BESCHWERDEKAMMERN BODS OF APPEAL OF CHAMBRES DE RECOURS

DES EtIROPXISCHEN THE EUROPEAN PATENT DE L'OFFICE EUROPEEN

PATENTANTS OFFICE DES BREVETS

Internal distribution code:

[Xj Publication in OJ
[ J To Chairmen and Members
( I To Chairmen

DECISION
of 13 May 1994

Case Ntunber: G 0007/93

Application Number: 87116757.3
Publication Number: 0268222
IPC: A61K 47/00

Language of the proceedings: EN

Title of invention:
Penetration enhancers for transdermal de1ivey of systemic
agents

Applicant:
Whitby Research, Inc.
Opponent:

Headword:
Late arnendments/WHITBY II

Relevant legal norms:

EPC Art. 96(2), 113(2), 123(1), 167(2)
EPC R. 51(4), (6), 86(3)

Keyword:
"Amendments after a Rule 51(6) communication - discretion of
Examining Division"
"Reservations under Article 167(2) EPC"

Decisions cited:

EPA Form 3030 10.93

 -2-

Headnote:

An approval of a notified te t submitted by an applicant

pursuant to Rule 51(4) EPC does not become binding once a
communication in accordance witt Rule 51(6) EPC has been
issued. Following issue of such a communication under
Rule 51(6) EPC and until issue c f a decision to grant the
patent, the Examining Division 1 - as a discretion under
Rule 86(3) EPC, second sentence, whether or not to allow
amendment of the application.

When exercising such discretion following issue of a

communication under Rule 51(6) EPC, an Examining Division must
consider all relevant factors. In particular it must consider
and balance the applicant's interest in obtaining a patent
which is legally valid in all of the designated States, and the
EPO's interest in bringing the examination procedure to a close
by the issue of a decision to grant the patent. Having regard
to the object underlying the issue of a communication under
Rule 51(6) EPC, which is to conclude the granting procedure on
the basis of the previously approved text, the allowance of a
request for amendment at that late stage in the granting
procedure will be an exception racher than the rule.

Reservations under Article 167(2) EPC do not constitute

requirements of the EPC which have to be met according to
Article 96(2) EPC.

C,

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Europalsches European ffice eumpöen
Pat.ntamt Patent Office des brevets

Beschwerdekammem Boards of Appeal Chambres de recours

Cage Number: G 0007/93

DECISION
of the Enlarged Board of Appeal
of 13 May 1994

Appellant: Whitby Research, Inc.

2801 Reserve Street
Richniond, VA 23261-7426 (US)

Representative: Kohier Schrnid + Partner

Pat entanwä ite
RuppmannstraEe 27
D-70565 Stuttgart (DE)

Decision referring a Decision of the Technical Board of Appeal 3.3.2

point of law: dated 25 May 1993 in case T 830/91.

Composition of the Board:

Chairman: P. Con
Members: G.D. Paterson
F. Antony
C. PayraudeaLl
Persson
Schulte
P. van den Berg
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Summary of Facts and Submissions

I. In case T 830/91 pending before Technical Board of

Appeal 3.3.2, the Examining Division issued a
communication under Rule 51(4) EPC, informing the
applicant of the text in which it intended to grant a
European patent, and requesting the applicant to
indicate his approval of such notified text within a set
period. The applicant approved the notified text in due
time.

The Examining Division then issued a communication under

Rule 51(6) EPC, inviting the applicant to pay the fees
for grant and printing and to file translations of the
claims within a further set period. Within such period,
the applicant filed a letter which purported to withdraw
his previously stated approval of the notified text, and
purported to declare his approval of a text with amended
claims as attached to such letter. The proposed amended
claims included what was stated to be a correction of a
clerical error in Claim 1, and three new sets of claims
for three designated Contracting States who have made
reservations under Article 167(2) (a) EPC allowing them
to provide that European patents which confer protection
on certain classes of subject-matter (in particular,
chemical, pharmaceutical and food products) shall, in
accordance with provisions applicable to national
patents in such States, be ineffective or revocable.

The Examining Division issued a communication in reply,

stating that correction of the clerical error in Claim 1
was possible under Rule 88 EPC, but that the other
proposed amendments were not allowable because the
applicant is bound by his previous approval of the
notified text. Subsequently, the Examining Division
issued a decision refusing the application pursuant to

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Article 97(1) and (2) EPC because there was no agreed

text as required by Article 113(2) EPC which could serve
as the basis for grant of a patent.

II. Following the filing of an appeal by the applicant,

Technical Board of Appeal 3.3.2 has referred the
following questions to the Enlarged Board of Appeal
under Article 112(1) (a) EPC:

In the light of Article 113(2) EPC, is Rule 51(6)

EPC to be interpreted such that an approval
submitted under Rule 51(4) EPC becomes binding once
a communication in accordance with Rule 51(6) EPC
has been issued?

Is the European Patent Office obliged to consider

reservations under Article 167(2) EPC as
constituting requirements of the EPC which have to
be met according to Article 96(2) EPC?

III. In its decision of referral, Technical Board of Appeal

3.3.2 drew attention in particular to the following
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SLLLA L. ¼- CJ_ 0

Question I

(1) Previous relevant jurisprudence

In Decision T 1/92, OJ EPO 1993, 685, Technical

Board of Appeal 3.3.2 held that approval of a
proposed text in response to a Rule 51(4) EPC
communication did not bind the applicant if such
approval was withdrawn and amendments proposed,
before expiry of the time limit set by the
Rule 51(4) EPC communication for giving
approval.

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In Decision T 675/90, OJ EPO 1994, 58, Technical

Board of Appeal 3.3.1 held that after the issue
of a Rule 51(6) EPC communication, the Examining
Division did not have any discretion under
Rule 86(3) EPC to consider requested amendments
to the text.

The facts of the case presently before Technical

Board of Appeal 3.3.2 were parallel to those of
Decision T 675/90.

Article 113(2) EPC

This provision was based on the "fundamental

right of parties to civil law proceedings to
decide the scope of their case", and in
particular to control the content of the patent
application at every stage of the proceedings.
Rule 51(6) EPC did not necessarily limit such
right, especially since according to
Article 164(2) EPC, Article 113(2) EPC must
prevail over any Implementing Regulation.

Rule 51 EPC

It seems that Rule 51(6) EPC should be

interpreted merely as obliging the EPO (after
having established that the applicant has
approved the text) to invite payment of certain
fees and filing of translations.

Balancing various interests

A speedy grant procedure is in the interest of

the public, but the grant of invalid patents
must be against the public interest.

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It would be inconsistent to limit the procedural

right of an applicant to request amendment by a
provision (Rule 51(4) EPC) which was introduced
in the interests of applicants. It does not seem
consistent to allow amendments to be requested
during self-opposition proceedings by the
patentee after grant, but not to allow such
amendments when requested by the applicant
before grant (cf. Decision G 1/84 OJ EPO 1985,
299)

The interest of the EPO in having practicable

working conditions should take third place after
the interests of the applicant and the public.

Question 2

The basic responsibility of the EPO is to issue valid

patents. While the validity of a patent in Contracting
States that have made a reservation under Article 167(2)
EPC is not an irrimediate condition under the EPC,
nevertheless the Guidelines for Examination (C-VI, 4.10)
suggest that requested amendments should be considered
if the reason for the request is that otherwise
unpatentable subject-matter would be claimed. It would
therefore seem reasonable to conclude that amendments
arising out of reservations under Article 167(2) EPC
would qualify as fundamentally important in this
respect.

IV. The President of the EPO submitted comments to the

Enlarged Board, essentially, as follows:

Question 1

(1) The EPC imposes requirements on the EPO which

must be met before a patent is granted, namely:

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- obtaining the applicant's approval of the

notified text (Articles 113(2) and 97(2) (a)
EPC);
- obtaining translations of the claims
(Article 97(5) and Rule 51(6) EPC);
- obtaining payment of fees for grant and
printing, and, if applicable, claims fees
(Article 97(2) and Rules 31(2) and 51(7)
EPC);
- issuing a decision to grant (Article 97(2)
EPC);
printing the specification (Article 98 EPC)
and publishing the mention of the grant of
the patent in the European Patent Bulletin
(Article 97(4) EPC): both of which require
specific technical preparations.

These steps in turn require as a functional necessity

that the final text of a patent must become fixed at a
point in time before the grant proceedings are closed.
This point in time must be before the Rule 51(6) EPC
communication is issued, because some of the steps
listed above, such as the payment of printing and claims
fees (by the applicant) and the issue of the decision to
grant and the publication of the patent (by the EPO)
depend upon the content of the text.

(ii) The practice of the EPa, as set out in the

Guidelines for Examination (C-VI, 4.9-4.11; C-
VI, 15.1) and in a Notice from the Vice-
president of DG2 dated 20 September 1988 (OJ EPO
1989, 43), is that further amendments are not
allowed after an applicant has approved the
notified text. The proper legal basis for this
practice is Rule 86(3) EPC.

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The nature of the binding force of an approval

by an applicant under Rule 51(4) EPC was such
that it was nevertheless mandatory for the EPO
to react, even after receipt of such approval,
if it is discovered that the text is deficient
as to satisfying the requirements of the EPC.

Contrary to Decision T 1/92, such "binding

force" of an approval under Rule 51(4) EPC comes
into existence upon the date of receipt of such
approval by the EPa.

The discretionary power to allow amendments

under Rule 86(3) EPC was limited by attributing
binding effect to the approval under Rule 51(4)
EPC, in the sense that no consent is given to
further amendments proposed by the applicant
which are not necessary to overcome substantial
deficiencies in the application documents: this
conformed with the EPC, in particular
Articles 113(2) and 125 EPC.

Questioxi

The Examining Divisions are not required under

Article 96(2) EPC to consider requirements of national
laws. The applicant's attention is drawn in every
Rule 51(4) EPC communication to the possibility of
obtaining separate sets of claims for designated States
who have made reservations under Article 167(2) EPC, as
voluntary practical assistance in this connection.

Reservations under Article 167(2) EPC are not considered

as constituting requirements of the EPC under
Article 96(2) EPC.

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V. The applicant submitted comments to the Enlarged Board

in reply to the President's comments. In particular it
was suggested that if the EPO was obliged to consider
reservations under Article 167(2) EPC as requirements of
the EPC which have to be met according to Article 96(2)
EPC, any undesirable prolongation of the examination
procedure would be avoided. In any event, if the EPO has
not specifically advised the applicant of the necessity
to file amended claims in respect of designated States
which have made reservations under Article 167(2) EPC,
the filing of such amended claims during proceedings
before the Examining Division should be allowable.

Reasons for the Decision

1. Background to referred question 1: summary of the

relevant procedure

Before deciding to grant a patent, in accordance with

Rule 51(4) EPC an Examining Division "shall inform the
applicant of the text in which it intends to grant it
and shall request him to indicate ... his approval of
the text notified". If no approval of the notified text
is filed in due time, the application is refused under
Rule 51(5) EPC.

After the applicant has approved the notified text, in

accordance with Rule 51(6) EPC I an Examining Division
"shall invite him to pay ... the fees for grant and
printing and shall also invite him to file ... a
translation of the claims in the two official languages
of the EPO other than the language of the proceedings",
within a set period of between two and three months. Any
claims fees not yet paid must also be paid within this
set period (Rule 51(7) EPC).

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According to Article 97(2) EPC, if it is established

that the applicant has approved the text in which the
Examining Division intends to grant the patent, and if
the fees for grant and printing have been paid within
the set period, and if the renewal fees and any
additional fees already due have been paid, the
Examining Division shall decide to grant the European
patent. The decision to grant the patent shall not take
effect until the date on which the European Patent
Bulletin mentions the grant (Article 97(4) EPC). The EPO
must publish a specification containing the description
claims and any drawings at the same time as it publishes
the mention of the grant (Article 98 EPC).

2. Question 1

2.1 The referring Board of Appeal has indicated its view

that Article 113(2) EPC is based on the fundamental
right of parties to civil law proceedings to decide the
scope of their case. In the Enlarged Board's view, this
provision of the EPC does not give any right to an
applicant in the sense that the EPO is in any way bound
to consider a request for amendment put forward by the
applicant. The effect of this provision is merely to
forbid the EPO from considering and deciding upon any
text of an application other than that "submitted to it,
or agreed, by the applicant or proprietor . ..".

The question whether an approval submitted under

Rule 51(4) EPC becomes binding once a communication in
accordance with Rule 51(c) EPC has been issued depends
rather upon the proper interpretation of Article 123(1)
EPC in conjunction with Rule 86(3) EPC. In particular
the final sentence of such Rule reads as follows: "No
further amendment may be made without the consent of the
Examining Division".

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This condition for amendment remains applicable so long

as the Examining Division retains competence over the
application, which is until it decides to grant the
European patent under Article 97(2) EPC. In particular,
this condition for amendment is applicable in the
circumstances of the referred question, namely after
issue of a communication under Rule 51(6) EPC. Thus as a
matter of legal power, following receipt of the
applicant's approval of the notified text under
Rule 51(4) EPC and following issue of a Rule 51(6) EPC
communication, the Examining Division still has a
discretion to allow amendment of an application until a
decision to grant a patent is issued.

Neither approval of the notified text by the applicant,

nor issue of a Rule 51(6) EPC communication by the EPO,
"binds" either the applicant or the EPO in the true
meaning of that word, namely so as to bar subsequent
amendment of the application. Contrary to the
President's views as set out in his comments to the
Enlarged Board, the Examining Division has a discretion
to allow amendment prior to issue of a decision to grant
a patent, either upon request by the applicant or on the
Examining Division's own motion.

Thus the Enlarged Board does not accept the

interpretation of these provisions of Rule 51 EPC as set
out in Decision T 675/90 and subsequently confirmed and
developed in Decision P 860/90 (not published in OJ
EPO), according to which the amendments to Rule 51 EPC
which came into effect on 1 June 1991 (OJ EPO 1991, 4)
had the effect of curtailing the discretion to allow
amendments as provided by Rule 86(3) EPC upon issue of a
communication under Rule 51(6) EPC.

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2.2 In general terms, the way in which the Examining

Division should exercise its discretion to allow an
amendment of an application must depend upon the
circumstances of each individual case, and must also
depend upon the stage of the pre-grant procedure which
the application has reached.

It is clear from the wording of the provisions in

Rule 51(4) to (6) EPC that the underlying object of the
Rule 51(6) EPC communication is to conclude the granting
procedure on the basis of the previously notified and
approved text of the application. Thus although the
Examining Division still has a discretion to allow
amendments at this stage of the pre-grant procedure,
such discretion must be exercised with the above
underlying object in mind.

2.3 The wording in Rule 86(3) EPC "No further amendment may
be made without the consent of the Examining Division'
simply means that the Examining Division may or may not
give its consent to a request for amendment by the
applicant. However, as stated at the end of
paragraph 2.2 above, since the underlying object of a
Rule 51(6) EPC communication is to conclude the granting
procedure on the basis of the approved text, a request
for amendment which is received by an Examining Division
after such a communication has been issued should be
considered in a different way from a similar request for
amendment received at a much earlier stage in the
overall examination procedure, and in particular before
approval by the applicant of a notified text. Such a
request should be considered in the context of the very
late stage in the pre-grant procedure at which it has
been made, and against the background that the Examining
Division has already completed its substantive
examination of the application, and that the applicant
has already had at least one opportunity to amend the

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application. Against such backgrou rid, the allowance of a

requested amendment after issue of a Rule 51(6) EPC
communication will be an exception rather than the rule.
Nevertheless the question remains, in what kind of
circumstances is it appropriate to make an exception to
the normal rule?

2.4 In the Enlarged Board's view, when considering the

possible circumstances when it may be appropriate for an
Examining Division to exercise its discretion under
Rule 86(3) EPC to allow an amendment after issue of a
Rule 51(6) EPC communication, it should be borne in mind
that a request for amendment at that stage may arise
either as a result of a realisation by the applicant of
a need for amendment, or as a result of a point raised
by the Examining Division, or as a result of
consideration of observations made by a third party
pursuant to Article 115 EPC. In any of these
circumstances, the discretion to allow amendment should
be exercised according to the same principles. Of
course, an objection should only be raised by an
Examining Division at that stage of the proceedings if
it is prepared to allow amendment to meet the objection.

2.5 When deciding whether or not to allow a request for

amendment at that stage of the pre-grant procedure, in
the exercise of its discretion under Rule 86(3) EPC, in
the Enlarged Board's judgment an Examining Division is
required to consider all relevant factors which arise in
a case. In particular, it must consider both the
applicant's interest in obtaining a patent which is
legally valid in all of the designated States, and the
EPO's interest in bringing the examination procedure to
a close by the issue of a decision to grant the patent,
and must balance these interests against one another.

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As stated in paragraph 2.3 above, the allowance of a

request for amendment at that stage will be an
exceptional case. Nevertheless, in the Enlarged Boards
view, a clear example of an exceptional case when it may
be appropriate to allow amendment, is when the applicant
requests separate sets of claims to be substituted in
respect of designated States that have made reservations
under Article 167(2) EPC. In such a case no further
substantive examination of the case may be required, and
any short delay caused by making the necessary
amendments is then of little weight, compared to the
importance to the applicant of obtaining a valid patent
in such designated States.

Similarly, other minor amendments which do not require

re-opening of substantive examination and which do not
appreciably delay the issuing of a decision to grant the
patent may be allowable after issue of a Rule 51(6) EPC
comrnunicat ion.

2.6 It may be added that if an Examining Division has

exercised its discretion under Rule 86(3) EPC against an
applicant in a particular case and the applicant files
an appeal against the way in which such discretion was
exercised, it is not the function of a Board of Appeal
to review all the facts and circumstances of the case as
if it were in the place of the first instance
department, in order to decide whether or not it would
have exercised such discretion in the same way as the
first instance department. If a first instance
department is required under the EPC to exercise its
discretion in certain circumstances, such a department
should have a certain degree of freedom when exercising
that discretion, without interference from the Boards of
Appeal. In the circumstances of a case such as that
before the referring Board, a Board of Appeal should
only overrule the way in which a first instance

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department has exercised its discretion if it comes to

the conclusion either that the first instance department
in its decision has not exercised its discretion in
accordance with the right principles as set out in
paragraph 2.5 above, or that it has exercised its
discretion in an unreasonable way, and has thus exceeded
the proper limits of its discretion.

3. Question 2

3.1 Under Article 96(2) EPC, an Examining Division is

required to consider whether the application or the
invention to which it relates meets the requirements of
the EPC. When a Contracting State to the EPC makes a
reservation under Article 167(2) EPC, it reserves the
right to make provisions in its national law on the
matters set out in Article 167(2) EPC. Such provisions
of national law are clearly not "requirements of the
EPC", within the meaning of Article 96(2) EPC. In the
Enlarged Board's view, the present practice of the
Examining Divisions in this respect, as summarised in
paragraph IV above under the heading "Question 2 11 is
,

correct.

Order

For these reasons, it is decided that:

The questions of law referred to the Enlarged Board of Appeal

are to be answered as follows:

1. An approval of a notified text submitted by an applicant

pursuant to Rule 51(4) EPC does not become binding once
a communication in accordance with Rule 51(6) EPC has
been issued. Following issue of such a communication

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under Rule 51(6) EPC and until issue of a decision to

grant the patent, the Examining Division has a
discretion under Rule 86(3) EPC, second sentence,
whether or not to allow amendment of the application.

2. The European Patent Office is not obliged to consider

reservations under Article 167(2) EPC as constituting
requirements of the EPC which have to be met according
to Article 96(2) EPC.

The Registrar: The Chairman:

j - 114 , (."z
J. Ruckerl P Gori

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