Tuesday, July 7, 2020

Murine Insufficiency

On June 24, 2020, the United Kingdom Supreme Court ("UK Supremes") gave judgment in Regeneron Pharmaceuticals Inc (Respondent) v. Kymab Ltd (Appellant), a case concerning European Patent (UK) No. 1 360 287 (the "'287 patent") and its divisional, European Patent (UK) No 2 264 163.  Claim 1 of the '287 patent (upon whose sufficiency all three claims at issue in this appeal depended) is as follows:
A transgenic mouse that produces hybrid antibodies containing human variable regions and mouse constant regions, wherein said mouse comprises an in situ replacement of mouse VDJ regions with human VDJ regions at a murine chromosomal immunoglobulin heavy chain locus and an in situ replacement of mouse VJ regions with human VJ regions at a murine chromosomal immunoglobulin light chain locus.
Here is the question as framed by the UK Supremes:
whether a product patent, the teaching of which enables the skilled person only to make some, but not all, of the types of product within the scope of the claim, passes the sufficiency test where the invention would contribute to the utility of all the products in the range, if and when they could be made.
A majority of the UK Supremes held that claim 1 lacked sufficiency, explaining
it is settled law, in relation to a product claim, that sufficiency requires substantially the whole of the range of products within the scope of the claim to be enabled to be made by means of the disclosure in the patent, and this both reflects and applies the principle that the contribution to the art is to be measured by the products which can thereby be made as at the priority date, not by the contribution which the invention may make to the value and utility of products, the ability to make which, if at all, lies in the future.
The UK Supremes found the three patent claims at issue in this case as poor in sufficiency as a transgenic church mouse.

Thank you to PatentlyO for bringing this decision to my attention.


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