Drafting Claims and Patent Specifications for
Chemical Inventions: A European Perspective
Andrew G. Smith
Europe play a different game
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Scenario
Claims
Prior art Claims
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•
1. A compound of formula I
wherein R1 is H, CN, NO2, or halo;
R2 is H, C1-6 alkyl, CH2OH, CH2SH or CH2NH2;
X is CHR3, S, O or NR3;
R3 is H, C1-C6 alkyl, phenyl or pyridyl;
or a salt thereof.
2. A compound according to claim 1, or salt thereof,
wherein R1 is CN, NO2 or halo.
1. A compound of formula I
wherein R1 is -H, -CN, CH3, OH
R2 is -H, -C1-6 alkyl, -CH2OH, -CH2SH or -CH2NH2;
X is CH2, S, O, N-phenyl, N-pyridyl or N-propyl;
or a salt thereof.
Prior art Examples
3. A compound according to claim 1, or salt
thereof, wherein R2 is C1-6alkyl, CH2SH or CH2OH.
4. A compound according to claim 1, or salt thereof
wherein X is NR3, R1 is CN and R2 is CH2CH3.
3nM
4µM
13mM
Article 123 (2) EPC
The European patent application or European patent may not
be amended in such a way that it contains subject-matter
which extends beyond the content of the application as
filed.
 The description, claims and drawings (G 11/91):
X
The Abstract (Art.85 EPC):
X
Priority document (T260/85):
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Assessing Allowability of an Amendment
Disclosure test: (T194/84).
•
•
•
An amendment is unallowable if the overall change in the content of
the application results in the skilled person being presented with
information which is not directly and unambiguously derivable
from that previously presented in the application as filed, even when
account is taken of matter which is implicit to a person skilled in the
art.
The term "directly" means that the invention including all of its
elements must be immediately recognizable (see T 514/88).
The term "unambiguously" means that there should not exist the
slightest doubt in the mind of the skilled reader that the invention
including all of its elements is actually disclosed in the application as
filed (see T 383/88).
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Allowable Amendments
Explicit disclosures in the description/claims/drawings.
Selection of one preferred feature disclosed in the description.
(T234/00).
Deleting an originally disclosed meaning from an independent list is
allowable provided that said deletions do not result in singling out a
particular combination of specific meanings but maintained the
remaining subject-matter as a generic group of compounds differing
from the original group only by its smaller size.
(T615/95 and T948/02)
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Unallowable Amendments
New (undisclosed) narrower inventions:
– Selection Inventions: (Guidelines, C-IV, 9.8)
– Selection from two lists, or parameter sub-range.
– Undisclosed individual compound.
Intermediate generalisation (Guidelines, C-IV, 9.8, T962/98)
Well-known Equivalents. (Guidelines, C-IV, 9.2, T 673/89 &T 685/90).
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Fallback Positions – Suggestions
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•
•
•
•
Broad claims should be accompanied
by narrow claims specifically focused
toward embodiments of most interest.
One fallback position in the claims for
each substituent
Multiple dependencies should be used
when drafting the claims to increase
the disclosure of sub-genera.
Provide multiple levels of fall back in
the description.
Fallback positions should apply for
each substituent and for the
combination of preferred features
X
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Preferred claims
Claims
Description
•
R1 is preferably CN , NO2 or -halo.
1. A compound of formula I
R1 is more preferably CN .
R2 is preferably C1-6alkyl, CH2SH or CH2OH.
R2 is more preferably H or C1-3alkyl.
wherein R1 is H, CN, NO2, or halo;
R2 is H, C1-6 alkyl, CH2OH, CH2SH or CH2NH2;
X is CHR3, S, O or NR3;
R3 is H, C1-C6 alkyl, phenyl or pyridyl;
or a salt thereof.
R2 is most preferably methyl or ethyl.
R3 is preferably H or methyl.
R3 is more preferably H.
X is preferably NR3.
2. A compound according to claim 1, or salt thereof,
wherein R1 is CN, NO2 or halo.
3. A compound according to claim 1 or 2, or salt ,
thereof, wherein R2 is C1-6alkyl, CH2SH or CH2OH.
4. A compound according to any one of claims 1 to 3,
or salt thereof, wherein X is NR3.
5. A compound according to any one of claims 1 to 4,
or salt thereof, wherein R3 is H or methyl.
A preferred embodiment is a compound of formula I
wherein R1 is CN, NO2 or halo and R2 is C1-6alkyl,
CH2SH or CH2OH.
A preferred compound of the invention is a compound
of formula I wherein R1 is CN and R2 is methyl or ethyl.
Inventive Step - Art. 56 EPC
Article 56 EPC defines one of the patentability requirements set in
Art. 52(1) EPC, i.e. it provides the legal definition of the term
“inventive step” under the EPC.
Art. 56 EPC, first sentence, reads:
An invention shall be considered as involving an inventive step
if,
• having regard to the state of the art,
• it is not obvious
• to a person skilled in the art.
Problem Solution Approach
To assess inventive step of the invention claimed, the Boards
normally apply the “problem and solution approach” (Guidelines, C-IV,
11.5). This consists essentially of:
• Identifying the closest prior art
• Comparing the claimed invention with the closest prior art
• Assessing the technical effect achieved by the claimed invention
when compared with the closest prior art.
• Defining the technical problem to be solved as the object of
the invention to achieve this effect
• Examining whether or not a skilled person, having regard to the
state of the art would have obviously suggested the claimed
technical features as a solution to the problem posed.
Structural non-obviousness
• T467/94 and T643/96 established that when considering the
modification of pharmaceutically active compounds it is essential to
appreciate that prima facie small modifications, electronically of
sterically, to an existing nucleus can have a dramatic effect on
activity
Prior Art
• “when deciding upon inventive step in relation to pharmacologically
active compounds it is not essential whether a particular substructure
of a compound could be replaced by another known isoteric one, but
whether information was available on the impact of such a
replacement on the pharmacological activity of the specific group of
compounds concerned.”
Experimental Data
Article 56
• Applicant has to provide experimental data to demonstrate or
make it at least plausible that the invention indeed works, i.e. that
a problem had been solved and not merely put forward at the
filing date of the application (T 0792/00, T 1329/04)
• If inventive step depends on improved effect: the improved effect
must be implied or at least related to an effect disclosed in the
original application (T 0893/02 ) advantage must at least be
plausible over whole scope; often comparative data needed with
regard to the closest prior art (T 0603/05)
• Late filed evidence will not help if evidence is the first disclosure
going beyond mere speculation (T 1306/04, T 1329/04, T
0861/08)
Selection of Comparator
U.S.
3nM
4µM
13mM
“…proving a reason to select a compound as a lead compound
depends on more than just structural similarity, but also knowledge in
the art of the functional properties and limitations of the prior art
compounds.” Takeda & Lilly v Zenith
EPO
“The crucial criteria are that the ‘closest prior art’ is normally a prior
art document disclosing subject-matter conceived for the same
purpose as the claimed invention and additionally having the most
relevant technical features in common, i.e. requiring the minimum of
structural modifications (T0730/96, T 606/89, etc.)”
Art. 83 EPC
Art. 83 EPC defines a requirement of the European patent
application namely it defines how an invention must be disclosed in
the European patent application:
“The European patent application shall disclose the invention in a
manner sufficiently clear and complete for it to be carried out by a
person skilled in the art”
Although not explicitly stated in Art. 83 EPC, according to the Case
Law of the Board of Appeal, a European patent application is
deemed to be in accordance with Art. 83 EPC, if the invention as
claimed fulfils the requirements of Art. 83 EPC.
Technical Effect in Claim
If a technical effect is expressed in the claim as a functional feature
of the subject matter claimed, it must be examined under Art. 83
EPC if the disclosure of the invention is sufficiently clear and
complete to allow the skilled person to carry out the invention as
claimed, i.e. It needs to be examined if the skilled person is enabled
to achieve the claimed effect without undue burden over the whole
scope claimed.
“...as the effect is part of the claim, it appears ... that only an
objection for insufficiency can be raised under certain
circumstances; these circumstances being that the application as
filed would not contain sufficient information on the relevant criteria
for finding appropriate alternatives over the claimed range with
reasonable effort.” (T 5/06, point 7)
Art 56 Vs Art 83
For Art. 56 or 83 EPC it follows that, depending on the wording of the
claim, the non-achievement of a technical effect underlying the
problem purportedly solved, has different consequences, depending
on the circumstances:
• if the effect is not expressed in a claim but is part of the
problem to be solved, there is a problem of inventive step
• If the effect is expressed in a claim, there is a problem of
sufficient disclosure (G1/03, point 2.5)
Late Filed Evidence
Guidelines C-VI, 5.3.5. referring to Articles 56 and 83
• Under certain circumstances later filed examples or new effects may be
taken into account as evidence in support of the patentability, e.g.
additional example to demonstrate that on the basis of the information
given in application the invention can be applied over the whole field
claimed, or as evidence for inventive step, provided that the new effect is
implied or at least related to an effect disclosed in the original application
(see also T 0893/02 re. Art 56)
No Help if:
• Art 56 - Evidence is the first disclosure going beyond mere speculation (T
1306/04, T 1329/04, T 0861/08)
• Art 83 - Effect is not made at least plausible in application per se (T
0609/02)
Double Patenting
Guidelines C IV-7.4:
“… it is an accepted principle in most patent systems that two
patents cannot be granted to the same applicant for one invention. It
is permissible to allow an applicant to proceed with two applications
having the same description where the claims are quite distinct in
scope and directed to different inventions.”
Guidelines C VI-9.1.6:
“… parent and divisional applications may not claim the same subject
matter…. This means not only that they must not contain claims of
substantially identical scope, but also that one application must not
claim the subject matter claimed in the other, even in different words.
The difference between the claimed subject matter of the two
applications must be clearly distinguishable.”
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Conflicting Case Law
T587/98
• No express or implicit provision in the EPC which prohibits the
presence in a divisional of a claim which is related to a claim in the
parent such that the parent claim includes all the features of the
divisional claim combined with an additional feature.
T307/03
• Suggested that double patenting objections could be raised in the
situation where one claim completely encompassed the other and
where there were partially overlapping claims.
• To avoid this objection of double patenting the Applicants would
have had to confine the subject matter of the Divisional to subject
matter not already claimed in the Parent.
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T 587/98 Vs. T 307/03
Claims of Parent represented by solid line
Claims of Divisional represented by dotted line
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EPO Policy
• Double patenting is only an issue if the subject
matter of a claim in the application/patent is
identical to the subject matter of a claim in the
related application, i.e. both related to the same
invention.
 No requirement that the wording is identical
• Another way to look at it:
 If claim X lacks novelty over claim Y, and claim Y lacks novelty over
claim X, then an objection of double patenting can be raised.
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Examples
Independent
claim 1
Dependent
claim 2
Feature A
Feature A
Feature B
Feature B
Feature C
Feature C
Independent
claim 1
Feature D
Feature D
Granted parent
Pending Divisional
Object to double patenting?
Yes – Claim 2 (parent) and claim 1 (divisional) relate to indentical
subject matter.
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Examples
Independent
claim 1
Feature A
Feature A
Feature B
Feature B
Feature C
Feature C
Independent
claim 1
Feature D
Granted parent
Pending Divisional
Object to double patenting?
No – Claim 1 of the parent is broader than and fully encompasses claim 1 of
the divisional, but the subject-matter of the two claims is not identical.
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Examples
Independent
claim 1
Feature A
Feature A
Feature B
Feature B
Feature C
Feature C
Feature D
Feature E
Granted parent
Independent
claim 1
Pending Divisional
Object to double patenting?
No – Feature E distinguishes the divisional from the parent
Feature D distinguishes the parent from the divisional
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Europe play a different game
• Added subject matter
• Obviousness / Inventive Step
• Double patenting
• How will the law be applied on a national level?
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Backup slides
Double Patenting Detail
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T 587/98 - Claims
• Parent
Claim 1:
A data storage device comprising:
- Substrate;
- First dielectric layer;
- Magneto-optic layer; and
- Second dielectric layer.
• Divisional Claim 1 claims 4 alternatives one of which is:
A data storage device comprising:
- Substrate;
- Dielectric layer; and
- Magneto-optic layer.
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T 587/98 – Exam Division
• Exam Division refused divisional application because
the subject matter claimed in the divisional and that
claimed in the parent overlapped and in the overlap
region the same subject matter was claimed twice
• Exam Division based its refusal on the Guidelines in
combination with Art. 125 EPC:
•
CIV-7.4 – “…it is an accepted principle in most patent systems that
two patents cannot be granted to the same applicant for one
invention.”
•
Art. 125 – In the absence of procedural provisions in this
Convention, the European Patent Office shall take into account the
principles of procedural law generally recognised in the Contracting
States.
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T 587/98 – Appeal
• Art. 125 does not provide basis for a prohibition on
double patenting:
•
•
Institution of divisional applications defined in the convention is
self-contained and complete
Prohibition of “conflicting” claims would be a matter of substantive
law rather than a matter of procedure
• No express or implicit provision in the EPC which
prohibits the presence in a divisional of a claim which
is related to a claim in the parent such that the
parent claim includes all the features of the divisional
claim combined with an additional feature
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T 307/03 - Claims
Parent:
•
Claim 1:
Double metal cyanide (DMC) complex comprising:
- up to 10 wt% of a crystalline DMC component;
- at least 90 wt% of a DMC component which is amorphous to X-rays and
comprises a water-soluble aliphatic alcohol as complexing agent.
•
Claim 3:
Complex as in claim 1 having a surface area of less than 30m2/g.
Divisional:
•
Claim 1 of 2nd Auxiliary Request:
Catalyst having a surface area of less than 30m2/g and comprising:
- up to 10 wt% of a highly crystalline DMC compound;
- at least 90 wt% of a substantially amorphous DMC complex which is prepared in
the presence of a water-soluble alcohol as a complexing agent.
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T 307/03 - Appeal
• Board acknowledges that the EPC does not contain any
specific provisions relating to double patenting
• Board does not regard this as decisive: double patenting
is expensive. Legislator cannot be expected to have
made provisions to regulate what will on the grounds of
economics alone be a very rare occurrence
• Nevertheless, Board concludes the principle of
prohibition of double patenting can be found in Art. 60
EPC:
The right to a European patent shall belong to the
inventor or his successor in title.
From this it is to be deduced that the inventor has a right
to the grant of one and only one patent
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T 307/03 - Appeal
• Double patenting objection can be raised in respect
of 2nd Aux. Request
• To avoid this objection of double patenting the
Applicants would have had to confine the subject
matter of the Divisional to subject matter not already
claimed in the Parent
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Case Law
T1391/07
• “....in the case in which the scopes of protection
conferred by the respective subject-matters overlap
only partially with each other as there is no
manifest objective reason to deny the legitimate
interest of the applicant in obtaining a protection
different from – although partially overlapping with that of the parent already granted.”
T877/06
• Followed reasoning of T1391/07
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