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Friday, 22 February 2013

Regeneron/Bayer v Genentech in Court of Appeal - first instance decision affirmed

Nearly a year ago this Kat reported on Regeneron Pharmacueticals Inc and Bayer AG v Genentech Inc [2012] EWHC 657 (see BAILII).

Cat's eye does not suffer
from macular degeneration
Nearly a year on, and we are treated to the Court of Appeal consideration of the matter, which hit the streets yesterday, and which you can also read on BAILII.  This Kat would like to thank his informant (you know who you are) for alerting him to the judgment, which he confesses he missed yesterday.

The case concerns the validity of Genentech patent EP1238986  and infringement thereof by the Regeneron product VEGF Trap Eye (a treatment for macular degeneration).  To remind our dear readers, the main claim was in the following terms:
Use of a hVEGF antagonist in the preparation of a medicament for the treatment of a non-neoplastic disease or disorder characterised by undesirable excessive neovascularisation, wherein the hVEGF antagonist is: (a) an anti-VEGF antibody or antibody fragment; (b) an anti-VEGF receptor antibody or antibody fragment; or (c) an isolated hVEGF receptor.
I covered the case in some detail last year, and if readers thought that I was surprised by the outcome, they would not be greatly mistaken.  At first instance Mr Justice Floyd found the patent valid (under the headings of novelty, inventive step and sufficiency) although he construed the claim in one respect (the meaning of " a medicament for the treatment of a non-neoplastic disease or disorder characterised by undesirable excessive neovascularisation")  in a manner different from that put forward by either the claimants or the defendant, stating:
I see no reason to recast the definition either as sought by Genentech or by the claimants. There was no evidence that anyone skilled in the art would have any difficulty in identifying a disease which is characterised by undesirable, excessive angiogenesis and one which is not. Further, the skilled person would not understand that the patentee was saying that the treatment would necessarily successfully deal with anything other than undesired angiogenesis in that disease. 
He also found the claims infringed by the Regeneron product.

So what of the appeal decision?  The claimant/appellants challenged the first instance judgment under every heading.  Kitchin LJ giving the leading judgment, with which Moses LJ and Longmore LJ agreed in the traditional formula, analysed each criticism of the judge's findings, and in each case upheld the first instance judgment.

Whereof there is little further to say, thereof I shall accordingly be silent.  Do our dear readers have any comments or thoughts?

1 comment:

Suleman said...

This is a really nice decision. It's impressive how inventive step was found when the claims were so barely novel. The Court accepted that the general confusion in the area was enough for the claims to be inventive, which I think is a very sophisticated approach.

Regeneron were a bit unlucky I think for the term 'hVEGF receptor' to be interpreted as including fragments of the receptor within a fusion protein. However the dependent claims help to force the broad interpretation (although the decision looks at the description for the interpretation).

In addition interesting to note that the patent was not insufficient in as far as it covered the infringement, though making it would require 'ingenuity' not provided by the patent.

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