This article was first published in EPLAW Patent Blog, February 2016.

Regeneron Pharmaceuticals Inc v Kymab Limited and Novo Nordisk A/S, High Court of England and Wales (Carr J), London, UK, 1 February 2016, Neutral Citation Number: [2016] EWHC 87 (Pat). 

On 3 February 2016 the Patents Court (Carr J) held that the disputed claims of two of Regeneron’s patents relating to transgenic mice used for the study of monoclonal antibodies were invalid for insufficiency. In contrast, shortly before the trial, EP287 was held to be valid by the Technical Board of Appeal in amended form (these amended claims then being the subject of the UK proceedings), but the written reasons are not yet available.

The claims in issue were claims 1, 5 and 6 of EP 1 360 287 (“EP287”) and claim 1 of a divisional of that patent, namely EP 2 264 163 (“EP163”). Claim 1 of EP 287 is a method of modifying a gene locus in an isolated mouse embryonic stem and claims 5 and 6 of EP 287 (which are dependent on claim 1 of EP287) are product-by-process claims which include “obtainable by” language (i.e. genetically modified cells and mice obtainable by the method of claim 1). Claim 1 of EP163 is a product claim to a transgenic mouse that produces hybrid antibodies.

Carr J adopted a broad construction in relation to all claims. In relation to each of the claims he held that “in situ replacement” of gene segments includes the case where a sequence is deleted and also when it is moved to a different location and inactivated. In relation to the product-by-process claims, Carr J followed the approach adopted by Birss J in Hospira v Genentech (see here) in holding that the scope of such claims extends to products that contain the introduced genes regardless of the method used.

On the law relating to sufficiency, the judge noted the established principle that if the invention does not work with substantially all of the products or methods falling within the scope of a particular claim, then that claim will be insufficient. On the facts, the judge held that claim 1 of EP287 was insufficient as it did not enable the genetic modification across the breadth of the claim (i.e. all sizes of genetic sequence modification) without undue burden and without invention. The judge held that even though none of the examples in the patent specification would have worked to make the modification claimed, even for the smallest genetic sequence that fell within the scope of the claim, the skilled person was still entitled to apply the common general knowledge to put the invention into effect. He noted that if an obvious, standard approach would occur to the skilled person which would necessarily and directly enable him to work the invention, then this would be an answer to the objection of insufficiency. However, in this case none of the proposed alternative approaches was held to have been one that would have occurred to the unimaginative skilled person. This meant that the skilled person would not have been able to employ the method claimed for even the smallest claimed genetic modification, let alone across the full breadth, and claim 1 of the patent was therefore insufficient.

As claims 5 and 6 of EP287 (the “obtainable by” claims) were wider than claim 1 of EP287, they were also held to be insufficient, although the judge indicated that he would have found these claims insufficient even if he had not found claim 1 insufficient. Claim 1 of EP163 also included fewer limitations than claim 1 of EP287 and was also found to be insufficient.

The other invalidity attacks of added subject matter, lack of novelty and lack of inventive step were all rejected. The judge also ruled that, had the patents not been invalid, they would have been infringed by Kymab’s mice strains.

Readers may also be aware of the practice in the UK of circulating draft judgments to the parties on a confidential basis a few days before they are made public so that typographical or other obvious errors may be highlighted to the judge before the final judgment is issued. In this case, Regeneron made further submissions following circulation of the draft judgment which alleged that there were certain material omissions from the draft judgment, and that the judge should consider these issues in order to provide further findings of fact for the Court of Appeal. The judge recognised that this was a very complex case and that it was important that counsel should draw to the attention of the court any material omissions in a judgment, rather than attempt to save up such points for the Court of Appeal. Nevertheless, the judge held (after inviting the opposing parties to respond) that the effect of the patentee’s post-judgment submissions was to seek to re-open the argument about whether the claimed inventions were enabled and declined to modify his judgment on the issues in dispute. He also discouraged post-judgment submissions of this nature in future cases.

A copy of the judgment can be found here.