Download Facts - WIPO

Patenting of Genes and Life Forms, and the impact of
Patenting on Upstream Science
Joseph Straus,
Munich
WIPO Open Forum on the Draft SPLT
Geneva, March 3, 2006
© J. Straus 2006
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Overview
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What are Genes – A Reminder
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Existing Legal Framework
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Facts and Experience of Relevance
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Status quo measured by 1997 HUGO’s yardstick
© J. Straus 2006
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Reminder I: DNA - Sequence - Gene
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DNA Sequence – any sequence of DNA building blocks
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Gene – fundamental physical and functional unit of heredity, in its
broadest sense, which consists of an ordered sequence of
nucleotides located in a particular position on a particular
chromosome, and which encodes specific functional products,
such as protein or RNA molecule.
© J. Straus 2006
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Reminder II: Double Nature of Gene Sequences
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Physical carrier of information
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Information as such – multifunctional
– The (actual)-biological function  e.g. coding for (a) protein(s)
(alternative splicing!)
– The (actual) – non-biological function – hybridising  e.g. DNA
probe, diagnostic marker, etc.
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Reminder III: Human Genome
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Human Genome Programme (HUGO) – 1995-2000
– 4 years
– 1st Billion base pairs
– 4 months
– 2nd Billion base pairs
– Eventually
– 10 % base pairs per month
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Celera (Craig Venter) – ca. 2 years – 3 Billion bp
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Result: instead of 100.000 some 30-35 (48?) thousands of genes
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40% alternatively spliced
© J. Straus 2006
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Mandatory TRIPS Protection Standards
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Patents must be available for inventions in all fields of
technology – no discrimination allowed (Art. 27 (1))
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Exclusions allowed – if necessary to prevent commercial
exploitation which would violate ordre public or morality – thus
applicable only if the respective exploitation not allowed (Art. 27
(2))
DSPLT
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Subject matter eligible for protection shall include products and
processes [, in all fields of technology,] which can be made and
used in any field of activity, except mere discoveries; … (Art. 12)
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Available Manœuvring Space
- Allowed Limitations of the Exclusive Right Conferred -
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Research Exemption covering: research for further improvements
and further developments, clinical trials of all kinds with patented
substances (see, e.g. USA, Japan), irrespective eventual
commercial aim, use as research tools (in academe?) (Art. 30)
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Compulsory and dependency compulsory licenses, also for plant
breeders vs. Patentees (Art. 31 TRIPS, EU Biotech Directive)
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EU Directive 98/44/EC Regime
Gene Sequences = Chemical Substances?
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If isolated from the human body or technically produced (e.g.
through synthesis) – sequences or partial sequences of a gene –
patentable inventions – even if structurally identical to that of a
natural element [Art. 5 (2)]. However
•
the industrial application of a sequence or a partial sequence of a
gene must be [specifically] disclosed in the application [Art. 5 (3)].
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A mere DNA sequence without indication of a function – not a
patentable invention [Recital 23] – thus „function“ integral part of
the notion „invention“.
© J. Straus 2006
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EU Directive 98/44/EC Regime
Gene Sequences = Chemical Substances?
•
Use of a sequence or partial sequence of a gene to produce a
protein or part of a protein „industrially applicable“ only if the
protein or part of the protein and its functions specifically
disclosed [Recital 24].
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Special rules on dependency in case or overlapping patented
sequences [Recital 25].
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Product protection for products containing or consisting of
genetic information extends to all material – EXCEPT TO THE
HUMAN BODY – „in which the product is incorporated and in
which the genetic information is contained and PERFORMS ITS
FUNCTION“ [Art. 9].
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No Patents for ESTs in the US
“643’ application does not meet the utility requirement of § 101
because Fisher does not identify the function for the underlying
protein-encoding genes. Absent such identification, we hold that
the claimed ESTs have not been researched and understood to the
point of providing an immediate, well-defined, real world benefit to
the public meriting the grant of a patent.”
[In. re Dane K. Fisher Fed. Cir. Sept. 7, 2005]
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Facts
Source NRC 2005
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© J. Straus 2006
Facts
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Facts
Source: NRC 2005
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Facts
Source: NRC 2005
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Facts
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Facts
Access to Genetic Discoveries
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85 % of US university-based genetic discoveries directly released
into the public domain – not covered by proprietary rights
[Henry et al. (2002)]
[Movery et al. (2001)]
© J. Straus 2006
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Facts
Impact on Industrial Development
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Amgen
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Biogen
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Genentech
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Millenium
and numerous other biotech companies – all originally based on
DNA and other biotech patents
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Facts
No empirical evidence for serious negative impacts on upstream
science:
No-specific
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Breakdowns
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Royalty stacking
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Patent trolls
[Walsh/Arora/Cohen (2005)]
[Straus/Holzapfel/Lindenmeir (2004)]
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NRCs concerns not shared – statutory research exemption in
Europe; Supreme Court Merck v. Integra in USA – Shielding
upstream research
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Status Quo Measured by 1997 HUGO’s Yardstick
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HUGO’s expectations overall fulfilled
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No negative impact of patenting on upstream science
empirically proven
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No substantial change of the system needed
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Provided the existing patentability requirements are strictly
applied
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