Transcript Patentability of inventions in the field of biotechnology Dr. Peter Burkhardt EPO Munich, Dir 2.4.03 April 8, 2010

Patentability of inventions in the field
of biotechnology
Dr. Peter Burkhardt
EPO Munich, Dir 2.4.03
April 8, 2010
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The European Patent Office
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European Patent Organisation
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Location
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Patentability in Biotechnology
• General patentability criteria (Articles 52 and
53 EPC)
• Rules 23b-e EPC
• EU Directive 98/44/EC as supplementary
means for interpretation of the EPC
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Main criteria for patentability
• Novelty
– not previously made available to the public
• Inventive step
– not obvious
• Industrial application
– use, function
• Sufficiency of disclosure
– invention must be repeatably described
• Clarity of claims
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Patentable subject-matter
• Isolated biological material even if it previously occurred in
nature (EU biotech directive/EPC)
– proteins (e.g. natural human proteins, enzymes), DNA (e.g.
human gene sequences), chemicals from microorganisms
(e.g. antibiotics)
– living organisms and cells: (stem) cells, bacteria, viruses;
animals, plants
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Patentable subject-matter
• Methods and uses of biotech-related products:
– producing a protein, PCR, in vitro diagnosis, in silico
screening, preparation of plants and animals
– making foods, medicines
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Exceptions to patentability
- Art. 53(b): European patents shall not be granted in respect
of plant or animal varieties or essentially biological
processes for the production of plants and animals.
- Reason: Avoid double protection in field of plant
breeding.
- Extension to animal breeding and "varieties" by analogy
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Exceptions to patentability
- Art. 53(c): European patents shall not be granted in respect
of therapeutic or surgical methods practiced (by doctors) on
humans or animals.
- Reason: Allow doctors to practice without restrictions by
patents
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Patentable medical-type claims
• Interferon for use as a medicine
• Use of interferon for the manufacture of a medicament for
treating cancer
• A method for diagnosing cancer comprising measuring the
concentration of interferon
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Traditional knowledge
•
EP-B-0 436 257 - “Neem” (insecticide) patent :
Revoked in opposition in 2001- Lack of novelty
Appealed by proprietor
Revocation confirmed (T416/01)
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Traditional knowledge
•
EP-A-0 973 534 - „Hoodia“ application (appetite suppressants):
Refused in examination during oral proceedings
Appealed by applicant
Order to grant „use claims“ (T543/04)
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Traditional knowledge
•
EP-B-0 744 888 - “Oil Maize” patent:
Opposition filed by Government of Mexico, Misereor, Greenpeace
Revoked in opposition – Novel (yes)
Not appealed
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Can plants be patented ?
•
Yes. If the technical feasibility of the invention is not confined
to a particular plant variety. Rule 27(b) EPC
Also
• Microbiological or other technical process, or a product
obtained by means of such a process other than a plant variety.
Rule 27(c) EPC
An example:
• Not allowable: A plant variety such as durum wheat type
wh222 deposited at a seed depository.
• Allowable: A transgenic plant and its seeds containing an
exogenous bacterial gene encoding Bt toxin.
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What is a plant variety?
• In analogy with the UPOV convention, Rule 26(4) EPC defines
"plant variety" as any plant grouping within a single botanical
taxon of the lowest known rank, which grouping, irrespective of
whether the conditions for the grant of a plant variety right are
fully met, can be:
•
defined by the expression of the characteristics that results
from a given genotype or combination of genotypes,
•
distinguished from any other plant grouping by the expression
of at least one of the said characteristics, and
•
considered as a unit with regard to its suitability for being
propagated unchanged.
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What is an "Essentially biological process"?
What is an
essentially
biological•
process?
Can be thought of as those processes traditionally
done by breeders.
– Article 2(1) UPOV Convention 1961 simultaneous
protection for the same botanical genus or species
by plant breeders' right and patent not allowed.
• Rule 26(5) EPC:
– "A process is essentially biological if it consists
entirely of natural phenomena such as crossing and
selection."
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But crossing and selection are not necessarily
natural phenomena...
T320/87 (an older decision)
• "Essentially biological" has to be judged on the basis of the
essence of the invention taking into account the totality of
human intervention and its impact on the result achieved.
• The necessity for human intervention alone is not yet a
sufficient criterion for its not being "essentially biological".
•
Human interference may only mean that the process is not
a "purely biological" process, without contributing anything
beyond a trivial level.
• Claims found not to concern "essentially biological
process".
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But crossing and selection are not necessarily
natural phenomena...
• EP 0 044 723 (T320/87) claimed (paraphrased):
A process for [---] producing hybrid seeds, comprising:
(a) selecting parent plants and selecting a second parent
plant;
(b) crossing parent plants to obtain phenotypically uniform
hybrids;
(c) cloning said first parent plant to produce a first cloned
parental line;
(d) crossing cloned parental line with second parent plant
to obtain [---] phenotypically uniform hybrids [---]; and
(e) repeating steps (c) and (d) as required to obtain hybrid
seed that yields phenotypically uniform hybrid plants.
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How much human intervention?
•
EP 0 572 412
Method of producing corn grain with enhanced quality grain
traits, comprising randomly interplanting two specified types of
corn seed, permitting pollination, and harvesting the corn grain.
Revoked in opposition (Article 53(b) - essentially biological
process)
Appeal filed, but later withdrawn
•
Questions to be answered:
Is interplanting a sufficient intervention?
Is "corn grain" a plant?
Can further use as a "commodity" exit the exemption?
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Human intervention continued.....
• EP 1 069 819
Method for production of Brassica oleracea, comprising
steps of crossing and selection, wherein molecular
markers used to identify desired hybrids
Opposition division: not an essentially biological process of
producing plants
Appeal pending (T83/05)
Referred to Enlarged Board as G2/07
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Human intervention continued.....
• EP 1 211 926
Method for breeding tomatoes having reduced water
content and product of the method
Opposition division: method claims of main request related
to an essentially biological process of producing plants
maintained in amended form encompassing only product
claims
Appeal pending (T1242/06)
Referred to Enlarged Board as G1/08
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How can I claim the products of plant breeding?
•
Excepted from patentability as a plant variety:
A plant obtained from seed deposited as Brassica napus
olifera 975N-1650 with the accession number 97838
• Allowable (e.g. EP-0 891 130, T0788/07):
 A hybrid plant comprising an inheritable and stable fertility
restorer gene for ogura coplasmic male sterility, produced by
a cross between a plant obtained from seed deposited as
Brassica napus olifera 975N-1650 with the accession
number 97838 as a male parent, and a second Brassica
plant as a female parent.....
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Hybrids

In line with T320/87:
"Hybrid seed and plants from such seed, lacking stability in
some trait of the whole generation population, cannot be
classified as plant varieties within the meaning of Article
53(b) EPC ."
 Also T788/07 (Reasons 3)
"Hybrid seed or plants thereof according to claims 1 to 5 are
not considered as units with regard to their "suitability for
being propagated unchanged" (Rule 26(4)(c) EPC) and are
therefore not regarded as plant varieties which are excluded
from patentability (Article 53(b) EPC).

In line with Rule 26(4):
"Plant variety" - DUS, irrespective of whether the conditions
for the grant of a plant variety right are fully met.....Hybrid
varieties?
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How can the results of a successful breeding
scheme be claimed?
• Plant breeding may be done with the aim of achieving a
particular fatty acid profile.
• Types of claim:
WO03/064576 - Refused in examination.
- Claim 1: A flax seed having a linolenic acid content of greater
than 65% of the total fatty acid content of said seed.
WO95/22598 - Revoked in opposition.
- Claim 1: Corn grain having a total oil content of at least 6.0%
of the total seed weight measured at zero percent moisture
wherein the oleic acid content is not Iess than 55% of the total
oil content.
- Claim 2: A corn oil obtainable from grain of claim 1.
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What's wrong with these claims?
• Claims lack a link to the underlying genotype. Not
characterised.
• Claims express a "result to be achieved"
• Particular examples are plant varieties
• Repeatability may rely on availability of particular plants/seeds;
need for deposit (Rule 28) - chance event...
• Oil can be made by other means: mixing, separation
• Breeding methods excepted from patentability
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Solutions
• Include a clear non-natural step, e.g. chemical mutagenesis,
molecular screen (depending on the outcome of G2/07 and
G1/08).
• Ensure materials are publicly available: deposit - R.31 EPC.
• Include genetic features in definition of plant material.
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Where to Get More Information
•
www.epo.org - Learning
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Where to Get More Information
•
e-learning modules
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