On 30 October 2024, the District Court of The Hague handed down two judgments in proceedings on the merits between Bristol-Meyers Squibb (“BMS”) against Sandoz and Teva respectively, in which Sandoz and Teva had claimed the invalidation of BMS’ compound patent for apixaban and the related supplementary protection certificate (“SPC”). In both cases, the District Court applied the G 2/21 test of the Enlarged Board of Appeal and held that the skilled person, in light of the common general knowledge and based on the application as originally filed, would derive the technical effect of improved Factor Xa inhibition, relied on by BMS for inventive step, as encompassed by the technical teaching and embodied by the same originally disclosed invention. As a result, Sandoz’ and Teva’s invalidity arguments were dismissed and an injunction against Sandoz was awarded.

BMS is the proprietor of EP 1 427 415 B1 (“EP 415”), which expired on 16 September 2022, and SPC (No 300500) based on this patent, which is in force until 19 May 2026.

In 2023, the The Hague Court of Appeal had granted BMS a preliminary injunction against Sandoz, Stada and Teva for marketing generic apixaban, dismissing the invalidity arguments which had been raised by the generic parties. Now, the District Court of The Hague has decided this case in proceedings on the merits. The central question to be answered by the District Court concerned (lack of) inventive step, in particular whether BMS may rely on the purported technical effect of improved Factor Xa inhibition for inventive step. This effect is relevant in the context of the problem and solution approach normally applied in the assessment of inventive step. It forms the basis for the formulation of the objective technical problem solved by a patent, and therefore for the assessment of the question whether the solution, offered by the patent, to such problem was obvious or not.

Decision of the District Court

According to the District Court, the original application teaches the skilled person the following:

• The skilled person understands that the focus of the application is on Factor Xa inhibitors and derives this from the emphasis on Factor Xa placed under “field of the invention” and “under background of the invention” in the description of the prior art and in the description of the role and importance of Factor Xa in the blood clotting process.
• The skilled person also understands that the application aims to provide not only new, but also improved Factor Xa inhibitors compared to the prior art, including WO 131 which is mentioned in the application. This is also explicitly stated under “background of the invention”.
• In view of the word “accordingly” under “summary of the invention”, the skilled person will understand that this refers back to what was previously mentioned under “background of the invention” (namely that it is desirable to find new compounds with improved (pharmacological) properties, namely improved Factor Xa inhibitory activity and selectivity for Factor Xa and in addition other favourable and improved pharmacological properties). Moreover, the skilled person will understand from the word “accordingly” that by providing the new lactam-containing compounds, the inventors have succeeded in this objective.
• The application discloses these lactam-containing compounds by their chemical names and the skilled person, based thereon, understands that and how the inventors actually synthesised them. The skilled person knows on the basis of this common general knowledge and the information provided in the application that a compound’s affinity for Factor Xa can then be tested easily and quickly and will also assume that this has been done for those compounds disclosed in the application. Moreover, the skilled person knows that the most preferred compounds of the application have a Ki value in the nanomolar range.
• According to the District Court, under these circumstances, it is not required that the application also discloses test results or other evidence.

The District Court considered, based on the factors mentioned above, that the technical teaching of the application concerns the provision of the lactam-containing compounds disclosed in the application as improved Factor Xa inhibitors (i.e. improved inhibition of and selectivity for Factor Xa). The District Court decided that the skilled person, based on the application, will derive the technical effect on which BMS seeks to rely for inventive step (i.e. apixaban’s improved Factor Xa inhibition) as encompassed by this technical teaching and as embodied by the same originally disclosed invention.

As a result, BMS is allowed to rely on this technical effect in support of the inventive step of its patent, and it is allowed to rely on post-published evidence in further support of its claim that this effect actually occurs (and that the objective technical problem has been solved by the patent). The District Court followed BMS in its conclusion that the selection of apixaban from a broader range of compounds disclosed in the prior art involves an inventive step and upheld the Dutch part of EP 415 and the SPC.

Concluding comments

The decision is a case specific interpretation/application of the G 2/21 test. In this case, the District Court held that the fact that the improved Factor Xa inhibitory effect of apixaban could be taken into account, in spite of the fact that the application contained no test results or other data showing that apixaban indeed had such effect. In another case, with different circumstances, it may well be that test results would be required, for example if the common general knowledge and prior art contain pointers away from the technical effect, which pointers would cause the skilled person to doubt the technical effect without the disclosure of test results in the application.

Furthermore, in our view, the determination of the technical teaching of the patent is based on a combination of rather indirect circumstances. Also, the District Court attached great importance to the word “accordingly” and it is at least debatable whether the skilled person would share the District Court’s interpretation. In any case, we believe that the District Court’s interpretation of G 2/21 and its application in a specific case will require some further refinement in order to truly close the door for speculative patents.

Also worth noting is that, although these decisions from the District Court of The Hague seem to be in line with (merits) decisions of French, Norwegian and Swedish courts in parallel cases, the test applied in these decisions appears based on a somewhat different interpretation of G 2/21. Furthermore, the English Courts and of the Irish Court have held the patent to be invalid. According to the District Court, the different outcome is explained by the fact that the English courts based their decision on the English Supreme Court’s decision in the Warner-Lambert (pregabalin) cases. However, the The Hague District Court’s decision does not mention that Lord Justice Arnold also dealt extensively with G2/21 and applied the ‘derivability’ criterion from G 2/21 differently from the District Court of The Hague. It is remarkable and arguably also undesirable that courts in different EPC states both apply the G 2/21 decision to the same set of facts but arrive at different outcomes.