Satisfying the Requirements for Industrial Applicability – England & Wales Court of Appeal Provides Guidance For Biotech Inventions

This case concerns an appeal [2010] EWCA Civ. 33 from the August 2008 judgment in Eli Lilly & Co. v Human Genome Sciences Inc., [2008] EWHC 1903 (Pat), wherein Mr. Justice Kitchin held all claims in HGS’s EP (UK) 0939804 invalid on three grounds: they were not susceptible of industrial application, they were insufficient and they were obvious because of a lack of technical contribution.

The Appeal focused on EPC Art. 57 “An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture” and used the Biotech Directive (99/44EPC) to shed light on the interpretation of Art. 57. The Appeal Court also looked extensively at, and gave great deference to, relevant decisions of the EPO Technical Boards of Appeal on issues of law stating: “Decisions of the TBAs on questions of law are of immense importance”.

The upshot was that Lord Justice Jacob, supported by Lady Justice Hallett and Mr Justice Lewison, determined that HGS had not described in its patent alone, or with the benefit of common general knowledge at the priority date, a sufficiently plausible utility for the claimed Neutrokine-α protein to have demonstrated “an immediate and concrete benefit”.  Consequently, the Appeal Court ruled that Art. 57 was not satisfied, despite the fact that Neutrokine- α was described in the patent as a TNF ligand superfamily member, and certain members of the superfamily were potential candidates for novel treatment protocols. On that point, Lord Justice Jacob dissected a paper “incorporated by reference in its entirety” into the patent, drawing the conclusion that the paper did not say “that any member of the superfamily (or its agonists) has real or indeed any potential as a therapeutic or diagnostic agent. It is merely saying some identified members may have some use because of their individual known properties”.

The Court acknowledged that discovering a nucleotide sequence encoding for a human protein and being able to show that the protein has some common homology with known proteins (i.e. is a member of a family) may satisfy art. 57. But “whether it does or does not (satisfy Art. 57) is case dependent and in particular depends upon how well established the functions of the other members of the family are”. In the present case, the Court agreed with Mr. Justice Kitchin that the therapeutic and diagnostic applications suggested in the patent were speculative, as supported by the facts that the activities of Neutrokine-α have only gradually been elucidated after the patent filing and much of its biology remains unclear and is the subject of continuing study.

Also, of interest to patent drafters was the negative inference drawn to the myriad potential uses for Neutrokine-α described in the patent, some of which were contradictory to others. On this issue the Court stated “In reality one was faced with a research program to see which, if any, of the possible uses of the Neutrokine-α or its antagonists was real”.

At the end of the judgment, Lord Justice Jacob discusses why the Mr. Justice Kitchin and the Appeals Court came to a different conclusion to the TBA, who allowed HGS’s appeal October 21, 2009 on a more restricted set of claims. Having devoted a significant part of the introduction to the judgment to the different procedures and approaches of the civil trial courts in England and Wales to proceedings in the EPO, Lord Justice Jacob artfully draws upon these differences to support his reasoning for invalidating the patent claims for lack of industrial applicability.

 

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