In the Patents Court of England & Wales, Mr Justice Carr has
recently decided on the infringement and validity of two patents
that relate to transgenic mice used as platforms for therapeutic
antibody discovery. The case is Regeneron Pharmaceuticals Inc v
Kymab Limited & Novo Nordisk A/S  EWHC87 (Pat) and
the patents in dispute were Regeneron's Patent (UK) No
1,360,287 ("the 287 Patent") and its divisional European
Patent (UK) No 2,264,163 ("the 163 Patent"). In his
decision of 1 February 2016, the judge dismissed Regeneron's
claim for infringement of the patents and allowed Kymab's and
Novo's counterclaim for revocation.
The technology protected by the patents was the replacement of
mouse variable (VDJ/VJ) gene with human variable genes to produce
immunoglobulin loci that will undergo the natural process of
rearrangement during B cell development to produce hybrid
antibodies. A locus comprising a combination of human variable gene
segments and endogenous mouse constant gene segments is known as a
"reverse chimeric locus". Subsequently, fully human
antibodies can be made by replacing the mouse constant regions with
the desired human counterparts.
The activity of Kymab that was alleged to infringe, was the
offering of various strains of transgenic mice to the
pharmaceutical industry, which were either per se or through the
process of their production covered by certain claims of the
patents. Carr J found that all strains of Kymab's mice were or
would be generated from a product within the scope of claims 5 and
6 of the 287 Patent and mice strains having both modified IgH and
IgK loci are within the scope of claim 1 of the 163 Patent. He
nonetheless dismissed the infringement case because all of the
claims of the 287 and 163 Patents were, the judge held, invalid for
In order to be sufficient a patent does not need to set out
every detail necessary for performance of the invention, because
the skilled person is entitled to use their common general
knowledge to fill in certain technical gaps. However, there is a
balance to be struck between ordinary steps of trial and error on
the one hand, and prolonged research, enquiry or experiment on the
other. In this case, the judge held the patents were insufficient
because, at the priority date of the patent, the skilled person
would not have been able to perform the invention over the whole
area claimed without undue burden and without needing inventive
skill. In particular, claim 1 of the 287 Patent was not capable of
being performed at the priority date. The problem lay in the
amounts of genetic sequence of which it contemplated the deletion
and insertion. On the evidence, none of the methods of the 287
Patent for achieving this would have worked; the task contemplated
was unprecedented and could not have been achieved, if at all,
without a great deal of creative thinking at the priority date.
Claims 5 and 6 of the 287 Patent and claim 1 of the 163 Patent were
also held invalid for insufficiency. These were considerably wider
in scope than claim 1 of the 287 Patent and so even if the judge
had concluded that claim 1 of the 287 Patent was sufficient and
therefore valid, he would still have concluded that these wider
claims were insufficient.
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