Legal provisions of COM(2023)231 - Supplementary protection certificate for medicinal products (recast) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2023)231 - Supplementary protection certificate for medicinal products (recast). |
|---|---|
| document | COM(2023)231 |
| date | April 27, 2023 |
CHAPTER I -
⌦ GENERAL PROVISIONS ⌫
Article 2 1
Scope ⌦ Subject matter ⌫
Any product ⌦ This Regulation lays down rules on the supplementary protection certificate (‘certificate’) for medicinal products ⌫ protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(6) ⇨ , Regulation (EC) No 726/2004 ⇦ or Directive 2001/82 of the European Parliament and of the Council 6 November 2001 on the Community code relating to veterinary medicinal products (7) Regulation (EU) 2019/6 may, under the terms and conditions provided for in this Regulation, be the subject of a certificate.
🡻 469/2009 (adapted)
Article 1 2
Definitions
For the purposes of this Regulation, the following definitions shall apply:
(1) ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;
(2) ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;
(3) ‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;
‘certificate’ means supplementary protection certificate;
(4) ‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and Article 36 of Regulation (EC) No 1901/2006 of 12 December 2006 on medicinal products for paediatric use 37;
🡻 2019/933 Art. 1 pt. 1
(5) ‘maker’ means the person, established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to third countries or for the purpose of storing, is carried out.
⇩ new
(6) ‘national application’ means an application for a certificate made before a competent national authority pursuant to Article 9;
(7) ‘centralised application’ means an application made before the Office pursuant to Article 20 with a view to the grant of certificates, for the product identified in the application, in the designated Member States;
(8) ‘centralised application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 30 of this Regulation and Article 36 of Regulation (EC) No 1901/2006;
(9) ‘designated Member State’ means a Member State for which a certificate is sought under the centralised examination procedure laid down in Chapter III, as identified in a centralised application for a certificate;
(10) ‘European patent’ means a patent granted by the European Patent Office (EPO) under the rules and procedures laid down in the European Patent Convention (‘EPC’)38;
(11) ‘unitary patent’ means a European patent which benefits from unitary effect in those Member States participating in the enhanced cooperation laid down in Regulation (EU) No 1257/2012;
(12) ‘competent national authority’ means the national authority that is competent, in a given Member State, for the grant of certificates and for the rejection of applications for certificates, as referred to in Article 9(1).
Chapter II
National applications for a certificate
🡻 469/2009
⇨ new
Article 3
Conditions for obtaining a certificate
1. A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application ⇨ , all of the following conditions are fulfilled ⇦:
(a) the product is protected by a basic patent in force;
(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 Directive 2001/82/EC Regulation (EU) 2019/6, as appropriate;
(c) the product has not already been the subject of a certificate;
(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product.
⇩ new
2. By way of derogation from paragraph 1, a certificate shall not be granted under this Chapter, in a Member State, on the basis of a national application where the requirements of Article 20(1) are fulfilled for the filing of a centralised application in which that Member State would be designated.
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.
🡻 469/2009 (adapted)
Article 4
⌦ Scope⌫ Subject matter of ⌦ the ⌫ protection
Within the limits of the protection conferred by the basic patent, the protection conferred by a certificate shall extend only to the product covered by the authorisation to place the corresponding medicinal product on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the certificate.
🡻 933/2019 Art. 1 pt. 2 (adapted)
Article 5
Effects of the certificate
1. Subject to the provisions of Article 4, Tthe certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.
2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (‘the certificate holder’), if ⌦ all of ⌫ the following conditions are met:
(a) the acts comprise ⌦ any of the following ⌫:
(i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or
(ii) any related act that is strictly necessary for the making, in the Union, referred to in point (i), or for the actual export; or
(iii) the making, no earlier than ⌦ 6 ⌫ six 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; or
(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 ⌫ six months before the expiry of the certificate.
(b) the maker, through appropriate and documented means, notifies the authority referred to in Article 9(1) in the Member State in which that making is to take place, and informs the certificate holder, of the information ⌦ referred to ⌫ listed in paragraph 5 of this Article no later than ⌦ 3 ⌫ three months before the start date of the making in that Member State, or no later than ⌦ 3 ⌫ three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a certificate, whichever is the earlier;
(c) if the information ⌦ referred to ⌫ listed in paragraph 5 of this Article changes, the maker notifies the authority referred to in Article 9(1) and informs the certificate holder, before those changes take effect;
(d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex -Ia II, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;
(e) the maker complies with paragraph 9 of this Article and, if applicable, with Article 12(2).
3. The exception laid down referred to in pParagraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing.
4. The information provided to the certificate holder for the purposes of paragraph 2, points (b) and (c), of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.
5. The information to be provided by the maker fFor the purposes of paragraph 2, point (b), of paragraph 2 ⌦ the maker shall provide all of the following information ⌫ shall be as follows:
(a) the name and address of the maker;
(b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;
(c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;
(d) the number of the certificate granted in the Member State of making, and the number of the certificate granted in the Member State of the first related act, if any, prior to that making; and
(e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.
6. For the purposes of notification to the authority under paragraph 2, points (b) and (c), of paragraph 2, the maker shall use the standard form for notification contained ⌦ set out ⌫ in Annex -Ia III.
7. Failure to comply with the requirements of ⌦ provide the information referred to in ⌫ paragraph 5, point (e), of paragraph 5 with regard to a third country shall only affect exports to that ⌦ third ⌫ country, and those exports shall, therefore, not benefit from the exception ⌦ laid down in paragraph 2 ⌫.
8. The maker shall ensure that medicinal products made pursuant to paragraph 2, point (a) (i), of paragraph 2 do not bear an active unique identifier within the meaning of Commission Delegated Regulation (EU) 2016/16139.
9. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who ⌦that⌫ performs acts falling under paragraph 2, point (a), of paragraph 2 is fully informed and aware of ⌦ all of ⌫ the following:
(a) that those acts are subject to paragraph 2;
(b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in paragraph 2, point (a)(i), of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in paragraph 2, point (a)(iii), of paragraph 2 could infringe the certificate referred to in ⌦ that ⌫ paragraph 2 where, and for as long as, that certificate applies.
10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.
Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.
Paragraph 2 shall not apply to certificates that have taken effect before 1 July 2019.
🡻 469/2009 (adapted)
⇨ new
Article 6
Entitlement to the certificate
1. The certificate shall be granted to the holder of the basic patent or his ⌦ to the ⌫ successor in title ⌦ of that holder ⌫.
⇩ new
2. Notwithstanding paragraph 1, where a basic patent has been granted in respect of a product that is the subject of an authorisation held by a third party, a certificate for that product shall not be granted to the holder of the basic patent without the consent of that third party.
🡻 469/2009 (adapted)
⇨ new
Article 7
Application for a certificate
1. The application for a certificate shall be lodged within ⌦ 6 ⌫ six months of the date on which the authorisation referred to in Article 3(1), point (b), to place the product on the market as a medicinal product was granted.
2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a certificate shall be lodged within ⌦ 6 ⌫ six months of the date on which the patent is granted.
3. The application for an extension of the duration may be made ⌦ lodged at the same time ⌫when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements of Article 8(1), point (d), or Article 8(2), respectively, are fulfilled.
4. The application for an extension of the duration of a certificate already granted shall be lodged not later than ⌦ 2 ⌫ two years before the expiry of the certificate.
Notwithstanding paragraph 4, for five years following the entry into force of Regulation (EC) No 1901/2006, the application for an extension of the duration of a certificate already granted shall be lodged not later than six months before the expiry of the certificate.
Article 8
Content of the application for a certificate
1. The application for a certificate shall contain ⌦ the following ⌫:
(a) a request for the grant of a certificate, stating in particular:
(i) the name and address of the applicant;
(ii) if ⌦ the applicant ⌫ he has appointed a representative, the name and address of ⌦ that ⌫ the representative;
(iii) the number of the basic patent and the title of the invention;
(iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3⌦ (1), point ⌫(b), and, if this authorisation is not the first authorisation for placing the product on the market in the ⌦ Union ⌫ Community, the number and date of that authorisation;
(b) a copy of the authorisation to place the product on the market, as referred to in Article 3(1), point (b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC or Article 35 14 of Directive 2001/82/EC Regulation (EU) 2019/6;
(c) ⌦ where ⌫ if the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the ⌦ Union ⌫ Community, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication ⇨ or, in the absence of such a notice, any other document proving that the authorisation has been issued, the date on which it was issued and the identity of the product authorised ⇦;
(d) where the application for a certificate for a medicinal product includes a request for an extension of the duration:
(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;
(ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006.
2. Where an application for a certificate is pending, an application for an extension of the duration in accordance with Article 7(3) shall include the particulars referred to in paragraph 1, point (d), of this Article and a reference to the application for a certificate already filed.
3. The application for an extension of the duration of a certificate already granted shall contain the particulars referred to in paragraph 1, point (d), and a copy of the certificate already granted.
4. Member States may provide that a fee is to be payable upon application for a certificate and upon application for the extension of the duration of a certificate.
Article 9
Lodging of an application for a certificate
1. The application for a certificate shall be lodged with the competent industrial property office of the Member State which granted the basic patent or on whose behalf it was granted and in which the authorisation referred to in Article 3(1), point (b), to place the product on the market was obtained, unless the Member State designates another authority for ⌦that ⌫the purpose.
The application for an extension of the duration of a certificate shall be lodged with the competent authority of the Member State concerned.
2. Notification of the application for a certificate shall be published by the authority referred to in paragraph 1. The notification shall contain at least ⇨ all of ⇦ the following information:
(a) the name and address of the applicant;
(b) the number of the basic patent;
(c) the title of the invention;
(d) the number and date of the authorisation to place the product on the market, referred to in Article 3(1), point (b), and the product identified in that authorisation;
(e) where relevant, the number and date of the first authorisation to place the product on the market in the ⌦ Union ⌫ Community;
(f) where applicable, an indication that the application includes an application for an extension of the duration.
3. Paragraph 2 shall apply to the notification of the application for an extension of the duration of a certificate already granted or where an application for a certificate is pending. The notification shall additionally contain an indication of the application for an extended duration of the certificate.
Article 10
Grant of the certificate or rejection of the application for a certificate
1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this ChapterRegulation, the authority referred to in Article 9(1) shall grant the certificate.
2. The authority referred to in Article 9(1) shall, subject to paragraph 3 ⌦ of this Article ⌫, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this ChapterRegulation.
3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time.
4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the authority shall reject the application.
5. Member States may provide that the authority referred to in Article 9(1) is to grant certificates without verifying that the conditions laid down in Article 3(1), points (c) and (d), are met.
6. Paragraphs 1 to 4 shall apply mutatis mutandis to the application for an extension of the duration.
Article 11
Publication
1. ⌦ The authority referred to in Article 9(1) shall publish, as soon as possible, ⌫ nNotification of the fact that a certificate has been granted shall be published by the authority referred to in Article 9(1). The notification shall contain at least ⇨ all of ⇦ the following information:
(a) the name and address of the holder of the certificate;
(b) the number of the basic patent;
(c) the title of the invention;
(d) the number and date of the authorisation to place the product on the market referred to in Article 3 (1), point (b), and the product identified in that authorisation;
(e) where relevant, the number and date of the first authorisation to place the product on the market in the ⌦ Union ⌫ Community;
(f) the duration of the certificate.
2. ⌦ The authority referred to in Article 9(1) shall publish, as soon as possible, ⌫ nNotification of the fact that the application for a certificate has been rejected shall be published by the authority referred to in Article 9(1). The notification shall contain at least the information listed in Article 9(2).
3. Paragraphs 1 and 2 shall apply to the notification of the fact that an extension of the duration of a certificate has been granted or of the fact that the application for an extension has been rejected.
🡻 2019/933 Art. 1 pt. 3
4. The authority referred to in Article 9(1) shall publish, as soon as possible, the information listed in Article 5(5), together with the date of notification of that information. It shall also publish, as soon as possible, any changes to the information notified in accordance with Article 5(2), point (c) of Article 5(2).
🡻 933/2019 Art. 1 pt. 4 (adapted)
Article 12
Fees
1. Member States may require that the certificate be subject to the payment of annual fees.
2. Member States may require that the notifications to in Article 5(2), points (b) and (c), of Article 5(2) be subject to the payment of a fee.
🡻 469/2009 (adapted)
⇨ new
Article 13
Duration of the certificate
1. The certificate shall take effect at the end of the lawful term of the basic patent for a period equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorisation to place the product on the market in the ⌦ Union ⌫ Community, reduced by a period of ⌦ 5 ⌫ five years.
2. Notwithstanding paragraph 1, the duration of the certificate may not exceed ⌦ 5 ⌫ five years from the date on which it takes effect.
3. The periods laid down in paragraphs 1 and 2 ⌦ of this Article ⌫ shall be extended by ⌦ 6 ⌫ six months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of ⌦ that ⌫ this Article may be extended only once.
Where a certificate is granted for a product protected by a patent which, before 2 January 1993, had its term extended or for which such extension was applied for, under national law, the term of protection to be afforded under this certificate shall be reduced by the number of years by which the term of the patent exceeds 20 years.
Article 14
Expiry of the certificate
The certificate shall lapse ⌦ in any of the following events ⌫:
(a) at the end of the period provided for in Article 13;
(b) if the certificate holder surrenders it;
(c) if the annual fee laid down in accordance with Article 12 is not paid in time;
(d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation or authorisations to place on the market in accordance with Directive 2001/83/EC or Directive 2001/82/EC Regulation (EU) 2019/6.
⇨ For the purposes of point (d), ⇦ Tthe authority referred to in Article 9(1) of this Regulation may decide on the lapse of the certificate either of its own motion or at the request of a third party.
Article 15
Invalidity of the certificate
1. The certificate shall be invalid ⌦ in any of the following events ⌫ if:
(a) ⌦ the certificate ⌫ it was granted contrary to the provisions of Article 3;
(b) the basic patent has lapsed before its lawful term expires;
(c) the basic patent is revoked or limited to the extent that the product for which the certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.
2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent ⇨ , or before a competent court of a Member State ⇦.
Article 16
Revocation of an extension of the duration of a certificate for a medicinal product
1. The extension of the duration may be revoked if it was granted contrary to the provisions of Article 36 of Regulation (EC) No 1901/2006.
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.
Article 17
Notification of lapse or invalidity
1. If the certificate lapses in accordance with point (b), (c) or (d) of Article 14, points (b), (c) or (d), or is invalid in accordance with Article 15, ⌦ the authority referred to in Article 9(1) shall publish ⌫ notification thereof shall be published by the authority referred to in Article 9(1).
2. If the extension of the duration is revoked in accordance with Article 16, ⌦ the authority referred to in Article 9(1) shall publish ⌫ notification thereof shall be published by the authority referred to in Article 9(1).
Article 18
Appeals
1. The decisions of the authority referred to in Article 9(1) or of the bodies referred to in Article 15(2) and Article 16(2) taken under this Regulation Chapter shall be open to the same appeals as those provided for in national law against similar decisions taken in respect of national patents.
⇩ new
2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate where the date of the first authorisation to place the product on the market in the Union, contained in the application for a certificate as provided for in Article 8, is incorrect.
🡻 469/2009 (adapted)
Article 19
Procedure
1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable under national law to the corresponding basic patent shall apply to the certificate, unless the national law lays down special procedural provisions for certificates.
2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded.
⇩ new
Chapter III
Centralised procedure for certificates
Article 20
Scope of the centralised application
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.
2. When the conditions under paragraph 1 are met, the filing of national applications shall be prohibited, in respect of the same product, in those Member States in which that basic patent is in force.
3. A centralised application shall be lodged with the European Union Intellectual Property Office established by Article 2 of Regulation (EU) 2017/1001 (‘the Office’).
4. Articles 1 to 7 and 13 to 18 shall apply to centralised applications.
5. The centralised application shall be lodged by using a specific application form.
The Commission is empowered to adopt implementing acts laying down rules on the application form to be used to lodge a centralised application. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.
Article 21
Content of the centralised application
The centralised application shall contain the following:
(a) designation of the Member States in which certificates are sought under the centralised procedure;
(b) the information referred to in Article 8(1).
Article 22
Examination of the admissibility of a centralised application
1. The Office shall examine the following:
(a) whether the centralised application complies with Article 21;
(b) whether the centralised application complies with Article 7;
(c) whether the application fee referred to in Article 34(1) has been paid within the prescribed period.
2. Where the centralised application does not satisfy the requirements referred to in paragraph 1, the Office shall request the applicant to take the measures necessary to satisfy those requirements, and shall set a deadline for such compliance.
3. Where the fee referred to in paragraph 1, point (c), has not been paid or has not been paid in full, the Office shall inform the applicant accordingly.
4. If the applicant does not satisfy the requirements referred to in paragraph 1 within the deadline referred to in paragraph 2, the Office shall reject the application.
Article 23
Publication of the centralised application
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.
Article 24
Examination of the centralised application
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.
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.
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.
4. The Office shall translate the examination opinion in the official languages of all designated Member States. The Office may use verified machine translation to that effect.
5. The Commission is empowered to adopt implementing acts laying down rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine centralised applications and prepare examination opinions, as well as the issuance of examination opinions by the Office. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.
Article 25
Observations by third parties
1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates in one or more of the Member States designated therein.
2. A natural or legal person that has submitted the written observations in accordance with paragraph 1 shall not be a party to the proceedings.
3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register.
4. Any observations by a third party shall be submitted in writing in one of the official languages of the Union and state the grounds on which they are based.
5. Any observations by a third party shall be notified to the applicant. The applicant may comment on the observations within a time limit set by the Office.
Article 26
Opposition
1. Within a period of 2 months following the publication of the examination opinion in respect of a centralised application, any person (‘opponent’) may file with the Office a notice of opposition to that opinion.
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.
3. Opposition shall be filed in writing, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the opposition fee has been paid.
4. The notice of opposition shall contain:
(a) the references of the centralised application against which opposition is filed, the name of its holder, and the identification of the product;
(b) the particulars of the opponent and, where applicable, of its representative;
(c) a statement of the extent to which the examination opinion is opposed, and of the grounds on which the opposition is based.
5. The opposition shall be examined by an opposition panel set up by the Office in accordance with the rules applicable to examination panels as referred to in Article 28. However, the opposition panel shall not include any examiner previously involved in the examination panel that examined the centralised application.
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.
7. The decision to reject an opposition as inadmissible shall be communicated to the holder of the centralised application, together with a copy of the notice of opposition.
A notice of opposition shall be inadmissible where a previous appeal relating to the same subject matter and cause of action has been adjudicated on its merits by the Office, and the decision of the Office on that appeal has acquired the authority of a final decision.
8. Where the opposition is not rejected as inadmissible, the Office shall promptly transmit the notice of opposition to the applicant, and shall publish it in the Register. If several notices of opposition have been filed, the Office shall promptly communicate them to the other opponents.
9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period.
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.
11. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall mention this in the Register.
12. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by specifying the details of the procedure for filing and examining an opposition.
Article 27
Role of competent national authorities
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.
2. The Office and the competent national authority shall conclude an administrative agreement before that competent national authority is appointed as participating office as referred to in paragraph 1.
The agreement shall specify the rights and obligations of the parties, in particular the formal undertaking by the competent national authority concerned to comply with this Regulation as regards the centralised examination procedure.
3. The Office may appoint a competent national authority as a participating office as referred to in paragraph 1 for 5 years. That appointment may be extended for further periods of 5 years.
4. The Office shall, before appointing a competent national authority, or extending its appointment, or before any such appointment expires, hear the competent national authority concerned.
5. Each competent national authority appointed under this Article shall provide the Office with a list identifying the individual examiners who are available for participation in examination and opposition proceedings. Each such competent national authority shall update that list in the event of a change.
Article 28
Examination panels
1. The assessments under Articles 24, 26 and 33 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 27(1) from two different participating competent national authorities.
2. Examiners shall be impartial in the exercise of their duties and shall declare to the Office any real or perceived conflict of interest upon their designation.
3. When setting up an examination panel, the Office shall ensure the following:
(a) geographical balance amongst the participating offices;
(b) the respective workload of the examiners is taken into account;
(c) no more than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).
4. The Office shall publish a yearly overview of the number of procedures, including those for examination, opposition and appeal, each competent national authority participated in.
5. The Commission is empowered to adopt implementing acts to determine the criteria in the ways the panels are to be set up, and the criteria for the selection of examiners. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.
Article 29
Appeals
1. Any party to proceedings under this Chapter, adversely affected by a decision of the Office, including the adoption of an examination opinion, may appeal the decision to the Boards of Appeal.
2. The filing of the appeal shall have suspensive effect. A decision of the Office that has not been contested shall take effect on the day following the date of expiry of the appeal period referred to in paragraph 3.
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.
4. Following an examination of admissibility of the appeal, the Boards of Appeal shall decide on the merits of the appeal.
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.
6. An action may be brought before the General Court of the European Union against a decision of the Boards of Appeal in relation to appeals, within 2 months of the date of notification of that decision, on grounds of infringement of an essential procedural requirement, infringement of the Treaty on the Functioning of the European Union, infringement of this Regulation or of any rule of law relating to their application or misuse of power. The action shall be open to any party to proceedings before the Board of Appeal adversely affected by its decision. The General Court shall have jurisdiction to annul or to alter the contested decision.
7. The decisions of the Boards of Appeal shall take effect on the day following the date of expiry of the period referred to in paragraph 6 or, if an action has been brought before the General Court within that period, as from the date following the day of dismissal of such action or of dismissal of any appeal filed with the Court of Justice of the European Union against the decision of the General Court. The Office shall take the necessary measures to comply with the judgement of the General Court or, in the event of an appeal against that judgement, the Court of Justice.
8. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by specifying the content and form of the notice of appeal referred to in paragraph 3, the procedure for the filing and examination of an appeal and the content and the form of the Boards of Appeal’s decision referred to in paragraph 4.
Article 30
Boards of Appeal
1. In addition to the powers conferred upon it by Article 165 of Regulation (EU) 2017/1001, the Boards of Appeal instituted by that Regulation shall be responsible for deciding on appeals against decisions of the Office taken on the basis of Article 29(1).
2. A Board of Appeal in matters regarding centralised applications for certificates shall consist of three members, at least two of whom are legally qualified. Where the Board of Appeal considers that the nature of the appeal so requires, it may call up to two further members for that case.
3. There shall be no Grand Board as referenced in Article 165 (2), (3) and 4, as well as Article 167 (2) of Regulation (EU) 2017/1001 in matters regarding centralised applications for certificates. Decisions taken by a single member as under Article 165 (2) of Regulation (EU) 2017/1001 shall not be possible.
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.
Article 31
Delegation of power regarding the Boards of Appeal
The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to certificates under this Regulation.
Article 32
National implementation of a centralised examination opinion
1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall transmit the examination opinion and its translations to the competent national authority of each designated Member State.
2. In respect of a centralised application, where a positive examination opinion has been issued for one or more designated Member State, the competent national authority of each of those Member States shall grant a certificate in accordance with applicable national rules and procedures.
3. By way of derogation from paragraph 2, a Member State may decide not to grant a certificate, where material circumstances, in that Member State, have changed since the filing of the centralised application in respect of one or more of the conditions laid down in Article 15(1), points (b) or (c), or Article 14, first paragraph, point (d). In such a case that Member State shall reject the application insofar as that Member State is concerned.
4. A certificate granted by a competent national authority under this Article shall be subject to Articles 4, 5, 11 and 12 to 19, and to the applicable national legislation.
5. Where a negative examination opinion has been issued for one or more designated Member State, the competent national authority of each of those Member States shall issue a rejection decision according to its applicable national rules and procedures.
Article 33
Centralised application for an extension of the duration of certificates
1. Where certificates for a given medicinal product have been granted through the centralised procedure, their holder may request an extension of the duration of those certificates by filing a centralised application for an extension of the duration of those certificates with the Office. That centralised application shall specify the designation of the Member States for which the extension is requested.
2. The centralised application for an extension of the duration of certificates shall be filed in accordance with Article 7(3) and (4), Article 8(1), point (d), Article 8(2), (3) and (4).
3. Articles 10, 11 and 17 shall apply, whereby references to ‘the authority referred to in Article 9(1)’ shall be understood as references to the Office.
4. Third parties may also submit observations in respect of a centralised application for an extension of the duration of certificates.
Article 34
Fees
1. The Office shall charge a fee for a centralised application for certificates, and for a centralised application for the extension of the duration of a certificate.
2. The Office shall charge a fee for an appeal, and for an opposition.
3. The Commission is empowered to adopt implementing acts to determine the amounts of the fees charged by the Office, the time limits within which they have to be paid, and the ways in which those fees are to be paid. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.
4. Article 12 shall apply to certificates granted under this Chapter.
Article 35
Register
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.
2. The Register shall include, for each centralised application or certificate, all of the following information:
(a) the name and address of the applicant or certificate holder;
(b) the name and business address of the representative, other than a representative as referred to in Article 37(3);
(c) the application as well as its date of lodging and date of publication;
(d) whether the application relates to a medicinal product or to a plant protection product;
(e) where applicable, an indication that the application includes an application for an extension of the duration;
(f) the designated Member States;
(g) the number of the basic patent;
(h) an identification of the product for which certificates are requested;
(i) the number and date of the authorisation to place the product on the market referred to in Article 3(1), point (b), and an identification of the product identified therein;
(j) the number and date of the first authorisation to place the product on the market in the Union;
(k) the date and a summary of the examination opinion in respect of each of the designated Member States;
(l) where applicable, the duration of the certificates to be granted;
(m) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a certificate;
(n) where applicable, the filing of an opposition, and its outcome, including where applicable a summary of the revised examination opinion;
(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;
(p) where applicable and available, the particulars of the certificates granted in each of the designated Member States;
(q) where applicable, a mention that the centralised application was rejected in one or more of the designated Member States;
(r) where applicable, a mention that a certificate has lapsed or was declared invalid;
(s) information on the payment of annual fees, as provided by the relevant competent national authorities.
3. The Register shall contain changes to the information in paragraph 2, including transfers, each accompanied by the date of recording of such entry.
4. The Register and information referred to in paragraphs 2 and 3 shall be available in all official languages of the Union. The Office may use verified machine translation for the information to be published in the Register.
5. Competent national authorities shall promptly share with the Office information relating to the grant, lapse, invalidity or transfers of certificates and to the rejection of applications under Chapters II and III, and to the payment of related annual fees.
6. The Executive Director of the Office may determine that information other than those referred to in paragraphs 2 and 3 shall be entered in the Register.
7. The Office shall collect, organise, make public and store the information referred to in paragraphs 2 and 3, including any personal data, for the purposes laid down in paragraph 10. The Office shall keep the Register easily accessible for public inspection.
8. The Office shall provide certified or uncertified extracts from the Register on request and on payment of a fee.
9. The processing of the data concerning the entries set out in paragraphs 2 and 3, including any personal data, shall take place for the purposes of the following:
(a) administering the applications in accordance with this Chapter and the acts adopted pursuant to it;
(b) maintaining the Register and making it available for inspection by public authorities and economic operators;
(c) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system.
10. All the data, including personal data, concerning the entries in paragraphs 2 and 3 shall be considered to be of public interest and may be accessed by any third party free of charge. For reasons of legal certainty, the entries in the Register shall be kept for an indefinite period of time.
11. The Register set up under this Article shall also be used to publish information relating to certificates for plant protection products under Regulation [COM(2023) 223], and relating to unitary certificates under Regulation [COM(2023) 222] and Regulation [COM(2023) 221].
Article 36
Database
1. In addition to the obligation to keep a Register, the Office shall collect and store in an electronic database all the particulars provided by applicants or any other third party observations pursuant to this Regulation or acts adopted pursuant to it.
2. The electronic database may include personal data, beyond those included in the Register, to the extent that such particulars are required by this Regulation or by acts adopted pursuant to it. The collection, storage and processing of such data shall serve the purposes of:
(a) administering the applications and/or certificate registrations as described in this Regulation and in acts adopted pursuant to it;
(b) accessing the information necessary for conducting the relevant proceedings more easily and efficiently;
(c) communicating with the applicants and other third parties;
(d) producing reports and statistics enabling the Office to optimise its operations and improve the functioning of the system.
3. The Executive Director shall determine the conditions of access to the electronic database and the manner in which its contents, other than the personal data referred to in paragraph 2 of this Article but including those listed in Article 35(3), may be made available in machine-readable form, including the charge for such access.
4. Access to the personal data referred to in paragraph 2 shall be restricted and such data shall not be made publicly available unless the party concerned has given his express consent.
5. All data shall be kept indefinitely. However, the party concerned may request the removal of any personal data from the database after 18 months from the expiry of the certificate or, the case being, the closure of the relevant inter partes procedure. The party concerned shall have the right to obtain the correction of inaccurate or erroneous data at any time.
Article 37
Transparency
1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council40 shall apply to documents held by the Office.
2. The Management Board of the Office shall adopt detailed rules for applying Regulation (EC) No 1049/2001 in the context of this Regulation.
3. Decisions taken by the Office under Article 8 of Regulation (EC) No 1049/2001 may be challenged through the European Ombudsman or form the subject of an action before the Court of Justice of the European Union, under the conditions laid down in Articles 228 and 263 TFEU respectively.
4. The processing of personal data by the Office shall be subject to Regulation (EC) No 45/2001 of the European Parliament and of the Council41.
Article 38
Representation
1. Natural or legal persons having neither their domicile nor their principal place of business or a real and effective industrial or commercial establishment in the European Economic Area shall be represented before the Office in accordance with this Article in all proceedings provided for by Chapter III of this Regulation, other than the filing of a centralised application.
2. Natural or legal persons having their domicile or principal place of business or a real and effective industrial or commercial establishment in the European Economic Area may be represented before the Office by an employee.
An employee of a legal person may also represent other legal persons which are economically linked with the legal person being represented by that employee.
The second subparagraph also applies where those other legal persons have neither their domicile nor their principal place of business nor a real and effective industrial or commercial establishment within the Union.
Employees who represent natural or legal persons shall, at the request of the Office or, where appropriate, of the party to the proceedings, file with the Office a signed authorisation for insertion in the files.
3. A common representative shall be appointed where there is more than one applicant or more than one third party acting jointly.
4. Only a practitioner established in the Union, entitled to act as a professional representative in patent matters before a national patent office or the European Patent Office, or a lawyer authorised to practise before the courts or tribunals of a Member State, may represent natural or legal persons before the Office.
Article 39
Combined applications
1. A centralised application may also include a request for the grant of a unitary certificate, as defined in Regulation [COM(2023) 222]42 (‘combined application’).
2. The combined application shall undergo a single centralised examination procedure, as well as a single opposition or appeal procedure, where it has been filed against an opinion or decision in respect of both the centralised application and the unitary certificate application.
3. The Member States for which the basic patent has unitary effect shall not be designated in the combined application for the parallel grant of national certificates. Any designation, in the combined application, of a Member State for which the basic patent has unitary effect shall be disregarded for the purpose of the examination of the combined application.
Article 40
Supplementary Protection Certificates Division
A Supplementary Protection Certificate Division (‘SPC Division’) shall be set up within the Office and shall be responsible for implementing the tasks set out in Chapter III of this Regulation and in Chapter III of Regulation [COM(2023) 223], as well as in Regulations [COM(2023) 222] and [COM(2023) 221], including in particular:
(a) receiving and supervising the examination of centralised applications for certificates, centralised applications for an extension of the duration of certificates, appeals and observations by third parties;
(b) adopting examination opinions on behalf of the Office in relation to centralised applications for certificates, as well as in relation to centralised applications for an extension of the duration of certificates;
(c) deciding on oppositions against examination opinions;
(d) maintaining the register and the database.
Article 41
Languages
1. All documents and information sent to the Office in respect of the procedures under this Regulation shall be in one of the official languages of the Union.
2. For the tasks conferred on the Office under this Regulation, the languages of the Office shall be all the official languages of the Union in accordance with Council Regulation No 143.
Article 42
Communications to the Office
1. Communications addressed to the Office may be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications may be submitted electronically.
2. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office.
Article 43
Decisions and communications of the Office
1. Decisions of the Office under this Chapter shall include examination opinions and shall state the reasons on which they are based. They shall be based only on reasons or evidence on which the parties concerned have had an opportunity to present their comments. Where oral proceedings are held before the Office, the decision may be given orally. Subsequently, the decision or opinion shall be notified in writing to the parties.
2. Any decision, opinion, communication or notice from the Office under this Chapter shall indicate the SPC Division and the relevant panel as well as the name or the names of the examiners responsible. It shall be signed by these examiners, or, instead of a signature, carry a printed or stamped seal of the Office. The Executive Director may determine that other means of identifying the SPC Division and the name of the examiners responsible, or an identification other than a seal, may be used where decisions or other communications are transmitted by any technical means of communication.
3. Decisions of the Office under this Chapter which are open to appeal shall be accompanied by a written communication indicating that any notice of appeal is to be filed in writing at the Office within 2 months of the date of notification of the decision in question. That communication shall also draw the attention of the parties to the provisions laid down in Article 29. The parties may not plead any failure on the part of the Office to communicate the availability of appeal proceedings.
Article 44
Oral proceedings
1. If the Office considers that oral proceedings would be expedient they shall be held either at the instance of the Office or at the request of any party to the proceedings.
2. Oral proceedings before an examination panel or opposition panel shall not be public.
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.
4. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for oral proceedings.
Article 45
Taking of evidence
1. In any proceedings before the Office, the means of giving or obtaining evidence shall include the following:
(a) hearing the parties;
(b) requests for information;
(c) the production of documents and items of evidence;
(d) hearing witnesses;
(e) opinions by experts;
(f) statements in writing sworn or affirmed or having a similar effect under the law of the State in which the statement is drawn up.
2. The relevant panel may commission one of its members to examine the evidence adduced.
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.
4. The parties shall be informed of the hearing of a witness or expert before the Office. They shall have the right to be present and to put questions to the witness or expert.
5. The Executive Director shall determine the amounts of expenses to be paid, including advances, as regards the costs of taking of evidence as referred to in this Article.
6. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for the taking of evidence.
Article 46
Notification
1. The Office shall, as a matter of course, notify those concerned of decisions, including opinions, summonses and of any notice or other communication from which a time limit is reckoned, or of which those concerned are to be notified under other provisions of this Chapter or of acts adopted pursuant to this Chapter, or of which notification has been ordered by the Executive Director.
2. Notification may be effected by different means, including electronic means. The details regarding electronic means shall be determined by the Executive Director.
3. Where notification is to be effected by public notice, the Executive Director shall determine how the public notice is to be given and shall fix the beginning of the 1-month period on the expiry of which the document shall be deemed to have been notified.
4. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for notification.
Article 47
Time limits
1. Time limits shall be laid down in terms of full years, months, weeks or days. Calculation shall start on the day following the day on which the relevant event occurred. The duration of time limits shall be no less than 1 month and no more than 6 months.
2. The Executive Director shall determine, before the commencement of each calendar year, the days on which the Office is not open for receipt of documents or on which ordinary post is not delivered in the locality in which the Office is located.
3. The Executive Director shall determine the duration of the period of interruption in the case of a general interruption in the delivery of post in the Member State where the Office is located or, in the case of an actual interruption of the Office's connection to admitted electronic means of communication.
4. If an exceptional occurrence, such as a natural disaster or strike, interrupts or interferes with proper communication from the parties to the proceedings to the Office or vice-versa, the Executive Director may determine that for parties to the proceedings having their residence or registered office in the Member State concerned or who have appointed a representative with a place of business in the Member State concerned all time limits that otherwise would expire on or after the date of commencement of such occurrence, as determined by the Executive Director, shall extend until a date to be determined by the Executive Director. When determining that date, the Executive Director shall assess when the exceptional occurrence comes to an end. If the occurrence affects the seat of the Office, such determination of the Executive Director shall specify that it applies in respect of all parties to the proceedings.
5. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by specifying the details regarding the calculation and duration of time limits.
Article 48
Correction of errors and manifest oversights
1. The Office shall correct any linguistic errors or errors of transcription and manifest oversights in its decisions, including opinions, or technical errors in publishing information in the Register, of its own motion or at the request of a party.
2. Where the Office has made an entry in the Register or taken a decision which contains an obvious error attributable to the Office, it shall ensure that the entry is cancelled or the decision is revoked. The cancellation of the entry in the Register or the revocation of the decision shall be effected within 1 year of the date on which the entry was made in the Register or that decision was taken, after consultation with the parties to the proceedings.
3. The Office shall keep records of any such corrections or cancellations.
4. Corrections and cancellations shall be published by the Office.
Article 49
Restitutio in integrum
1. The applicant or any other party to proceedings before the Office under this Chapter, who, in spite of all due care required by the circumstances having been taken, was unable to comply with a time limit vis-à-vis the Office shall, upon application, have his rights re-established if the obstacle to compliance has the direct consequence, by virtue of the provisions of this Chapter, of causing the loss of any right or means of redress.
2. The application for re-establishment shall be filed in writing within 2 months of the removal of the obstacle to compliance with the time limit. The omitted act shall be completed within this period. The application shall only be admissible within the year immediately following the expiry of the unobserved time limit.
3. The application for re-establishment shall state the grounds on which it is based and shall set out the facts on which it relies. It shall not be deemed to be filed until the fee for re-establishment of rights has been paid.
4. The SPC Division, or where applicable the Boards of Appeal, shall decide upon the application.
5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article, or in Article 26(1) and (3).
Article 50
Interruption of proceedings
1. Proceedings before the Office under this Chapter shall be interrupted:
(a) in the event of the death or legal incapacity of the applicant or of the person authorised by national law to act on behalf of the applicant. To the extent that that death or incapacity does not affect the authorisation of a representative appointed under Article 38, proceedings shall be interrupted only on application by such representative;
(b) in the event of the applicant being prevented, for legal reasons resulting from action taken against his property, from continuing the proceedings before the Office;
(c) in the event of the death or legal incapacity of the representative of the applicant, or of that representative being prevented, for legal reasons resulting from action taken against his property, from continuing the proceedings before the Office.
2. Proceedings before the Office shall be resumed as soon as the identity of the person authorised to continue them has been established.
3. The Commission is empowered to adopt delegated acts in accordance with Article 55 to supplement this Regulation by setting out the detailed arrangements for the resumption of proceedings before the Office.
Article 51
Costs
1. The losing party in opposition proceedings, including in related appeal proceedings, shall bear the fees paid by the other party. The losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative, within the maximum rates set for each category of costs in the implementing act to be adopted in accordance with paragraph 7. The fees to be borne by the losing party shall be limited to the fees paid by the other party in those proceedings.
2. Where each party succeeds on some and fails on other heads, or if reasons of equity so dictate, the SPC Division or Board of Appeal shall decide a different apportionment of costs.
3. Where proceedings are terminated the costs shall be at the discretion of the SPC Division or Board of Appeal.
4. Where the parties conclude before the SPC Division or Board of Appeal a settlement of costs differing from that provided for in paragraphs 1 to 3, the body concerned shall take note of that agreement.
5. The SPC Division or Board of Appeal shall fix the amount of the costs to be paid pursuant to paragraphs 1 to 3 of this Article when the costs to be paid are limited to the fees paid to the Office and the representation costs. In all other cases, the registry of the Board of Appeal or SPC Division shall fix, on request, the amount of the costs to be reimbursed. The request shall be admissible only for the period of 2 months following the date on which the decision for which an application was made for the costs to be fixed becomes final and shall be accompanied by a bill and supporting evidence. For the costs of representation an assurance by the representative that the costs that have been incurred shall be sufficient. For other costs, it shall be sufficient if their plausibility is established. Where the amount of the costs is fixed pursuant to the first sentence of this paragraph, representation costs shall be awarded at the level laid down in the implementing act adopted pursuant to paragraph 7 of this Article and irrespective of whether they have been actually incurred.
6. Decisions on the fixing of costs adopted in accordance with paragraph 5 shall state the reasons on which they are based, and may be reviewed by a decision of the SPC Division or Board of Appeal on a request filed within 1 month of the date of notification of the awarding of costs. It shall not be deemed to be filed until the fee for reviewing the amount of the costs has been paid. The SPC Division or the Board of Appeal, as the case may be, shall take a decision on the request for a review of the decision on the fixing of costs without oral proceedings.
7. The Commission shall adopt implementing acts specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.
8. When specifying the maximum rates with respect to travel and subsistence costs, the Commission shall take into account the distance between the place of residence or business of the party, representative or witness or expert and the place where the oral proceedings are held, the procedural stage at which the costs have been incurred, and, as far as costs of representation are concerned, the need to ensure that the obligation to bear the costs may not be misused for tactical reasons by the other party. In addition, subsistence expenses shall be calculated in accordance with the Staff Regulations of Officials of the Union and the Conditions of Employment of Other Servants of the Union, laid down in Council Regulation (EEC, Euratom, ECSC) No 259/6844. The losing party shall bear the costs for one party in the proceedings only and, where applicable, one representative only.
Article 52
Enforcement of decisions fixing the amount of costs
1. Any final decision of the Office fixing the amount of costs shall be enforceable.
2. Enforcement shall be governed by the rules of civil procedure in force in the Member State in the territory of which it is carried out. Each Member State shall designate a single authority responsible for verifying the authenticity of the decision referred to in paragraph 1 and shall communicate its contact details to the Office, the Court of Justice and the Commission. The order for enforcement shall be appended to the decision by that authority, with the verification of the authenticity of the decision as the sole formality
3. When these formalities have been completed on application by the party concerned, the latter may proceed to enforcement in accordance with the national law, by bringing the matter directly before the competent authority.
4. Enforcement may be suspended only by a decision of the Court of Justice. However, the courts of the Member State concerned shall have jurisdiction over complaints that enforcement is being carried out in an irregular manner.
Article 53
Financial provisions
1. The expenses incurred by the Office in carrying out the additional tasks given to it in accordance with this Regulation shall be covered by the procedural fees to be paid to the Office by applicants and, if needed, by a fraction of the annual fees paid to competent national authorities by the holders of certificates granted under Chapter III. That fraction shall initially be set at a certain value but shall be reviewed every 5 years, with the objective of achieving financial sustainability for the activities carried out by the Office under this Regulation as well as Regulations [COM(2023) 223], [COM(2023) 222] and [COM(2023) 221], insofar as expenses incurred by the Office are not covered by fees under these Regulations.
2. For the purposes of paragraph 1, each competent national authority shall keep an account of the annual fees paid to it by holders of certificates granted under this Chapter.
3. The expenses incurred by a competent national authority participating in proceedings under this Chapter shall be covered by the Office and shall be paid annually, on the basis of the number of proceedings in which that competent national authority was involved during the preceding year.
4. The Commission is empowered to adopt implementing acts laying down rules on the financial transfers between the Office and Member States, the amounts of these transfers, and the remuneration to be paid by the Office regarding the participation of competent national authorities referred to in paragraph 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 56.
🡻 469/2009 (adapted)
Article 20
Additional provisions relating to the enlargement of the Community
Without prejudice to the other provisions of this Regulation, the following provisions shall apply:
(a) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate was lodged within six months from 1 January 2007;
(b) any medicinal product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a medicinal product was obtained:
(i) in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;
(ii) in the Community not earlier than six months prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;
(c) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Estonia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to 1 January 2000, within the six months provided for in the Patents Act of October 1999;
(d) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Cyprus prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted;
(e) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Latvia prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004;
(f) any medicinal product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a medicinal product was obtained in Lithuania prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004;
(g) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate was lodged within six months from 1 May 2004;
(h) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Malta prior to 1 May 2004 may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 May 2004;
(i) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate was lodged within six months starting no later than 1 May 2004;
(j) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than 1 January 2007;
(k) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovenia prior to 1 May 2004 may be granted a certificate, provided that the application for a certificate was lodged within six months from 1 May 2004, including in cases where the period provided for in Article 7(1) has expired;
(l) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of 1 July 2002 if the market authorisation was obtained before that date.
🡻 2012 Act of Accession (adapted)
(m) any medicinal product protected by a valid basic patent and for which the first authorisation to place it on the market as a medicinal product was obtained after 1 January 2003 may be granted a certificate in Croatia, provided that the application for a certificate is lodged within six months from the date of accession.
🡻 469/2009 (adapted)
Article 5421
Transitional provisions
1. This Regulation shall not apply to certificates granted in accordance with the national legislation of a Member State before 2 January 1993 or to applications for a certificate filed in accordance with that legislation before 2 July 1992.
With regard to Austria, Finland and Sweden, this Regulation shall not apply to certificates granted in accordance with their national legislation before 1 January 1995.
🡻 2012 Act of Accession (adapted)
2. This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of ⌦ Czechia ⌫ the Czech Republic, Estonia, Croatia, Cyprus, Latvia, Lithuania, Malta, Poland, Romania, Slovenia and Slovakia prior to their respective date of accession.
⇩ new
Chapter IV
Final provisions
Article 55
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
3. The delegation of power referred to in Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Article 56
Committee procedure
1. The Commission shall be assisted by a Committee on Supplementary Protection Certificates. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
🡻 2019/933 Art. 1 pt. 5 (adapted)
Article 5721a
Evaluation
1. No later than five years after the date referred to in Article 5(10), and every five ⌦ 5 ⌫ years thereafter, the Commission shall carry out an evaluation of Article 5(2) to (9) and Article 11 in order to assess whether the objectives of those provisions have been achieved, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. In addition to evaluating the impact of the exception of making for the purpose of export, special account shall be taken of the effects of making for the purpose of storing 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 on access to medicines and on public health expenditure, and of whether the waiver and in particular the period provided for in Article 5(2), point (a)(iii), of Article 5(2) is sufficient to achieve the objectives referred to in Article 5, including public health.
⇩ new
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.
Article 58
Transitional provisions for pending applications
Article 20(2) shall not apply to national applications for certificates that are pending before competent national authorities on the xxxxxx [OP – please insert the date of application of this Regulation] and that meet the conditions under Article 20(1).
🡻 469/2009 (adapted)
Article 5922
Repeal
Regulation ⌦ (EC) No 469/2009 ⌫ (EEC) No 1768/92, as amended by the acts listed in Annex I, is repealed.
References to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IVII.
🡻 (adapted)
Article 6023
Entry into force ⌦ and application ⌫
This Regulation shall enter into force on the 20th ⌦ twentieth ⌫ day following its publication in the Official Journal of the European Union.
⇩ new
Articles 20 to 53 and 55 to 57 shall apply from xxxxx [OP: please insert: the first day of the 12th month after the entry into force].
🡻 469/2009
This Regulation shall be binding in its entirety and directly applicable in all Member States.