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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

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OverviewOverview

• What are Genes – A Reminder

• Existing Legal Framework

• Facts and Experience of Relevance

• Status quo measured by 1997 HUGO’s yardstick

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Reminder I: DNA - Sequence - GeneReminder I: DNA - Sequence - Gene

• DNA Sequence – any sequence of DNA building blocks

• 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.

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Reminder II: Double Nature of Gene SequencesReminder II: Double Nature of Gene Sequences

• Physical carrier of information

• 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 GenomeReminder III: Human Genome

• Human Genome Programme (HUGO) – 1995-2000

– 4 years – 1st Billion base pairs

– 4 months – 2nd Billion base pairs

– Eventually – 10 % base pairs per month

• Celera (Craig Venter) – ca. 2 years – 3 Billion bp

• Result: instead of 100.000 some 30-35 (48?) thousands of genes

• 40% alternatively spliced

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Mandatory TRIPS Protection StandardsMandatory TRIPS Protection Standards

• Patents must be available for inventions in all fields of

technology – no discrimination allowed (Art. 27 (1))

• 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))

• 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)

DSPLTDSPLT

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Available Manœuvring SpaceAvailable Manœuvring Space

- Allowed Limitations of the Exclusive Right Conferred -- Allowed Limitations of the Exclusive Right Conferred -

• 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)

• 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 EU Directive 98/44/EC Regime

Gene Sequences = Chemical Substances?Gene Sequences = Chemical Substances?

• 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)].

• A mere DNA sequence without indication of a function – not a

patentable invention [Recital 23] – thus „function“ integral part of

the notion „invention“.

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EU Directive 98/44/EC RegimeEU Directive 98/44/EC Regime

Gene Sequences = Chemical Substances?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].

• Special rules on dependency in case or overlapping patented

sequences [Recital 25].

• 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 USNo 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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FactsFacts

Source NRC 2005

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FactsFacts

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FactsFacts

Source: NRC 2005

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FactsFacts

Source: NRC 2005

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FactsFacts

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FactsFacts

Access to Genetic DiscoveriesAccess to Genetic Discoveries

• 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)]

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FactsFacts

Impact on Industrial DevelopmentImpact on Industrial Development

• Amgen

• Biogen

• Genentech

• Millenium

and numerous other biotech companies – all originally based on

DNA and other biotech patents

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FactsFacts

No empirical evidence for serious negative impacts on upstream No empirical evidence for serious negative impacts on upstream science:science:

No-specific

• Breakdowns

• Royalty stacking

• Patent trolls

[Walsh/Arora/Cohen (2005)]

[Straus/Holzapfel/Lindenmeir (2004)]

• 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 YardstickStatus Quo Measured by 1997 HUGO’s Yardstick

• HUGO’s expectations overall fulfilled

• No negative impact of patenting on upstream science

empirically proven

• No substantial change of the system needed

• Provided the existing patentability requirements are strictly

applied

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