Disunity before the EPO AIPLA Biotechnology committee March 17 th, 2011 Simon Wright BSc EPA CPA

Main topics EPO law on disunity/restriction practice Differences from US PTO practice Procedural implications and practical tips Changes in timing of divisionals

Disunity practice (1) EP patent application must relate to one invention or “group of inventions so linked to form a single inventive concept” (Art. 82) EPC There must be one or more “special technical features” which “define a contribution…over the prior art” (Rule 44)

Disunity practice (2) Rules demand that the independent claims must have at least one common novel feature In practice this linking feature needs to provide patentability over the closest prior art, i.e. both novelty and non-obviousness

Disunity practice (3) As a guide, the following groups are unitary: –a product –a process adapted to make that product –use of that product; and –apparatus specifically designed to conduct the process

Disunity practice (4) EPO sees inventions in terms of the protein or nucleotide sequence (so each protein is a different invention) For each protein (or product), if new, one can claim: –Protein per se –Uses of the protein (medical or otherwise) –Manufacture of the protein –Products comprising or encoding protein (vectors, etc.)

Disunity practice (5) Contrast with US PTO EPO regards “concept” as the heart of the invention (e.g. each protein) US PTO regards each category (product, use, process, etc.) as different inventions But the US PTO may regard different proteins in same category (e.g. product) as the same invention

Disunity practice - example 3 proteases A, B and C – try to draft novel generic claim covering all 3 proteases (e.g. all have common novel feature, such as same mutation or internal domain, or novel property/function) For all 3 proteases, can claim: –Protease itself, nucleotide encoding protease, compositions comprising protease or DNA, medical uses of both, manufacture of both, inhibitors of protease (e.g. antibodies), so downstream products

Disunity practice - example 3 proteases A, B and C – no common novel feature, e.g. each has different mutation, so disunity For protease A, can claim: –Protease A, nucleotide encoding protease A, compositions comprising protease or DNA, medical uses of both, manufacture of both, inhibitors of protease (e.g. antibodies), so downstream products File divisionals to proteases B and C US PTO may regard A, B and C as same invention but only products allowed in same case In the US, file divisionals to uses, etc.

Disunity practice Disunity a priori, e.g. clearly unrelated protein and antibody Disunity a posteriori, e.g. after searching Prior art destroys novelty of claim, so no common linking feature, or the common link is no longer novel – more likely and increasingly common The art thus fragments the claim into different inventions - EPO will only search the first invention as defined in the claims – often highly unpredictable splitting of matter by Examiner

Procedure (1) At the search stage, there is no mechanism for traversing disunity EPO will only search 1 st invention, as defined in dependent claims, and only searched matter can be examined Now get search opinion (like 1 st Office Action) at search stage, earlier engagement with Examiner Only during substantive examination can you traverse disunity Can appeal, attend hearing (but Examiner will have conducted earlier search so reversal difficult)

Procedure (2) Significant difference between –convention (not ex-PCT) and divisional applications (where one can pay for additional searches – usually a 1 month term); and –Ex-PCT applications (no longer possible to pay additional search fees) EPC 2000, came into force December 2007

Procedure – for ex-PCT cases (3) US PTO was ISA EPO will carry out search for first invention claimed. No opportunity for further searching Can only “elect” the first invention for further prosecution, i.e. EPO will only examine the first (and searched) invention Re-order claims on EP phase entry to place most important invention first EPO search can be on a different invention from the US PTO!

Procedure – for ex-PCT cases (4) EPO was ISA No further searching by EPO Substantive examination only on matter searched in Int’l phase and covered by ISR So pay additional search fees in Int’l phase? Delete unsearched claims to save costs (and pursue in a divisional?) Next time, don’t elect EPO as the ISA!

New restrictions and objections at search stage - 1 The EPO Search Examiner will now object if: -R62a: there are multiple independent claims in the same claim category (apparatus, method etc.); and/or (These are only allowed if claims are to: –plurality of inter-related products –different uses of a product or apparatus –different solutions to same problem where not appropriate to cover a single independent claim) -R63: the claims fail to meet the requirements of the EPC such that they are unsearchable

Restrictions or objections at search stage - 2 Applicant gets opportunity to indicate the subject matter to be searched if either or both objections raised – 2 month non-extendable term set If matter to be searched is not indicated or clarified then the EPO will search first independent claim in each claim category or, in case of R63, may declare the claims unsearchable Will carry on restricting search if lack of unity too

Restrictions or objections at search stage - 3 EPO legislation now requires applicant to limit to searched subject matter during examination Cannot amend to (re)introduce unsearched subject matter Applicants therefore advised to get claims into “searchable” shape on filing, to avoid restrictions on searched subject matter Restricted searches can waste claims fees!

Practical Tips (1) Try to draft generic claims with lots of intermediate generalisations (fallback positions) for maximum flexibility and to keep unity Identify common features present in the proteins/DNA/antibodies of the invention, etc. and claim those Anticipate objections and the art (conduct searches before filing) Place most important embodiments first in the claims File several applications at the outset?

Practical Tips – (2) When entering EP regional phase: EPO will only search one invention, therefore identify novel and potentially inventive unified claim strings and limit to those Place most important invention first Avoid R62a restriction by amending claims to have one independent claim per category Delete plainly disunified inventions? If so, pursue these in a divisional Amend/compact claims down to 15 (claims fee is 210 EUR for each claim above 15)

Divisional Applications – 1 New 2 year time limit for divisional applications Limits applicant’s ability to file “voluntary” divisionals later in prosecution Intended to improve legal certainty for third parties and reduce EPO’s workload Counters alleged “abuse” by applicants

Divisional Applications – 2 Previous EPO practice Applicant can file a divisional application from any pending earlier European Patent application –Division may be voluntary or in response to lack of unity –Divisionals from divisionals – “cascade” allowed (this has been controversial) –Divisional may be filed at any time before grant, lapse or refusal of immediate parent

Divisional Applications – 3 New Rules Before grant, lapse or refusal but also before: “24 months from the Examining Division’s first communication in respect of the earliest application for which a communication has been issued” – voluntary division No extensions of time or further processing Deadline applies to whole patent family, i.e. any divisionals of divisionals must also be filed within 24 month term set by earliest application

Divisional Applications – 4 New Rules …or 24 months from an Examining Division communication raising a new objection of lack of unity – mandatory division Doubt over what is a “new” lack of unity objection Allows for late division in response to new lack of unity – but likely to be rare Can only divide the application objected to No extensions of time or further processing

Divisionals - Example 1 First exam report issues 1 May 2010 objecting to lack of unity – inventions A and B –Any divisionals must be filed by 1 May 2012 Limit to A and file divisional application to B Exam report on divisional ‘B’ issues 1 September 2012 with new lack of unity objection – inventions B1 and B2 –Divisional applications can now be filed (only for invention B1 or B2) up to 1 September 2014

Divisionals – Example 2 First exam report issues 1 May 2010 with objection of lack of unity – inventions A, B & C –All divisionals must be filed before 1 May 2012 Limit to A and file one divisional to B & C Exam report on divisional ‘B & C’ issues 1 Sept 2012 with disunity objection to inventions B & C –Not a new objection of lack of unity so previous deadline stands. Now too late to divide further, so ALL divisionals should have been filed by 1 May 2012

Divisionals – Alternative tack? Alternatively, applicant proactively removes B & C before unity objected to Same 1 May 2012 divisional filing deadline File a voluntary divisional to B and C before then When disunity objection raised on divisional (even if after May 2012) a fresh 2 year term is set for dividing out B or C Need for second divisional has probably been delayed beyond May 2012 May be problems though…

Divisional Applications Can one “Engineer” a new unity objection, e.g. by adding new non-unified claims during prosecution or when filing a divisional? Voluntary amendments now limited to response to search opinion Examiner’s discretion –whether to enter any amendment after first exam report –whether to raise an objection of lack of unity at all Examiner may not object to unity at all! “Engineering” option is unpredictable & risky

Q&A Thanks for listening in! Simon Wright BSc EPA CPA

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