Dutch Patent Office and District Court deny SPC for Novartis/Genmab MS drug

In July 2021, Danish biotechnology company Genmab submitted an application for a supplementary protection certificate for ofatumumab, an indication which treats multiple sclerosis, to the Netherlands Patent Office (OCNL). Ofatumumab is a monoclonal antibody and CD20-inhibitor.

However, the OCNL rejected the application in March 2022 on the basis that Genmab had already marketed ofatumumab as a medicinal product for leukemia treatment. Genmab appealed the decision, requesting that OCNL agree to a direct appeal to the administrative court. However, the District Court of The Hague has sided with the OCNL. This approach from the Netherlands is contrary to the approach taken by patent offices across Europe.

A back story

In October 2003, Genmab filed an application for a European patent, granted under EP 1 558 648 and entitled “ Human monoclonal antibodies against CD20″. In the meantime, Genmab developed a medicine for the treatment of chronic lymphatic leukemia, with ofatumumab as the active ingredient.

The company marketed the medicine under brand name Arzerra. In April 2010, the European Commission granted a marketing authorisation (EU/1/10/625) for the product and in 2015, Novartis – Genmab’s partner for ofatumumab distribution – exclusively licensed all relevant rights under EP 648.

Based on EP 648 and the Arzerra marketing authorisation, Genmab applied to the OCNL for a Dutch SPC for ofatumumab. However, in December 2018, Genmab requested that the European Commission withdraw the product’s marketing authorisation due to disappointing results among cancer patients. The EPO also withdrew the substance patent in 2021.

Kesimpta the next development

Following the withdrawal of both this patent and the marketing authorisation, Genmab and Novartis developed an MS treatment under brand name Kesimpta, protected by EP 3 284 753. The EPO granted the patent, which came into effect in February 2018, based on Genmab’s application split from the previous substance patent. The European Commission then granted Novartis a marketing authorisation for Kesimpta (EU/1/21/1523) in March 2021.

In June 2021, Genmab applied for a Dutch SPC for Kesimpta, arguing that the relevant marketing authorisation was the first EU marketing authorisation for the MS product. It also referred to the granting of the basic patent, with ofatumumab as an active ingredient to treat MS. However, the OCNL rejected Genmab’s application on the basis that the Kesimpta marketing authorisation was not the first for the marketing of ofatumumab as a medicinal product.

Referring to regulations

In its argument, the OCNL referred to Article 3(d) of the SPC Regulation 2, which states that “the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product”. Point B stipulates that “a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as appropriate”.

The OCNL based its initial decision on the so-called ‘Santen’ ruling. In 2020, a French Court of Appeal judgment stated that: “Article 3(d) of Regulation (EC) No 469/2009… must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application”.

Furthermore, according to the OCNL, the parties carrying out research into a second or subsequent application for the active substance does not automatically make it eligible for an SPC.

Genmab fights back

At the District Court of The Hague, Genmab argued that the success of Kesimpta as an MS treatment demonstrates that the OCNL should grant an SPC. The company argued that the OCNL must view Article 3(b) and Article 3(d) of the SPC Regulation in conjunction, since the previous authorisation for Arzerra is no longer in force.

Furthermore, in its judgment, the court states that “the (current) marketing authorisation on which the SPC is based must be the first authorisation for the marketing of the product as a medicinal product… From no document submitted by Genmab or ruling of the ECJ, the court shows that the ‘first authorisation for marketing the product as a medicinal product’ must be a (still) valid marketing authorisation.”

It also points out that the Dutch decision is contrary to the approach of Austria, Estonia, Spain, Greece, Italy, Latvia, Lithuania and Romania, and requested its questions to be referred to the European Court of Justice (CJEU). However, the court has refused the latter point.

For Novartis/Genmab
Freshfields Bruckhaus Deringer (Amsterdam): Rutger Kleemans (partner)

For the Netherlands Patent Office
Martijn de Lange (patent examiner)

District Court of The Hague, the Netherlands
Edger Brinkman (chairman); GP Kleijn; Margot Kokke