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Patenting an Enzyme

Dr Elizabeth JonesUK 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 monopolye.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

A patent does not:prevent others patenting a development falling with the scope of the claim

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)

• SEQ 2

• SEQ 180% to SEQ 1

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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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• 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

Enablement

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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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But these are all patentable:

Bacteria and cells

Plants

Transgenic animals

Excluded subject matter:

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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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Individual countries

Initial Filing

Start

National Filing

12 months 18 months

Publication

Search and Examination

Grant

Getting patents abroad

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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Europe only

Initial Filing

Start

European Filing

12 months 18 months

Publication

Search and Examination

Grant

UK

Germany

France

Italy

Sweden

Finland

Norway

Getting patents abroad

Developments

can be added

into application

Patent application is pending during search/examination process in EPO

3+ years

Enforceable rights

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Worldwide

Initial Filing

Start

International

(PCT) Filing

12 months 18 months

Publication

International Search and Examination

National or Regional phases

Europe

US

Australia

Canada

Japan

China

India

30 months

Getting patents abroad

National/Regional Search and Examination

Grant

Developments

can be added

into application

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 enzymeMETHOD• Method of making the enzyme• Method of using the enzyme• Method of screening for the presence of the enzymeUSE• 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 developmentsBalance 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

Patentable:

If prior art ignored

If earlier results published

0 2 yrs 4 yrs 6 yrs

New enzyme discovered for a particular use

Sequence and functional domains identified

Enzyme variants generated and tested

Optimized commercial enzyme produced

Developments

Publishable results

Yes YesProbably not without

structural informationYes

Probably not without

structural informationProbably

Possibly if unexpected advantages

Unlikely

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0 2 yrs 4 yrs 6 yrs

New enzyme discovered for a particular use

Sequence and functional domains identified

Enzyme variants generated and tested

Optimized commercial enzyme produced

Developments

Patent filing(with priority filing)

No Yes Yes Maybe

Patent Scope 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

Patent prior art Broad application, published at year 3.5

Broad application, published at year 3.5

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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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

Sources of Information

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DehnsSt Bride’s House10 Salisbury SquareLondon EC4Y 8JDUnited Kingdom

Tel.: +44 20 7632 7200Fax: +44 20 7353 8895mail@dehns.com

Elizabeth Jonesejones@dehns.com

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