Human Genome Sciences v Eli Lilly

The case concerned a patent held by Human Genome Sciences disclosing a novel gene and its encoded protein (Neutrokine-alpha), as well as information about its structure and activities.  The main question on appeal was whether the requirement for industrial applicability was satisfied by disclosing the sequence, protein and related information, without any specific information about function.

The Court unanimously allowed the appeal and answered yes, since genotyping and other medical research methods tend to have proved that the protein is from a specific group (the TNF ligand superfamily) and a person skilled in the art would have known that members of that group had a particular function (in proliferation, differentiation and migration of T-cells).

The procedural history is that in mid-2008, within a month of each other, the Opposition Division of the EPO and Kitchin J in the Patents Court both revoked the patent on the basis of no known function.  The EPO Board of Appeal overturned that decision in Oct 2009, for reasons largely followed by the Supreme Court, while the Court of Appeal upheld Kitchin J’s decision in Feb 2010.  The stage was therefore set for an EPO vs. national courts battle.

The main considerations on appeal were: (1) consistency with EPO jurisprudence; and (2) policy considerations.

1. Lord Neuberger at [107] identified 15 points that reflected the Board’s consistent approach to the questions in the case (many of which were also referred to by Lord Hope).  Essentially, being a member of a group where all or some members have a known function seems to be sufficient to establish industrial applicability. Interestingly, this was the case even though Neutrokine-alpha’s membership of the TNF family was not mentioned in the claims and was only implicit in the specification.  Though the Court expressed great reluctance to overturn the decisions below, it was considered necessary because this was a case of the UK courts applying a different test to the EPO, not just assessing the evidence differently or using a different procedure.

2. Policy considerations were undoubtedly important to the result in this case, with clear concerns about chilling effects on the biotech industry evident in all of the reasons.  However, there is a vast difference between the relatively weak requirement imposed by this decision and the clearly onerous requirement of full-scale clinical determination of therapeutic function, as alluded to at various points.

 No doubt more thoughts will surface as the decision settles!

Human Genome Sciences v Eli Lilly [2011] UKSC 51