UK Supreme Court overrules Court of Appeal in Biotechnology case

Human Genome Sciences (HGS) Inc. v Eli Lilly and Company [2011] UKSC 51

The Supreme Court has ruled on its first biotechnology case, following the replacement of the House of Lords with the UK Supreme Court.  In what some consider a surprising decision, the Court overturned the decision of the Court of Appeal which had maintained the first instance decision in the Patents Court.  This case relates to a granted patent directed to neurocrine-α, a cytokine which is a member of the tumour necrosis factor alpha (TNF--α) super family.  The decision dealt with the requirement for industrial applicability and sufficiency for biotechnology inventions.

This case is especially interesting because the European Patent Office (EPO) Technical Board of Appeal came to the opposite conclusion to the UK Patents Court and Court of Appeal, finding the claims patentable. 

The patentee, HGS, had identified a novel sequence with structural similarities to TNF-α and therefore concluded that it was a member of the TNF-α super family.  In addition to this conclusion, there was minimal further characterising information, as follows:

• The tissue distribution of neurocrine-α, and
• The expression of neurocrine-α in B-lymphomas and T-lymphomas

The key question before the Court was whether this was sufficient information, combined with common general knowledge to support a granted patent.  At both the first instance court and the Court of Appeal, the judges had ruled that it was not.  Lord Justice Jacob wrote the judgement for the Court of Appeal decision finding the claims to lack industrial applicability. 

Lord Neuberger who wrote the lead  decision for the Court observed that in a number of recent decisions the House of Lords drew attention to the importance of UK patent law aligning itself, as far as possible with the jurisprudence of the EPO.  He stated that although this does not mean the courts should consider EPO Board of Appeal decisions to be binding on them, if the Board had adopted a consistent approach on an issue in a number of decisions, it would require very unusual facts to justify a national court not following that approach.  He went onto say that there has been little helpful UK guidance on the application of Article 57 EPC (industrial applicability) to patents for biological material but there had been a number of decisions of the EPO Appeal Boards.

In his analysis, Lord Neuberger distilled out 15 principles from the EPO jurisprudence,  governing the requirements of Article 57 EPC in relation to biological material and including some specifically relevant to additional members of a family or super family of proteins. Lord Neuberger stated that the first instance judge and the Court of Appeal did not give sufficient weight to the jurisprudence of the EPO Appeal Boards and then having applied this jurisprudence over-turned the lower courts rulings.  In particular he focused on:

• The problem solved by an invention can be isolating a further member of a family;
• The recognition that a protein is important for the pharmaceutical industry may suffice, even if the role has not been clearly defined;
• A ‘plausible’ or ‘reasonably credible’ claimed use or an ‘educated guess’ can suffice, which can be at the biochemical, the cellular or the biological level;
• Such plausibility can be assisted by being confirmed by ‘later evidence’, although later evidence on its own will not do.

In this case the fact that all known members of the TNF super family were expressed on T-cells and were able to co-stimulate T-cell proliferation was considered sufficient to support industrial applicability.

Philip French, Head of Biotechnology at Appleyard Lees said ‘it is still the case that if you identify a new sequence but do not understand its function this will not be patentable, however, this decision  has lowered the threshold for industrial applicability and sufficiency for biological inventions, especially if the sequence is another in a family of proteins.  If the sequence is another in a member of a family of proteins, inventive step may be an issue if it was just a routine cloning exercise to identify the new protein.’

This is not the end of this case because the UK Supreme Court remitted the case back to the Court of Appeal to consider issues decided by the first instance judge but not yet considered by them.  However, this is unlikely to significantly affect the decision.

For more information, please contact our head of Biotechnology, Philip French.