Court of Appeal, following EPO, reverses Carr J in Regeneron v Kymab dispute

After five years, Regeneron has
finally captured its transgenic mouse
The AmeriKat has had very little time to digest this morning's Court of Appeal decision in Regeneron v Kymab & Novo Nordisk [2018] EWCA Civ 671 which reversed Mr Justice Carr's finding that Regeneron's patents were insufficient.  The Court also accepted Regeneron's argument on construction.  But for those who would like a teach-in on the English law of sufficiency, the Court of Appeal, led by Lord Justice Kitchin, provides a helpful summary of the English case law on sufficiency.   Some of the key sufficiency extracts (on the law) are set out below.  

At [238]:
"We draw the following points from [Biogen v Medeva [1997] RPC 1]: 
i) The extent of the patent monopoly, as defined by the claims, must correspond to the technical contribution to the art its disclosure has made in order for it to be justified.  
ii) The specification must enable the invention to be performed to the full extent of the monopoly claimed. But if the invention discloses a principle capable of general application, the claims may be in correspondingly general terms.  
iii) If the patentee has found a new product which has a beneficial effect but cannot demonstrate there is a common principle by which that effect will be shared by other products of the same class, he will be entitled to a patent for that product but not for the class. But if he has disclosed a beneficial property which is common to the class, he will be entitled to a patent for all the products of that class even though he has not himself made more than one or two of them.  
iv) There is more than one way in which the breadth of the claim may exceed the technical contribution to the art embodied in the invention. The patent may claim results which it does not enable, such as making a wide class of products when it enables only one of those products and discloses no principle which would enable others to be made. Or it may claim every way of achieving a result when it enables only one way and it is possible to envisage other ways of achieving that result which make no use of the invention."
At [245]:
"We believe the following further points of relevance to this appeal can be taken from the decision of the House of Lords in Kirin-Amgen and the decisions of the Court of Appeal and the House of Lords in Lundbeck
i) a principle of general application is simply an element of a claim which is stated in general terms;  
ii) a claim containing such an element is sufficiently enabled if the skilled person can reasonably expect the invention to work with anything which falls within the general term; and  
iii) a particular form of an element of a claim may improve the way the invention works and be inventive. However, the patent is not insufficient simply because the specification does not enable that improvement. It is still a way (albeit an improved way) of working the original invention."
And then, at [247], addressing Regeneron v Genentech [2013] EWCA Civ 93:
"In discussing the general legal principles applicable to the insufficiency attack, Kitchin LJ (with whom Longmore and Moses LJJ agreed) said this at [100]-[101]: 
"It must therefore be possible to make a reasonable prediction the invention will work with substantially everything falling within the scope of the claim or, put another way, the assertion that the invention will work across the scope of the claim must be plausible or credible. The products and methods within the claim are then tied together by a unifying characteristic or a common principle. If it is possible to make such a prediction then it cannot be said the claim is insufficient simply because the patentee has not demonstrated the invention works in every case 
On the other hand, if it is not possible to make such a prediction or if it is shown the prediction is wrong and the invention does not work with substantially all the products or methods falling within the scope of the claim then the scope of the monopoly will exceed the technical contribution the patentee has made to the art and the claim will be insufficient. It may also be invalid for obviousness, there being no invention in simply providing a class of products or methods which have no technically useful properties or purpose."
Applying these principles, the court found no reason to interfere with the judge's findings rejecting the broad insufficiency attacks. The court then turned to the infringement - insufficiency squeeze, upheld the judge's finding that VEGF-Trap fell within the scope of the claims and rejected the contention that this rendered the claims insufficient:
This does not, however, mean the patent is insufficient. A claim for an invention of broad application may properly encompass embodiments which may be provided or invented in the future and which have particularly advantageous properties, provided such embodiments embody the technical contribution made by the invention. VEGF-Trap does indeed embody the technical contribution made by the patent; it has a therapeutic effect in patients suffering from ARMD by treating the angiogenesis associated with that condition, and it does so by binding to VEGF and inhibiting its biological activity. VEGF-Trap is therefore one of those improvements which Lord Hoffmann had in mind in Kirin-Amgen [2004] UKHL 46, [2005] RPC 9 at [117]."
This exposition is, we believe, entirely consistent with the principles we have identified. A claim is not insufficient simply because it encompasses inventive improvements provided they embody the technical contribution the disclosure of the invention has made to the art."
Applying these principles to the facts, the Court of Appeal concluded that the claims were adequately enabled across their scope (consistent with the Board of Appeal with respect of the 287 patent - T 220/14 of 9 November 2015).  On an initial reading, despite the reversal, the AmeriKat does not believe the law on sufficiency has changed at all (or to any material degree).  As the the Court themselves stated:
"We are conscious that in so deciding we are arriving at a conclusion which is different from that of an experienced patent judge. However, we have had the benefit of hearing fully developed argument upon aspects of the evidence which did not receive the same degree of attention at trial; we have come to the conclusion that the judge erred in his approach to the interpretation of claim 1 of the 287 patent; and we are satisfied that, in assessing the sufficiency of the disclosure of the patents, he did not attach sufficient weight to the character of the invention as claimed in each of the claims in issue, the contribution that its disclosure has made to the art and the need to confer a fair degree of protection on the patentee."
The IPKat Team will be back to report on the details of the decision and application to the technology, separately.
Court of Appeal, following EPO, reverses Carr J in Regeneron v Kymab dispute Court of Appeal, following EPO, reverses Carr J in Regeneron v Kymab dispute Reviewed by Annsley Merelle Ward on 16:14:00 Rating: 5

2 comments:

Contradictory said...

So that means in some circumstances it is OK to cover embodiments which could not have been made at the filing date, which is not too shocking. However I wonder whether this is the start of the end for use of 'squeeze' arguments in the UK, which the EPO seldom uses. Perhaps it is time now for us to align with the EPO in treating each test for validity and infringement independently and not worrying too much about the minor contradictions that emerge.

Pam said...

Chemical and biotech practice invented the concept of sufficiency across the breadth of a claim, and it is only correct that this concept evolves as it needs to. However there also has to be natural justice. Carr essentially couldn't stomach that infringement could be found where the infringing embodiment could not have been made at the relevant date for validity. According to the court of appeal's reasoning presumably non-functional (i.e. not solving the problem) embodiments could also infringe. Surely that is wrong it is for the UK courts to fix this anomaly with a new test for infringement where certain embodiments covered by the literal language of the claim cannot be covered for infringement purposes? Given how keen the UK courts have been over doctrine of equivalents, perhaps they now need to consider decreasing infringement scope for the sake of 'fairness'

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