Samsung Bioepis and Simmons repel Janssen infringement claims over SPC waiver

The District Court in The Hague has handed down a decision pertaining to the application of the SPC waiver in a case between Janssen Biotech and Samsung Bioepis. Claimant Janssen had argued that the defendant must produce a relevant marketing authorisation before it could begin distributing its Sterala biosimilar upon the patent’s expiry. However, the court dismissed the argument on all counts, finding that Samsung Bioepis could continue distribution of the biosimilar to third countries.

The decision is in strong contrast with a previous German decision, whereby the Munich Regional Court handed down an injunction against biosimilar company Formycon for what it decreed a lack of relevant marketing authorisation for export distribution. Janssen was also the claimant in the German proceedings.

Samsung Bioepis to export biosimilar

Basic patent EP 1 309 692 B1, which covers “ANTI-IL-12 Antibodies, compositions, methods and uses”, forms the basis for Janssen’s drug Stelara, which has the active ingredient ustekinumab. It is used in the treatment of conditions including the autoimmune disorder Crohn’s disease, as well as other conditions such as psoriasis and ulcerative colitis. EP 892 formed the basis of an SPC for Stelara for the UK, Italy and Denmark. All expire in July 2024.

Samsung Bioepis developed a biosimilar of ustekinumab, named SB17. In October 2023, the company announced its intention to manufacture and stock its biosimilar in Denmark and Italy, in order to export the products to third countries (the UK, Canada and South Korea), and to place the product on the EU market following its expiry. Both actions come under the exemptions permitted by Article 5(2)(a) of the SPC Regulation.

SPC waiver in play

Both parties agreed that Samsung Bioepis meets the conditions for an EU stockpile exemption. However, Janssen argued that its competitor did not meet the conditions of valid production-for-export exemption to third countries. This was based on three arguments.

Firstly, that Samsung Bioepis’ notification did not mention the marketing authorisation reference number in the countries of export; secondly, that Janssen’s patent rights are in force in the countries to which the defendant intends to export; and thirdly, that Samsung Bioepis may not, under the production-for-export exemption, store the biosimilar products in the EU for later exporting to third countries.

As such, Janssen claimed that Samsung Bioepis’s intention to export its biosimilar products to third countries, and to market the product in the EU, was tantamount to infringement. It requested the court hand down a preliminary injunction, and for the court to refer the case to the Court of Justice of the European Union (CJEU). However, the Dutch first-instance court rejected all requests, including the CJEU referral. A case on the merits is possible, although neither party has confirmed if or when this will go ahead.

Machteld Hiemstra

A new approach

Under the SPC waiver, the production of an imitation product is permitted, under certain conditions, within the EU even before patent protection expires. This is according to regulation EC 2019/933, which has supplemented the previous SPC regulation (EC/469/2009) since 2019.

The manufacturing waiver applies, for example, if a generic or biosimilar drug is destined for export to third countries outside the EU where the SPC protection does not exist.

In addition, a pharmaceutical manufacturer may start producing generics and biosimilars of a drug still under protection six months before the SPC expires, even within the EU. This is to ensure it has sufficient quantities of the product available for sale on the first day after the protection period expires.

In stark contrast

Unlike the German court, which in October 2023 found that Formycon lacked a marketing authorisation number for the export of the biosimilar to a third country outside the EU (case ID: 21 O 12020/23), the Dutch court upheld the provisions granted by the waiver. In German proceedings, Formycon had argued that, to start production for export, it is sufficient to communicate the marketing authorisation number for a third country as soon as it becomes available.

Bas Berghuis van Woortman

Thus, the Regional Court Munich took a drastically different path after presiding judge Georg Werner handed down a preliminary injunction against Formycon. The dispute in Munich also concerns the German SPC DE 12 2009 000 025.7 and the same patent EP 692.

The decision in Germany was met with criticism from external parties, which argued that the court had taken the wrong approach via false interpretation of the SPC waiver.

Regulatory expertise required

Samsung Bioepis turned to regular advisors Simmons & Simmons, using a team from the Dutch and UK offices. In the Netherlands, the partners in charge are Bas Berghuis van Woortman, who is head of the firm’s IP practice, and Machteld Hiemstra.

A leading partner in regulatory law, Hiemstra rejoined Simmons & Simmons as partner in spring 2023, following a brief spell at Pinsent Masons. UK partner Scott Parker assisted the team from London.

Peter van Schijndel

European IP boutique Hoyng ROKH Monegier, led by partner Peter van Schijndel, led the case for Janssen.  For the German case against Formycon, Düsseldorf-based Rospatt Osten Pross teamed up with Hoyng ROKH Monegier, Latham & Watkins and Carpmaels & Ransford. All advise the client across the US, the UK and in the Netherlands.

For Janssen Biotech
Hoyng ROKH Monegier (Amsterdam): Peter van Schijndel (partner); associates: Akiva Friedmann, Pien Haase, Inez ten Brink

For Samsung Bioepis
Simmons & Simmons (Amsterdam): Bas Berghuis van Woortman, Machteld Hiemstra (both partners); associate: Bouke Algie
Simmons & Simmons (London): Scott Parker (partner); associate: Benjamin Thomas

District Court of The Hague, The Hague
Hugo van Heemstra (judge in preliminary relief proceedings), J.M.N. van Limpt-Schrover (assistant judge)