Kymab Prevails As The UK Supreme Court Affirms The Requirement For Sufficient Disclosure

Published date10 December 2020
Subject MatterIntellectual Property, Litigation, Mediation & Arbitration, Patent, Trials & Appeals & Compensation
Law FirmVenner Shipley
AuthorMr Paul A. Harris and David Pountney

The UK Supreme Court (UKSC) has upheld Kymab's appeal that two of Regeneron's patents are invalid for lack of sufficient disclosure. This important decision highlights the potential risks involved in filing patent applications too early and affirms the principle that in order to be valid a patent claim must be enabled across its entire scope.

The UKSC has handed down its much anticipated judgment in Regeneron Pharmaceuticals Inc. v Kymab Ltd. [2020] UKSC 27. The UKSC found that various patents belonging to US biotech company Regeneron, concerning transgenic mice to produce human-mouse chimeric antibodies, were invalid for lack of sufficient disclosure.

The decision was not, however, unanimous with Lady Black dissenting and agreeing with the Court of Appeal's approach.

The law of sufficiency

As well as being both novel and inventive, to be valid a patent must be sufficiently disclosed to enable the skilled person to perform the invention. Under both the European Patent Convention and the Patents Act 1977, patent claims must be enabled across their full scope. This means the skilled person must be able to make the product using (a) the information disclosed in the patent, with (b) the common general knowledge available at the priority date, without having to undertake further experimentation or make further inventions of their own.

Background to the dispute

This long-running dispute concerned the infringement and validity of two of Regeneron's patents concerning the creation of types of transgenic mice capable of producing human-murine chimeric antibodies suitable for treating a variety of diseases. The monopoly claimed by Regeneron involved the insertion of human antibody genes into the mouse genome, such that the resulting antibodies do not provoke an adverse immunological response in humans.

Pre-existing transgenic mouse technology had utilised the complete human gene sequence of the antibodies to be produced, but this was known to result in antibodies with reduced affinity in comparison with antibodies produced by unmodified mice.

Regeneron had filed applications for its 'VelocImmune' transgenic mice technology in 2001. The 287 and 163 patents (collectively the 'Murphy Patents') concerned the use of reverse chimeric locus technology to insert human antibody genes into the mouse genome in order to produce mice possessing chimeric human-murine antibody genes, which could be used to produce human antibodies having fewer adverse immunological side effects.

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