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
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