Pharmaceuticals

Sandoz and Vondst repel preliminary injunction over blood clot drug patent

The District Court of The Hague has rejected a PI brought by Bristol Myers Squibb against Sandoz, helping clear the way for the company to proceed with the launch of its generic apixaban product. Bristol Myers Squibb already markets the drug in Europe, although a recent UK court decision invalidated the same patent as is involved in the Dutch proceedings.

16 May 2022 by Amy Sandys

Sandoz, Bristol Myers Squibb Bristol Myers Squibb has been denied a preliminary injunction against Sandoz in the Netherlands, after the generic drug company registered its new product launch on the Dutch G-Standaard register for pharmacies ©rh2010/ADOBE STOCK

In preliminary injunction proceedings (case no: C/09/627925 / KG ZA 22-326), the District Court of The Hague has rejected an application by innovator drug company Bristol Myers Squibb against Sandoz. The move was intended to prevent the latter from launching a generic version of the blood clot treatment in the Dutch market.

The decision follows on from recent revocation proceedings in the UK, in which the court invalidated a Bristol Myers Squibb patent for the blockbuster drug.

Sandoz takes a chance

Recently, the global market share of apixaban has increased due to a heightened demand for anticoagulant drugs. In the Netherlands, the current case is the result of Sandoz preparing to launch its own generic version of the drug by registering it with the Dutch G-Standaard.

Bristol Myers Squibb owns EP 14 27 415 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 external sources, apixaban alone generated around $7 billion in revenue for the company in 2021.

In early April 2022, the UK High Court invalidated EP 415 following a challenge by Sandoz and joint claimant, Teva (case numbers: HP-2020-000042 and HP-2021-000003). Following the UK decision, Sandoz prepared to launch its generic version of apixaban in the Netherlands.

G-Standaard medicine

Prior to this, however, Sandoz had to first publish the product in the G-Staandard. This is an online drug database which lists all products dispensed or used by Dutch pharmacies.

Generic drug companies must always publish their products in the database at least one month before an intended launch. This is to allow, if necessary, an innovator company to launch preliminary injunction proceedings. In this instance, Bristol Myers Squibb took Sandoz’s registeration of the drug in the G-Standaard as an infringing act and launched PI proceedings.

However, the judge has now rejected the provisional claims from Bristol Myers Squibb, based largely on the balance of inconvenience. The court claimed that Sandoz maintaining its presence in the database would not negatively impact the company. The District Court of The Hague also dismissed Sandoz’s counterclaim, to prevent the defendant seizing evidence or issuing summons.

Since Bristol Meyers Squibb was unsuccessful in its claim against the alleged infringement, the court could find no evidence of this being a threat.

Bristol Myers Squibb on appeal

Since, in the first Dutch case, the parties underwent PI proceedings, the court is yet to come to a decision on the case merits. However, regarding EP 451, presiding judge Edgar Brinkman provisionally examined infringement and validity. He concluded that he would not uphold the infringement claim against Sandoz, because it is likely the case on the merits will invalidate the patent in a similar manner to in the UK.

Thus, in the Dutch proceedings, the parallel UK decision is especially important. Since the UK court found the patent invalid, it is very likely that UK case law will be referred to in the Dutch court. According to Dutch law, the judgment from a respected court is a substantial enough reason to provisionally invalidate the patent in the Netherlands.

For now, BMS has four weeks to appeal the decision. Teva has also filed a patent revocation action against Bristol Myers Squibb in the Netherlands on the same patent, which will be heard later in 2022.

Sandoz brings more

Invalidity proceedings against foreign parts of EP 451 are also pending in France, Italy, Sweden, Portugal and Ireland. However, these are mostly initiated by Teva. In parallel UK proceedings, Sandoz also worked alongside Teva to bring the invalidity claims against Bristol Myers Squibb.

The dispute is also not yet over in the UK, as Sandoz and Teva also brought claims against five formulation patents (case numbers: HP-2020-000048; HP-2021-000009).

Sandoz has since settled validity and infringement on four patents, EP 25 38 925EP 30 17 811EP 32 57 500 and EP 32 51 660. Meanwhile the action is proceeding on claims one to seven of remaining patent EP 32 46 021. Teva’s actions were also pending in full for all five patents, although the EPO Technical Boards of Appeal has now revoked EP 925.

Otto Swens

Vondst and Hogan Lovells at work

Amsterdam-based IP boutique Vondst acted for the generic drug company Sandoz in the Dutch proceedings. Partners Otto Swens and Aarvid van Oorschot led the team.

Vondst is especially visible for pharmaceutical litigation in the Dutch patent market, with Lillian Hesslink, of patent attorney firm De Vries & Metman, providing support on the technical side in this case. She is very visible for generic drug companies in Europe, with ties to Teva, among others.

Hogan Lovells turned out for its regular client Bristol Myers Squibb, with partners Ruud van der Velden and Rik Zagers advocating for the company in front of the court. 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.

Ruud van der Velden

In this case, 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.

For Sandoz
Vondst (Amsterdam): Otto Swens, Arvid van Oorschot (partners); associates: Tjerk Sigterman, Nicky Brouwer
De Vries & Metman (Amsterdam): Lillian Hesselink (patent attorney)
In-house (Holzkirchen): Sara Burghart (lead IP litigation counsel)

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

District Court of The Hague, The Hague
Edgar Brinkman (presiding judge), Hans van Walderveen