Supreme Court of United Kingdom: While deciding the instant appeal which challenged the validity of two patents seeking monopoly over the creation of a range of different types of transgenic mouse, the 5 Judge Bench of Lord Reed (President), Lord Hodge, Lady Black, Lord Briggs and Lord Sales, with a ratio of 4:1, reversed the Court of Appeal’s decision favouring Regeneron Pharmaceuticals (respondent in the instant appeal). The majority held that the Court of Appeal’s analysis of the issue diluted the sufficiency requirement which is the bedrock of patent law, thus tilting the balance of patent law in favour of patentees and against the public.
The question before the Court was that whether a product patent, the teaching of which enables the skilled person only to make some, but not all of the types of product within the scope of the claim, passes the sufficiency test where the invention would contribute to the utility of all the products in the range. As per the facts of the case, in 2001 Regeneron 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 genetic material from a human. The resulting mouse can be used to produce antibodies which are suitable for medical treatment in humans, but are sufficiently similar to mouse antibodies that they do not cause immunological sickness in the mouse. In 2013 Regeneron sued Kymab Ltd. (the appellant in the instant appeal), for infringement of its patents. Kymab was producing its own genetically modified ‘Kymice’, with a similar genetic structure to Regeneron’s mice. Kymab contended that the patents filed by Regeneron were invalid because they lacked ‘sufficiency’ which means that documents filed for the patent must be detailed enough to enable scientifically skilled readers to make the invention for themselves. The Court of Appeal however observed that patents filed by Regeneron had sufficient information to enable a skilled reader to insert some of the human material into a mouse’s genes, thereby upholding Regeneron’s patents on the principle of general application.
To analyse the question, the Court deemed it fit to delve into the complex technicalities of genetic engineering for medical purposes. The majority stated that a patent reflects a ‘bargain between the inventor and the public’. The inventor gains a time-specific monopoly over the making and use of a product and in return, the public gains the ability to make the product after the expiry of the monopoly. As part of this bargain, the inventor must publish ‘sufficient information to enable a skilled member of the public to make the product’. The patentees must not make broad claims. If they claim the right to make a range of products, sufficiency would mean they must disclose enough information to enable a skilled person to make the full range which is claimed; this means a relevant range that affects the utility of the product. It was noted that the amount of human material was an important factor that was thought to affect the diversity of useful antibodies that the mice would produce. Mice at the more valuable end of the range could not be made using Regeneron’s patents. Regeneron was claiming a monopoly that was far wider than its contribution to the art, which is why the patents granted to Regeneron are invalid due to the lack of sufficiency.
The dissenting judgment was delivered by Lady Black. She observed that,
“application of the sufficiency requirement depends on the nature of the individual invention and the facts of the case. The Court of Appeal characterised Regeneron’s invention as a principle of general application which solved the problem of immunological sickness, thereby meeting the sufficiency requirement as the invention was deployed in each mouse across the range, irrespective of the quantum of human material incorporated”. [Regeneron Pharmaceuticals Inc v. Kymab Ltd,  Bus LR 1394, decided on 24-06-2020]