Meanwhile in Europe: HGS Inc v Eli Lilly & co The industrial application test for novel proteins: All in the family? AIPLA Biotech committee meeting 25 January 2012 John J. Allen NautaDutilh NV The Netherlands Europe

Human Genome Sciences Inc v Eli Lilly & co. UK Supreme Court 2 November 2011 Central themes: Discovery vs. invention Article 52/57 EPC: industrial application Patent specification requirements/thresholds: role and function of novel proteins EPO vs national courts

The Facts EP claims: nucleotide sequence encoding for novel protein Neutrokine-  amino acid sequence antibodies

EP 804 description Neutrokine-  identified as member of TNF ligand superfamily of cytokines All 8 members of superfamily are involved in regulation of cell proliferation, activation and differentiation Neutrokine-  : expressed in various cells/organs Potentially useful for diagnosis, prevention or treatment of “extraordinarily large and disparate number of immune system disorders and conditions” (Kitchin J.) NO DATA /STUDIES TO SUPPORT THIS

Neutrokine-  : mere discovery or an invention? Article 52 EPC: European patents shall be granted for any inventions, in all fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application Article 57 EPC: An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture.

Neutrokine-  Litigation: EPO Opposition Division 3 December 2008 Patent revoked (lack of inventive step) UK 1st instance decision 17 October 2008: Kitchin J revokes the patent “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”

Neutrokine-  Litigation (II): EPO board of appeal decision 21 October 2009 (T0018/09): Patent deemed valid UK Court of Appeal decision 9 February 2010 Confirms 1st instance decision (patent invalid)

UK Supreme Court: Facts Review of EPO case law Policy considerations

Facts: Role/function/Activity of Neutrokine-  as a member of the TNF superfamily, Neutrokine-  : Exhibits activity on leukocytes is active in proliferation, differentiation and migration will have a wide range of anti-inflammatory activities

Facts (II): As per 25 October 1996: The skilled person: team, familiar with TNF superfamily would conduct literature search on existing members knows bioinformatics can assist in search for new members

Facts (III): the superfamily TNF superfamily had some common features (e.g. structural, all expressed by activated T cells, play a role in T cell proliferation and T cell mediated immune responses) Some played a role in B cell proliferation and antibody secretion No disease had been identified in which all TNF superfamily members were involved

Facts (IV): The skilled person would expect from a family member Activity relating to T cells probably involved in T cell mediated immune responses Co-stimulant of T cell proliferation/effect on B cell proliferation

Review of EPO case law T 0870/04 (BDPI1 Phoshatase/Max planck ) T 1329/04 (Factor9/John Hopkins) T 0604/04 (PF4A receptors/Genentech) T 0898/05 (Hemapoietic receptor/ZymoGenetics) T 1425/06 (Serine protease/Bayer) T 1165/06 (IL-17 related polypeptide/Schering)

Application of EPO case law principles: Decisive factors for finding validity: existence and structure of Neutrokine-  and encoding gene disclosed tissue distribution expression in T-cell and B-cell lymphomas teaches membership of TNF ligand superfamily discloses a real possibility of exploitation (sufficient: on biochemical, cellular or biological level) absence of experimental data: not fatal (plausible use/educated guess) post filing evidence interest pharmaceutical industry

Explicit policy considerations Plainly appropriate in principle and highly desirable in practice to interpret the provisions of the EPC in the same way Where the Board 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. “The wider picture” : industry policy, promotion of innovation

Thank you.