On 15 August, the Court of Appeal of The Hague (the Court) ruled for the first time on the inventive step test in patent law following the much-anticipated G2/21 decision on plausibility of the Enlarged Board of Appeal (EBA) of the European Patent Office. The multi-jurisdictional dispute centred on the interpretation of G2/21 in relation to the blockbuster blood thinner apixaban.
In short, the Court held that the only requirement set out in G2/21 is that the technical effect relied upon by the patent applicant or proprietor must be ‘derivable’ for the person skilled in the art from the technical teaching of the application documents. The Court held that the patent in question prima facie survived this test and therefore imposes a preliminary injunction against three generic companies.
Background: marketing generic versions of blood-clot drug apixaban
The dispute that led to this decision concerns the active ingredient apixaban, a blood thinner (anticoagulant) marketed by pharmaceutical company Bristol Myers Squibb (BMS) under the name 'Eliquis®'. Generic companies Sandoz, Stada and Teva allegedly infringed BMS' apixaban Supplementary Protection Certificate (SPC) based on patent EP 1 427 415. The generics raised an invalidity defence, which yielded several failed attempts by BMS to obtain a preliminary injunction in the Netherlands prior to the decision in this case.
At first instance, the preliminary injunction judge of the District Court of The Hague took the position that the technical effect of apixaban - as an improved inhibitor of factor Xa (which helps prevent the formation of blood clots) - is not derivable from the application as filed. At best, the person skilled in the art derives that the compounds described therein are suitable as factor Xa inhibitors, according to the first instance judge. Among other things, the PI judge noted that the application claimed a multitude of compounds (140 examples, many of which logically did not show improved inhibition at all), and that there was no clear indication for the skilled person that apixaban was the compound of special interest. BMS appealed and the Court consolidated the proceedings against the three generics.
Court’s decision: the test according to G2/21 is met by BMS’ patent
The Court overturned these previous first-instance rulings and ordered Sandoz, Stada, and Teva to withdraw their generic versions of apixaban from the Dutch market effective immediately. The Court agrees with BMS that the only requirement set out in G2/21 for being allowed to take into account a technical effect - as determined in applying the problem-solution approach by comparing the invention disclosed in the patent with the closest prior art - when formulating the objective technical problem and assessing inventive step on that basis, is that “for the skilled person, using his common general knowledge in the art, it is ‘derivable’ from the application on the priority date that the claimed technical effect is encompassed by the technical teaching thereof and embodies the same invention disclosed therein” (paragraph 6.6). The - according to the EBA - ‘generic catchword’ plausibility does not appear as a distinctive legal concept or requirement in the Court’s decision.
Applied to this case, the Court finds that the person skilled in the art can derive from the patent application that (i) the asserted technical effect of the invention was finding a compound with improved factor Xa inhibition and (ii) apixaban was the most promising compound in that respect. The Court held that the skilled person would note that apixaban was the only compound synthesized on a large scale and recrystallized twice, yielding a quantity and purity required for further development. As such, the test according to G2/21 is met by BMS’ patent according to the Court.
In (prima facie) upholding the validity of the patent, the Court sided with, amongst others, courts in France and Norway. However, in parallel proceedings the UK court found that the technical effect had not been made plausible in the application as filed. In Dutch case law, it was common practice that, when formulating the objective technical problem, the technical effects of the invention claimed by the patentee could only be taken into account if the skilled person, given what was disclosed in the original application and his common general knowledge, would have found it plausible at the relevant date that those effects occur. With this decision, the Dutch Court gives an interpretation of G2/21 that seems a bit more patentee-friendly than that of the UK Court of Appeal.
As such, the decision could be good news for patent owners. At least for the time being, as it seems plausible (…) that the Court's decision will be challenged before the Dutch Supreme Court. In addition, merits proceedings are pending before the District Court of The Hague with court hearings coming up in Q4-2023 and Q1-2024. Clearly, we haven’t heard the last of this, as BMS' apixaban SPC does not expire until May 2026.
Ruling of the Court of Appeal of The Hague:
- The Court’s preliminary decision of 15 August 2023 (in Dutch)