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Tuesday, 9 February 2010

Lack of industrial applicability: Neutrokine-α again

In August 2008 Mr Justice Kitchin delivered a mega-judgment in Eli Lilly & Co v Human Genome Sciences Inc, [2008] EWHC 1903 (Pat) on patent validity (noted by the IPKat here). 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.

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, holding that

* the court had to construe the "industrial 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 industrial applicability, "industry" was 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.

* applying all of these principles, HGS's patent -- however meritorious its discovery might have been -- was invalid for lack of industrial applicability.
HGS, having had some success in having its patent upheld by the Technical Board of Appeal of the European Patent Office on the basis of more restricted claims, appealed to the Court of Appeal (Lord Justice Jacob, Lady Justice Hallett and Mr Justice Lewison), which today in a 38-page judgment [2010] EWCA Civ 33 dismissed the appeal even in respect of the more restricted claims, on the basis that the invention was not susceptible of industrial application. Conscious of the fact that it was reaching a contrary decision to that of the EPO, the Court (in its judgment delivered by Jacob LJ) went to great lengths to explain and contrast the functions of the EPO and the Court of Appeal and the manner in which each reached its decision before concluding that (at paras 157-158)
"157. ... The upshot of all this is that Board, working on different evidence and using a different procedure came to a different conclusion on the facts. We are not bound to follow, or even give deference to, the Board’s findings of fact.

158. For the above reasons I have come to the clear conclusion that the Judge was right to hold that the invention failed to comply with Art. 57".
The IPKat is greatly impressed with the care and sensitivity with which the Court expressed its difference of opinion to that of the EPO Board. Merpel says, this case is also notable for the degree of cooperation between the EPO and the Court, the former employing its accelerated procedure for the latter's benefit.

2 comments:

MaxDrei said...

Haven't yet read the Decision carefully, but already I'm thinking that it will be studied all over the world, as an excellent guide to the relationship between opposition proceedings at the EPO and a nullity suit at a national court. I regret therefore that Robin Jacob did not point out to readers that:

1. In the EPO, only 9% of people have English as their first language but nevertheless are required, in the large majority of oppositions, to pronounce on materials that are very largely in English.

2. EPO opposition procedure is supposed to be a written procedure. Oral proceedings are not to be compared with a "trial".

Readers would then be in a better position to understand why EPO tribunals take in written evidence very late: it is somehow to compensate for the absence of any real trial of the evidence and to give the 3-member team of judges more of a breathing space in which to assimilate the English language materials. Those representing litigants at the EPO have to aim to "win" not only at oral proceedings but also at the session that occurs inside the EPO the day before oral proceedings.

Having to judge cases in a language which is not the first language of the judges imposes on DG3 a burden not suffered by any national court. The EPO has developed its own special way of managing that burden.

Jeremy said...

MaxDrei: thanks for your thoughtful comment. One small point: you write "Having to judge cases in a language which is not the first language of the judges imposes on DG3 a burden not suffered by any national court". Some of us are watching with interest and curiosity for the first Intellectual Property Office hearing in the UK to be held in the beautiful and official, but little-known, Welsh language: http://www.ipo.gov.uk/ourpublications-wls.htm

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