Harmony and BLyS in Europe and the UK

Abstract

*Marks & Clerk LLP, 62–68 Hills Road, Cambridge, CB2 1LA, UK Tel.: +44 1223 345 520 Fax: +44 1223 365 560 E-mail: gwilliams@marks-clerk.com Photograph © Marks & Clerk LLP What level of disclosure is required to obtain a patent? When asserting a physiological or therapeutic function of a molecule, how concrete must these functions be? The first patents case before the UK Supreme Court recently ruled on these issues, as well as considering the often vexed question surrounding the relationship between UK and European courts and whether the UK is bound to follow European case law. European patent law requires, among other things, that an invention be “susceptible of industrial application” (Article 57 EPC glosses this as “An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture.”) [1]. The race to the patent office to establish priority for an invention can conflict with the need to ensure that a use for the invention is disclosed. Often, such a use is self-evident; however, in the biotechnology sector this can be more doubtful, with in silico or expression data often hinting at a possible use for a gene or peptide, but final confirmation of this not coming for some time afterwards. This is the case with the recently approved lupus treatment Benlysta (belimumab), an antibody to the B-cell survival factor BLyS, the scientific development of which is summarised in [2]. The patent portfolio surrounding belimumab ultimately reaches back to early patent filings directed to BLyS and led to the first judgment on a patents case from the UK Supreme Court [201]. In 1996, Human Genome Sciences (HGS) filed a patent application disclosing the sequence of a novel peptide termed neutrokine-a [101]. The application indicated that the peptide is a member of the TNF superfamily, based on sequence homology and, as a consequence of this family membership, predicted various uses for the peptide, including inhibition of T-cell proliferation and treatment of autoimmune diseases. These predictions were made on little more evidence than membership of the TNF superfamily and were accompanied by what some might term typical patent verbiage. In the words of Lord Neuberger, “The specification, or description, of the Patent ... is confusingly long, diffuse, and widely expressed, running to over 25 closely typed pages, and nearly 200 paragraphs of descriptive text, and a further 12 pages of sequences of polypeptide amino acids and DNA nucleotides ...The specification ‘contains extravagant and sometimes contradictory claims...” Perhaps rather more tolerantly, the Technical Board of Appeal of the European Patent Office (‘the Board’) referred to the patent as having been drafted on a ‘boiler plate’ basis, which it described as ‘a practice used by patentees’” [201]. As an example of these contradictory claims, the judge noted that the patent suggests that both neutrokine-a and its antagonists inhibit immune-cell