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Supreme Court sets out eight principles of sufficiency in Regeneron case

Bloomsbury IP/IT Law Briefing

Author:
James Nurton
Publisher:
Bloomsbury Professional

In a 4-1 split decision (Regeneron Pharmaceuticals Inc v Kymab Ltd [2020] UKSC 27), the UK Supreme Court has found two patents for transgenic mice invalid for insufficiency, reversing the decision of the Court of Appeal.

Regeneron had sued Cambridge, UK-based Kymab alleging that the latter’s Kymouse transgenic mouse platform infringed two patents (EP 1,360,287 and EP 2,264,163 also known as the Murphy patents). The two patents at issue cover Regeneron’s VelocImmune platform, which is used to produce antibodies for treating diseases including COVID-19.

In February 2016, following a trial in the High Court, Mr Justice Henry Carr revoked the patents for insufficiency. However, in March 2018 the Court of Appeal reversed that finding and found the patents to be infringed, in a judgment written by Lord Justice Kitchin.

In its judgment, the Supreme Court reviewed the science on genetic engineering, as well as EPO and UK case law, and set out eight principles on sufficiency:

‘i) The requirement of sufficiency imposed by article 83 of the EPC exists to ensure that the extent of the monopoly conferred by the patent corresponds with the extent of the contribution which it makes to the art.

ii) In the case of a product claim, the contribution to the art is the ability of the skilled person to make the product itself, rather than (if different) the invention.

iii) Patentees are free to choose how widely to frame the range of products for which they claim protection. But they need to ensure that they make no broader claim than is enabled by their disclosure.

iv) The disclosure required of the patentee is such as will, coupled with the common general knowledge existing as at the priority date, be sufficient to enable the skilled person to make substantially all the types or embodiments of products within the scope of the claim. That is what, in the context of a product claim, enablement means.

v) A claim which seeks to protect products which cannot be made by the skilled person using the disclosure in the patent will, subject to de minimis or wholly irrelevant exceptions, be bound to exceed the contribution to the art made by the patent, measured as it must be at the priority date.

vi) This does not mean that the patentee has to demonstrate in the disclosure that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made. Patentees may rely, if they can, upon a principle of general application if it would appear reasonably likely to enable the whole range of products within the scope of the claim to be made. But they take the risk, if challenged, that the supposed general principle will be proved at trial not in fact to enable a significant, relevant, part of the claimed range to be made, as at the priority date.

vii) Nor will a claim which in substance passes the sufficiency test be defeated by dividing the product claim into a range denominated by some wholly irrelevant factor, such as the length of a mouse’s tail. The requirement to show enablement across the whole scope of the claim applies only across a relevant range. Put broadly, the range will be relevant if it is denominated by reference to a variable which significantly affects the value or utility of the product in achieving the purpose for which it is to be made.

viii) Enablement across the scope of a product claim is not established merely by showing that all products within the relevant range will, if and when they can be made, deliver the same general benefit intended to be generated by the invention, regardless how valuable and ground-breaking that invention may prove to be.’

Applying these, the Court found the patents in this case were ‘clearly’ invalid. It found that, at the priority date, the disclosure of the two patents and the common general knowledge only enabled transgenic mice to be made containing a very small part of the human variable region gene locus. Claiming a monopoly covering the whole range of the human antibody gene structure therefore went beyond the contribution made by the product to the art.

The majority judgment, authored by Lord Briggs, criticized the Court of Appeal’s understanding of ‘the essential patent bargain’ saying: ‘In the case of a product claim, the contribution to the art is the product which is enabled to be made by the disclosure, not the invention itself. Patents are about products and processes, not pure ideas.’ The Court also rejected the Court of Appeal’s conclusion that an invention may be ‘enabled’ in relation to a particular type of product falling within the scope of the claim even if it does not permit the skilled person to make it.

Lord Briggs added: ‘To water down [the sufficiency] requirement would tilt the careful balance thereby established in favour of patentees and against the public in a way which is not warranted by the EPC, and which would exceed by a wide margin the scope for the development of the law by judicial decision-making in a particular Convention state.’ He said that the contribution to the art should be measured by products which can be made at the priority date, not by products made at some future date: ‘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.’

Lady Black dissented, arguing that the patent claim was enabled across its scope ‘being deployed in each mouse across the range, irrespective of the quantum of human material incorporated’ and that protection across the full range coincided with the technical contribution of the patents.

One of the patents at issue was upheld by the EPO Technical Board of Appeal in 2015 (Decision T 2220/14) and appeal proceedings on the other patent are pending at the EPO. The UK Supreme Court did not refer to these EPO rulings in its judgment.