Transcript Module_6A_Part_3

Content of the module
• IP for the creative industries
• Patented computer-implemented
inventions
• Software
• Biotechnological inventions
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Precise details about biotechnologies
Definition: a biotechnology is a technology based on biology,
especially when used in agriculture, food science and medicine.
Applications: in four major industrial areas
- health care (medical: pharmaceutical products, genetic testing, gene
therapy, cloning…),
- crop production and agriculture,
- non food (industrial) uses of crops and other products (biodegradable
plastics, vegetable oil, biofuels…),
- and environmental uses.
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Precise details about biotechnological inventions
Biotechnological inventions are:
– Products consisting of or containing biological material,
– Process for:
• Production of biological material,
• Processing biological material,
• Use of biological material.
Biological material is:
material containing genetic information:
• capable of reproducing itself,
• Or being reproduced in a biological system.
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Patentable inventions
Principle : Inventions in all fields of technology are
generally patentable, provided that they are:
- New,
- Involve an inventive step,
- Are susceptible of industrial application.
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1998 Biodirective
Purpose:
To harmonise the laws and practices of member states on biotechnological
inventions.
Objective:
To clarify the distinction between what is patentable and what is not
patentable in biotechnological field.
To confirm that the human body* may not be regarded as patentable
inventions.
Problem:
Implementation in national laws:
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• Too late,
• Different interpretations.
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General exceptions to patentability
• discoveries, scientific theories and mathematical,
methods,
• aesthetic creations,
• schemes, rules and methods for performing mental acts,
playing games or doing business, and programs for
computers,
• presentations of information.
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Discoveries in relation to biotechnology (1/2)
Rule: Mere discoveries are not regarded as inventions:
– Acknowledgment of a novel substance in nature,
– Acknowledgment of a novel property of a known
substance,
– Description of a genomic structure.
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Discoveries in relation to biotechnology (2/2)
Rule: Mere discoveries are not regarded as invention
But: A discovery that solves a technical problem can
be an invention = can be patentable:
– Antibiotics from a natural micro-organism,
– Purified proteins for use as medicaments,
– Isolated genes with unexpected use.
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Stakes to patentability
In biotechnological field
The stakes to patentability related to biotechnologies are to
weight the following aspects:
Ethical issues
Advantages
Inventions whose exploitation would be
contrary to “ordre public” or morality.
For example use of human embryos.
For example the possibility of treating
diseases.
Bioethics
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Advantages
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Patentable Biotechnological Inventions (1/4)
Biological material which is:
– isolated from its natural environment,
or
– produced by means of a technical process even if it
previously occurred in nature.
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Patentable Biotechnological Inventions (2/4)
• Plants or animals:
– Not a plant variety, a species or a race.
• Processes for the production of plants and animals
which are not essentially biological:
– Not crossing,
– Not selection.
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Exception:
Plants varieties are not patentable
• Definition: Plant Variety means any plant grouping within a single
botanical taxon of the lowest known rank:
genus
=> species => variety
mammal =>
dog
=> doberman
• Varieties of all botanical genera and species, including, inter alia,
hybrids between genera or species, are not patentable.
• Other kind of protection can be applied to plant varieties.
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Patentable Biotechnological Inventions (3/4)
• Microbiological process:
– process involving microbiological material,
– process performed upon microbiological material,
– or process resulting in microbiological material.
• Other technical process.
• A product obtained by means of such processes
(not a plant or animal variety) is patentable.
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Exception:
Some biological processes are not patentable
• Essentially biological processes* for the production of
plants or animals (not microbiological processes or the
products thereof) are not patentable.
• “Broccoli patent” (EP1069819).
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Exception: Broccoli patent
A method of increasing a specific compound in Broccoli, through
conventional breeding methods, but unique selection methods
• A patent granting this type of selection methods would also include
the selected plant variety.
• A Biological process:
– “consists entirely of natural phenomena such as crossing or selection”
– “... ENTIRELY...” ?
• Now pending at the EPO highest instance Enlarged Board of
Appeal.
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Patentable Biotechnological Inventions (4/4)
• A sequence isolated from the human body, may constitute a
patentable invention, even if the structure of that element is
identical to that of a natural element.
• Industrial applicability must explicitly be stated in the
application i.e. a beneficial use must be defined.
• At least one of:
–
–
–
–
structural function,
molecular function,
cellular function,
biological function.
• Computer based proof can be accepted as experimental data.
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Exceptions: the human body and its elements
are not patentable
The human body:
– In the various stages of its formation,
Or
– Development.
Its elements:
– The mere discovery of its elements,
– For example: sequences or partial sequences of a gene.
Are not patentable.
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Other varied exceptions to patentability
a) processes for cloning human beings,
b) processes for modifying the germ line genetic identity of
human beings,
c) uses of human embryos for industrial or commercial
purposes,
d) processes for modifying the genetic identity of animals which
are likely to cause them suffering without any substantial
medical benefit to man or animal,
– animals resulting from such processes.
Are not patentable.
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Other varied exceptions to patentability
Inventions which by commercial exploitation would be
contrary to "ordre public" or morality:
• “BRCA1 case” (EP705902),
• “Edinburgh stem cell patent”
(EP0695351).
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Myriad Genetics alias BRCA1 case
Concerns methods and materials used to isolate and detect
a human breast and ovarian cancer predisposing gene (BRCA1)
• EPO granted (2001) patents covering all diagnostic and therapeutic
applications based on the gene’s sequence.
• Opponents argued:
– Monopoly abuse,
– Wide-ranging patent rights prohibits further research on therapies and
diagnosis,
– Negative for public health.
• Patent in amended form (finalised in Sep 2007).
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Edinburgh stem cells patent
Concerns a method of genetically modifying animal stem cells
to give them a survival advantage over unwanted cells
•
•
•
•
EPO granted (1999),
EPO admitted a mistake: the patent did not exclude human,
Applicant changed patent, but further appeals followed.
After oral hearing at TBA in 2002:
The patent now covered only modified human and animal stem
cells other than embryonic stem cells.
• A hearing will be held at Enlarged Board of Appeal.
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Deposit of biological material
Biological material that is nessesary to carry out the invention
must either be:
– available to the public,
– described in such a manner as to enable the invention to be carried
out by a person skilled in the art.
or
– deposited with a recognised depositary institution (the Budapest
Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure of 28 April
1977).
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Compulsory licence and cross-licence
Compulsory licence between:
• A breeder having a plant variety right,
and
• A holder of a patent concerning a biotechnological invention.
Cross-licence on reasonable terms.
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Scope of protection (1/2)
The protection conferred by a patent on a biological
material possessing specific characteristics as a result
of the invention shall be extended to any biological
material derived from it through propagation or
multiplication in an identical or divergent form and
possessing those same characteristics.
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Scope of protection (2/2)
The protection conferred by a patent on a process that
enables a biological material to be produced
possessing specific characteristics as a result of the
invention shall be extended to any biological material
directly obtained through that process.
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First medical use
Substance X for use as a medicament:
Known substance – no known medical use.
Broad claim – “for use as medicament”.
Substantiation at least one medical use is needed.
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Second medical use
Swiss-type Claim:
Use of substance X,
for the manufacture of a medicament,
for the treatment of disease Y.
EPC 2000 (December 13, 2007):
Compound X for the use,
in the treatment of a disease Y.
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Supplementary Protection Certificates (SPC)
SPC for a product which constitute:
• The “active ingredient”, or combination of active ingredients,
of a “medicinal product”,
or
• The “active substance”, or combination of active substances,
of a “plant protection product”.
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ANNEX
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Other varied exceptions to patentability
• Methods for treatment of the human or animal body by:
– Surgery,
– Therapy.
It is not considered to be in the public interest for patients to be
denied life-saving procedures (e.g. CPR), because someone else
has a patent on the process.
• Diagnostic methods practised on the human or animal
body.
Are not patentable.
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Possible patent on diagnostic methods
Diagnostic methods are patentable provided they:
– Comprise at least the following steps:
• Examination,
• Analysis,
• Decision.
– Not necessitating the presence of the body
(person or animal).
– The result does not make an immediate particle medical
treatment possible.
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THANK YOU FOR YOUR ATTENTION!
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