Patenting Issues in Biotechnology & Chemistry

USPTO & EPO

Dr. Leonard Werner-Jones

AIPLA Mid-Winter MeetingFeb. 2-5, 2011

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Euro-PCT

Should the ISA be the USPTO or the EPO?

Is there a potential problem with unity following the EPO‘s criteria?

Are there multiple independent claims in the same category?

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INTERNATIONAL PHASE

Mandatory response Comment on written opinion and/or Make amendments

Communication (R. 161 EPC)

1 month, inextendible(will be changed to 6M (May 2011))

Further processing

EPO = ISA and/or IPEANegative preliminary opinion on

patentability

Amendments

Maintain on entry into European phase

No response required

Art. 19 PCT/Art. 34 PCT

Entry into regional phase

International phase

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Rule 161/162 EPC

Defines the subject matter to be searched in SESR if EPO not the ISA, as well as the subject matter to be addressed in the written opinion of the SESR.

Defines the number of claims to be paid in EP phase. (Claims 16-50 = 210 €; Claims 51 and up = 525 €)

Is the last point that Applicant can file amendments to the claims and specification on his own volition.

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Unity at the EPO: Art. 82 EPC / Rule 44 EPC

General inventive concept linking the subject matter of the invention.

General inventive concept must be both novel and inventive over the prior art.

General inventive concept is best defined as a structural feature found throughout the claims. Can be a functional feature though and does not necessarily need to be articulated in the claims.

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Limited Search of EURO-PCT cases

Claim 1: AClaim 2: B

No Unity Obejction

Lacks Unity B

AASearched Examined

Divisional

ISR SESR

PCT Phase

ISA not EPO

EP Regional Phase

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Limited Search of EURO-PCT cases

Claim 1: AClaim 2: B

No Unity Obejction

Lacks Unity A

BBSearched Examined

Divisional

ISR SESR

PCT Phase

ISA not EPO

EP Regional Phase

BA

AmendmentsB now 1st

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Limited Search of EURO-PCT cases

Claim 1: AClaim 2: B

Lacks Unity

Lacks Unity

A

BBSearched Examined

Divisional

ISR SESR

PCT Phase

ISA not EPO

EP Regional Phase

BA

AmendmentsB now 1st

ASearched

No AdditionalSearch Fees

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Limited Search of EURO-PCT cases

Claim 1: AClaim 2: B

AA

Examined

ISR

PCT Phase

ISA = EPO

EP Regional Phase

AB

Searched

NO AdditionalSearch Fees

AB

A or B

AdditionalSearch Fees A

B

NO SESR

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“ first mentioned in the claims”Rule 64 EPC

If the European Patent Office considers that the European patent application does not comply with the requirement of unity of invention, it shall draw up a partial search report on those parts of the application which relate to the invention, or the group of inventions within the meaning of Article 82, first mentioned in the claims….

Guidelines: B-VII-1.1When determining which invention is the invention or unitary group of inventions first mentioned in the claims, the examiner takes account of the content of the dependent claims, disregarding trivial claims.

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Multiple Ind. Claims of Same Category vs. Unity

Where the application both lacks unity of invention and fails to comply with the requirements of Rule 43(2), the examiner may raise an objection under either Rule 43(2) (i.e. Rule 62a) or Art. 82 or under both.

The Applicant cannot contest which of these objections has priority (cf. T 1073/98).

Thus, subject matter may be unified but claims will need to be limited due to Rule 62a EPC.

Possibility of alternative claim language “or” for consolidation of claims, but beware of Rule 63 EPC (i.e. “conciseness”).

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EPO vs. USPTO as the ISA EPO:

(+) Legal certainty of unity. (+) No Rule 62a EPC limitation (Rule 43(2) EPC objection during

prosecution – no limitation of search though). (-) 1 month term to respond to Rule 161 EPC (will be expanded to 6

months) (-) can be costly with additional search fees (but at least know what

subject matter may be pursued)

USTPO: Uncertainty as to whether unity objection will be raised and if it is

raised what group will be searched. May be triggered by new prior art in SESR. Claim fees due nevertheless.

Don‘t know whether Rule 62a EPC objection will be raised and whether arguments will be successful. Claim fees due nevertheless.

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DEFINITION OF AN ANTIBODY: AGAINST ANTIGEN X

If antigen X is novel and inventive: An antibody against antigen X is usually considered

to be novel and inventive, assuming that antigen X is well-defined in the application (T0542/95)

If antigen X is known: The provision of a novel antibody against a known

antigen involves an inventive step only if it shows unexpected properties, or if it was unexpected that such an antibody could be produced at all (T0735/00; T0512/94; T0355/92; T0645/02)

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DEFINITION OF AN ANTIBODY:TARGET EPITOPE

If the antibody is defined by the specification of small, well-defined (e.g. linear) epitope to which the antibody should bind, then usually allowable it is clear to what the antibody binds, and usually such

antibodies can be reliably produced by immunization with the epitope

in contrast, see T0735/00, relating to a poorly defined epitope

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DEFINITION OF AN ANTIBODY:PROCESS OF PRODUCTION

Product-by-process claims for antibodies are allowable provided that the product is novel and inventive (GL C-III 4.12).

Process only play a role if introduces structural features which further distinguish product from prior art.

If the antibody can be characterized by other technical features, e.g. structural features, hybridoma deposit, rather than by its production process, then this should be done (T0130/90; T0150/82).

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DEFINITION OF AN ANTIBODY: FUNCTIONAL FEATURES

Claims comprising functional features are acceptable under Article 84 EPC (i.e. clarity) if said functional features are clear and unequivocally testable by the skilled person (T0299/86; T1300/05).

It must be beyond any doubt that the functional features do not disguise lack of novelty (T0735/00). Applicant may be requested to provide evidence that the claimed antibody differs from a particular prior art antibody.

If the target to which the antibody binds is not explicitly given, the claim may not be clear and/or sufficiently disclosed (Articles 84 and 83 EPC).

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DEFINITION OF AN ANTIBODY: STRUCTURAL FEATURES

It is not sufficient to characterize an antibody by only one of its variable domain (VH or VL) sequences, since an antibody needs at least a VH and a VL domain for proper and specific antigen binding. (Art. 84 EPC; Clarity) Exceptions: antibodies from camelids or sharks, which are

naturally devoid of light chains. It is not sufficient to characterize an antibody by one

or two of the CDR sequences, since antigen binding specificity, apart from some exceptions, depends on all three CDRs and four framework regions.

A definition in the claim of the antibody's target and/or function is not mandatory, but may be necessary in some cases to distinguish from the prior art.

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DEFINITION OF AN ANTIBODY: HYBRIDOMA DEPOSIT NUMBER

The hybridoma cell line must be deposited with a recognized depository institution in order to meet the disclosure requirements of Article 83 and Rule 31 EPC.

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INVENTIVENESS FOR ANTIBODIES

Deposit of Hybridoma Different Cross reactivity (T355/92; T478/92) Specific Choice of Antigen (T510/94) Inhibition of Biological Function in vitro / in vivo Unexpected high Binding Affinity

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