Dr. Leonard Werner-Jones Patenting Issues in Biotechnology & Chemistry USPTO & EPO Dr. Leonard Werner-Jones AIPLA Mid-Winter Meeting Feb. 2-5, 2011

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?

Entry into regional phase (will be changed to 6M (May 2011)) INTERNATIONAL PHASE EPO = ISA and/or IPEA Negative preliminary opinion on patentability Art. 19 PCT/Art. 34 PCT Amendments International phase Entry into regional phase Maintain on entry into European phase Communication (R. 161 EPC) 1 month, inextendible (will be changed to 6M (May 2011)) Further processing No response required Mandatory response Comment on written opinion and/or Make amendments

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.

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.

Limited Search of EURO-PCT cases PCT Phase EP Regional Phase ISA not EPO ISR SESR A A Claim 1: A Claim 2: B Searched Examined No Unity Obejction Lacks Unity B Divisional

Limited Search of EURO-PCT cases PCT Phase EP Regional Phase ISA not EPO ISR SESR BA B B Claim 1: A Claim 2: B Searched Examined Lacks Unity No Unity Obejction Amendments B now 1st A Divisional

Limited Search of EURO-PCT cases PCT Phase EP Regional Phase ISA not EPO ISR SESR BA A B B Claim 1: A Claim 2: B Searched Searched Examined No Additional Search Fees Amendments B now 1st Lacks Unity Lacks Unity A Divisional

Limited Search of EURO-PCT cases PCT Phase EP Regional Phase NO SESR ISA = EPO ISR AB AB A or B Claim 1: A Claim 2: B Additional Search Fees A AB A NO Additional Search Fees Searched Examined

“ 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-1.1 When 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.

ONE INDEPENDENT CLAIM PER CATEGORY (Rule 62a EPC) *Patented claims cannot relate to non-searched subject matter (Rule 137(5) EPC) R. 43(2) EPC allows: interrelated products Biotech: gene - gene construct - host - protein - medicament Plurality of independent claims not compliant with R. 43(2) EPC 2 months inextendible Search Indicate claims on the basis of which search is to be carried out/ counter-arguments Search is carried out on basis of the first claim in each category OR Restrict claims to searched subject matter Examination *No PCT Equivalent Opportunity to pursue divisional application

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”).

EPO vs. USPTO as the ISA EPO: USTPO: (+) 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.

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)

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

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).

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).

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.

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.

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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