UK test for industrial applicability of gene patents is realigned with that of the EPO

The United Kingdom Supreme Court has given its judgement on the correct interpretation of the industrial applicability requirement, when applied to biological inventions. 

The Background

Human Genome Sciences succeeded in having granted a patent to the encoding nucleotide sequence, amino acid sequence, and certain antibodies of a new human protein called Neutrokine-α. Eli Lilly brought proceedings before the UK Court and the European Patent Office (EPO), submitting that the specification did not adequately disclose a use for the protein, and instead gave only wide-ranging and generalised suggestions based on the protein's purported membership of a superfamily of ligands.  The EPO's Technical Board of Appeal (TBA) decided that it did and maintained the patent, whereas in the UK, the High Court and Court of Appeal concluded that it did not and ordered that the patent be revoked. 

The Judgement

In recognising a lack of UK authority on this matter, particularly as regards biological material, the Supreme Court looked to the decision-rich jurisprudence of the EPO for an explanation of how the "susceptible of industrial application" requirement may be satisfied. 

The Supreme Court decided that the reasoning applied by the High Court and Court of Appeal was not consistent with the approach adopted by the TBA, from which it compiled a number of general and specific principles regarding industrial applicability, including: 

-       The absence of any experimental or wet lab evidence of activity of the claimed protein is not necessarily fatal; and

-        A "plausible" or "reasonably credible" claimed use, or an "educated guess", can suffice.

On the issue of protein superfamilies having known activities, the Court decided that the disclosure of a novel family member may, in itself, be enough to justify patentability. 

The Supreme Court decision re-aligns the UK test for industrial applicability with that of the EPO by overturning the decisions of the lower Courts.