EPLAW Patent Blog

UK - Medimmune v. Novartis

Medimmune v Novartis & Anor and Novartis v Medimmune & Anor, Court of Appeal, London, UK, 10 October 2012, Case no. [2012] EWCA Civ 1234

This is a joint appeal relating to Medimmune's and MRC's jointly held patents for phage display technology:

1. In action HC09C04770 MedImmune Limited (“MedImmune”), alleged Novartis Pharmaceuticals UK Limited (“Novartis”) had infringed European Patents (UK) Nos. 0 774 511 and 2 055 777 by selling a product called ranibizumab which is used for the treatment of wet age-related macular degeneration of the eye.  Novartis disputed infringement and counterclaimed for revocation of the patents. The judge held at first instance that both patents were invalid on the grounds of obviousness and because the claims were not entitled to priority from the relevant priority document, it being conceded that if they were not entitled to priority then the patents were invalid. Novartis disputed infringement and counterclaimed for revocation of the patents. The judge held at first instance that both patents were invalid on the grounds of obviousness and because the claims were not entitled to priority from the relevant priority document. The appeal was persued only in respect of the '777 patent.

UK - MedImmune v Novartis

MedImmune Limited v Novartis Pharmaceuticals (UK) Limited & another, High Court, 3 February 2012, Case No. HC11C01304, Neutral Citation Number: [2012] EWHC 181 (Pat)

On Friday 11 February 2012, Mr Justice Arnold handed down his second judgment in the ongoing litigation between MedImmune and Novartis.   

In his first judgment in July 2011 (which may be read here), Mr Justice Arnold held that MedImmune’s patents, relating to antibody phage display, were not infringed by Novartis’ dealings in ranibizumab (trade name Lucentis), a treatment for wet age-related macular degeneration, in the UK and were invalid.  That decision is under appeal.

This second judgment dealt with MedImmune’s UK SPC for ranibizumab and represented the UK Courts’ first consideration of the recent CJEU rulings in Medeva (C-322/10), Queensland (C-630-10) and the associated line of references.

In his judgment, Mr Justice Arnold found that the guidance provided by the CJEU in Medeva is not sufficiently clear.  The Judge expressed his disappointment that the CJEU did not actually answer Question 1 of the Medeva questions.  He held that the test laid down by the CJEU and its progeny is unclear save in its rejection of the infringement test in respect of combination cases.  Mr Justice Arnold went on to say that “regrettably”, further references will be required to clarify what is meant by “specified or identified in the wording of the claims”. 

Notwithstanding these views, in this case, the Judge did not make a further reference to the CJEU.  Instead, he decided that the Court of Appeal will be able to consider whether to make a reference at the appropriate time.  This judgment does not therefore take matters much further forward in the debate about the meaning of the CJEU decisions save that it has now been acknowledged by Mr Justice Arnold that there is still a great deal of uncertainty about the appropriate test to use to assess compliance with Article 3(a) of the SPC Regulation.

Read the decision (in English) here.

Head note:  Sarah Routledge