Judgment of 24.06.2020, [2020] UKSC 27, Supreme Court United Kingdom.
A claimed product is sufficiently disclosed if at least one way of carrying out the invention is clearly indicated by the disclosure of the patent enabling the person skilled in the art to prepare substantially the full range of products covered by the claims of the patent.
A potential contribution of an invention to the value of products that currently cannot be made, but might be capable of being made in the future, does not exempt from the obligation of sufficient disclosure.
The infringement and validity of two European patents in the UK – parent patent EP 1 360 287 and an associated divisional application filed by the biotechnology company Regeneron are subject of the patent dispute. The patents in dispute refer to transgenic mice, producing hybrid antibodies after appropriate genetic modification, and their production. For this purpose, variable regions of human DNA are introduced into the genome of mice. As constant regions of the murine DNA are retained, the health of the mice is little affected and the mice are able to produce significant amounts of hybrid antibodies.
In the first instance, the court declared the patents to be invalid due to insufficient disclosure. This was based on the fact that on the priority date, a person skilled in the art had only been able to replace some variable murine gene sequences with human gene sequences, but that the protection covered by the patents had included a complete replacement of murine variable gene sequences with human variable gene sequences.
In contrast, the Court of Appeal understood the subject of the patents as a general principle and stated that the invention was patentable even if not every embodiment could be made.
The defendant in the parallel infringement proceedings appealed the Court of Appeal’s decision.
Decision:
The Supreme Court clarified that the claimed transgenic mice were not a single product, but a wide class of products, as the gene structure of the hybrid antibodies could contain variable variants of human gene sequences or all variants of a particular gene locus. On the priority date, however, only gene structures with a few human gene sequences could be made. The patents did not disclose how a gene structure could be made in which the entire human variable region could be combined with the constant murine region. For these reasons, the invention did not enable a person skilled in the art to carry out the invention. In addition, the protection covered by the patents did not correspond to the contribution of the invention to the prior art. Thus, the requirement of sufficient disclosure was not met. It is not crucial whether the invention could contribute to products that might be producible in the future, but whether the contribution to the prior art made by the disclosure corresponds to the protection covered by the patent.
Conclusion:
The decision once more sets high requirements for sufficient disclosure of inventions in patents. As a result, this decision underlines how important it is to describe in the patent application that a product or process has a technical effect over the full range of the claims and to support it with experimental results when preparing the patent application.
Dr. Christoph Heinemann Dr. Kerstin Wienhold