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ARTICLE · 22 APRIL 2016

Medac's 'Second Medical Use' Metoject PEN Patent Found Invalid

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Medac's patent to methotrexate for subcutaneous administration for the treatment of inflammatory autoimmune diseases (including rheumatoid arthritis (RA)), has been found invalid.

CanadaIntellectual Property
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Medac's patent to methotrexate for subcutaneous administration for the treatment of inflammatory autoimmune diseases (including rheumatoid arthritis (RA)), has been found invalid.

Birss J's 13 January 2016 decision (Accord Healthcare Limited v Medac Gessellschaft für Klinishe Spezialpräparate mbH [2016] EWHC 24 (Pat)) includes interesting guidance on the composition of the skilled team, what constitutes 'common general knowledge', the role of plausibility in the context of a squeeze between obviousness and sufficiency, and the usefulness of cross-examination in patent cases.

Background

Methotrexate has been used as a chemotherapeutic agent in cancer as far back as the 1950s. It was later approved for the treatment of psoriasis and rheumatoid arthritis (RA). In 2006 in the UK, no product was approved for subcutaneous (i.e. below the skin) administration for inflammatory autoimmune diseases. However, approved formulations were available in the UK for

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