Regeneron Pharmaceuticals Inc v Kymab Ltd: SC 24 Jun 2020

SC Kymab Ltd (‘Kymab’) alleges that the relevant patents are invalid for insufficiency because they did not enable the ordinary skilled person to work the claimed invention across the breadth of the claims. The patents are concerned with biotechnology, and in particular the production of human antibodies using transgenic mice. By the priority date, the potential uses of antibodies (also known as immunoglobulins) for treating human disease had been well recognised, and a number of different antibodies had been developed and approved for such use. The patents describe a technique for making such antibodies.
Regeneron appealed the decision of Henry Carr J that European Patent (UK) No 1 360 287 and its divisional European Patent (UK) No 2 264 163 are invalid. Kymab cross-appealed against the judge’s finding that its various strains of transgenic mice would infringe claims 5 and 6 of the 287 patent and claim 1 of the 163 patent if those patents had not been invalid. Regeneron’s appeal was allowed by the Court of Appeal. Kymab’s cross-appeal was dismissed.
Held: (Lady Black dissenting) Kymab’s appeal was allowed, holding that the patents were invalid.
An inventor must publish enough information to allow a skilled member of the public to make the product: ‘The essence of the bargain between the patentee and the public is that the patentee dedicates the invention to the public by making full disclosure of it, in return for a time-limited monopoly over its use. The benefit afforded to the public is not merely the disclosure, but the ability to ‘work the invention’ after the expiry of the monopoly by the use of the disclosure. Where the invention enables patentees to make a particular product, and they seek a monopoly over the making and exploitation of the product (which is what a product claim does), they must disclose enough in the teaching of the patent to enable the public also to make the product.’
Thus a patent holder only gains a legal protection which is proportional to the technical contribution to the art, and encourages inventors to conduct research for the benefit of society. Regeneron was claiming a monopoly which was far wider than its contribution to the art; its published patents did not enable a skilled person to make mice containing more than a very small section of the human variable region.
Lord Reed, President, Lord Hodge, Lady Black, Lord Briggs, Lord Sales
[2020] UKSC 27, UKSC 2018/0131
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England and Wales
At PatCRegeneron Pharmaceuticals Inc v Kymab Ltd and Another PatC 1-Feb-2016
The parties disputed the validity of K’s patented mouse. R said that the specification was insufficient to allow reproduction, and that it was therefore incomplete.
Held: The specification was insufficient, and the patents invalid. The issue . .
Appeal fromRegeneron Pharmaceuticals, Inc v Kymab Ltd and Another CA 28-Mar-2018
The claimant R now appealed from a finding that its two patents involving transgenic mice were invalid. The ‘in situ replacement’ failed to comply.
Held: The appeal succeeded. . .
Request for leaveRegeneron Pharmaceuticals, Inc v Kymab Ltd and Another CA 23-May-2018
Leave to appeal to Supreme Court refused. Other post judgment issues – form of order. . .
CitedFerrazzini v Italy ECHR 12-Jul-2001
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CitedMay and Baker Ltd and others v Boots Pure Drug Company Ltd HL 9-Feb-1950
A beneficial therapeutic effect was said to be of the essence of the claim. The House considered whether in defending the validity of a patent, the patentee might be allowed an application to amend the patent specification. The patentee had not been . .
CitedBiogen Plc v Medeva Plc HL 31-Oct-1996
The claim patented sought to protect a genetic molecule rather than a whole mouse namely that the molecule would, if inserted into a suitable host cell, cause the cell to make antigens of the Hepatitis B virus. A recombinant method of making the . .
CitedRockwater Ltd v Technip France Sa (Formerly Coflexip Sa), Technip Offshore UK Limited (Formerly Coflexip Stena Offshore Limited) CA 6-Apr-2004
Jacob LJ said that the skilled person who must be enabled to make the product from a patent specification, is not expected to be inventive or even, as is sometimes said, imaginative . .
CitedH Lundbeck A/S v Generics (UK) Ltd and others CA 10-Apr-2008
The court heard an appeal against a finding that a patent for a chemical compound was invalid for insufficiency.
Held: The appeal succeeded.
Enough information to ‘work the invention’ meant in order to make the product. . .
CitedActavis Group Ptc EHF and Others v Icos Corporation and Another SC 27-Mar-2019
The court considered: ‘the application of the test of obviousness under section 3 of the Patents Act 1977 to a dosage patent. In summary, a patent, whose validity is not challenged, identified a compound as an efficacious treatment but did not . .
CitedGenerics (UK) Ltd and others v H Lundbeck A/S HL 25-Feb-2009
Patent properly granted
The House considered the patentability of a chemical product, citalopram made up of two enantiomers, as opposed to the process of its creation, questioning whether it could be new or was insufficient within the 1977 Act.
Held: The appeal . .
CitedKirin-Amgen Inc and others v Hoechst Marion Roussel Limited and others etc HL 21-Oct-2004
The claims arose in connection with the validity and alleged infringement of a European Patent on erythropoietin (‘EPO’).
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These lists may be incomplete.
Updated: 22 June 2021; Ref: scu.651925