{"id":7410,"date":"2020-06-29T14:20:00","date_gmt":"2020-06-29T13:20:00","guid":{"rendered":"https:\/\/www.hgf.com\/?p=7410"},"modified":"2026-02-18T09:46:05","modified_gmt":"2026-02-18T09:46:05","slug":"uk-supreme-court-invalidates-regenerons-transgenic-mouse-patents-for-lack-of-sufficiency","status":"publish","type":"post","link":"https:\/\/www.hgf.com\/de\/knowledge-hub\/legal-updates\/uk-supreme-court-invalidates-regenerons-transgenic-mouse-patents-for-lack-of-sufficiency\/","title":{"rendered":"UK Supreme Court invalidates Regeneron’s transgenic mouse patents for lack of sufficiency"},"content":{"rendered":"

In its long-awaited judgment on the dispute over patents for transgenic mice, the UK Supreme Court has held by a majority (Lady Black dissenting) that Regeneron\u2019s patents are invalid for a lack of sufficiency (Regeneron Pharmaceuticals Inc (Respondent) v Kymab Ltd (Appellant)<\/em>\u00a0[2020] UKSC 27)<\/a>.<\/p>\n

The judgment reinforces the established case law on sufficiency \u2013 that is, a patent specification must enable substantially the whole range of products falling within a claim to be made by the skilled person at the priority date. The Supreme Court overturned the Court of Appeal\u2019s previous ruling that this standard for sufficiency might be lowered where a ground-breaking invention provides a \u201cprinciple of general application\u201d.<\/p>\n

Background<\/h5>\n

Regeneron\u2019s invention related to transgenic mice which have been engineered to produce chimeric antibodies comprising a mouse constant region and a human variable region. Kymab claimed that Regeneron\u2019s patents (EP1360287 and its divisional EP2264163) were invalid for lack of sufficiency \u2013 the legal requirement that a patent must provide sufficient information to enable a skilled person to carry out the invention.<\/p>\n

The main claim on which the issue of sufficiency rested defined a transgenic mouse comprising in situ replacement of regions of the mouse antibody genetic locus with corresponding human regions (a \u201cReverse Chimeric Locus\u201d). This claim was interpreted by the Court of Appeal as covering a range of products comprising some or all segments of the human variable region. Kymab argued that, at the priority date (February 2001), it was not possible to insert DNA encoding the whole of the human variable region into the mouse chromosome, and thus some products falling within the claimed range could not be made.<\/p>\n

Diverging views of the Courts<\/h5>\n

The Court of Appeal held that although the disclosure of the patent, together with the common general knowledge at the priority date, did not enable\u00a0all\u00a0products falling with Regeneron\u2019s claim to be made, the requirement of sufficiency was still met because \u201chaving regard to the nature and extent of the contribution the disclosure of the invention has made to the art, the scope of the claim is no more than necessary to confer fair protection<\/em>\u201d.<\/p>\n

However, reflecting on the UK and EPO case law, the Supreme Court concluded that enablement across the scope of a product claim will not be established merely by showing that all products within the relevant range will (if they can be made at some point in the future) provide the benefit of the invention, regardless of how ground-breaking the invention may be.<\/p>\n

Underpinning the Supreme Court\u2019s judgment was the concept of the \u201cpatent bargain\u201d. In return for a monopoly over a claimed product or process, the patentee must provide enough information for others to make use of the invention after expiry of the patent. The Supreme Court held that the requirement of sufficiency was only met if the disclosure of the patent, together with the common general knowledge as of the priority date, enabled the skilled person to make substantially all types of products falling within the claimed range. Since mice containing a large part or all of the human variable region locus, which are more valuable, could not be made using the teachings of the patent, the monopoly claimed by Regeneron was found to extend beyond the contribution made by the patentee to the art.<\/p>\n

Conclusions<\/h5>\n

The majority judgment of the Supreme Court was unequivocal in its backing of the well-established law on sufficiency, going as far to say that the Court of Appeal had \u201cwatered down the sufficiency requirement which is a bedrock of patent law, tilting the balance of patent law in favour of patentees and against the public<\/em>\u201d.<\/p>\n

The judgment serves as a reminder to patentees about the fundamental importance of satisfying the \u201cpatent bargain\u201d. Over-reaching claims that cannot be properly justified by the technical contribution made to the art are invalid. Applicants are therefore reminded to resist the temptation to extend their claims beyond the limits of what they have made and tested without reasonable justification for doing so.<\/p>\n

This article was prepared by HGF Partner\u00a0Rachel Fetches<\/a>\u00a0and Patent Director\u00a0Dr Jennifer Bailey<\/a>.\u00a0If you would like further advice on this or any other matter, please contact Rachel or Jennifer.\u00a0 Alternatively, you can contact your usual HGF representative or visit our\u00a0Contact page<\/a>\u00a0to get in touch with your nearest HGF office.<\/p>\n","protected":false},"excerpt":{"rendered":"

In its long-awaited judgment on the dispute over patents for transgenic mice, the UK Supreme Court has held by a majority (Lady Black dissenting) that Regeneron\u2019s patents are invalid for …<\/p>\n","protected":false},"author":315,"featured_media":9004111222139204,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[497,509],"tags":[],"class_list":["post-7410","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-knowledge-hub","category-legal-updates","sector-pharmaceuticals","service-patents","sector_groups-law"],"acf":[],"yoast_head":"\nUK Supreme Court invalidates Regeneron's transgenic mouse patents for lack of sufficiency - HGF<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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