Source: EURLEX
Language: en
Format: md

**Council of the**
**European Union**

**Interinstitutional File:**

**2023/0130(COD)**

**INFORMATION NOTE**

**Brussels, 2 July 2024**
**(OR. en)**

**10565/24**

**CODEC 1396**
**PI 81**
**PHARM 86**
**MI 661**
**COMPET 748**
**IND 344**
**PE 145**

From: General Secretariat of the Council

To: Permanent Representatives Committee/Council

Subject: Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL on the supplementary protection certificate for
medicinal products (recast)

          - Outcome of the European Parliament's first reading
(Strasbourg, 26 to 29 February 2024)

**I.** **INTRODUCTION**

The rapporteur, Tiemo WÖLKEN (S&D, DE), presented a report on the above proposal for a

Regulation on behalf of the Committee on Legal Affairs (JURI) which contained 65 amendments

(amendments 1 to 65) to the proposal.

In addition, the EPP group tabled one amendment (amendment 66).

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**II.** **VOTE**

When it voted on 28 February 2024, the plenary of the European Parliament adopted amendments 1

to 65 to the proposal for a Regulation. No other amendment was adopted.

The Commission's proposal as thus amended constitutes the Parliament's first-reading position

which is contained in its legislative resolution as set out in the Annex hereto.

10565/24 LL/ec 2

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**ANNEX**

**(28.2.2024)**

## **P9_TA(2024)0099** **Supplementary protection certificate for medicinal products (recast)**

**European Parliament legislative resolution of 28 February 2024 on the proposal for a**
**regulation of the European Parliament and of the Council on the supplementary protection**
**certificate for medicinal products (recast) (COM(2023)0231 – C9-0146/2023 –**
**2023/0130(COD))**

**–**
**(Ordinary legislative procedure** **recast)**

_The European Parliament_,

–
having regard to the Commission proposal to Parliament and the Council (COM(2023)0231),

–
having regard to Article 294(2) and Article 114(1) of the Treaty on the Functioning of the
European Union, pursuant to which the Commission submitted the proposal to Parliament
(C9-0146/2023),

–
having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–
having regard to the opinion of the European Economic and Social Committee of 27
September 2023 **[1]**,

–
having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured
use of the recasting technique for legal acts **[2]**,

–
having regard to Rules 110 and 59 of its Rules of Procedure,

–
having regard to the report of the Committee on Legal Affairs (A9-0022/2024),

**1** OJ C, C/2023/865, 08.12.2023, ELI: http://data.europa.eu/eli/C/2023/865/oj.
**2** OJ C 77, 28.3.2002, p. 1.

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A. whereas, according to the Consultative Working Party of the legal services of the European
Parliament, the Council and the Commission, the Commission proposal does not include any
substantive amendments other than those identified as such in the proposal and whereas, as
regards the codification of the unchanged provisions of the earlier acts together with those
amendments, the proposal contains a straightforward codification of the existing texts,
without any change in their substance;

1. Adopts its position at first reading hereinafter set out, taking into account the
recommendations of the Consultative Working Party of the legal services of the European
Parliament, the Council and the Commission;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially
amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national
parliaments.

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**Amendment 1**

**Proposal for a regulation**
**Recital 2**

_Text proposed by the Commission_ _Amendment_

(2) Pharmaceutical research plays a
decisive role in the continuing
improvement in public health.

**Amendment 2**

**Proposal for a regulation**
**Recital 3**

(2) Pharmaceutical research plays a
decisive role in the continuing
improvement in public health. _**Medicinal**_
_**products, in particular those that are the**_
_**result of long, costly research will not**_
_**continue to be developed in the Union**_
_**unless they are covered by favourable**_
_**rules that provide for sufficient protection**_
_**to encourage such research. However, it**_
_**is difficult to establish a direct link**_
_**between such favourable rules and Union**_
_**competitiveness because while such rules**_
_**make Union markets more attractive,**_
_**medicines’ geographical origin and**_
_**authorised medicines from third countries**_
_**are equally eligible to receive all Union**_
_**incentives, just as Union based innovative**_
_**companies can equally benefit from**_
_**incentives in third countries.**_

_Text proposed by the Commission_ _Amendment_

_**(3)**_ _**Medicinal products, in particular**_
_**those that are the result of long, costly**_
_**research will not continue to be developed**_
_**in the Union unless they are covered by**_
_**favourable rules that provide for**_
_**sufficient protection to encourage such**_
_**research.**_

_**deleted**_

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**Amendment 3**

**Proposal for a regulation**
**Recital 8**

_Text proposed by the Commission_ _Amendment_

(8) One of the conditions for the grant of
a certificate should be that the product is
protected by the basic patent, in the sense
that the product should fall within the
scope of one or more claims of that patent,
as interpreted by the person skilled in the
art _**by**_ the description of the patent _**on its**_
filing date. This should not necessarily
require that the active ingredient of the
product be explicitly identified in the
claims _**.**_ Or, in the event of a combination
product, this should not necessarily require
that each of its active ingredients be
explicitly identified in the claims, provided
that each _**of them**_ is specifically
identifiable in the light of all the
information disclosed by that patent.

(8) One of the conditions for the grant of
a certificate should be that the product is
protected by the basic patent, in the sense
that the product should fall within the
scope of one or more claims of that patent,
as interpreted by the person skilled in the
art _**in light of**_ the description _**and drawings**_
of the patent _**, on the basis of that person’s**_
_**general knowledge in the relevant field**_
_**and of the prior art at the**_ filing date _**or**_
_**priority date of the basic patent**_ . This
should not necessarily require that the
active ingredient of the product be
explicitly identified in the claims or, in the
event of a combination product, this should
not necessarily require that each of its
active ingredients be explicitly identified in
the claims, provided that each _**active**_
_**ingredient**_ is specifically identifiable in the
light of all the information disclosed by
that patent _**, on the basis of the prior art at**_
_**the filing date or priority date of the basic**_
_**patent**_ .

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**Amendment 4**

**Proposal for a regulation**
**Recital 9**

_Text proposed by the Commission_ _Amendment_

(9) To avoid overprotection, it should be
provided that no more than one certificate,
whether national or unitary, may protect
the same product in a Member State.
Therefore it should be required that the
product, or any _**therapeutically equivalent**_
derivative such as salts, esters, ethers,
isomers, mixtures of isomers, complexes or
biosimilars, should not have already been
the subject of a prior certificate, _**either**_
_**alone or in combination with one or more**_
_**additional active ingredients,**_ whether for
the same therapeutic indication or for a
different one.

**Amendment 5**

**Proposal for a regulation**
**Recital 13**

(9) To avoid overprotection, it should be
provided that no more than one certificate,
whether national or unitary, may protect
the same product in a Member State.
Therefore it should be required that the
product, or any derivative such as salts,
esters, ethers, isomers, mixtures of isomers,
complexes or biosimilars, should not have
already been the subject of a prior
certificate, whether for the same
therapeutic indication or for a different

one.

_Text proposed by the Commission_ _Amendment_

(13) Where the marketing authorisation
submitted in support of the application for
a certificate for a biological medicinal
product identifies that product by means of
its International Nonproprietary Name
(INN), the protection conferred by the
certificate should extend to all
_**therapeutically equivalent products**_ having
the same International Nonproprietary
Name as the product referred to in the
marketing authorisation, irrespective of
possible minor differences between a
subsequent biosimilar and the product
authorised, which are usually unavoidable
given the nature of biological products.

(13) Where the marketing authorisation
submitted in support of the application for
a certificate for a biological medicinal
product identifies that product by means of
its International Nonproprietary Name
(INN), the protection conferred by the
certificate should extend to all _**biosimilar**_
having the same International
Nonproprietary Name as the product
referred to in the marketing authorisation,
irrespective of possible minor differences
between a subsequent biosimilar and the
product authorised, which are usually
unavoidable given the nature of biological
products.

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**Amendment 6**

**Proposal for a regulation**
**Recital 24**

_Text proposed by the Commission_ _Amendment_

(24) The Office should have the
possibility to charge a fee for the
centralised application for a certificate and
for an application for the extension of
duration of certificates in the case of
paediatric medicinal products, as well as
other procedural fees such as a fee for
opposition or appeal. The fees charged by
the Office should be laid down by an
implementing act.

**Amendment 7**

**Proposal for a regulation**
**Recital 30**

(24) The Office should have the
possibility to charge a fee for the
centralised application for a certificate and
for an application for the extension of
duration of certificates in the case of
paediatric medicinal products _**in**_
_**accordance with Article 86 of Directive**_
_**(EU) .../... [2023/0132(COD)],**_ as well as
other procedural fees such as a fee for
opposition or appeal. The fees charged by
the Office should be laid down by an
implementing act.

_Text proposed by the Commission_ _Amendment_

(30) The examination of a centralised
application for a certificate should be
conducted, under supervision of the Office,
by an examination panel including one
member of the Office as well as two
examiners employed by the national patent
offices. This would ensure that optimal use
be made of expertise in supplementary
protection certificates matters, located
today at national offices only. To ensure an
optimal quality of the examination, suitable
criteria should be laid down in respect of
the participation of specific examiners in
the centralised procedure, in particular as
regards qualification and conflicts of
interest.

(30) The examination of a centralised
application for a certificate should be
conducted, under supervision of the Office,
by an examination panel including one
member of the Office as well as two
examiners employed by the national patent
offices. This would ensure that optimal use
be made of expertise in supplementary
protection certificates _**and related patent**_
matters, located today at national offices
only. To ensure an optimal quality of the
examination, _**the Office and the competent**_
_**national authorities should make sure**_

_**that designated examiners have the**_
_**relevant expertise and sufficient**_
_**experience in the assessment of**_
_**supplementary protection certificates.**_
_**Additional**_ suitable criteria should be laid
down in respect of the participation of
specific examiners in the centralised
procedure, in particular as regards
qualification and conflicts of interest.

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**Amendment 8**

**Proposal for a regulation**
**Recital 32 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(32a) To guarantee an effective protection**_
_**of innovation, in certain urgent situations,**_
_**including where the expiry of the basic**_
_**patent is imminent, an expedited**_
_**examination procedure might be**_
_**necessary, notwithstanding the possibility**_
_**for third parties to submit observations**_
_**and make use of other remedies provided**_
_**for in this Regulation. Therefore, a**_
_**mechanism for applicants to request an**_
_**expedited examination procedure should**_
_**be provided.**_

**Amendment 9**

**Proposal for a regulation**
**Recital 33**

_Text proposed by the Commission_ _Amendment_

(33) After the completion of the
examination of a centralised application,
and after the time limits for appeal and
opposition have expired, or, the case being,
after a final decision on the merits has been
issued, the opinion should be transmitted to
the respective national patent offices of the
designated Member States.

(33) After the completion of the
examination of a centralised application,
and after the time limits for appeal and
opposition have expired, or, the case being,
after a final decision on the merits has been
issued, the opinion should be transmitted to
the respective national patent offices of the
designated Member States. _**The Office**_
_**shall ensure the transmission takes place**_
_**within a timeframe allowing national**_
_**patent offices to grant the certificate or**_
_**reject the application, as applicable,**_
_**before the expiry of the basic patent.**_

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**Amendment 10**

**Proposal for a regulation**
**Recital 38**

_Text proposed by the Commission_ _Amendment_

(38) Where the applicant or another party
is adversely affected by a decision of the
Office, the applicant or that party should
have the right, subject to a fee, to file
within 2 months an appeal against the
decision, before a Board of Appeal of the
Office. This also applies to the examination
opinion, that may be appealed by the
applicant. Decisions of that Board of
Appeal should, in turn, be amenable to
actions before the General Court, which
has jurisdiction to annul or to alter the
contested decision. In case of a combined
application including a request for a
unitary certificate, a common appeal may
be filed.

**Amendment 11**

**Proposal for a regulation**
**Recital 39**

(38) _**To safeguard procedural rights and**_
_**ensure a complete system of remedies,**_
where the applicant or another party is
adversely affected by a decision of the
Office, the applicant or that party should
have the right, subject to a fee, to file
within 2 months an appeal against the
decision, before a Board of Appeal of the
Office. This also applies to the examination
opinion, that may be appealed by the
applicant. Decisions of that Board of
Appeal should, in turn, be amenable to
actions before the General Court, which
has jurisdiction to annul or to alter the
contested decision. In case of a combined
application including a request for a
unitary certificate, a common appeal may
be filed.

_Text proposed by the Commission_ _Amendment_

(39) When appointing members of the
Boards of Appeal in matters regarding
centralised applications for certificates,
their prior experience in supplementary
protection certificate or patent matters
should be taken into account.

(39) When appointing members of the
Boards of Appeal in matters regarding
centralised applications for certificates,
their _**relevant expertise, independence and**_
_**sufficient**_ prior experience in
supplementary protection certificate or
patent matters should be taken into

account.

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**Amendment 12**

**Proposal for a regulation**
**Recital 41 a (new)**

_Text proposed by the Commission_ _Amendment_

_**(41a) The timely entry of generics and**_
_**biosimilars onto the Union market is**_

_**important, in particular to increase**_
_**competition, to reduce prices and to**_
_**ensure both the sustainability of national**_
_**healthcare systems and better access to**_
_**affordable medicines for patients in the**_
_**Union. The importance of such timely**_
_**entry was underlined by the Council in its**_
_**conclusions of 17 June 2016 on**_
_**strengthening the balance in the**_
_**pharmaceutical systems in the Union and**_
_**its Member States. On the other hand, it**_
_**should be borne in mind that intellectual**_

_**property rights remain one of the**_
_**cornerstones of innovation,**_
_**competitiveness and growth in the**_
_**internal market.**_

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**Amendment 13**

**Proposal for a regulation**
**Recital 45**

_Text proposed by the Commission_ _Amendment_

(45) In _**those**_ specific and limited
circumstances, and in order to create a
level playing field between makers
_**established in the Union and third-**_
_**country**_ makers, it is appropriate to _**provide**_
_**for an exception to**_ the protection
conferred by a certificate so as to allow _**the**_
making _**of a product, or a medicinal**_
_**product containing that product,**_ for the
purpose of export to third countries _**or of**_
_**storing,**_ and any related acts in the Union
strictly necessary for _**that**_ making or for the
actual export _**or the actual storing**_
_**(‘related acts’)**_, where such acts would
otherwise require the consent of _**the**_
certificate holder. For instance, such
_**related**_ acts could include the _**possessing**_,
offering to supply, _**supplying, importing**_,
using or _**synthesising**_ of an active
ingredient for the purpose of making a
medicinal product _**. They could also consist**_
_**of**_ temporary _**storing**_ or advertising _**of the**_
_**product**_ for the exclusive purpose of export
to _**third-country**_ destinations. The
exception should also apply to related acts
performed by third parties who are in a
contractual relationship with the maker.

(45) In _**those**_ specific and limited
circumstances, and in order to create a
level playing field between _**Union-based**_
makers _**and third country**_ makers, the
protection conferred by a _**supplementary**_
_**protection**_ certificate _**in accordance to**_
_**Regulation (EU) 2019/933**_ should be
restricted, so as to allow making for the
_**exclusive**_ purpose of export to third
countries and any related acts in the Union
strictly necessary for making or for the
actual export _**itself**_, where such acts would
otherwise require the consent of _**a**_
certificate holder _**(‘related acts’)**_ . For
instance, related acts could include the _**,**_
_**possession, supply**_, offering to supply,
_**import**_, use or _**synthesis**_ of an active
ingredient for the purpose of making a
medicinal product _**containing that product,**_
_**or**_ temporary _**storage of the product**_ or
advertising for the exclusive purpose of
export to _**third country**_ destinations. The
exception should also apply to related acts
performed by third parties who are in a
contractual relationship with the maker.

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**Amendment 14**

**Proposal for a regulation**
**Recital 60**

_Text proposed by the Commission_ _Amendment_

(60) To ensure transparency, a register
should be set up that can serve as a single
access point providing information on
applications for certificates under the
centralised procedure, including on
certificates granted on that basis by
competent national authorities, which
should share with the Office any related
information. The register should be
available in all official languages of the
Union.

**Amendment 15**

**Proposal for a regulation**
**Article 2 – paragraph 1 – point 12 a (new)**

(60) To ensure transparency, a register
should be set up that can serve as a single
access point providing information on
applications for certificates under the
centralised procedure, including on
certificates granted on that basis by
competent national authorities, which
should share with the Office any related
information. The register should be
available in all official languages of the
Union. _**However, the information provided**_
_**in the register should not be used in**_
_**regards to practices of patent linkage and**_
_**no regulatory or administrative decisions**_
_**related to generics or biosimilars, such as**_
_**marketing authorisations, pricing and**_
_**reimbursement decisions or tender bids to**_

_**the existence of the SPC, should be based**_
_**on information provided for in the**_
_**register.**_

_Text proposed by the Commission_ _Amendment_

_**(12a) ‘economically linked’ means, in**_
_**respect of different holders of two or more**_
_**basic patents protecting the same product,**_
_**that one holder, directly or indirectly**_
_**through one or more intermediaries,**_
_**controls, is controlled by or is under**_
_**common control with another holder.**_

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**Amendment 16**

**Proposal for a regulation**
**Article 3 – paragraph 1 – point b**

_Text proposed by the Commission_ _Amendment_

(b) a valid authorisation to place the
product on the market as a medicinal
product has been granted in accordance
with Directive 2001/83/EC, Regulation
(EC) No 726/2004 or Regulation (EU)
2019/6, as appropriate;

**Amendment 17**

**Proposal for a regulation**
**Article 3 – paragraph 3**

(b) a valid authorisation to place the
product on the market as a medicinal
product has been granted in accordance
with Directive .../... [2023/0132(COD) _**]**_,
Regulation (EC) No 726/2004 or
Regulation (EU) 2019/6, as appropriate;

_Text proposed by the Commission_ _Amendment_

3. The holder of more than one patent
for the same product shall not be granted
more than one certificate for that product.
However, where two or more applications
concerning the same product and
emanating from two or more holders of
different patents are pending, one
certificate for that product may be issued to
each of those holders, where they are not
economically linked.

3. The holder of more than one patent
for the same product shall not be granted
more than one certificate for that product.
However, where two or more applications
concerning the same product and
emanating from two or more holders of
different patents are pending, one
certificate for that product may be issued to
each of those holders, where they are not
economically linked. _**The same principle**_
_**shall apply mutatis mutandis to**_
_**applications submitted by the holder**_
_**concerning the same product for which**_
_**one or more certificates or unitary**_
_**certificates have been previously granted**_
_**to other different holders of different**_
_**patents.**_

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**Amendment 18**

**Proposal for a regulation**
**Article 5 – paragraph 2 – introductory part**

_Text proposed by the Commission_ _Amendment_

2. By way of derogation from
paragraph 1, the certificate shall not confer
protection against certain acts which would
otherwise require the consent of the the
certificate holder, if all of the following
conditions are met:

**Amendment 19**

**Proposal for a regulation**
**Article 5 – paragraph 2 – point a – point i**

2. By way of derogation from
paragraph 1 _**, and in accordance with**_
_**Regulation (EU).../... [2023/0130(COD)]**_,
the certificate shall not confer protection
against certain acts which would otherwise
require the consent of the certificate holder,
if all of the following conditions are met:

_Text proposed by the Commission_ _Amendment_

(i) the making of a product, or a
medicinal product containing that product,
for the purpose of export to third countries;

**Amendment 20**

**Proposal for a regulation**
**Article 5 – paragraph 2 – point a – point ii**

(i) the making of a product, or a
medicinal product containing that product,
for the purpose of export to third countries;

_**or**_

_Text proposed by the Commission_ _Amendment_

(ii) any related act that is strictly
necessary for _**the**_ making _**,**_ in the Union _**,**_
_**referred to in point (i),**_ or for the actual
export;

(ii) any related act that is strictly
necessary for _**that**_ making in the Union or
for the actual export _**itself**_ ; _**or**_

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**Amendment 21**

**Proposal for a regulation**
**Article 5 – paragraph 2 – point a – point iii**

_Text proposed by the Commission_ _Amendment_

(iii) _**the**_ making, no earlier than 6 months
before the expiry of the certificate, _**of**_ a
product, or a medicinal product containing
that product, for the purpose of storing it in
the Member State of making _**,**_ in order to
place that product, or a medicinal product
containing that product, on the market of
Member States after the expiry of the
_**corresponding**_ certificate;

**Amendment 22**

**Proposal for a regulation**
**Article 5 – paragraph 2 – point a – point iv**

(iii) making, no earlier than 6 months
before the expiry of the certificate, a
product, or a medicinal product containing
that product, for the purpose of storing it in
the Member State of making in order to
place that product, or a medicinal product
containing that product, on the market of
Member States after the expiry of the
certificate; _**or**_

_Text proposed by the Commission_ _Amendment_

(iv) any related act that is strictly
necessary for the making _**,**_ in the Union _**,**_
referred to in point (iii), or for the actual
storing, provided that such related act is
carried out no earlier than 6 months before
the expiry of the certificate.

**Amendment 23**

**Proposal for a regulation**
**Article 8 – paragraph 1 – point d a (new)**

(iv) any related act that is strictly
necessary for the making in the Union _**as**_
referred to in point (iii), or for the actual
storing _**itself**_, provided that such related act
is carried out no earlier than 6 months
before the expiry of the certificate.

_Text proposed by the Commission_ _Amendment_

_**(da) if applicable, the consent of the**_
_**third party referred to in Article 6(2) of**_
_**this Regulation.**_

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**Amendment 24**

**Proposal for a regulation**
**Article 8 – paragraph 1 – point d b (new)**

_Text proposed by the Commission_ _Amendment_

_**(db) information on any direct public**_
_**financial support received for research**_
_**related to the development of the product.**_

**Amendment 25**

**Proposal for a regulation**
**Article 11 – paragraph 1 – introductory part**

_Text proposed by the Commission_ _Amendment_

1. The authority referred to in Article
9(1) shall publish, _**as soon as possible**_,
notification of the fact that a certificate has
been granted . The notification shall
contain all of the following information:

**Amendment 26**

**Proposal for a regulation**
**Article 11 – paragraph 1 – point f a (new)**

1. The authority referred to in Article
9(1) shall publish, _**without undue delay**_,
notification of the fact that a certificate has
been granted. The notification shall contain
all of the following information:

_Text proposed by the Commission_ _Amendment_

_**(fa) information on any direct public**_
_**financial support received for research**_
_**related to the development of the product.**_

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**Amendment 27**

**Proposal for a regulation**
**Article 15 – paragraph 1 – point a**

_Text proposed by the Commission_ _Amendment_

(a) the certificate was granted contrary
to Article 3;

**Amendment 28**

**Proposal for a regulation**
**Article 16 – paragraph 2**

(a) the certificate was granted contrary
to Article 3 _**or 6(2)**_ ;

_Text proposed by the Commission_ _Amendment_

2. Any person may submit an
application for revocation of the extension
of the duration granted under this Chapter
to the body responsible under national law
for the revocation of the corresponding
basic patent.

**Amendment 29**

**Proposal for a regulation**
**Article 18 – paragraph 2 a (new)**

2. Any person may submit an
application for revocation of the extension
of the duration granted under this Chapter
to the body responsible under national law
for the revocation of the corresponding
basic patent _**or before a competent court of**_
_**a Member State**_ .

_Text proposed by the Commission_ _Amendment_

_**2a.**_ _**Full transparency shall be ensured**_
_**throughout the whole appeal proceeding,**_
_**which shall be open, whenever possible, to**_
_**public participation.**_

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**Amendment 30**

**Proposal for a regulation**
**Article 20 – paragraph 1**

_Text proposed by the Commission_ _Amendment_

1. Where the basic patent is a European
patent, including a unitary patent, and the
authorisation to place the product on the
market has been granted through the
centralised procedure under Regulation
(EC) No 726/2004 or Regulation (EU)
2019/6, the procedure in this Chapter shall
apply.

**Amendment 31**

**Proposal for a regulation**
**Article 23 – paragraph 1**

1. Where the basic patent is a European
patent, including a unitary patent, and the
authorisation to place the product on the
market has been granted _**, as appropriate,**_
_**in accordance with Directive .../...**_

_**[2023/0132(COD)],**_ through the centralised
procedure under Regulation (EC) No
726/2004 or Regulation (EU) 2019/6, the
procedure in this Chapter shall apply.

_Text proposed by the Commission_ _Amendment_

If the centralised application complies with
Article 22, or if an application for an
extension of the duration of certificates
complies with Article 33(2), the Office
shall publish the application, without
undue delay _**, in the Register**_ .

**Amendment 32**

**Proposal for a regulation**
**Article 24 – paragraph 1**

If the centralised application complies with
Article 22, or if an application for an
extension of the duration of certificates
complies with Article 33(2), the Office
shall publish the application, _**in the**_
_**Register**_ without undue delay _**and no later**_
_**than five working days after**_ .

_Text proposed by the Commission_ _Amendment_

1. The Office shall assess the
application on the basis of all the
conditions in Article 3(1) for each of the
designated Member States.

1. The Office shall assess the
application on the basis of all the
conditions in Articles 3(1) and _**(3) and**_
_**Article 6(2)**_ for each of the designated
Member States.

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**Amendment 33**

**Proposal for a regulation**
**Article 24 – paragraph 2**

_Text proposed by the Commission_ _Amendment_

2. Where the centralised application for
a certificate and the product to which it
relates comply with Article 3(1) in respect
of all or some of the designated Member
States, the Office shall adopt a reasoned
positive examination opinion in respect of
such Member States. The Office shall
notify that opinion to the applicant.

**Amendment 34**

**Proposal for a regulation**
**Article 24 – paragraph 3**

2. Where the centralised application for
a certificate and the product to which it
relates comply with Article 3(1) and _**(3)**_
_**and Article 6(2)**_ in respect of all or some of
the designated Member States, the Office
shall adopt a reasoned positive examination
opinion in respect of such Member States.
The Office shall notify that opinion to the
applicant _**and publish the opinion on the**_
_**dedicated register without undue delay**_ .

_Text proposed by the Commission_ _Amendment_

3. Where the centralised application for
a certificate and the product to which it
relates does not comply with Article 3(1) in
respect of all or some of the designated
Member States, the Office shall adopt a
reasoned negative examination opinion in
respect of such Member States. The Office
shall notify that opinion to the applicant.

3. Where the centralised application for
a certificate and the product to which it
relates does not comply with Article 3(1)
and _**(3) and Article 6(2)**_ in respect of all or
some of the designated Member States, the
Office shall adopt a reasoned negative
examination opinion in respect of such
Member States. The Office shall notify that
opinion to the applicant _**and publish the**_
_**opinion on the dedicated register without**_
_**undue delay**_ .

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**Amendment 35**

**Proposal for a regulation**
**Article 24 – paragraph 5 a (new)**

_Text proposed by the Commission_ _Amendment_

_**5a.**_ _**The Office shall adopt an**_
_**examination opinion within 6 months**_
_**after publication of the centralised**_
_**application in the Register. Without**_
_**prejudice to Articles 25, 26 and 28 of this**_
_**Regulation, whenever duly justified for**_
_**reasons of urgency, the applicant may**_
_**submit a request for an expedited**_
_**procedure. Where the request for an**_
_**expedited examination procedure is**_
_**deemed justified, the Office shall adopt an**_
_**examination opinion within 4 months**_
_**from the publication of the application for**_
_**a unitary certificate.**_

**Amendment 36**

**Proposal for a regulation**
**Article 25 – paragraph 3 a (new)**

_Text proposed by the Commission_ _Amendment_

_**3a.**_ _**Whenever the expedited procedure**_
_**applies in accordance with to Article 24**_
_**(5a), observations shall be submitted**_
_**within six weeks after publication of the**_
_**application in the Register.**_

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**Amendment 37**

**Proposal for a regulation**
**Article 26 – paragraph 2**

_Text proposed by the Commission_ _Amendment_

2. Opposition may only be filed on the
grounds that one or more of the conditions
set out in Article 3 are not fulfilled for one
or more of the designated Member States.

**Amendment 38**

**Proposal for a regulation**
**Article 26 – paragraph 4 – point c a (new)**

2. Opposition may only be filed on the
grounds that one or more of the conditions
set out in Article 3 _**or 6**_ are not fulfilled for
one or more of the designated Member
States.

_Text proposed by the Commission_ _Amendment_

_**(ca) any evidence the opponent relies on**_
_**in support of the opposition.**_

**Amendment 39**

**Proposal for a regulation**
**Article 26 – paragraph 6**

_Text proposed by the Commission_ _Amendment_

6. If the opposition panel notes that the
notice of opposition does not comply with
paragraphs 2, 3 or 4, it shall reject the
opposition as inadmissible, and
communicate _**this to**_ opponent, unless these
deficiencies have been remedied before
expiry of the opposition filing period
referred to in paragraph 1.

6. If the opposition panel notes that the
notice of opposition does not comply with
paragraphs 2, 3 or 4, it shall reject the
opposition as inadmissible, and
communicate _**its decision as well as the**_

_**reasoning for its decision to the**_ opponent,
unless these deficiencies have been
remedied before expiry of the opposition
filing period referred to in paragraph 1.

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**Amendment 40**

**Proposal for a regulation**
**Article 26 – paragraph 9**

_Text proposed by the Commission_ _Amendment_

9. The Office shall issue a decision on
the opposition within 6 months, unless the
complexity of the case requires a longer
period.

**Amendment 41**

**Proposal for a regulation**
**Article 26 – paragraph 9 a (new)**

9. The Office shall issue a decision on
the opposition _**including a detailed**_
_**reasoning for that decision**_ within 6
months, unless the complexity of the case
requires a longer period.

_Text proposed by the Commission_ _Amendment_

_**9a.**_ _**In cases where several oppositions**_
_**have been filed against an examination**_
_**opinion, the Office shall deal with the**_
_**oppositions jointly and issue one single**_
_**decision in regards to all oppositions filed.**_

**Amendment 42**

**Proposal for a regulation**
**Article 26 – paragraph 10**

_Text proposed by the Commission_ _Amendment_

10. If the opposition panel considers that
no ground for opposition prejudices the
maintenance of the examination opinion, it
shall reject the opposition, and the Office
shall mention this in the Register.

10. If the opposition panel considers that
no ground for opposition prejudices the
maintenance of the examination opinion, it
shall reject the opposition and _**notify the**_
_**opponent of its decision,**_ and the Office
shall mention this in the Register.

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**Amendment 43**

**Proposal for a regulation**
**Article 26 – paragraph 12 a (new)**

_Text proposed by the Commission_ _Amendment_

_**12a. Full transparency shall be ensured**_
_**throughout the whole opposition**_
_**proceeding, which shall be open,**_
_**whenever possible, to public participation.**_

**Amendment 44**

**Proposal for a regulation**
**Article 27 – paragraph 1**

_Text proposed by the Commission_ _Amendment_

1. On a request made to the Office, any
competent national authority may be
appointed by the Office as a participating
office in the examination procedure. Once
a competent national authority is appointed
in accordance with this Article, that
authority shall designate one or more
examiners to be involved in the

examination of one or more centralised
applications.

**Amendment 45**

**Proposal for a regulation**
**Article 28 – paragraph 3 – point a**

1. On a request made to the Office, any
competent national authority may be
appointed by the Office as a participating
office in the examination procedure. Once
a competent national authority is appointed
in accordance with this Article, that
authority shall designate one or more
examiners to be involved in the

examination of one or more centralised
applications _**, on the basis of their relevant**_
_**expertise and of their experience in the**_
_**field**_ .

_Text proposed by the Commission_ _Amendment_

(a) _**geographical balance amongst the**_
_**participating offices**_ ;

(a) _**relevant expertise and sufficient**_
_**experience in the examination of patents**_
_**and supplementary protection certificates,**_
_**ensuring, in particular, that at least one**_
_**examiner has a minimum of five years of**_
_**experience in the examination of patents**_
_**and supplementary protection certificates**_ ;

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**Amendment 46**

**Proposal for a regulation**
**Article 28 – paragraph 3 – point a a (new)**

_Text proposed by the Commission_ _Amendment_

_**(aa) where possible, geographical**_
_**balance amongst the participating offices;**_

**Amendment 47**

**Proposal for a regulation**
**Article 28 – paragraph 3 – point c**

_Text proposed by the Commission_ _Amendment_

(c) no _**more than one**_ examiner
employed by a competent national
authority making use of the exemption _**laid**_
_**down**_ in Article 10(5).

**Amendment 48**

**Proposal for a regulation**
**Article 29 – paragraph 3**

(c) _**that there is**_ no examiner employed
by a competent national authority making
use of the exemption _**set out**_ in Article
10(5) _**of this Regulation**_ .

_Text proposed by the Commission_ _Amendment_

3. Notice of appeal shall be filed in
writing at the Office within 2 months of the
date of notification of the decision. The

notice shall be deemed to have been filed
only when the fee for appeal has been paid.
In case of an appeal, a written statement
setting out the grounds of appeal shall be
filed within _**4**_ months of the date of

notification of the decision _**.**_

3. Notice of appeal shall be filed in
writing at the Office within 2 months of the
date of notification of the decision. The

notice shall be deemed to have been filed
only when the fee for appeal has been paid.
In case of an appeal, a written statement
setting out the grounds of appeal _**,**_
_**including corresponding evidence relied**_
_**on,**_ shall be filed within _**3**_ months of the
date of notification of the decision

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**Amendment 49**

**Proposal for a regulation**
**Article 29 – paragraph 3 a (new)**

_Text proposed by the Commission_ _Amendment_

_**3a.**_ _**Any reply to statement of the**_
_**grounds of appeal shall be submitted in**_
_**writing within three months from the date**_
_**of the notification of the statement of the**_
_**grounds of appeal. Where applicable, the**_
_**Office shall set a date for an oral hearing**_
_**within three months after the filing of the**_
_**reply to the grounds of appeal or within**_
_**six months of the filing of grounds of**_
_**appeal, whichever is earlier. The Office**_
_**shall issue a written decision within three**_

_**months of the oral hearing or of the filing**_
_**of the reply to the statement of grounds of**_
_**appeal, as applicable.**_

**Amendment 50**

**Proposal for a regulation**
**Article 29 – paragraph 5**

_Text proposed by the Commission_ _Amendment_

5. Where an appeal before the Boards
of Appeal of the Office results in a
decision which is not in line with the
examination opinion and is remitted to the
Office, the decision of the Boards _**may**_
annul or alter that opinion before
transmitting it to the competent national
authorities of the designated Member
States.

5. Where an appeal before the Boards
of Appeal of the Office results in a
decision which is not in line with the
examination opinion and is remitted to the
Office, the decision of the Boards _**shall**_
annul or alter that opinion before
transmitting it to the competent national
authorities of the designated Member
States.

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**Amendment 51**

**Proposal for a regulation**
**Article 30 – paragraph 4**

_Text proposed by the Commission_ _Amendment_

4. Members of the Boards of Appeal in
matters regarding centralised applications
for certificates shall be appointed in
accordance with Article 166 (5) of
Regulation (EU) 2017/1001.

**Amendment 52**

**Proposal for a regulation**
**Article 30 – paragraph 4 a (new)**

4. Members of the Boards of Appeal in
matters regarding centralised applications
for certificates shall be appointed in
accordance with Article 166 (5) of
Regulation (EU) 2017/1001. _**When**_
_**appointing members of the Boards of**_
_**Appeal in matters regarding centralised**_
_**applications for certificates, their prior**_
_**experience in supplementary protection**_
_**certificate or patent matters should be**_
_**taken into account.**_

_Text proposed by the Commission_ _Amendment_

_**4a.**_ _**Article 166(9) of Regulation (EU)**_
_**2017/1001 shall apply to Boards of Appeal**_
_**in matters regarding centralised**_
_**applications for certificates.**_

**Amendment 53**

**Proposal for a regulation**
**Article 32 – paragraph 1 – subparagraph 1 a (new)**

_Text proposed by the Commission_ _Amendment_

_**Such transmission shall take place**_
_**without undue delay within a timeframe**_
_**allowing the competent national**_
_**authorities of each designated Member**_
_**State to grant or reject a certificate, as**_
_**applicable, according to applicable**_
_**national procedures, before the expiry of**_
_**the basic patent.**_

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**Amendment 54**

**Proposal for a regulation**
**Article 32 – paragraph 5 a (new)**

_Text proposed by the Commission_ _Amendment_

_**5a.**_ _**The competent national authority**_
_**shall inform the applicant of its decision**_
_**without undue delay.**_

**Amendment 55**

**Proposal for a regulation**
**Article 33 – paragraph 4**

_Text proposed by the Commission_ _Amendment_

4. Third parties may also submit
observations in respect of a centralised
application for an extension of the duration
of certificates.

**Amendment 56**

**Proposal for a regulation**
**Article 35 – paragraph 1**

4. Third parties may also submit
observations _**or an opposition**_ in respect of
a centralised application for an extension
of the duration of certificates.

_Text proposed by the Commission_ _Amendment_

1. The Office shall develop, keep and
maintain an electronic Register, providing
up-to-date information regarding the status
of all published centralised applications,
and of all centralised applications for an
extension of the duration of certificates.

1. The Office shall develop, keep and
maintain an electronic _**, searchable and**_
_**public**_ Register, providing up-to-date
information regarding the status of all
published centralised applications, and of
all centralised applications for an extension
of the duration of certificates.

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**Amendment 57**

**Proposal for a regulation**
**Article 35 – paragraph 2 – point j a (new)**

_Text proposed by the Commission_ _Amendment_

_**(ja) information on any direct public**_
_**financial support received for research**_
_**related to the development of the product;**_

**Amendment 58**

**Proposal for a regulation**
**Article 35 – paragraph 2 – point k**

_Text proposed by the Commission_ _Amendment_

(k) the date and _**a summary of**_ the
examination opinion in respect of each of
the designated Member States;

**Amendment 59**

**Proposal for a regulation**
**Article 35 – paragraph 2 – point n**

(k) the date and the examination opinion
in respect of each of the designated
Member States;

_Text proposed by the Commission_ _Amendment_

(n) where applicable, the filing of an
opposition, and its outcome, including
where applicable a summary of the revised
examination opinion;

**Amendment 60**

**Proposal for a regulation**
**Article 35 – paragraph 2 – point o**

(n) where applicable, the filing of an
opposition, _**its status**_ and its outcome,
including where applicable a summary of
the revised examination opinion;

_Text proposed by the Commission_ _Amendment_

(o) where applicable, the filing of an
appeal, and the outcome of the appeal
proceedings, including where applicable a
summary of the revised examination
opinion;

(o) where applicable, the filing of an
appeal, _**its status**_ and the outcome of the
appeal proceedings, including where
applicable a summary of the revised
examination opinion;

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**Amendment 61**

**Proposal for a regulation**
**Article 35 – paragraph 11 a (new)**

_Text proposed by the Commission_ _Amendment_

_**11a. By way of derogation of Article**_
_**35(9)(b) public authorities shall not use**_
_**the information provided for in the**_
_**register for practices of patent linkage**_
_**and no regulatory or administrative**_
_**decisions related to generics or biosimilar**_
_**shall be based on information provided**_
_**for in the register and be used for refusal,**_
_**suspension, delay, withdrawal or**_
_**revocation of marketing authorisation,**_
_**pricing and reimbursement decisions or**_
_**tender bids.**_

**Amendment 62**

**Proposal for a regulation**
**Article 44 – paragraph 2**

_Text proposed by the Commission_ _Amendment_

_**2.**_ _**Oral proceedings before an**_
_**examination panel or opposition panel**_
_**shall not be public.**_

**Amendment 63**

**Proposal for a regulation**
**Article 44 – paragraph 3**

_**deleted**_

_Text proposed by the Commission_ _Amendment_

3. Oral proceedings before the Boards
of Appeal, including delivery of the
decision and, as the case may be, of a
revised opinion, shall be public, unless the
Boards of Appeal decide otherwise in cases
where admission of the public could have
serious and unjustified disadvantages, in
particular for a party to the proceedings.

3. Oral proceedings before _**an**_
_**examination panel, an opposition panel or**_
the Boards of Appeal, including delivery of
the decision and, as the case may be, of a
revised opinion, shall be public, unless the
_**examination panel, the opposition panel**_
_**or the**_ Boards of Appeal decide otherwise
in cases where admission of the public _**to**_
_**all or a part of the oral proceedings**_ could
have serious and unjustified disadvantages,
in particular for a party to the proceedings.

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**Amendment 64**

**Proposal for a regulation**
**Article 45 – paragraph 3**

_Text proposed by the Commission_ _Amendment_

3. If the Office or the relevant panel
considers it necessary for a party, witness
or expert to give evidence orally, it shall
issue a summons to the person concerned
to appear before it. The period of notice
provided in such summons shall be at least
1 month, unless they agree to a shorter
period.

**Amendment 65**

**Proposal for a regulation**
**Article 57 – paragraph 2**

3. If the Office or the relevant panel
considers it necessary for a party, witness
or expert to give evidence orally, it shall
issue a summons to the person concerned
to appear before it. _**Where an expert is**_
_**summonsed, the Office or the relevant**_
_**panel, as applicable, shall verify that the**_
_**person is free of any conflict of interest.**_
The period of notice provided in such
summons shall be at least 1 month, unless
they agree to a shorter period.

_Text proposed by the Commission_ _Amendment_

2. By [OP, please insert: five years after
the date of application], and every 5 years
thereafter, the Commission shall also carry
out an evaluation of the application of
Chapter III.

2. By … [OJ: please insert: five years
after the date of application], and every 5
years thereafter, the Commission shall also
carry out an evaluation of the application
of Chapter III _**, and present a report on the**_
_**main findings to the European**_
_**Parliament, the Council and the**_
_**European Economic and Social**_
_**Committee**_ . _**The evaluation should assess**_

_**in particular whether the objectives of the**_
_**provisions in that Chapter have been**_
_**achieved.**_

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