Bristol-Myers Squibb and Hogan Lovells remove generics from Dutch market in apixaban dispute

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

In the Netherlands, the pharmaceutical company has succeeded for the first time in removing generic products sold by Sandoz, Stada and Teva from the market. In mid-August, the Court of Appeal in The Hague ruled in an emergency decision that all three generic drug manufacturers’ products infringe Bristol-Myers Squibb’s apixaban SPC, which is based on EP 1 427 415 (case IDs: 200.327.532/01 and 200.327.173/01).

Forced from the market

The companies are no longer allowed to register their generic 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.

If generic manufacturers do not comply, they face a fine of €100,000 per day or €1,000 per product that violates EP 415. Sandoz and Teva have now ceased to sell their products in the Netherlands. JUVE Patent does not know whether Stada currently sells its products on the Dutch market.

Bristol-Myers Squibb owns EP 415 and a corresponding supplementary protection certificate, which is valid until 2026. These cover the compound apixaban, which the 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. According to sources, apixaban alone generated around $7 billion in revenue for the company in 2021. EP 415 expired in September 2022.

Successful second attempt

Bristol-Myers Squibb had already tried to force Sandoz out of the Dutch market last year, but failed to obtain a PI at the District Court of The Hague in May 2022. The appeals judges have now overturned the District Court of The Hague’s three PI judgments.

After the decision of the Enlarged Board of Appeal in G 2/21 on plausibility, Bristol-Myers Squibb brought new PI proceedings against Sandoz. After Stada and Teva meanwhile had entered the Dutch market, Bristol-Myers Squibb also filed PIs against the two generics companies but failed again at the first instance (case IDs: C/09/644989 / KG ZA 23-240 against Sandoz; C/09/644996 / KG ZA 23-244 against Stada; C/09/646434 / KG ZA 23-322 against Teva).

The District Court judges were not convinced that the decision G2/21 does not change the application of the concept of plausibility and rejected the PI requests at the end of May 2023.

Three combined

Bristol-Myers Squibb appealed these decisions. The Court of Appeal consolidated all three proceedings and has now decided them together. The court reached the preliminary decision that after the Enlarged Board of Appeal handed down its G2/21 decision, the likelihood of EP 415 being held valid in the pending nullity proceedings is high and the court therefore granted a PI against the three generics companies.

All three companies can still appeal the decision to the Dutch Supreme Court, claiming procedural errors. However, the Dutch Supreme Court will not discuss the validity of EP 415 and infringement. The companies have until mid-October to decide whether to take this step.

Ups and downs for Bristol-Myers Squibb

On 13 October, however, the District Court of The Hague will hear the main action brought by Bristol-Myers Squibb against Sandoz. Sandoz responded to the infringement suit with a revocation claim. If the court were to declare the patent invalid, the PI decision of the Court of Appeal would lapse. However, if the District Court judges rule in favour of Bristol-Myers Squibb on infringement, Sandoz will be barred from the market until the SPC expires.

Bristol-Myers Squibb had also launched an infringement action against Teva in the Netherlands, which Teva also countered with a revocation claim. The court temporarily suspended proceedings and will probably not hear the case until 2024.

Recently, the original manufacturer has also had some success in France. In June, the Judicial Court of Paris rejected Teva’s pleas for an invalidation of EP 415. But just a few weeks prior, the UK Court of Appeal went in a different direction and confirmed the invalidity of Bristol-Myers Squibb’s apixaban patent.

The apixaban dispute is also playing out in many other European countries, including Italy and Norway.

Ruud van der Velden

No surprise on the advisor side

In the Dutch apixaban litigation, the companies are relying on their core counsel. Hogan Lovells turned out for its regular client Bristol-Myers Squibb. Ruud Van der Velden’s team, together with patent attorney Martin Klok from V.O., advised Bristol-Myers Squibb in the first round of PI proceedings against Sandoz.

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 represented Bristol-Myers Squibb in the UK parallel proceedings. In France, however, the company is working with Gide Loyrette Nouel in the apixaban dispute.

Amsterdam-based IP boutique Vondst acted again for the generic drug company Sandoz in the Dutch proceedings. Partners Otto Swens and Arvid van Oorschot advised the drug manufacturer in the first round of the dispute with Bristol-Myers Squibb in 2021.

Judith Krens

At that time Sandoz also worked with Lilian Hesselink, of patent attorney firm De Vries & Metman, providing support on the technical side in this case.

Pinsent Masons for Teva

Teva also relied on Pinsent Masons in the Netherlands. Amsterdam-based partner Judith Krens is leading the Dutch case together with patent attorney firm NLO. Pinsent Masons also represents Teva in the UK and Irish proceedings. The generics manufacturer is a key client of the European patent practice.

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

For Bristol-Myers Squibb
Hogan Lovells (Amsterdam): Ruud Van der Velden (lead), Rik Zagers, Gertjan Kuipers, Bert Oosting (all partners); associate: Charmayne Sijm
V.O. (Amsterdam): Martin Klok (patent attorney)

For Sandoz
Vondst (Amsterdam): Otto Swens, Arvid van Oorschot (partners); associates: Tjerk Sigterman, Nicky Brouwer
De Vries & Metman (Amsterdam): Lilian Hesselink (patent attorney)

Otto Swens

For Stada and Centrafarm
Brinkhof (Amsterdam): Daan de Lange (partner, lead); associates: Berber van der Wansem, Maarten Groeneveld

For Teva
Pinsent Masons (Amsterdam): Judith Krens (partner, lead); associates: Marthe Riewald, Maud de Haas
NLO (The Hague): Mari Korsten (patent attorney) – public knowledge

Court of Appeal The Hague, the Netherlands
Rian Kalden (presiding judge), Peter Blok, Michel Bonneur