Patentability of inventions in the field

of biotechnology

Dr. Peter Burkhardt

EPO Munich, Dir 2.4.03 April 8, 2010
 The European Patent
Organisation

European Patent
Organisation

European Patent Administrative

Office Council

The executive body The legislative body

The Office's task is to examine
European patent applications.
Important functions:
• to adopt the budget
• to approve the President's actions
in implementing the budget
• to amend the Implementing
Regulations and Rules relating
to Fees
The Administrative Council consists of
delegates from the member states.

The European Patent Office

08.04.2010 European Patent Organisation 2
36 member states
Austria • Belgium • Bulgaria • Croatia •
Cyprus • Czech Republic • Denmark •
Estonia • Finland • France • Germany •
Greece • Hungary • Iceland • Ireland •
Italy • Latvia • Liechtenstein • Lithuania •
Luxembourg • Former Yugoslav
Republic of Macedonia • Malta •
Monaco • Netherlands • Norway •
Poland • Portugal • Romania •
San Marino • Slovakia • Slovenia •
Spain • Sweden • Switzerland •
Turkey • United Kingdom
European patent applications and patents
can also be extended at the applicant's
request to the following states:
Albania • Bosnia-Herzegovina •
Montenegro • Serbia

08.04.2010 3
 Locations
Munich The Hague
PschorrHöfe

Headquarters Munich
Isar building

Brussels
Bureau

Vienna
Berlin
The European Patent Office
08.04.2010 Location 4
 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

08.04.2010 5
 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

08.04.2010 6
 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

08.04.2010 7
 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

08.04.2010 8
 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

08.04.2010 9
 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

08.04.2010 10
 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

08.04.2010 11
 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)

08.04.2010 12
 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)

08.04.2010 13
 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

08.04.2010 14
 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.

08.04.2010 15
 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.

08.04.2010 16
 What is an "Essentially biological process"?
What is an
essentially
biological• Can be thought of as those processes traditionally
process?
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."

08.04.2010 17
 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".

08.04.2010 18
 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.

08.04.2010 19
 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?

08.04.2010 20
 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

08.04.2010 21
 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

08.04.2010 22
 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.....

08.04.2010 23
 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?

08.04.2010 24
 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.

08.04.2010 25
 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

08.04.2010 26
 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.

08.04.2010 27
 Where to Get More Information

• www.epo.org - Learning

08.04.2010 28
 Where to Get More Information

• e-learning modules

08.04.2010 29