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Finnish Market Court Rejects Applicability of Strong Presumption of Entitlement to Priority Right in Recent Rulings

25 September 2024

Authors: Vilhelm Schröder and Hilma Mäkitalo-Saarinen

Introduction

On 22 May 2024, the Finnish Market Court (the “Court") issued two judgments: one concerning the invalidation of a patent and its supplementary protection certificate (“SPC”), and the other addressing the alleged infringement of an SPC. Both cases arose from the same series of events, and the Court decided to hear them together in a single legal proceeding.

The Course of Events

Two inventors employed by DuPont Pharmaceuticals Company (“DuPont Pharma”) developed an invention for which a European patent FI/EP 1 427 415 (the “Patent”) was subsequently validated in Finland. In connection with this invention, the inventors filed a provisional US patent application.

In 2001, group companies of Bristol-Myers Squibb Company (”BMS Company”) acquired DuPont Pharma, which was later renamed BMS Pharma. The inventors transferred their rights to the provisional US patent application to BMS Pharma. In 2002, BMS Company submitted an international patent application for the same invention, claiming priority based on the original provisional US patent application.

The European Patent Office (“EPO”) granted patent FI/EP 1 427 415 to BMS Company, which was later assigned to Bristol-Myers Squibb Holdings Ireland Unlimited Company (“BMS”), also the holder of SPC number 443.

The first judgment of the Market Court focused on whether the right of priority had been validly transferred from the inventors to BMS Company. Plaintiffs Teva B.V. and Teva Finland Oy contended that patent FI/EP 1 427 415, which expired in 2022, did not properly claim priority from the provisional US application, as the transfer of rights had not been executed correctly. As a result, the plaintiffs requested that the Court declare both the patent and the associated SPC 443 invalid in Finland.

In the second case, BMS and Oy Bristol-Myers Squibb (Finland) Ab petitioned the Court for a ruling confirming that ratiopharm GmbH and Teva Finland Oy had infringed SPC 443 by marketing, importing, and holding Apixaban products. The plaintiffs also sought a preliminary injunction prohibiting the defendants from continuing these actions for as long as SPC 443 was valid. The preliminary injunction was initially granted by the Court by a separate decision.

Rulings

A key issue in the cases was determining which legal framework should govern the validity of the priority transfer. Teva contended that US federal law should apply, given that both the inventors and the involved companies were based in the US. Teva argued that for the priority transfer between BMS Pharma and BMS Company to be valid, it needed to be executed in writing before the subsequent application was filed. Since this procedure was not followed, Teva claimed the priority was invalid.

In contrast, BMS argued that the validity should be evaluated based on the strong presumption of entitlement to priority right established by the EPO’s Enlarged Board of Appeal in decision G 1/22 and G 2/22. BMS maintained that under this presumption, it bore no burden to prove the validity of the priority, rather, Teva was responsible for proving the absence of priority. Additionally, BMS proposed that the validity could alternatively be supported by an implicit agreement between BMS Pharma and BMS Company, as recognised in the G 1/22 and G 2/22 ruling.

The Court noted that decision G 1/22 and G 2/22 addressed the EPO’s authority to assess a party's right to claim priority under Article 87(1) of the EPC. It was also noted that the decision explicitly acknowledged that achieving uniform legal conditions across all contracting states is inherently unfeasible. Consequently, the Court found no grounds to apply the strong presumption of entitlement to priority right in this case.

The Court concluded that BMS Company did not have the right to claim priority, which rendered all patent claims lacking in novelty. Since there was no right to claim priority, the novelty of the Patent had to be assessed based on the level of prior art as of the filing date. The Patent lacked novelty because the content of international patent application no. WO 03/049681 A2, in conjunction with the general knowledge of a person skilled in the art, constituted an obstacle to the novelty of independent claim 1 as well as the associated dependent claims. As a result, the patent was declared invalid, and SPC 443, granted based on this patent, was also invalidated in accordance with Article 15(1)(c) of Regulation (EC) No 469/2009 on supplementary protection certificates for medicinal products.

Since SPC 443 was invalidated, the defendants, ratiopharm GmbH and Teva Finland Oy, could not be deemed to have infringed the certificate as alleged by the plaintiffs. Consequently, the plaintiffs’ claims were dismissed and the preliminary injunction previously ordered by the Court was lifted.

The rulings provide important clarification on the legal context following the G 1/22 and G 2/22 decision by the EPO, which had left unresolved whether the strong presumption of entitlement to priority right would apply in national courts. However, it could be noted that the Court's decision was not unanimous. The dissenting member noted that the Enlarged Board of Appeal’s recent ruling in cases G 1/22 and G 2/22 had overturned the previously established practice, which required that the right of priority was transferred before the filing of a subsequent application, unless all applicants from the earlier application were also applicants on the later one. The dissenting member argued that, under the new interpretation, it was sufficient for the transfer of priority to occur before the priority request, which could be done even after the subsequent application was filed, provided that national law did not impose stricter requirements. The dissenting member contended that the invention covered by the Patent did not lack novelty and that there were no grounds to declare the Patent invalid based on the reasons presented by Teva. The dissenting member also noted that similar claims had been initiated, for example, in France, Norway, and Sweden, but those claims had been rejected in the aforementioned jurisdictions.

The decisions are not final.

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