Posted by Laura Ercoli on Wednesday October 9th, 2024

Imminent infringement of a medicinal product under UPC rules: an interesting decision – C. Germinario

The Düsseldorf Local Division of the Unified Patent Court has issued an order that offers useful guidance on how a patent holder’s claim of “imminent infringement” of a patented medicinal product is to be assessed according to UPC rules, as briefly explained by Claudio Germinario.

On 6 September 2024, Düsseldorf’s Local Division of the Unified Patent Court issued order UPC_CFI_165/2024, providing some guidance on interesting aspects of patent infringement in the area of medicinal products, in relation to generic and biosimilar drugs.

A declaration of patent infringement may be issued if the following conditions are met: i) the allegedly infringing product must be identical to the product that is the subject of a claim (which is normally the original medicinal product) and ii) the product must be the subject of one of the actions listed in Art. 25(a) of the Unified Patent Court Agreement (UPCA). Alternatively, the alleged infringer must have carried out preparatory acts unequivocally proving its intention to carry out in the immediate future one of the acts that constitute infringement (Art. 62(1) UPCA).

The first condition – that the allegedly infringing product is identical to the original product – is automatically satisfied in the case of generic medicines and most likely satisfied in the case of biosimilar medicines.

The second condition is also easily satisfied when the generic and/or biosimilar medicine is already available on the market.

Assessing a so-called “imminent infringement” pursuant to art. 62(1) UPCA is not quite as straightforward.

The launch on the market of a medicine, whether original, generic or biosimilar, requires a certain number of scientific, administrative and public/commercial steps. In detail: positive outcome of the clinical trials; grant of a Marketing Authorization (M.A.); negotiating sale price with the Health Authority, establishing the conditions of reimbursement by the National Health System; presenting the new drug to the relevant medical personnel and at specialist public conferences; offering for sale through the usual commercial channels, for instance online or directly to an interested party, or through participation in hospital tenders.

Which of these actions can amount to an imminent infringement justifying an order for preliminary measures is a question for which the Local Division of the UPC of Düsseldorf seems to provide some answers.

Preliminarily, we must point out that according to established national case law of several European Union states, including Italy, simply obtaining a M.A. for a generic medicine does not in itself constitute an infringement of the original medicine’s patent. This obviously implies that, in principle, none of the preparatory steps (pre-clinical and clinical trials, request for a M.A.) necessary to obtain the M.A. represents an infringement in itself.

The facts in the case

The context of the facts underlying the Düsseldorf order involved a biosimilar medicinal product (a monoclonal antibody); the alleged infringer did not dispute the fact that the product was identical to the corresponding “original” antibody. The M.A. for the same therapeutic application had already been obtained.

The alleged infringer had promoted its biosimilar product at a specialist conference, specifying that a M.A. had already been granted. Negotiations with the competent Health Authority for the definition of price and reimbursement conditions were also apparently under way in some EU countries where the launch was expected for the end of 2024. Preliminary business contacts with potential buyers had started, by offering samples of the medicinal product for medical evaluation, but without naming a date for the commercial launch of the medicinal product.

The court’s findings

In spite of the above preparations having taken place, the Local Division of Düsseldorf did not find in favour of an imminence of infringement.

The Court pointed out that for a patent infringement to be considered imminent, there must be concrete indications of imminence in the general circumstances. A situation of imminent infringement must be characterised by certain circumstances which indicate that the infringement has not yet occurred, but that the potential infringer has already created the conditions for it to occur. The infringement is ready to happen, as all preparations for it have been successfully completed.

In other words, only a concrete offer for the sale of a medicinal product generating a demand that can be promptly satisfied, respecting all regulatory and administrative requirements, can constitute imminent infringement.

On the basis of the evidence and testimonies submitted in the case, the Court concluded that the price negotiation procedure with the Regulatory Authority and the definition of the conditions for reimbursement by the public Health System had not yet been finalized and therefore that the alleged infringer was not in a position to promptly supply the medicine yet.

If this order is confirmed by other judgments, one could conclude that not only the obtaining of a M.A., but also other preliminary additional public/commercial activities such as the promotion of the medicine at conferences or the offer for (future) sale may be insufficient to substantiate the case of “imminent infringement”, when not all steps necessary for the market launch have actually been completed.