Grünenthal and Freshfields win injunction against Teva testosterone drug

In the Netherlands, German pharmaceutical company Grünenthal has been successful in preliminary relief proceedings against Teva over long-acting testosterone drug Nebido (case ID: C/09/653142). The medicine’s active substance is testosterone undecanoate, which doctors prescribe to treat long-term testosterone deficiency, or hypogonadism, in men. It is administered every ten to 14 weeks via intramuscular injection.

Grünenthal acquires Bayer patent

According to the Summary of Product Characteristics (SmPC), part of the marketing authorisation which describes and approves a medicine’s specific properties and application, Nebido is presented in an ampoule or injection vial containing four ml of solution. This contains 250 ml dissolved in castor oil and co-solvent, benzyl benzoate (BzBzo). The medicine contains 2000 mg of BzBzo in total.

Originally Bayer AG developed Nebido, with Grünenthal GmbH acquiring its production and sales in 2022. Since February 2023, the Dutch Patent Office (OCNL) has registered the German company as the holder of EP 1 457 208, “Methods and pharmaceutical compositions for reliable achievement of acceptable serum testosterone levels”. Grünenthal B.V. also holds the Dutch marketing authorisation for Nebido. The patent expires in March 2024.

Beware generic launch

In December 2022, Teva was granted a Dutch marketing authorisation to market a generic version of Nebido, named ‘Testosterone Teva’. With its similar SmPC, however, Grünenthal accused it of infringing EP 208 with its planned launch of the generic drug in the Netherlands. Teva sought a dismissal of the claims and ordered Grünenthal to pay the costs of the proceedings. It also argued that there was a ‘serious, non-negligible chance’ that the court would invalidate EP 208 in future proceedings on the merits, in reference to parallel judgments in the UK and Germany.

However, the court concurred with the claimant, judging that Teva is infringing the patent and rejecting Teva’s invalidity defence based on lack of inventive step, plausibility and sufficiency of disclosure. Teva also argued that the court cannot base an injunction on limited claims in preliminary injunction proceedings. However, registration of the limited claims by Grünenthal in the Dutch patent register rendered this defence irrelevant. Teva intends to appeal the decision.

In interim proceedings on 13 September, the interim relief judge had previously ordered Teva to remove its product from the October 2023 G-Standaard. For the summary judgment proceedings not to lose effect, the claimant has to issue proceedings on the merits within six months. By this time, the patent will have expired.

Invalidated elsewhere

This is not the only recent decision concerning the two patent, however. In February 2023, the Federal Patent Court in Munich invalidated the German part of EP 208, as well as several requests for relief, due to lack of inventive step starting from the Von Eckardstein prior art (case ID: 3 Ni 21/21 (EP)).

Rutger Kleemans

In July 2023, the UK High Court invalidated the English part of EP 208 at first instance as insufficient for lack of plausibility (no case ID yet available) and confirmed its non-obviousness.

However, since the Netherlands has not yet heard a case on the merits between Grünenthal and Teva, case law dictates that the court takes into account the German and UK approaches.

The defendant advanced the argument that, since both courts found the Grünenthal patent invalid, it followed that the Dutch court should throw out the case for infringement.

But the Dutch court countered that this argument was irrelevant, since the Dutch patent has narrower claims than in the German and English proceedings. The judge also argued that the debate in the Netherlands concerns different issues than the other jurisdictions. It also considered the EPO’s recent findings in G2/21.

G2/21 in consideration

Similar to the recent Court of Appeal ruling in the case between Bristol-Myers Squibb and generic drug companies Sandoz, Stada and Teva regarding apixaban, the court considered the EPO’s recent decision on plausibility in G2/21. In the apixaban case, the court reached the preliminary decision that, after the Enlarged Board of Appeal handed down its G2/21 judgment, the likelihood of EP 415 being held valid in the pending nullity proceedings was high. Thus, the court granted a PI against the three generics companies.

Likewise, in the present case, presiding judge Margot Kokke concluded that “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… it is not necessary for the patentee to provide proof, or make it plausible in summary proceedings, that the technical effect works with at least the majority of the claimed compositions.”

Arvid van Oorschot

Leading Dutch firms

So far, Grünenthal has appealed against the German judgment. JUVE Patent has no information with regard to the current status in the UK.

While Freshfields Bruckhaus Deringer’s omnipresent partner Rutger Kleemans was once again visible in the case for Grünenthal, associate Allard van Duijn led proceedings. Martin Klok, patent attorney of V.O., acted alongside the Freshfields team.

Teva turned to regular advisor Vondst, and leading partners Arvid van Oorschot and Otto Swens, to assist it in proceedings. Jeannette Verbart, partner at De Vries & Metman, acted as the lead patent attorney on the side of Teva.

For Grünenthal
Freshfields Bruckhaus Deringer (Amsterdam): Rutger Kleemans (partner); associate: Allard van Duijn (lead)
V.O. (Amsterdam): Martin Klok (partner, patent attorney)
In-house (Aachen): Florian Dehmel (head of global patents and trademarks), Ulrike Albus (senior counsel patents and trademarks)

For Teva
Vondst (Amsterdam): Otto Swens, Arvid van Oorschot (both partners); associates: Steven Moonen, Merel Hendriks
De Vries & Metman (Amsterdam): Jeannette Verbart (partner, patent attorney)

District Court of The Hague, the Netherlands
Margot Kokke (presiding judge)