Patenting an Enzyme
Dr Elizabeth Jones
UK and European Patent Attorney
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Summary of Presentation
► Value of patents
► What is patentable
► How to obtain a patent
► Patent claims
► Patenting an enzyme
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Value of patents
• others can not work commercially in claimed scope
• monopoly for 20 years from filing
• patent can only be enforced once granted
• most inventions which are novel, inventive and can be
used commercially can be patented
• claims define monopoly
e.g. “An enzyme comprising a sequence as set forth in
SEQ ID NO:1 or a sequence with 80% sequence identity.”
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Value of patents
A patent does not:
provide freedom to operate
• Patent only prevents others working
within the claim scope
• Licence for a third party’s patent may still
be necessary
• Normal governmental regulations apply
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Value of patents
• SEQ 2
A patent does not:
prevent others patenting a development
80% to
SEQ 1
falling with the scope of the claim
• SEQ 1
A selection invention may be possible.
Granted patent:
“An enzyme comprising a sequence as set forth in SEQ ID NO:1 or a sequence
with 80% sequence identity.”
New patent:
"An enzyme comprising a sequence as set forth in SEQ ID NO:2.” (where the
sequence falls within the previous claim but the enzyme has specific,
previously unidentified properties not present in the whole family)
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What is patentable
Is the subject matter patentable?
• Novel
• Inventive
• Industrially applicable
• Enabled (full description and data
where necessary)
• Not excluded subject matter
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Novelty
New relative to any earlier public disclosure:
•
•
•
•
•
•
•
Scientific article
Patents
Conference disclosure
Discussions
Internet disclosure
Any form – including oral, written and use
Includes your own disclosures
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Inventive step
• The technology must not be an obvious development
relative to the earlier public disclosures
 would not be obvious to a person “skilled in the art”
Excludes for example:
 obvious modifications (e.g. for
production, administration, stability)
 homologues of known enzymes
 use of related enzymes for the same
use
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Enablement
• The technology must be
sufficiently disclosed in the
patent application
 application needs to
be carefully drafted and
include all details/data
needed to carry out the
invention
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Enablement
Data required to support the application:
• Support required across the full scope of the claims.
• Agricultural inventions may be “sufficient” with in vitro/lab
tests, but preferably require field testing.
• Medical indications require support at least at in vitro,
preferably in vivo level.
• Difficult to treat conditions require particularly good
evidence, e.g. cancer, HIV.
• Post-filing evidence only allowed in some countries.
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Excluded subject matter:
•
•
•
•
Not technical in nature, e.g. Abstract ideas
Discoveries, scientific theories, mathematical models
Human body
Contrary to morality (e.g. human cloning
use of human embryos)
Can be different in different countries.
USA’s current restrictions on protecting natural
products and “laws of nature” is far reaching.
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Excluded subject matter:
But these are all patentable:
Bacteria and cells
Plants
Transgenic animals
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Other issues to consider before filing a
patent application:
• Would it be easy for a third party to design around your
patent?
• Can the development be commercialized?
• Could the patent be enforced?
• Is patent protection the most appropriate?
• How would you use the patent?
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How to obtain a patent:
Procedure to obtain a national application:
1. File a priority application (not mandatory)
2. File a national application within 12 months claiming priority
3. Search and examination of application by Examiner:
i) Examiner searches application to identify prior art;
ii) Examiner raises objections (usually);
iii) Applicant (usually via representative) responds to objections by argument
and/or amendments to application;
iv) Ultimately Examiner grants patent or refuses application
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Getting patents abroad
Individual countries
Initial Filing
National
Filing
Publication
Grant
Search and
Examination
Start
12 months 18 months
Developments
can be added
into application
Patent application is pending
during search/examination
process in patent office
2+ years
Enforceable
rights
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Getting patents abroad
Europe only
UK
Germany
France
Initial Filing
European
Filing
Publication
Grant
Italy
Sweden
Finland
Search and
Examination
Start
12 months 18 months
Developments
can be added
into application
Patent application is pending
during search/examination
process in EPO
Norway
3+ years
Enforceable
rights
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Getting patents abroad
Worldwide
Europe
US
Australia
Initial Filing
International
Publication
(PCT) Filing
International
Search and
Examination
Start
12 months 18 months
Developments
can be added
into application
Canada
National or
Regional
phases
Japan
Grant
China
India
National/Regional
Search and Examination
30 months
Patent application is pending
during search/examination
process in patent offices
3-5 years
Enforceable
rights
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Patent Claims
Claims
What types of claims are possible:
• Product - e.g. A DNA molecule, a protein, an apparatus.
• Method - e.g. A method of making a product, a method of
screening.
• Use – e.g. Use of a product as a herbicide.
• Use limited product – e.g. Compound for use in treating a
disease.
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Patenting an enzyme
Possible claims:
PRODUCT
• Enzyme
• Composition containing the enzyme
• DNA encoding the enzyme
• Vector containing the DNA
• Host cell containing the vector
• Antibody which recognizes the enzyme
METHOD
• Method of making the enzyme
• Method of using the enzyme
• Method of screening for the presence of the enzyme
USE
• Use of the enzyme for a specific purpose
USE-LIMITED PRODUCT
• Enzyme for a medical use
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Claim scope
•
•
•
•
•
•
•
Claim language must be clear and concise
Take prior art into account
Claims should be unified
Provide fall-backs
Include only essential features
Cover embodiments for which data is presented
Cover reasonable variants
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Examples
Invention - A new enzyme has been identified which may be
used in a known reaction system to produce X.
The enzyme and its uses may be claimed.
Possible claims to the enzyme and its uses:
1. A polypeptide comprising an amino acid sequence as set
forth in SEQ ID No. 1 or a sequence with 90% sequence
identity to said sequence.
2. A method of producing X comprising contacting Y with the
polypeptide of claim 1 under reaction conditions Z.
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Examples
Invention – A known enzyme has been identified which may be
used in a new reaction system to produce X.
The enzyme can not be claimed, but its new uses may be.
Possible claim to the new use:
1. A method of producing X comprising contacting Y with a
polypeptide comprising an amino acid sequence as set
forth in SEQ ID No. 1 or a sequence with 90% sequence
identity to said sequence under reaction conditions Z.
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Examples
Invention - A variant of a known enzyme has been identified
which may be used in a known reaction system to produce X.
The enzyme and its uses may be claimed IF that variant has
unanticipated, special properties, supported by evidence.
Possible claims to the enzyme and its uses:
1. A polypeptide comprising an amino acid sequence as set
forth in SEQ ID No. 2 or a sequence with 98% sequence
identity to said sequence.
2. A method of producing X comprising contacting Y with the
polypeptide of claim 1 under reaction conditions Z.
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What may not be patentable
► Homologue of a known enzyme for a known use (e.g. from
a different species)
► Enzyme with similar properties to a known enzyme for a
known use (particularly if the sequence is similar)
► Enzyme optimized relative to known enzyme for a known
use, using known techniques and yielding no more than
expected improvements
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Claiming developments
Balance between:
► Timing of data generation
► Timing of own or third party publications, including patents
► Term of protection
► Scope of protection and design around
Key considerations:
► Selection inventions are possible but require data
► Your own earlier applications become relevant prior art
► Broad claims may protect later variants but may expire too early
► Narrow claims may protect later variants and expire later
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When to file a patent application
Balancing need to publish with avoiding prior disclosure
0
New enzyme
Developments discovered for a
particular use
2 yrs
4 yrs
6 yrs
Sequence and
functional
domains
identified
Enzyme variants
generated and
tested
Optimized
commercial
enzyme
produced
Yes
Yes
Yes
Probably
Possibly if
unexpected
advantages
Unlikely
Publishable
results
Patentable:
If prior art
ignored
Probably not without
If earlier
results
published
Probably not without
structural information
structural information
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0
New enzyme
Developments discovered for a
particular use
Patent filing
(with priority
filing)
Patent Scope
No
4 yrs
2 yrs
Sequence
and
functional
domains
identified
Enzyme variants
generated and
tested
6 yrs
Optimized
commercial
enzyme
produced
Yes
Yes
Maybe
Broad: New
enzyme and
variants and
method of use
Narrow: Specific variants
and method of use
Very narrow:
Specific optimized
enzyme and method
of use
Broad application,
published at year 3.5
Broad application,
published at year
3.5
Patent prior art
Narrow application,
published at year
5.5
Term
Years 3-23
Years 5-25
Years 7-27
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When to file a patent application
Factors that may be relevant to deciding when/if to file
the patent application:
• Do you have relevant data and are you likely to obtain any
more?
• How active is this area?
• Is the work derivative or does it open up a new field?
• Do you need patent protection to secure funding?
• What is the likely life of the product?
• How quickly will the developments be made?
• Is there pressure to publish?
• How do you intend to use the patent?
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When to sell a patent/application
Factors that may be relevant to deciding when/if to sell
a patent application:
•
•
•
•
•
•
Has patentability been assessed?
Is the term remaining reasonable for commercialization?
Is there freedom to operate?
Are other developments in the pipeline?
How close are you to a commercial product?
Can you afford the patenting costs going
forward?
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Thank you for your attention!
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Sources of Information
General information
UK Patent Office: www.ipo.gov.uk/patent.htm
European Patent Office: www.epo.org
Chartered Inst. of Pat. Attorneys: www.cipa.org.uk
Dehns: www.dehns.com/site/information/information_sheets/
Patent Searching
Espacenet patent database: http://worldwide.espacenet.com/
US Patent Office database: www.uspto.gov/patft/index.html
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Dehns
St Bride’s House
10 Salisbury Square
London EC4Y 8JD
United Kingdom
Tel.: +44 20 7632 7200
Fax: +44 20 7353 8895
[email protected]
Elizabeth Jones
[email protected]
© Dehns 2014
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