Recently the English Court of Appeal confirmed that it is not possible to patent a discovered gene sequence. They also explained how, when they disagree with decisions of the European Patent Office (EPO), it is most likely that the court, rather than the EPO, has got it right.
In Eli Lilly v Human Genome, [2010] EWCA Civ 33, the Court of Appeal was considering an appeal from a judgement of Kitchin J in which he had held that European patent (UK) 0939804 of Human Genome was invalid as relating to an unpatentable invention.
In dismissing the appeal, Jacob LJ, giving the judgment of the court, noted that the Technical Board of Appeal (TBA) of the EPO had upheld the European patent, after opposition, on the basis of more restricted claims. He considered the decision making process in the English courts and at the EPO to explain why the English court came to a decision at variance with that of the TBA.
English Courts v the EPO
Jacob LJ commented that first instance trials in England involve intensive investigation and testing of evidence, with acknowledged cost penalties. The evidence is tested by the process of cross-examination. The judge will not only have expertise in patent law but considerable general technical expertise. In this particular case the Court of Appeal had also used a scientific advisor from King's College, London.
The opposition procedure at the EPO was contrasted with this and referred to as "administrative". It was noted that there is no cross-examination and no compulsory disclosure of documents. It was also noted that there is much more latitude for the admission of fresh material on appeal.
Therefore Jacob LJ concluded that the EPO could not investigate matters as profoundly as in a trial in an English court. The Court of Appeal, therefore, would continue to take note of EPO decisions which clearly laid down a principle of law, they would feel able to depart from any EPO decisions which involved the assessing of facts of an individual case.
Can gene sequences be patented?
In concluding that Kitchin J was correct in determining that the invention in this case was not patentable, Jacob LJ commented:
"However clever and inventive you may have been in discovering a gene sequence, you cannot have a patent for it or for the protein which it encodes if you do not disclose how it can be used."
The decision of the TBA was reviewed in great detail, as was Kitchin J's judgment, and the court decided that the Board's decision depended on their assessment of the facts, and not on any principle of law.
The patent discloses the nucleotide and amino acid sequence of a novel member of the TNF ligand superfamily which it calls Neutrokine-a. The patent identifies the polypeptide as a member of the TNF ligand superfamily and includes a long description of its activities and its uses. The description, however, is not supported by any data obtained from in vitro or in vivo studies and is essentially a prediction based upon what was known about other members of the TNF superfamily.
The court held that the patent was just too speculative to provide anything of practical value other than information upon which a research programme can be based. Therefore it did not pass the test enshrined in the Patents Act which requires that the subject matter of a patent is "susceptible of industrial application".
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
