25 augustus 2023

LGGA Pharma Update - 25 Augustus 2023

On 15 August 2023, the Court of Appeal of The Hague (”CoA”) rendered its decision in the PI proceedings between Bristol-Myers Squibb Holdings Ireland Unlimited Company (“BMS’’) and Sandoz B.V. (“Sandoz’’), Centrafarm B.V. et al. (“Centrafarm”) & Teva B.V. et al. (“Teva’’). The CoA is of the preliminary opinion that EP 1 427 415 B1 (“EP 415”) makes the technical effect plausible, allowing post-published evidence to be taken into account. The CoA comes to its finding after the Enlarged Board of Appeal (“EBA’’) handed down its decision in G2/21. The likelihood of EP 415 being held valid in the pending final relief proceedings is high and therefore a PI against the generic companies is granted.
Making this case of particular interest is that two out of the three CoA Judges are also Appeal Judges in the UPC. This case may show the position the UPC may take on plausibility.

BMS is the owner of EP 415 and of SPC no. 300500 based on this patent (“SPC”). EP 415 was in force in the Netherlands until 16 September 2022. The SPC relates to apixaban or pharmaceutically acceptable salt forms thereof (marketed by BMS as Eliquis®) and is in effect from 17 September 2022 until 19 May 2026.

What preceded 

The first apixaban case in the Netherlands was the PI proceedings between BMS and Sandoz. The Provisions Judge of the District Court of The Hague (“PI Judge” rendered his decision on 10 May 2022. According to the PI Judge, there is no inventive step due to lack of plausibility and therefore a good chance that the patent (and the SPC) will be held invalid in final relief proceedings. A PI against the sale of generic apixaban by Sandoz was denied. No appeal was filed.

On 23 March 2023 the EBA decided case G2/21 on plausibility. It considered three questions about the circumstances in which it is permissible to rely on post-published evidence of a technical effect in support of inventive step. The EBA provides guidelines on whether or not to consider post-filed evidence.

The new PI proceedings

After the EBA ruling, BMS filed another interim relief proceedings against Sandoz and against Centrafarm. BMS requested the PI Judge to grant a PI against both generic companies, alleging infringement of the NL part of EP 415 and the related SPC. The key question was whether the G2/21 decision changed the position taken in the earlier preliminary judgement given on 10 May 2022 and what the standard of plausibility should be in the Netherlands for taking into account post-published evidence. According to the Provisions Judge, the G2/21 decision does not change the application of the concept of plausibility, as the EBA embraces the consistent line of case law of the Technical Boards of Appeal. Therefore, the PI request of BMS is dismissed.

BMS also filed interim relief proceedings against Teva before the same Provisions Judge, requesting a PI against Teva. In this case the Parties agreed that a judgement should be rendered identical to the judgment of 17 May 2023, so that all cases could subsequently be heard in the same appeal proceedings. The Provisions Judge rejected the PI against Teva on the same grounds as expressed in his  decision of 17 May 2023.

The main considerations of the CoA

The key question in the interim relief appeal proceedings is which criteria should be applied in order to decide whether or not post-published evidence can be accepted to hold a patent claim inventive (ab initio plausibility or ab initio implausibility) in light of the decision of the EBA in G2/21.

Unlike the Provisions Judge, the CoA holds the patent inventive. It finds that the post-published evidence can be taken into account. According to the CoA, the sole criterion in G2/21 for taking into account a technical effect when applying the PSA is 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. This entails that it is not obliged that the patent application always needs to provide ‘’proof’’ or needs to make plausible that the technical claimed effect actually occurs. This needs to be filled in on a case-by-case basis. The CoA refers to par. 77 of G2/21 to stress that the admission of post-published evidence is different in assessing inventive step when compared to assessing sufficiency of disclosure.

The circumstances of the apixaban case imply that on the priority date the average person skilled in the art could derive from the application, WO 652, that apixaban has the most advantageous effect as an fXa inhibitor. Therefore, the criterion as described in G2/21 has been met. The patent application disclosed more than a mere verbal statement of the technical effect so there is no reason for the skilled person in the art to doubt that the function of apixaban (an improved fXa inhibitor) could not be achieved (ab initio implausibility). There is no requirement that any evidence to that effect should be included in the application. The CoA stated that in the final relief proceedings in France and Norway, the Courts came to a similar conclusion based on the same reasoning. It is remarkable that the CoA explicitly considers the decisions of these countries as highly persuasive to the detriment of the UK High Court and Appeal Court decisions, which it distinguishes as being made on the basis of assessing sufficiency of disclosure. The CoA points out (sections 3.21-3.24) that in many countries invalidity proceedings have been instituted, some of which have been decided, others are pending, two of which in NL. 


mr. M.H.J. (Marleen) van den Horst

Advocaat & Partner

Mr. B. (Benjamin) Niemeijer

Advocaat & Partner

Bel: 0172-503 250