Superfamily, shame about the Neutrokine

Yesterday Mr Justice Kitchin delivered a mega-judgment in Eli Lilly & Co v Human Genome Sciences Inc, [2008] EWHC 1903 (Pat), yet another significant Patents Court for England and Wales decision on patent validity.

In short, HGS owned a patent that disclosed the nucleotide and amino acid sequence of a novel member of the TNF ligand superfamily, the polypeptide Neutrokine-α: this was a cytokine (a protein which acted as an inter-cellular mediator in inflammation and cellular responses). The history of the patent was as follows: a European application was filed on in October 1996 and it was granted nearly nine years later, in August 2005. The patent correctly identified the polypeptide as a member of the TNF ligand superfamily, listing a long description of its activities and uses. There was however no scientific data to support that description, which was really a prediction based on knowledge of other members of the TNF superfamily.

In these proceedings Eli Lilly sought to revoke HGS's patent on several grounds, including an allegation that there was no disclosure of an invention susceptible to industrial application in that HGS had filed its application without knowing the biological activity or function of Neutrokine, the identity of any receptor, the conditions which it caused or the diseases which it might be used to treat.

Kitchin J revoked the patent for lack of industrial application, insufficiency and obviousness. In his view

* the court to construe the "indutrial applicability" provision of the Patents Act 1977 so that, so far as possible, it had the same effect as Article 52 of the European Patent Convention (EPC).

* in the context of indutrial applicability, "industry" to be construed broadly. It included all manufacturing, extracting and processing activities of enterprises that were carried out continuously, independently and for commercial gain. "Industry" need not however have been conducted for profit -- and a product which was shown to be useful to cure a rare disease could be considered capable of industrial application even if it had never been intended for use in trade at all.

* the skilled person had to be able to derive an invention's industrial application from its description in the patent, read with the benefit of common general knowledge. Accordingly that description had to disclose a practical way of exploiting the invention in at least one field of industrial activity. This requirement had recently been re-formulated as an enquiry as to whether there was a sound and concrete basis for recognising that the contribution was (or was not) capable of leading to practical application in industry. Even so, it was still necessary to disclose, in definite technical terms, the purpose of the invention and the manner in which it was to be used to solve the given technical problem.

* there also had to be a real prospect of exploitation of the invention that could be derived directly from the specification, if it was not already obvious from the nature of the invention or the background art. This requirement could not be satisfied it what was described was merely an interesting research result that could yield an as-yet unidentified industrial application.

* the purpose of granting a patent was not to reserve an unexplored field of research for the applicant -- nor was it to give the patentee unjustified control over others who were actively investigating in that area and who might eventually have found ways actually to exploit it.

* if a substance was disclosed and its function was essential for human health, its identification as having that function immediately suggested a practical application -- but if its function was not known, or was incompletely understood, and no disease had been identified that was attributable to an excess or deficiency of it, and no other practical use was suggested for it, the requirement of industrial applicability was not satisfied.

* the use of a claimed invention in order to discover more about its own properties was not of itself an industrial application for the purposes of patentabiity.

* appliying all of these principles, HGS's patent -- however meritorious its discovery might have been -- was invalid for lack of industrial applicability.

The IPKat is impressed with the judge's masterful summary of the deeper meaning of "industrial applicability"; a patent has to contain a teaching -- the skilled addressee should not be faced with a do-it-yourself kit for working out where the invention lies. He believes that this is the first case in which any British court has had to consider the circumstances in which a patent relating to a gene sequence can validly be granted on the basis of it being capable of industrial application. Merpel says, this case carries another important message: the state of the art when the patent's validity comes under scrutiny cannot be used retrospectively in order to correct deficiencies in the patent at the time when it was filed.