Practische aspecten van octrooien

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Patenting genomics based inventions patenti
ng life ?
GeNeYouS Symposium January 20, 2004
Nikki Rethmeier Ph.D.
Netherlands Industrial Property Office
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Workshop outline
I. Patent law II. Patenting (genomics)
inventions III. Gene patents, the discussion
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Patent law what is a patent ?
Derived from Latin litterae patentes (open
letters) document issued by or in the name of
the souvereign addressed to all subjects
The first letter patents was issued to John of
Utynam in Great Britain in 1449 for a method of
making coloured glass . . .
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Patent law what is a patent ?
An exclusive right, granted by the state, to
exclude others from making, selling, etc. your
invention during a specific period in the
jurisdiction of the state.
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What is an invention ?
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Workshop outline
I. Patent law II. Patenting (genomics)
inventions III. Gene patents, the discussion
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Patenting (genomics)inventions
Allowable subject matter

• A method to
• Use of X for
• A product

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Patenting (genomics) inventions
Is each invention patentable ?
NO !
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Patenting inventions Legal requirements
1. Novelty (art. 54 EPC) 2. Inventive step
(art. 56 EPC) 3. Industrial application (art. 57
EPC) 4. Clarity (art. 84 EPC) 5. Sufficiency of
disclosure (art. 83 EPC)
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Unpatentable subject material Europe

• Scientific theories, mathematical methods
• Aesthetic creations
• Computer programs
• Business methods
• Method for treatment of human / animal body
• Plant or animal variety
• Discoveries
• Inventions contrary to ordre public

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Unpatentable (genomics) inventions
Explicitly mentioned in the EU directive on
biotechnology (98/44/EC)

• Plant or animal variety
• (parts of) human body which are not isolated
• (partial) DNA sequence without description
  function
• Method for cloning humans
• Method for altering genetic identity humans
• Method for altering genetic identity animals
  suffering?
• Industrial or commercial use of embryos

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Patentable (genomics) inventions
According to EPC, Dutch Patent Act 1995 and EU
directive on biotechnology (98/44/EC)
Inventions (product, method or use)

• Methods (e.g. DNA-array, cDNA screening)
• Isolated (parts of) proteins
• Genetically modified organism
• Isolated (partial) DNA sequence with function

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Workshop outline
I. Patent law II. Patenting (genomics)
inventions III. Gene patents, the discussion
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Gene patents, the discussion

• Clash between private and public sector
• Largely political, instigated by society
• Standing practice at patent offices

• Patent law subject to criticism

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Gene patents

• Objections
• Patents on life are immoral
• A gene is a discovery rather than an invention
• Inventing around not possible
• Gene patents increase medical costs

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Gene patents

• Patents for inventions in any technical field
• Isolating a gene and discovering its function
• contains a technical feature
• Reward for inventor, just like any invention
• Medicines only exist because of patents

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Gene patents

• Current (additional) legal requirements
• DNA molecule must be in isolated form
• Patent must disclose a function of the DNA

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The Myriad Genetics case

• US company, first to isolate the BRCA-1 gene
• Gene correlates with predisposition to breast
  cancer
• Myriad currently holds several patents,
  covering
• the BRCA-1 DNA sequence,
• mutations therein, and
• diagnostic methods based on BRCA-1.

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The Myriad Genetics case
Isolated case or precedent?

• Myriad has obtained monopoly on
• diagnostic testing for breast cancer

The test developed by Myriad is not suited
for testing of European patients
Alternative tests developed by others are
possibly blocked by the Myriad patent
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Gene patents patenting life ?