High Court: Discovery of documents ordered in Biogen’s patent infringement proceedings against Celltrion



The discovery of two categories of document sought by Celltrion in patent infringement proceedings initiated by Biogen have been ordered in the High Court.

Granting one of the categories on Celltrion’s terms, and another on terms offered by Biogen; Mr Justice Max Barrett explained that the principles of discovery (relevance, necessity and proportionality) for patent cases were no different to those applicable to other cases.

Infringement proceedings

Biogen Inc., F Hoffmann-La Roche AG, and Genentech Inc. (Biogen) initiated proceedings against Celltrion Inc., Celltrion Healthcare Hungary Kft., Mundipharma International Ltd, and Mundipharma Pharmaceuticals Ltd (Celltrion) for infringement of:

  1. Irish Patent No. 1 951 304 entitled ‘Method for treating Joint Damage’ which protects rituximab in the MabThera label use for the treatment of arthritis (valid until 14th November, 2026) (the ‘304 Patent’); and
  2. Irish Patent No. 2 055 313 entitled ‘Treatment of hematologic malignancies associated with circulating tumor cells using chimeric anti-CD20 antibody’ which protects rituximab in the MabThera label use for the treatment of chronic lymphocytic leukaemia (valid until 9th November, 2019)

The substance of the dispute

In February 2017, the European Medicines Agency granted a marketing authorisation to Celltrion for a biosimilar of Biogen’s medicinal product MabThera (rituximab) under the designation ‘Truxima®’.

Truxima is intended for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

It is Biogen’s case that Truxima infringes the 304 Patent and the 313 Patent; while Celltrion contend that each of the 304 Patent and the 313 Patent is invalid. Accordingly, Celltiorn have counterclaimed for invalidity and seek orders revoking each of the said patents, on grounds of:

  1. added matter,
  2. lack of novelty, and
  3. insufficiency.

The prior art documents relied on by Celltrion were specified in the particulars of objection.

Application for discovery

In the High Court, Celltrion made an application for discover of 15 categories of documents. Of the 15 categories, categories 3, 4, 5, 6, 7, 8, 9, and 15(i) were in dispute.

Justice Barrett said that the general principles applicable were identified in BAM PPP PGGM Infrastructure Cooperatie UA v National Treasury Management Agency IECA 246, as echoed in Boehringer Ingelheim Pharma GmBH v. Norton (Waterford) Ltd in which it was noted: “the principles applicable to discovery in patent cases… not different to discovery in other types of cases”.

Justice Barrett also considered Boehringer Ingelheim Pharma GmbH v. Norton (Waterford) Ltd IECA 67 at length.

In the context of the applicable case law, Justice Barrett refused to make an order of discovery in respect of Categories 3, 4, 6, 7 and 8.

Justice Barrett ordered discovery of the Category 5 documentation – described as “All documents relating to the decision to undertake the trial of rituximab for use to treat chronic lymphocytic leukaemia as described within the claims of the 313 Patent, which came into existence at any time between 09.11.96-09.11.00”

To ensure that the requirements of relevance, necessity and proportionality are satisfied, Justice Barrett ordered that Celltrion conduct only a reasonable search of the type contemplated by rule 31.7 of the United Kingdom’s Civil Procedure Rules.

Justice Barrett also discovery of Category 15(i) on the terms offered by Biogen.

Celltrion sought documents and communications concerning the study described in the “O’Brien Study”, entitled “Phase I/II Study of Rituxan in Chronic Lymphocytic Leukaemia (CLL)”. Including but not limited to any communications between Biogen and the authors of the O’Brien Study relating to the O’Brien Study.

Biogen had offered an alternative counter-offer being what had been offered and accepted in the United States, i.e. “an electronic search utilising appropriate search terms of the discovery previously made by them in the US Massachusetts proceedings, with the search confined to the documents disclosed in those proceedings and search terms being selected with a view to locating documents which would fall within this category.

Stating that there had been no explanation as to why the offer was not sufficient, Justice Barrett said that to satisfy the requirements of relevance, necessity and proportionality, he would order discovery on the terms offered by Biogen.

  • by Seosamh Gráinséir for Irish Legal News