23 October 2023

LGGA Pharma Update - 23 October 2023

On 3 October 2023, the Provisions Judge of the District Court of The Hague rendered its decision in the PI proceedings between Grünenthal GmbH. et al. (“Grünenthal’’) and Teva B.V. et al. (“Teva’’). The Provisions Judge (“PI Judge”) is of the preliminary opinion that EP 1 457 208 B9 (“EP 208”) makes the technical effect plausible and is inventive. The likelihood of EP 208 being held valid in final relief proceedings is high and therefore a PI against Teva
is granted. Making this case particularly interesting is that in parallel final relief proceedings, courts in Germany and the United Kingdom have found EP 208 invalid. The PI Judge (who is also a Judge in the Dutch local division of the UPC) is of the preliminary opinion that the plausibility standard in the Netherlands is different from that in the UK, referring to the recent PI decision of the Court of Appeal in the Apixaban case.

Grünenthal is since July 2022 the owner of the Dutch part of EP 208 that is in force in the Netherlands until 14 March 2024. It markets the patented drug, which is a long-acting testosterone drug, under the name ‘Nebido’.

What preceded 

After Teva received a Dutch marketing authorisation for its generic product called ‘Testosterone Teva’ in December 2022, Grünenthal sent warning letters to Teva in February and April 2023, Teva did not respond until 24 August 2023 when it notified Grünenthal that it planned to enter its generic product in the G-Standaard of October 2023. Grünenthal initiated PI proceedings against Teva before the District Court of The Hague, accusing Teva of infringing EP 208.

The interim claim in the PI proceedings 

A first, interim hearing was held on 12 September 2023 dealing with the incidental (provisional) claim of Grünenthal, requesting the PI Judge to order Teva to withdraw the listing of its generic product from the October G-standard in order to avoid it being published. 

The PI Judge handed down its interim decision on 13 September 2023, ordering Teva to withdraw its product from the October 2023 G-Standaard. According to the PI Judge, Grünenthal has a profound interest in maintaining the status quo as Teva is not yet on the market (nor any other generic) nor listed in the G-Standard, so no price erosion has taken place yet. The fact that Teva chose to ignore the warning letters is explicitly taken into account in the ultimate balance of interest in favour of Grünenthal.

The main claims in the PI proceedings 

On 26 September, the second oral hearing on the main claims was held. Grünenthal claimed that EP 208 is (about to be) infringed and is seeking a PI prohibiting manufacturing and distributing the generic product and an injunction against unlawful conduct. 

The PI Judge rendered its decision on the main claims on 3 October 2023, finding the Dutch part of EP 208 provisionally valid and infringed. According to the PI Judge the Dutch part of EP 208 and the Dutch PI proceedings differ from the German and English final relief proceedings because: i) the claims of Dutch part of EP 208 have been substantially limited by Grünenthal during the Dutch PI proceedings, ii) the statements presented, the expert evidence and substantive debate were not identical and iii) the Dutch plausibility standard in the light of inventive step, after G2/21, differs from the plausibility standard in the UK.

In formulating the Dutch plausibility standard, the PI judge refers to the G2/21 decision and to the recent decision of the Court of Appeal in the Apixaban case (section 4.35-4.43). which we have discussed in our Pharma Update of 25 August. The PI judge mentions that the plausibility criterion formulated by the Enlarged Board of Appeal in G2/21 is an abstract criterion. It must be filled in based on the specific circumstances of the case. This leads the PI Judge in section 4.41 to consider: “In applying the G2/21 test when assessing the inventive step of a claim in which the technical effect is not included as a feature, unlike the referral from Teva to the TBA case Agrevo, it is not necessary for the patentee to provide proof, or make it plausible in PI proceedings, that the technical effect works with at least the majority of the claimed compositions.” 

The PI Judge observes that the outcome could have been different if Teva had made it plausible that the person skilled in the art, based on the application, could not derive, or has reasons to question that the technical effect would occur over the full breadth of claim 1 as limited in the Dutch part of EP 208.

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

Attorney at Law & Partner

I. E. H. M. (Iris ) Arts

Attorney at Law

Call: +31 172 530 250