Transcript The industrial application test for novel proteins All in the family?

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 0 939 804 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.
[email protected]