UK – SC REJECTS PATENT FOR GENETICALLY MODIFIED MOUSE

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LORDSHIPS AT THE UK SUPREME COURT, Copyright credits The Guardian

The Supreme Court of United Kingdom delivered an interesting verdict vide its order dated 24-6-2020. Regeneron Pharmaceuticals Inc filed patents for a new type of genetically modified mouse which was a hybrid version of the gene that produces antibodies, combining a section of the mouse’s genetic material with a section of the genetic material from a human. In 2013, Regeneron sued Kymab Ltd for infringements of its patents. Kymab was producing its own genetically modified mice, with a similar genetic structure to Regeneron’s mice. Kymab argued that the patents filed were invalid because they fell foul of a patent law rule called sufficiency which means that documents filed with the patent must be detailed enough to enable scientifically skilled readers to make the invention for themselves. The Court of Appeal upheld the patents and Kymab appealed to the Supreme Court.

The Supreme Court allowed Kymab’s appeal by a majority of four to one, holding that the patents are invalid. Regeneron’s patents did not enable a skilled person to make mice containing more than a very small section of the human variable region. The amount of human material was an important factor which was thought to affect the diversity of useful antibodies which the mice would produce. Mice at the more valuable end of the range could not be made using Regeneron’s patents. So Regeneron was claiming a monopoly which was far wider than its contribution to the art. The Court of Appeal’s analysis had watered 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.

57. Application of those principles to the facts of the present case shows clearly that Claim 1 fails for insufficiency. At the priority date the disclosure of the two patents, coupled with the common general knowledge, did not enable transgenic mice to be “made” with a Reverse Chimeric Locus containing more than a very small part of the human variable region gene locus. The extent to which that variable region of the human antibody gene structure could be included in the hybrid antibody gene structure was, at that date, understood to be a very important factor affecting the diversity of useful antibodies capable of being “discovered” by the use of transgenic mice, so that the range thus denominated was a relevant range for sufficiency purposes, even though it did not affect the immunological health of the transgenic mouse. Thus the claim to a monopoly over the whole of that range went far beyond the contribution which the product made to the art at the priority date, precisely because mice at the more valuable end of the range could not be made, using the disclosure in the patents

See the order