BMS scores another win against Sandoz and Teva over apixaban in Den Haag

In its recent ruling, the District Court of The Hague comes to the conclusion, that Sandoz’ generic product infringes Bristol-Myers Squibb’s EP 1 427 415 and a corresponding supplementary protection certificate, which is valid until 2026. The judges also considered the patent to be valid and rejected revocation claims by Sandoz and Teva (case IDs: C/09/643554 and C/09/624883).

EP 415 and the SPC cover the compound apixaban, which the innovator company markets under brand name Eliquis. By thinning the blood, the drug can help treat thromboembolic disorders such as blood clots, especially following hip or knee surgery.

Eliquis is one of Bristol-Myers Squibb’s most important blockbuster products, and for several years now a dispute has been raging throughout Europe over the market entry of generic products containing the active ingredient apixaban.

Win in PI and on the merits

In May 2022 the District Court of The Hague rejected a PI brought by Bristol-Myers Squibb against Sandoz. The innovator did not appeal this decision.

However, after the Enlarged Board of Appeal of the EPO handed down its ruling in G 2/21 on plausibility, Bristol-Myers Squibb brought new PI proceedings against Sandoz, Stada and Teva in spring 2023. After it was again rejected in the first instance, the Court of Appeal in The Hague ruled in August of the same year that all three generic drug manufacturers’ products infringe Bristol-Myers Squibb’s apixaban SPC (case IDs: 200.327.532/01 and 200.327.173/01).

The appeal court banned the generic companies from registering their apixaban products on the so-called ‘G-Standaard’. This is tantamount to a sales ban in the Netherlands, because the G-Standaard is an online drug database which lists all products dispensed or used by Dutch pharmacies.

Appeals are pending

Following the Court of Appeal decision in the PI proceedings the generic drug manufacturers ceased to sell their products in the Netherlands. However, appeals against this PI decision filed by Sandoz and Teva are pending at the Supreme Court. The opinion of the Advocate General is due on 22 November.

Meanwhile, the dispute took its course on the merits, resulting in the recent decision by the District Court of the Hague. Sandoz intends to appeal. Infringement actions on the merits against Teva and Stada are still pending.

Up to Supreme Court

Hogan Lovells turned out for its regular client Bristol-Myers Squibb, with partner Ruud van der Velden and counsel Rik Zagers taking the lead. Amsterdam based Partner Gertjan Kuipers and associate Django Wagenaer were part of the team advising BMS.

The innovator pharmaceutical company has a long relationship with Hogan Lovells, regularly instructing the firm for various proceedings across Europe. For example, the London office led by partner Daniel Brook worked for BMS in the UK parallel proceedings.

Patent attorney firm V.O. and specifically partner Martin Klok worked alongside Hogan Lovells. The two firms are often seen working together in pharmaceutical cases.

In the pending appeal at the Supreme Court, a team from De Brauw Blackstone Westbroek, specialized on Supreme Court cases, represents BMS, assisted by the Hogan Lovells lawyers.

Key advisors from the start

Amsterdam-based IP boutique Vondst has been acting in the Dutch proceeding for the generic drug company Sandoz since the dispute began in 2021. The team around partners Otto Swens and Arvid van Oorschot included associates Tjerk Sigterman and Nicky Brouwer.

Lilian Hesselink and Wouter Mooij of patent attorney firm De Vries & Metman, provides support on the technical side in this case.

Teva is a key client of Pinsent Masons and relied on Amsterdam-based partner Judith Krens. She leads the case together with patent attorney firm NLO. Pinsent Masons also represents Teva in the UK and Irish proceedings.

Stada and its Dutch subsidiary Centrafarm relied on Daan de Lange from Amsterdam-based IP firm Brinkhof in the PI proceedings. The firm regularly acts for generic drug manufacturers and also advises Sandoz in other proceedings.