The UK’s highest court recently considered the provisions of the European Patent Convention (EPC) centering on the “susceptible of industrial application” requirement in the context of a patent describing a DNA sequence for a new protein, Neutrokine-α, which was a member of a group of similar proteins known as the TNF ligand superfamily. The patent disclosed that the protein was a member of the superfamily and provided an extremely long list of potential applications for which the protein could be used, but did not provide any experimental evidence to support them. Human Genome Sciences v. Eli Lilly, Case No. 2011 UKSC 51 (UK Supreme Court, Nov. 2, 2011) (Neuberger, L. J.).
The European equivalent of the U.S. utility doctrine (codified in 35 U.S.C. § 101) can be found in Articles 52(1) and 57 of the EPC. Article 52(1) provides that European patents must be “susceptible of industrial application” and Article 57 explains that “susceptible of industrial application [means] it can be made or used in any kind of industry, including agriculture.”
Eli Lilly challenged the validity of the patent for lack of industrial applicability both in opposition proceedings before the European Patent Office (EPO) and before the English High Court. At first instance in both the EPO and the UK the patent was invalidated for lack of industrial applicability.
In the English Court, Justice Kitchin referred to the wide-ranging and speculative list of possible uses for the protein and the lack of a proven practical industrial use. He concluded that the “functions” of Neutrokine-α “were, at best, a matter of expectation and then at far too high a level of generality to constitute a sound or concrete basis for anything except a research project.”
In stark contrast, the Technical Board of Appeal of the EPO later upheld the patent. The Board’s reasoning was that the fact that certain properties of Neutrokine-α were shared with all members of the superfamily group meant that the specification provided a “plausible” statement, supported by post-published evidence, that Neutrokine-α had particular biological properties.
Coming back to the UK, the Court of Appeal—having considered the appeal decision in the EPO—once again rejected the patent on grounds of lack of industrial applicability. Lord Justice Jacob concluded that “[i]t is not good enough to say this protein … probably has a pharmaceutical use. Such a statement is indeed plausible, but is of no real practical use. You are left to find out what that use is.”
Against this background, the Supreme Court conducted a thorough review of EPO case-law on industrial applicability and held that the EPO had developed clear and consistent jurisprudence on industrial applicability that did not require a practical use to be demonstrated. In particular, the case law supported that the requirement of a plausible and specific possibility of exploitation can be at the biochemical, cellular or biological level. The English High Court and Court of Appeal had therefore applied the wrong test to industrial applicability, and the Supreme Court upheld the patent.
Lord Justice Neuberger commented on the desirability of applying EPO jurisprudence in the UK. He commented that “where the [EPO] has adopted a consistent approach to an issue in a number of decisions, it would require very unusual facts to justify a national court not following that approach.” Although there might be cases in which national courts and the EPO would come to different conclusions based on different evidence, he did not consider this to be such a case.
Lord Justice Neuberger also considered the relevance of U.S. case law and noted the utility requirements set by the U.S. Court of Appeals for the Federal Circuit in Fisher that “an invention is useful to the public as disclosed in its current form” as opposed to “proving useful at some future date after further research.” Ultimately however, while there had been moves to harmonize patent law over the past 50 years or more, he considered that there were significant and fairly fundamental differences between the wording of the relevant articles of the EPC and 35 USC § 101. The UK Supreme Court thus saw risks in looking to U.S. jurisprudence and therefore relied solely upon the jurisprudence of the EPO.
Practice Note: This decision marks a further move of the UK courts toward following EPO case law more rigidly than has historically been the case and will go some way to ensure that future decisions in the UK are more in line with European jurisprudence. Practitioners might also note the very different standards of utility applied in the U.S. (which must show utility in its disclosed form) and the perhaps lower hurdle of industrial applicability in Europe (which, so long as “plausible,” can be satisfied by reference to underlying biological mechanisms).© 2013 McDermott Will & Emery