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On the requirements of an imminent patent infringement within the meaning of Art. 62 (1) UPCA
Local Division Düsseldorf, decision dated 06 September 2024, UPC_CFI_165/2024, UPC_CFI_166/2024 – Novartis / Genentech
In proceedings concerning the granting of provisional measures, the Local Division Düsseldorf had to deal with the question of when a patent infringement within the meaning of Art. 62 (1) UPCA is “imminent”.
Facts of the case
The Applicant is the proprietor of the patent in dispute, which relates to a pharmaceutical formula concerning antibody biosimilars. The Defendants belong to a group of companies. The Defendant in the parallel proceedings UPC_CFI_166/2024 is the parent company of Defendants 1) to 7) in proceedings UPC_CFI_165/2024. The parent company holds a 100% share in Defendant 1), which is responsible for marketing and distribution in Europe. Defendant 1) is a 100% shareholder in Defendants 2) to 7). The parent company has developed a biosimilar product containing the antibody omalizumab (hereinafter “attacked embodiment”), the phase III clinical trial of which was based on a settlement with the Applicant’s product containing the patented formula. Between July and October 2023, the Defendants filed actions for revocation of the patent in suit in several countries. In November 2023, a representative of the Defendant stated in a Korean healthcare news portal that the Defendant’s goal was to be the first company to supply this antibody biosimilar to major countries. Shortly thereafter, the Applicant sent an authorization enquiry to the Defendants. The Defendants replied that their product did not make use of the teaching of the patent in suit. Furthermore, the patent in suit was not legally valid. On 25 March 2024, the parent company published a press release in which it expressed its intention to launch the product on the European market as soon as possible if the European marketing authorization was granted. In the same month, the Defendants took part in a trade fair in Belgium, where they offered information about the attacked embodiment at their booth. On 10 April 2024, Defendant 2) sent an email to a potential customer informing it about the positive signal for an imminent granting of a marketing authorization and at the same time offering to keep him informed about relevant news.
The marketing authorization for the attacked embodiment was granted by the European Medicines Agency on 16 May 2024. The Defendants then published a further press release about the market authorization on 24 May 2024 and announced that they would rapidly expand their market share. The Applicant then applied for the adoption of provisional measures.
Decision of the Local Division
The Local Division rejects the application for provisional measures on the grounds that there is no imminent patent infringement within the meaning of Art. 62 (1) UPCA.
In order to assess whether a patent infringement is imminent, the overall circumstances of the specific case must be considered. There must be certain circumstances that indicate that the potential infringer has already created the complete conditions for the patent infringement to take place. The Applicant bears the burden of presentation and proof for this.
In the Local Division’s view, the decisive factor is therefore whether the Defendants’ conduct leads to the conclusion that it is highly likely that they intend to enter the market during the patent term without further ado. This is the case if the Defendants have made a concrete offer on the market. The Local Division denies this. It would have been necessary for the Defendants to advertise the product with all approvals and fixed prices so that customers could place an order. However, potential customers are familiar with the regulations in the pharmaceutical industry and know that only a vague statement on market entry is available if pricing has not yet been finalized.
Thus, from the Local Division’s point of view, not all conditions had been met for the product to be offered directly on the European market. However, the announcement after market approval was granted is not yet sufficient, as there was no specific timeframe for price negotiations or a situation in which samples were sent to potential customers, for example.
Conclusion:
The Local Division’s decision was issued in connection with pharmaceuticals, which must fulfill further regulatory requirements in order to enter the market. However, the question of when the actual indications of a competitor entering the market have become so concrete that the property right holder can take action against it on the basis of the so-called risk of first entry is of fundamental importance.
As the facts of the case here had to be treated in a special way, it remains to be seen to what extent a similarly strict standard should be applied in other factual constellations. In any case, the facts of the case should be examined in detail to determine whether all requirements have already been met or steps have been taken to offer the product directly on the market.