPC be left to Paris or just the patents for which the basic patent is expired and the SPC is in force?

If the Milan Central Division is competent over the validity/declaration of non-infringements of basic patents, irrespective of whether they are subject to an SPC, Milan could play a decisive role in ruling on important pharma cases.

Moreover, pharma patents are usually classified in both Section A (Human necessities) and Section C (Chemistry) of the IPC. This could potentially raise a further issue about the allocation of pharma patents to the competent Section of the Central Division. In fact, according to the Rules of Procedure of the UPC (in particular Rule 17), the Registry is to assign the case based on the first classification of either the single patent or, where the action involves more than one patent, the first patent listed in the statement of claim, according to Annex II of the UPCA.

Might pharma cases therefore become a bone of contention between the Milan and Munich section? Time will no doubt tell, and we will be reporting developments of interest.

This news item is based on the full article, authored by Mario Pozzi of SIB LEX with our Davide Rondano and Sofia Santoro, published by the IP Watchdog: The Best is Yet to Come: The Milan Section of the UPC Central Division Opens Its Doors.