In his July 31 judgment in Eli Lilly & Co v Human Genome Sciences Inc, High Court judge Mr Justice Kitchin laid down a set of principles which he said the UK courts should apply when considering whether or not a given patent possessed industrial applicability.
Kitchin said: 1) the notion of ‘industry’ should be construed broadly; 2) the capability of industrial exploitation must be derivable from the description in the patent read in conjunction with the skilled person’s common general knowledge; 3) the description must disclose a practical way of exploiting the invention in at least one field of industrial activity; 4) conversely, the requirement will not be satisfied if what is described is merely an interesting research result. The patent should not act so as to reserve for the applicant an unexplored field of research; 5) If a substance is disclosed and its function is essential for human health then the identification of the substance having that function will immediately suggest a practical application, but if the function is not known or understood and no disease has been identified which is attributable to an excess or a deficiency of it then the requirement of industrial application is not satisfied; 6) using the claimed invention to find out more of its own activities is not itself an industrial application; and 7) it is no bar to patentability that the invention has been found by homology studies using bioinformatics.
The case is thought to be the first in which the UK courts have 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.
While the issue is not usually a problem in sectors such as the mechanical arena, where a claimed invention frequently has a real and practical application, the position has been less clear-cut in biotechnology, where there has been a dearth of UK cases.
Justice Kitchin held that the Neutrokine-α patent filed by Maryland biopharmaceutical company Human Genome Sciences in 1996 and granted on 17 August 2005 - was invalid on the grounds of obviousness, insufficiency and lack of industrial applicability.
Neutrokine-α is one of a number of names given to a particular gene member of the Tumour Necrosis Factor (TNF) superfamily of proteins. HGS was the first of several companies to file for a patent on the TNF gene. But according to Indianapolis-based pharmaceutical manufacturer Lilly, HGS did so without having any real knowledge as to the biological activity or function of Neutrokine-α, the identity of any receptor, the conditions which it causes or the diseases which it could treat.
Justice Kitchin agreed with Lilly’s revocation action, which claimed that HGS’ description of the activities and uses of Neutrokine-α had no scientific data to support it and was therefore really a prediction based on knowledge of other members of the TNF superfamily.
“In my judgment the skilled person would come to the conclusion that the inventors had no idea as to the activity of Neutrokine-α when drafting the patent,” said Kitchin. “It teaches the skilled person nothing useful about its activity other than that Neutrokine-α is another member of the TNF ligand superfamily.”
HGS’ patent was filed before any traditional so-called wet experimental work could be performed. It was only subsequent research that had shown that proteins and antibodies described in the patent were of therapeutic use.
HGS subsequently developed a monoclonal antibody to Neutrokine-α which is in clinical trials. But Lilly has spent $50 million developing its own monoclonal antibody to Neutrokine-α and plans to spend another $250 million bringing it to the clinic.
Kitchin’s ruling is a reminder that 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.
Biotechnology products are an increasing source of revenue for the pharmaceutical industry, with sales in excess of $75 billion in 2007. As a result, biotech companies are frequently targeted by traditional pharmaceutical companies as a way of expanding their drug pipeline. Roche recently bid $44 billion to take full control of Genentech, the first ever biotechnology company. Patent protection is therefore vital to safeguard the huge investments made by the industry in this area.
Bristows partner Edward Nodder said of the judgment, which is expected to influence decisions in other European jurisdictions and at the EPO: “[It] provides strong guidance on what the threshold should be for a valid patent in this field of technology, which had previously received relatively little judicial consideration.”
Lilly instructed a Howrey team led by partner Mark Hodgson, with Andrew Waugh and Colin Birss acting as counsel. HGS was represented by Bristows breakaway firm Powell Gilbert, with Simon Thorley and Justin Turner as counsel.
