Disunity before the EPO
AIPLA Biotechnology committee
March 17th, 2011
Simon Wright BSc EPA CPA
swright@jakemp.com
www.jakemp.com
Main topics
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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:
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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:
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–
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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 1st invention, as defined in
dependent claims, and only searched matter can be
examined
• Now get search opinion (like 1st 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)
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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
swright@jakemp.com
www.jakemp.com
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