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England and Wales High Court (Patents Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Accord Healthcare Ltd v Medac Gesellschaft Für Klinische Spezialpräparate Mbh  EWHC 24 (Pat) (13 January 2016)
Cite as:  EWHC 24 (Pat)
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Strand, London, WC2A 2LL
B e f o r e :
| ACCORD HEALTHCARE LIMITED
|- and -
|MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH
Charlotte May QC and Mark Chacksfield (instructed by Bristows) for the Defendant
Hearing dates: 23rd, 24th, 26th November 2015
Crown Copyright ©
Mr Justice Birss:
Claim 1: Use of methotrexate for the production of a medicament to be administered subcutaneously for the treatment of inflammatory autoimmune diseases, wherein the methotrexate is present in a pharmaceutically acceptable solvent at a concentration of about 50 mg/ml.
Claim 13: Use according to claim 7, wherein the ready-made syringe contains a dosage of 5 to 40 mg, in particular 5.0, 7.5, 10.0, 12.5, 15.0, 17.5, 20.0, 22.5, 25.0, 27.5, 30.0, 32.5, 35.0, 37.5 or 40.0 mg, of methotrexate.
Claim 15: Methotrexate for use in the treatment of inflammatory autoimmune diseases, wherein the methotrexate is to be administered subcutaneously and the methotrexate is present in a pharmaceutically acceptable solvent at a concentration of about 50 mg/ml.
Claim 27: Methotrexate for use according to claim 21, wherein the ready-made syringe contains a dosage of 5 to 40 mg, in particular 5.0, 7.5, 10.0, 12.5, 15.0, 17.5, 20.0, 22.5, 25.0, 27.5, 30.0, 32.5, 35.0, 37.5, or 40.0 mg, of methotrexate.
i) Obviousness in the light of:a) The common general knowledge alone;b) A paper "Methotrexaat buiten de kliniek" by Jansen et al. (1999) Pharmaceutisch Weekblad, Volume 134, No 46, p1592 (Jansen). The original language of the paper is Dutch. There is an agreed translation;c) A letter "Tolerance of parenteral, higher dose methotrexate in children with juvenile chronic arthritis" by Russo and Katsicas (2000) Clinical and Experimental Rheumatology, Volume 18, No 3, p425, (Russo);d) The fact that the patent encompasses embodiments which make no technical contribution. This is directed to claims 1 and 15 which provide no limitation on volume. Accord argues that some of the products within the claim offer no pain reduction advantage over the prior art and therefore the claim encompasses embodiments which make no technical contribution.
ii) Insufficiency. The argument is that the patent does not render it plausible that the claimed concentration could be safely administered to patients. This is a squeeze on inventive step.
The person skilled in the art
Common general knowledge
i) Morning stiffness;
ii) Arthritis (soft tissue swelling or fluid) of at least three joints;
iii) Arthritis of hand joints;
iv) Symmetrical arthritis;
v) Rheumatoid nodules;
vi) Abnormal amounts of serum rheumatoid factor; and
vii) Radiographic changes in the joint.
"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which formed part of the state of the art…"
Obviousness over Russo
Obviousness over Russo – conclusion
Obviousness over Jansen
Obviousness over common general knowledge alone
Obviousness – no technical benefit