Cambridge biopharma business Kymab has won a landmark UK Supreme Court verdict that invalidates patent claims by US giant Regeneron.
It is the latest court victory for the Babraham-based antibodies powerhouse over its New York rival.
With investment totalling $220 million Kymab is using its antibody platforms to realise new opportunities in therapeutic antibodies and vaccine development.
Kymab reveals that the Supreme Court of the United Kingdom has held that all of the claims of two patents (European Patents EP(UK) 1 360 287 and EP(UK) 2 264 163, the ‘Murphy patents’) owned by Regeneron Pharmaceuticals Inc that were asserted against Kymab are invalid.
The court’s decision upholds the February 2016 verdict of the High Court trial judge, Mr. Justice Henry Carr to revoke the claims and reverses the Appeal Court’s determination that they were valid.
A five-member panel of the Supreme Court heard arguments in February and announced their decision today. It was held that the relevant claims of the Murphy patents were invalid for insufficiency because they did not enable the ordinary skilled person to work the claimed invention across the breadth of the claims, in line with established jurisprudence of the UK courts and European Patent Office.
The Supreme Court noted that Kymab’s ability to create transgenic mice with the entire human antibody variable region depended upon Kymab’s own inventions made separately after the priority date of the Murphy patents.
Kymab CEO Simon Sturge said: “We are grateful that the Court has recognised the shortcomings of the Regeneron patents and reinforced the established law that requires that an invention is adequately enabled across its scope.
“Kymab’s IntelliSelect® platforms continue to generate best‑in‑class, fully human monoclonal antibodies, underpinned by our extensive IP estate.”
Dr Penny Gilbert, partner at Powell Gilbert LLP, added: “This case raised fundamentally important questions of patent law relevant to a wide variety of innovative life science companies in the UK.
“The Supreme Court has confirmed that patents should not be available for inventions that are not adequately enabled. Kymab has shown tremendous resilience in defending this case since Regeneron commenced proceedings in September 2013 and we are pleased to have helped them achieve this great result.”
The Murphy patents sought to cover genetically modified mice containing chimeric human-mouse antibody genes and the human antibodies made using such mice.
The European Patent Office had previously upheld the patents but had not considered evidence that was available to the UK Courts. Counterparts of the Murphy patents have also been litigated by third parties in the US where an equivalent Murphy patent was found to be invalid.
Kymab’s patent estate provides protection in the United States, Europe, Japan and other globally important commercial markets for human antibody therapeutics.
Its patents cover human antibodies produced using transgenic platforms that employ chimeric human-mouse antibody genes. In September 2019 and January 2020, Regeneron filed requests at the US Patent Office’s PTAB (Patent Trial & Appeal Board) seeking Inter Partes Review (IPR) proceedings against 5 of Kymab’s US patents.
The PTAB rejected all five petitions filed by Regeneron leaving each patent and their claims in full force in the US. Regeneron filed oppositions against Kymab’s Japanese patents, but these patents were upheld in unappealable decisions by the Japanese Patent Office.
In August 2019 the Australian Patent Office (IP Australia) rejected on all grounds an opposition by Regeneron against Kymab’s patent protecting therapeutic antibodies produced from transgenic mouse platforms. Regeneron appealed to the Australian Federal Court, but in May 2020 Regeneron agreed to discontinue its appeal and Kymab’s Australian patent is now upheld and in force.
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