From Paul Cole of Lucas & Cole

On February 9th the Court of Appeal ([2010] EWCA Civ 33; Jacob L.J.) held that Human Genome Sciences Patent EP-B-093

9804 for Neutrokine-α did not meet the industrial applicability requirement of a.52(1) EPC and should be revoked for the United Kingdom. In reaching its decision the Court affirmed a first instance finding of Kitchen J. ([2008] EWHC 1903) but differed from a 2009 finding of the EPO Appeal Board (Neutrokine/HUMAN GENOME SCIENCES Case T 0018/09) that the patent was valid. Since the proceedings relate to the national phase of the granted European patent, protection in other EPC contracting states is unaffected by the decision.

The patent in issue reported the discovery of the new protein and stated that it might be relevant to the treatment of a wide range of diseases ranging from solid tumours to schistosomiasis and other parasitic diseases. No experimental evidence was included in the specification to support these claims which were described at first instance by Kitchen J as “extravagant and sometimes contradictory”. Kitchen J. commented:

“I accept Professor Saklatvala’s evidence that the idea that Neutrokine-α and antagonists to Neutrokine-α could be used to treat the extraordinary range of diseases identified was fanciful. He found it hard to believe that anyone could seriously suggest on the basis of no experimental data at all that that Neutrokine-α was the answer to so many conditions, from treating cancer to treating worms. 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.”

In affirming the first instance decision, the court held that there was no difference as regards legal principles between the decision of Kitchin J. and the main decisions of the EPO Appeal Boards regarding DNA sequences and bioinformatics, including Max-Planck T 0870/04 (May 2005), Johns Hopkins T 1329/04 (June 2005), Genentech T 0604/04 (March 2006), ZymoGenetics T 0898/05 (July 2006), Bayer T 1452/06 (May 2007) and Schering T 1165/06 (July 2007). It was now settled that the research tool justification for patenting a new nucleotide sequence or polypeptide was not enough to satisfy the EPC. The following passage from the Max Plank decision showed the dangers if patenting too far upstream were allowed:

“[21] In the board’s judgment, although the present application describes a product (a polypeptide), means and methods for making it, and its prospective use thereof for basic science activities, it identifies no practical way of exploiting it in at least one field of industrial activity. In this respect, it is considered that a vague and speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool as described is not sufficient for fulfilment of the requirement of industrial applicability. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant.”

However, the Court of Appeal emphasized that what was binding was applicable legal principle, and that each case should be judged on its own facts. It was therefore not legitimate to invite the court to decide the case by reference to the facts of other cases.

Kitchin J.’s factual finding that the potential uses were merely speculative was supported inter alia by a statement of the time from real experts with no axe to grind who were not prepared to say that mere membership of the TNF-ligand superfamily was enough to indicate that any member of the family could be “a candidate for a novel treatment protocol” and his decision on the evidence before him could not be faulted. Although Kitchin J. and the Technical Board of Appeal asked the same key question and identified the same “kernel” the real difference was that Kitchin J. found on the facts before him that the “kernel” did not provide any basis for supposing that the invention was susceptible of industrial application whereas on the facts before it the Board thought there was. One difference in the relevant records was a last minute affidavit by a Dr. Kelsoe which was not before the UK court, and which had never been tested by cross-examination. On the evidence before Kitchen J. the Court of Appeal was not prepared to find that a skilled person would read the patent in the way adopted by the Board, and it was not proper to equate “a first step at the onset of research work” with “an immediate and concrete benefit”. The factual findings of Kitchin J. were to be preferred since they had been arrived at following an intensive examination of the evidence. In conclusion:

“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.”

It is not yet known whether a further appeal to the Supreme Court (the successor to the House of Lords) will be attempted. As there is no dispute as to the underlying law, it seems unlikely that any further appeal will be permitted.

Human Genome Sciences will become one of the most important UK authorities on industrial applicability. It is also likely to be widely read for its observations concerning the differences between proceedings in national courts and in EPO oppositions and concerning the limitations on the extent to which EPO Appeal Board findings should be of persuasive authority for national courts of the EPC contracting states.