On 30 October 2024, the District Court of The Hague ruled in two separate final relief proceedings that EP 1 427 415 B1 (“EP 415”) and the SPC of Bristol-Myers Squibb (“BMS”) on apixaban are valid and, in the case of Sandoz infringed (BMS/Sandoz and Teva/BMS). With these rulings, the NL District Court allows post-published evidence. G2/21 (plausibility) and G1/22 and G2/22 (priority) are taken into account.
What preceded: interim relief (PI) proceedings
The first PI decision on apixaban in the Netherlands goes back to 10 May 2022 when the Provisions Judge of the District Court of The Hague denied a PI, requested by BMS against the sale of generic apixaban by Sandoz.
After the decision in G2/21 of 23 March 2023, BMS started new PI proceedings against Sandoz and STADA/Centrafarm, later also against Teva. In separate decisions of 17 May 2023 and 31 May 2023, the Provisions Judge again ruled in favour of the generic companies and denied the requested PI, stating that G2/21 did not change the position regarding the rejection of post-published evidence. The Provisions Judge assessed it as likely that the claims of EP 415 would not be considered inventive due to lack of plausibility in final relief proceedings.
All decisions were appealed by BMS. Contrary to the Provisions Judge, the Court of Appeal (CoA) held EP 415 inventive and found that the post-published evidence could be taken into account when assessing inventive step. Reference is made to our Pharma Update of 25 August 2023.
Two NL final relief (invalidity) proceedings
The final relief proceedings which have now been decided, were initiated well before the PI proceedings, but delayed in view of G2/21.
Priority in view of G1/22 and G2/22
The Court first considers the attack on priority. The generic companies argued that BMS cannot rely on priority document US 165 because, at the date of filing of the EP 415 application, the applicant (BMS Company, the predecessor of BMS) was not the holder of priority document US 165. The transfer of US 165 from the holder of the priority document to the applicant of EP 415 did not take place until several years after the filing of the EP 415 application.
In its judgment, the District Court refers to G1/22 and G2/22, in which the EBA stated that, under the EPC, the holder claiming priority is presumed to be entitled to rely on the priority document claimed. This presumption also applies where the European patent is derived from an international (PCT) application and/or where the applicants of the priority document are different from the applicant of the subsequent application. The burden of proof to rebut this presumption lies with the party contesting the right to priority. With regard to G1/22 and G2/22, the Court finds that implicit consent to the transfer of priority rights is sufficient. As the EBA considers the possibility of a nunc pro tunc transfer of priority rights, the Court concludes that, in this case, the deed of transfer after the filing date can be relied on to claim priority and the generic companies failed to provide sufficient evidence to rebut the presumption of priority.
Plausibility in view of G2/21
In light of the inventive step attack brought by the generic companies, the main issue in the final relief proceedings is whether BMS can rely on a claimed technical effect for inventive step. The Court first applies the PSA as set forth in G2/21 and then analyses if for the skilled person, having the common general knowledge in mind, and based on the application as originally filed, said technical effect is derivable as being encompassed by the technical teaching and embodied by the same originally disclosed invention. Like the CoA, the District Court considers that, in view of the decision in G2/21, there is no obligation that the patent application must always “prove” or make plausible that the claimed technical effect actually occurs. The District Court concludes that the claimed technical effect is disclosed, inter alia, in one of the preferred embodiments mentioned in the patent application. It therefore admits BMS’s post-published evidence and finds that the post-published evidence shows an improvement in the technical effect.
Other jurisdictions
The Court further notes that also in France, Norway and Sweden EP 415 was held valid, albeit following a different line of reasoning. The English High Court ruled differently because – according to the Dutch Court – it applied a different test (plausibility in the context of sufficiency) as set forth the Supreme Court’s decision in Warner- Lambert. Likewise the Irish Court. Multiple invalidity proceedings on EP 415 are still pending, e.g. in Bulgaria, Czech Republic, Denmark, Finland, Hungary, Italy, Croatia, Poland, Portugal, Slovakia, Spain and Switzerland.
Conclusion
The decisions show that depending on the circumstances, post-published evidence may be admissible if the technical effect is derivable for the skilled person from the application as filled and is part of its overall technical teaching. Earlier, in Insud Pharma / Galenicum, the Court of Appeal of The Hague had decided that post-published evidence may be rejected if the technical effect is not derivable from the application.
The decisions also show that the rebuttal of the presumption of priority as presented in G1- and G2/21, along with the subsequent decisions of the Court of The Hague, remains a very challenging proposition in practice.
