2023/0130(COD) Supplementary protection certificate for medicinal products. Recast
Lead committee dossier:
Progress: Awaiting Council's 1st reading position
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | JURI | ||
| Former Responsible Committee | JURI |
WÖLKEN Tiemo ( S&D)
|
|
| Former Committee Opinion | INTA | ||
| Former Committee Opinion | ENVI | ||
| Former Committee Opinion | IMCO | ||
| Fromer Committee Recast Technique Opinion | JURI |
ADAMOWICZ Magdalena ( EPP)
|
Lead committee dossier:
Legal Basis:
RoP 113, TFEU 114-p1
Legal Basis:
RoP 113, TFEU 114-p1Subjects
Events
2024/07/08
EC - Commission response to text adopted in plenary
Documents
2024/02/28
EP - Results of vote in Parliament
Documents
2024/02/28
EP - Decision by Parliament, 1st reading
Details
The European Parliament adopted by 518 votes to 29, with 70 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast).
As a reminder, this proposal for a recast of Regulation (EC) No 1610/96 lays down the rules on the supplementary protection 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 plant protection product, to an administrative authorisation procedure.
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.
The European Parliament's position adopted at first reading under the ordinary legislative procedure amends the Commission's proposal as follows:
Content of the application for a certificate
The application for a certificate should contain if applicable, the consent of the third party as well as information on any direct public financial support received for research related to the development of the product. The authority should publish, without undue delay, notification of the fact that a certificate has been granted.
Publication of the centralised application
If the centralised application complies, or if an application for an extension of the duration of certificates complies with the provisions laid down in the Regulation, the Office should publish the application, in the Register without undue delay and no later than five working days after.
Examination of the centralised application
The Office should adopt an examination opinion within 6 months after publication of the centralised application in the Register. 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 should adopt an examination opinion within 4 months from the publication of the application for a unitary certificate. Whenever the expedited procedure applies, observations should be submitted within six weeks after publication of the application in the Register.
Opposition
Within a period of 2 months following the publication of the examination opinion in respect of a centralised application, any person may file with the Office a notice of opposition to that opinion. The notice of opposition should contain any evidence the opponent relies on in support of the opposition. The Office should 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.
In cases where several oppositions have been filed against an examination opinion, the Office should deal with the oppositions jointly and issue one single decision in regards to all oppositions filed. Full transparency should be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Competent national authorities
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, that authority should 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.
Examination panels
The assessments should be carried out by an examination panel consisting of one member of the Office and two examiners from two different participating national competent authorities. When setting up an examination panel, the Office should ensure the following:
- 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;
- where possible, geographical balance amongst the participating offices.
Appeal
Any reply to statement of the grounds of appeal should 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 should 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 should 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.
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.
Implementation of an examination of a centralised application at national level
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 should 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.
Register
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.
Documents
2024/02/27
EP - Debate in Parliament
Documents
2024/02/01
EP - Committee report tabled for plenary, 1st reading
Details
The Committee on Legal Affairs adopted the report by Tiemo WÖLKEN (S&D, DE) on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast).
As a reminder, this proposal for a recast of Regulation (EC) No 1610/96 lays down the rules on the supplementary protection 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 plant protection product, to an administrative authorisation procedure.
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.
The committee responsible recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure should amend the proposal as follows:
Content of the application for a certificate
The application for a certificate should contain if applicable, the consent of the third party as well as information on any direct public financial support received for research related to the development of the product . The authority should publish, without undue delay, notification of the fact that a certificate has been granted. The notification should contain information on any direct public financial support received for research related to the development of the product.
Publication of the centralised application
If the centralised application complies, or if an application for an extension of the duration of certificates complies with the provisions laid down in the Regulation, the Office should publish the application, in the Register without undue delay and no later than five working days after.
Examination of the centralised application
The Office should adopt an examination opinion within 6 months after publication of the centralised application in the Register. 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 should adopt an examination opinion within 4 months from the publication of the application for a unitary certificate. Whenever the expedited procedure applies, observations should be submitted within six weeks after publication of the application in the Register.
Opposition
Within a period of 2 months following the publication of the examination opinion in respect of a centralised application, any person may file with the Office a notice of opposition to that opinion. The notice of opposition should contain any evidence the opponent relies on in support of the opposition. The Office should 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.
In cases where several oppositions have been filed against an examination opinion, the Office should deal with the oppositions jointly and issue one single decision in regards to all oppositions filed. Full transparency should be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Competent national authorities
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, that authority should 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.
Examination panels
The assessments should be carried out by an examination panel consisting of one member of the Office and two examiners from two different participating national competent authorities. When setting up an examination panel, the Office should ensure the following:
- 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;
- where possible, geographical balance amongst the participating offices.
Appeal
Any reply to statement of the grounds of appeal should 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 should 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 should 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.
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.
Implementation of an examination of a centralised application at national level
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 should 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 .
Register
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.
Documents
2024/01/24
EP - Vote in committee, 1st reading
2023/11/14
EP - Amendments tabled in committee
Documents
2023/11/09
EP - Specific opinion
Documents
2023/11/09
DE_BUNDESRAT - Contribution
Documents
2023/10/13
EP - Committee draft report
Documents
2023/09/20
ESC - Economic and Social Committee: opinion, report
Documents
2023/09/11
EP - Committee referral announced in Parliament, 1st reading
2023/07/19
EP - WÖLKEN Tiemo (S&D) appointed as rapporteur in JURI
2023/04/27
EC - Document attached to the procedure
Documents
2023/04/27
EC - Document attached to the procedure
Documents
2023/04/27
EC - Document attached to the procedure
Documents
2023/04/27
EC - Legislative proposal published
Details
PURPOSE: to simplify the EU’s supplementary protection certificates (SPC) system as regards national SPCs for medicinal products and improve its transparency and efficiency.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: a supplementary protection certificate (SPC) is an intellectual property right that extends the term of a patent (up to five years) for a human or veterinary pharmaceutical or plant protection product that has been authorised by regulatory authorities, thereby encouraging innovation and promoting growth and employment in these sectors.
However, SPC protection is only available at national level. As a result, the current system suffers from fragmentation, leading to complex and costly procedures and legal uncertainty.
The unitary patent will enter into force on 1 June 2023, allowing for a single patent that covers all participating Member States in a unitary manner.
The Commission’s intellectual property action plan of November 2020, which builds on the SPC evaluation, highlighted the need to tackle the remaining fragmentation of the EU’s intellectual property system.
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.
This proposal is part of the ‘EU patent package’ announced in 2023 which, besides the revision, modernisation and introduction of a system for unitary SPCs , includes a new initiative on compulsory licensing and legislation on standard-essential patents . The proposal also complements the unitary patent system, which is a major step towards the completion of the single market for patents.
In addition to this proposal, parallel proposals are being made to create a centralised procedure for the grant of national certificates for medicinal products, a unitary certificate for plant protection products and a unitary certificate for medicinal products.
CONTENT: this proposal for a recast of Regulation (EC) No 1610/96 lays down the rules on the supplementary protection 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 plant protection product, to an administrative authorisation procedure.
The SPC reform introduces a centralised examination procedure , implemented by the EU Intellectual Property Office (EUIPO), in close cooperation with the EU's national intellectual property (IP) offices. Under this scheme, a single application will be subject to a single examination process which, if positive, will result in the grant of a unitary SPC and of national SPCs in further Member States.
While that examination would be conducted by a centralised authority, the actual granting of SPCs would be done by the respective national offices of the designated Member States, based on a positive opinion from the central examination authority. The opinion of the central examination authority would be binding upon the national offices of the designated Member States.
The core substantive features of the proposed centralised procedure – i.e. the conditions for obtaining certificates, as well as their legal effect – are the same as those of the existing SPC regime. This proposal introduces new procedural provisions as regards the centralised examination and is not intended to modify the scope nor the effect of the rights conferred by national SPCs currently granted according to Regulation (EC) No 469/2009.
The new rules, however, do not alter the competence of national IP Offices in granting national SPCs, following the binding opinion issued by the examination authority, run by the EUIPO. The reform of the national SPC regime does also not alter the eligibility criteria to obtain an SPC, which remain the ones currently foreseen in Article 3 in the existing legislation for both pharmaceutical products and plant protection products.
Documents
2023/01/01
EP - ADAMOWICZ Magdalena (EPP) appointed as rapporteur in JURI
Documents
- Commission response to text adopted in plenary: SP(2024)270
- Results of vote in Parliament: Results of vote in Parliament
- Decision by Parliament, 1st reading: T9-0099/2024
- Debate in Parliament: Debate in Parliament
- Committee report tabled for plenary, 1st reading: A9-0022/2024
- Amendments tabled in committee: PE756.105
- Specific opinion: PE756.057
- Contribution: COM(2023)0231
- Committee draft report: PE753.704
- Economic and Social Committee: opinion, report: CES2306/2023
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2023)0117
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2023)0118
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2023)0119
- Legislative proposal published: COM(2023)0231
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SWD(2023)0117
- Document attached to the procedure: EUR-Lex SWD(2023)0118
- Document attached to the procedure: EUR-Lex SWD(2023)0119
- Economic and Social Committee: opinion, report: CES2306/2023
- Committee draft report: PE753.704
- Specific opinion: PE756.057
- Amendments tabled in committee: PE756.105
- Commission response to text adopted in plenary: SP(2024)270
- Contribution: COM(2023)0231
Votes
A9-0022/2024 – Tiemo Wölken – Commission proposal #
2024/02/28 Outcome: +: 526, 0: 70, -: 23
PPE
Renew
ECR
ID
NI
The Left
Verts/ALE| Amendments | Dossier |
| 216 |
2023/0130(COD)
2023/11/14
JURI
216 amendments...
Amendment 100 #
Proposal for a regulation Article 26 – paragraph 9 9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. The decision shall include detailed reasons.
Amendment 100 #
Proposal for a regulation Article 26 – paragraph 9 9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. The decision shall include detailed reasons.
Amendment 101 #
Proposal for a regulation Article 26 – paragraph 9 a (new) 9 a. If more than one opposition is filed in respect of the same examination opinion, the Office shall hear the oppositions jointly and issue a common decision.
Amendment 101 #
Proposal for a regulation Article 26 – paragraph 9 a (new) 9 a. If more than one opposition is filed in respect of the same examination opinion, the Office shall hear the oppositions jointly and issue a common decision.
Amendment 102 #
Proposal for a regulation Article 26 – paragraph 11 11. If the opposition panel considers that
Amendment 102 #
Proposal for a regulation Article 26 – paragraph 11 11. If the opposition panel considers that
Amendment 103 #
Proposal for a regulation Article 26 – paragraph 12 a (new) 12 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 103 #
Proposal for a regulation Article 26 – paragraph 12 a (new) 12 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 104 #
Proposal for a regulation Article 27 – paragraph 1 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 experience in the field .
Amendment 104 #
Proposal for a regulation Article 27 – paragraph 1 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 experience in the field .
Amendment 105 #
Proposal for a regulation Article 27 – paragraph 5 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
Amendment 105 #
Proposal for a regulation Article 27 – paragraph 5 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
Amendment 106 #
Proposal for a regulation Article 28 – paragraph 1 1. The assessments under Articles 24
Amendment 106 #
Proposal for a regulation Article 28 – paragraph 1 1. The assessments under Articles 24
Amendment 107 #
Proposal for a regulation Article 28 – paragraph 3 – point -a (new) (-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 107 #
Proposal for a regulation Article 28 – paragraph 3 – point -a (new) (-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 108 #
Proposal for a regulation Article 28 – paragraph 3 – point a Amendment 108 #
Proposal for a regulation Article 28 – paragraph 3 – point a Amendment 109 #
Proposal for a regulation Article 28 – paragraph 3 – point a a (new) (a a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one of them has a minimum of 5 years of experience in patent and supplementary protection certificate examination;
Amendment 109 #
Proposal for a regulation Article 28 – paragraph 3 – point a a (new) (a a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one of them has a minimum of 5 years of experience in patent and supplementary protection certificate examination;
Amendment 110 #
Proposal for a regulation Article 28 – paragraph 3 – point c (c)
Amendment 110 #
Proposal for a regulation Article 28 – paragraph 3 – point c (c)
Amendment 111 #
Proposal for a regulation Article 28 – paragraph 3 – point c (c) no
Amendment 111 #
Proposal for a regulation Article 28 – paragraph 3 – point c (c) no
Amendment 112 #
Proposal for a regulation Article 28 – paragraph 4 4. The Office shall publish a yearly overview of the number of procedures, including those for examination
Amendment 112 #
Proposal for a regulation Article 28 – paragraph 4 4. The Office shall publish a yearly overview of the number of procedures, including those for examination
Amendment 113 #
Proposal for a regulation Article 29 – 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, together with any evidence relied upon, shall be filed within 4 months of the date of notification of the decision.
Amendment 113 #
Proposal for a regulation Article 29 – 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, together with any evidence relied upon, shall be filed within 4 months of the date of notification of the decision.
Amendment 114 #
Proposal for a regulation Article 29 – 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
Amendment 114 #
Proposal for a regulation Article 29 – 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
Amendment 115 #
Proposal for a regulation Article 29 – paragraph 3 – subparagraph 1 (new) Any written statement in reply to the grounds of appeal shall be filed within 3 months from the date of the notification of the statement setting out the grounds of appeal. A date for oral hearing shall be set by the Office within 3 months after the filing of the reply to the grounds of appeal or within 6 months of the filing of grounds of appeal, whichever is earlier. A written decision of the Office shall issue within 3 months after the date of the oral hearing.
Amendment 115 #
Proposal for a regulation Article 29 – paragraph 3 – subparagraph 1 (new) Any written statement in reply to the grounds of appeal shall be filed within 3 months from the date of the notification of the statement setting out the grounds of appeal. A date for oral hearing shall be set by the Office within 3 months after the filing of the reply to the grounds of appeal or within 6 months of the filing of grounds of appeal, whichever is earlier. A written decision of the Office shall issue within 3 months after the date of the oral hearing.
Amendment 116 #
Proposal for a regulation Article 29 – paragraph 4 a (new) 4 a. The examination and/or opposition panels should also be amenable to representing themselves and defending their examination opinion as a party to the appeal proceedings.
Amendment 116 #
Proposal for a regulation Article 29 – paragraph 4 a (new) 4 a. The examination and/or opposition panels should also be amenable to representing themselves and defending their examination opinion as a party to the appeal proceedings.
Amendment 117 #
Proposal for a regulation Article 29 – paragraph 5 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
Amendment 117 #
Proposal for a regulation Article 29 – paragraph 5 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
Amendment 118 #
Proposal for a regulation Article 29 – paragraph 5 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
Amendment 118 #
Proposal for a regulation Article 29 – paragraph 5 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
Amendment 119 #
Proposal for a regulation Article 30 – paragraph 4 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.
Amendment 119 #
Proposal for a regulation Article 30 – paragraph 4 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.
Amendment 120 #
Proposal for a regulation Article 32 – paragraph 1 1. After the period during which an appeal
Amendment 120 #
Proposal for a regulation Article 32 – paragraph 1 1. After the period during which an appeal
Amendment 121 #
Proposal for a regulation Article 32 – paragraph 1 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 any appeal or opposition (including, where applicable, any appeal to the General Court or the Court of Justice) has been issued, the Office shall transmit the final examination opinion and its translations to the competent national authority of each designated Member State.
Amendment 121 #
Proposal for a regulation Article 32 – paragraph 1 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 any appeal or opposition (including, where applicable, any appeal to the General Court or the Court of Justice) has been issued, the Office shall transmit the final examination opinion and its translations to the competent national authority of each designated Member State.
Amendment 122 #
Proposal for a regulation Article 33 – paragraph 4 4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates
Amendment 122 #
Proposal for a regulation Article 33 – paragraph 4 4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates
Amendment 123 #
Proposal for a regulation Article 34 – paragraph 2 2. The Office shall charge a fee for an appeal
Amendment 123 #
Proposal for a regulation Article 34 – paragraph 2 2. The Office shall charge a fee for an appeal
Amendment 124 #
Proposal for a regulation Article 35 – paragraph 1 1. The Office shall develop, keep and maintain an electronic, searcheable 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.
Amendment 124 #
Proposal for a regulation Article 35 – paragraph 1 1. The Office shall develop, keep and maintain an electronic, searcheable 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.
Amendment 125 #
Proposal for a regulation Article 35 – paragraph 2 – point j a (new) (j a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for.
Amendment 125 #
Proposal for a regulation Article 35 – paragraph 2 – point j a (new) (j a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for.
Amendment 126 #
Proposal for a regulation Article 35 – paragraph 2 – point j a (new) (j a) information on any direct public financial support received for research related to the development of the product;
Amendment 126 #
Proposal for a regulation Article 35 – paragraph 2 – point j a (new) (j a) information on any direct public financial support received for research related to the development of the product;
Amendment 127 #
Proposal for a regulation Article 35 – paragraph 2 – point j b (new) (j b) where applicable, any third party observation and any related documents;
Amendment 127 #
Proposal for a regulation Article 35 – paragraph 2 – point j b (new) (j b) where applicable, any third party observation and any related documents;
Amendment 128 #
Proposal for a regulation Article 35 – paragraph 2 – point k (k) any documents from the examination procedure and the date and a copy summary of the examination opinion in respect of each of the designated Member States;
Amendment 128 #
Proposal for a regulation Article 35 – paragraph 2 – point k (k) any documents from the examination procedure and the date and a copy summary of the examination opinion in respect of each of the designated Member States;
Amendment 129 #
Proposal for a regulation Article 35 – paragraph 2 – point m (m) where applicable, the date and a
Amendment 129 #
Proposal for a regulation Article 35 – paragraph 2 – point m (m) where applicable, the date and a
Amendment 130 #
Proposal for a regulation Article 35 – paragraph 2 – point n Amendment 130 #
Proposal for a regulation Article 35 – paragraph 2 – point n Amendment 131 #
Proposal for a regulation Article 35 – paragraph 2 – point n (n) where applicable, the filing of an opposition,
Amendment 131 #
Proposal for a regulation Article 35 – paragraph 2 – point n (n) where applicable, the filing of an opposition,
Amendment 132 #
Proposal for a regulation Article 35 – paragraph 2 – point o (o) where applicable, the filing of an appeal,
Amendment 132 #
Proposal for a regulation Article 35 – paragraph 2 – point o (o) where applicable, the filing of an appeal,
Amendment 133 #
Proposal for a regulation Article 35 – paragraph 2 – point r – point 1 (new) 1) where applicable, the filing of an action to the General Court or the Court of Justice of the European Union, its status, a copy of the decision and where applicable a copy of the revised examination opinion;
Amendment 133 #
Proposal for a regulation Article 35 – paragraph 2 – point r – point 1 (new) 1) where applicable, the filing of an action to the General Court or the Court of Justice of the European Union, its status, a copy of the decision and where applicable a copy of the revised examination opinion;
Amendment 134 #
Proposal for a regulation Article 35 – paragraph 2 – point s a (new) (s a) any documents and communications between the Office and any party in the proceedings.
Amendment 134 #
Proposal for a regulation Article 35 – paragraph 2 – point s a (new) (s a) any documents and communications between the Office and any party in the proceedings.
Amendment 135 #
Proposal for a regulation Article 35 – paragraph 9 – point b (b) maintaining the Register and making it available for inspection by
Amendment 135 #
Proposal for a regulation Article 35 – paragraph 9 – point b (b) maintaining the Register and making it available for inspection by
Amendment 136 #
Proposal for a regulation Article 35 – paragraph 11 a (new) 11 a. By way of derogation from Article 35(9), point (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 biosimilars shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids
Amendment 136 #
Proposal for a regulation Article 35 – paragraph 11 a (new) 11 a. By way of derogation from Article 35(9), point (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 biosimilars shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids
Amendment 137 #
Proposal for a regulation Article 35 – paragraph 11 a (new) 11 a. The existence on the Register of a granted or applied for supplementary protection certificate shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products.
Amendment 137 #
Proposal for a regulation Article 35 – paragraph 11 a (new) 11 a. The existence on the Register of a granted or applied for supplementary protection certificate shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products.
Amendment 138 #
Proposal for a regulation Article 38 – paragraph 2 – subparagraph 2 An employee of a legal person may also represent other legal persons which are
Amendment 138 #
Proposal for a regulation Article 38 – paragraph 2 – subparagraph 2 An employee of a legal person may also represent other legal persons which are
Amendment 139 #
Proposal for a regulation Article 39 – paragraph 2 2. The combined application shall undergo a single centralised examination procedure, as well as a single
Amendment 139 #
Proposal for a regulation Article 39 – paragraph 2 2. The combined application shall undergo a single centralised examination procedure, as well as a single
Amendment 140 #
Proposal for a regulation Article 40 – paragraph 1 – point c Amendment 140 #
Proposal for a regulation Article 40 – paragraph 1 – point c Amendment 141 #
Proposal for a regulation Article 44 – paragraph 2 Amendment 141 #
Proposal for a regulation Article 44 – paragraph 2 Amendment 142 #
Proposal for a regulation Article 44 – paragraph 2 2. Oral proceedings before an examination panel
Amendment 142 #
Proposal for a regulation Article 44 – paragraph 2 2. Oral proceedings before an examination panel
Amendment 143 #
Proposal for a regulation Article 44 – paragraph 3 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.
Amendment 143 #
Proposal for a regulation Article 44 – paragraph 3 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.
Amendment 144 #
Proposal for a regulation Article 45 – paragraph 3 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 summoned, it shall be verified that that expert 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.
Amendment 144 #
Proposal for a regulation Article 45 – paragraph 3 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 summoned, it shall be verified that that expert 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.
Amendment 145 #
Proposal for a regulation Article 49 – paragraph 5 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article
Amendment 145 #
Proposal for a regulation Article 49 – paragraph 5 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article
Amendment 146 #
Proposal for a regulation Article 51 – paragraph 1 1. The losing party in
Amendment 146 #
Proposal for a regulation Article 51 – paragraph 1 1. The losing party in
Amendment 147 #
Proposal for a regulation Article 55 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 147 #
Proposal for a regulation Article 55 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 148 #
Proposal for a regulation Article 55 – paragraph 3 3. The delegation of power referred to in Articles
Amendment 148 #
Proposal for a regulation Article 55 – paragraph 3 3. The delegation of power referred to in Articles
Amendment 149 #
Proposal for a regulation Article 55 – paragraph 6 6. A delegated act adopted pursuant to Articles
Amendment 149 #
Proposal for a regulation Article 55 – paragraph 6 6. A delegated act adopted pursuant to Articles
Amendment 150 #
Proposal for a regulation Article 57 – paragraph 2 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
Amendment 150 #
Proposal for a regulation Article 57 – paragraph 2 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
Amendment 151 #
Proposal for a regulation Article 57 – paragraph 2 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 and present a report on the main findings to the European Parliament and to the Council.
Amendment 151 #
Proposal for a regulation Article 57 – paragraph 2 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 and present a report on the main findings to the European Parliament and to the Council.
Amendment 152 #
Proposal for a regulation Article 60 – paragraph 2 Articles 20 to 53 and 55 to 57 shall apply from xxxxx [OP: please insert: the first day of the
Amendment 152 #
Proposal for a regulation Article 60 – paragraph 2 Articles 20 to 53 and 55 to 57 shall apply from xxxxx [OP: please insert: the first day of the
Amendment 45 #
Proposal for a regulation Recital 3 Amendment 45 #
Proposal for a regulation Recital 3 Amendment 46 #
Proposal for a regulation Recital 3 (3) Medicinal products, especially . in particular . those that are the result of long, costly research will not continue to be developed in
Amendment 46 #
Proposal for a regulation Recital 3 (3) Medicinal products, especially . in particular . those that are the result of long, costly research will not continue to be developed in
Amendment 47 #
Proposal for a regulation Recital 5 Amendment 47 #
Proposal for a regulation Recital 5 Amendment 48 #
Proposal for a regulation Recital 5 (5) That this situation leads to a lack of protection which penalises pharmaceutical research , and there is a risk that research centres situated in the Member States relocate to countries that offer greater protection, despite it is challenging to establish a clear link between SPC protection and the location of R&D.
Amendment 48 #
Proposal for a regulation Recital 5 (5) That this situation leads to a lack of protection which penalises pharmaceutical research , and there is a risk that research centres situated in the Member States relocate to countries that offer greater protection, despite it is challenging to establish a clear link between SPC protection and the location of R&D.
Amendment 49 #
Proposal for a regulation Recital 8 Amendment 49 #
Proposal for a regulation Recital 8 Amendment 50 #
Proposal for a regulation Recital 8 (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
Amendment 50 #
Proposal for a regulation Recital 8 (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
Amendment 51 #
Proposal for a regulation Recital 9 (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,
Amendment 51 #
Proposal for a regulation Recital 9 (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,
Amendment 52 #
Proposal for a regulation Recital 9 (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
Amendment 52 #
Proposal for a regulation Recital 9 (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
Amendment 53 #
Proposal for a regulation Recital 11 Amendment 53 #
Proposal for a regulation Recital 11 Amendment 54 #
Proposal for a regulation Recital 12 (12) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not
Amendment 54 #
Proposal for a regulation Recital 12 (12) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not
Amendment 55 #
Proposal for a regulation Recital 13 (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
Amendment 55 #
Proposal for a regulation Recital 13 (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
Amendment 56 #
Proposal for a regulation Recital 13 (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
Amendment 56 #
Proposal for a regulation Recital 13 (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
Amendment 57 #
Proposal for a regulation Recital 15 (15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 1
Amendment 57 #
Proposal for a regulation Recital 15 (15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 1
Amendment 58 #
Proposal for a regulation Recital 17 (17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 1
Amendment 58 #
Proposal for a regulation Recital 17 (17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 1
Amendment 59 #
Proposal for a regulation Recital 24 (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 the paediatric
Amendment 59 #
Proposal for a regulation Recital 24 (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 the paediatric
Amendment 60 #
Proposal for a regulation Recital 24 (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.
Amendment 60 #
Proposal for a regulation Recital 24 (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.
Amendment 61 #
Proposal for a regulation Recital 24 (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
Amendment 61 #
Proposal for a regulation Recital 24 (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
Amendment 62 #
Proposal for a regulation Recital 28 (28) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. Third parties should have the possibility to make observations also in opposition and appeal proceedings. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 62 #
Proposal for a regulation Recital 28 (28) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. Third parties should have the possibility to make observations also in opposition and appeal proceedings. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 63 #
Proposal for a regulation Recital 30 (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.
Amendment 63 #
Proposal for a regulation Recital 30 (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.
Amendment 64 #
Proposal for a regulation Recital 32 Amendment 64 #
Proposal for a regulation Recital 32 Amendment 65 #
Proposal for a regulation Recital 32 a (new) (32 a) 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 may be needed, notwithstanding the possibility for third parties to submit observations and other remedies provided for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be foreseen.
Amendment 65 #
Proposal for a regulation Recital 32 a (new) (32 a) 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 may be needed, notwithstanding the possibility for third parties to submit observations and other remedies provided for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be foreseen.
Amendment 66 #
Proposal for a regulation Recital 33 (33) After the completion of the examination of a centralised application, and after the time limits for appeal
Amendment 66 #
Proposal for a regulation Recital 33 (33) After the completion of the examination of a centralised application, and after the time limits for appeal
Amendment 67 #
Proposal for a regulation Recital 38 (38)
Amendment 67 #
Proposal for a regulation Recital 38 (38)
Amendment 68 #
Proposal for a regulation Recital 39 (39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 68 #
Proposal for a regulation Recital 39 (39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 69 #
Proposal for a regulation Recital 41 a (new) (41 a) The timely entry of generics and biosimilars onto the Union market is key for public health purposes, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by 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 pharmaceutical systems in the Union and its Member States.
Amendment 69 #
Proposal for a regulation Recital 41 a (new) (41 a) The timely entry of generics and biosimilars onto the Union market is key for public health purposes, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by 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 pharmaceutical systems in the Union and its Member States.
Amendment 70 #
Proposal for a regulation Recital 60 (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 for within the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generic or biosimilars should be based on information provided for in the register, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the supplementary protection certificate.
Amendment 70 #
Proposal for a regulation Recital 60 (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 for within the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generic or biosimilars should be based on information provided for in the register, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the supplementary protection certificate.
Amendment 71 #
Proposal for a regulation Recital 60 (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. The register shall not be used for practices of patent linkage, such as conditioning any regulatory or administrative decisions related to generic or biosimilar medicinal product, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC.
Amendment 71 #
Proposal for a regulation Recital 60 (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. The register shall not be used for practices of patent linkage, such as conditioning any regulatory or administrative decisions related to generic or biosimilar medicinal product, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC.
Amendment 72 #
Proposal for a regulation Article 2 – paragraph 1 – point 12 a (new) (12 a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that (i) one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder, (ii) that the different holders have concluded tacit or explicit agreements in relation to the basic patents, in relation to applications for a certificate on the product or in relation to an authorisation to place the product on the market as a medicinal product or (iii) that they otherwise exercise concerted practices concerning the placing of the product on the market as a medicinal product.
Amendment 72 #
Proposal for a regulation Article 2 – paragraph 1 – point 12 a (new) (12 a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that (i) one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder, (ii) that the different holders have concluded tacit or explicit agreements in relation to the basic patents, in relation to applications for a certificate on the product or in relation to an authorisation to place the product on the market as a medicinal product or (iii) that they otherwise exercise concerted practices concerning the placing of the product on the market as a medicinal product.
Amendment 73 #
Proposal for a regulation Article 3 – paragraph 3 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
Amendment 73 #
Proposal for a regulation Article 3 – paragraph 3 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
Amendment 74 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 74 #
Proposal for a regulation Article 5 – paragraph 1 1.
Amendment 75 #
Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, 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 75 #
Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, 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 76 #
Proposal for a regulation Article 5 – paragraph 2 – point a – point iv a (new) (iv a) any act in accordance with Article [85] of Directive (EU) .../... [2023/0132(COD)].
Amendment 76 #
Proposal for a regulation Article 5 – paragraph 2 – point a – point iv a (new) (iv a) any act in accordance with Article [85] of Directive (EU) .../... [2023/0132(COD)].
Amendment 77 #
Proposal for a regulation Article 7 – paragraph 4 a (new) 4 a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.
Amendment 77 #
Proposal for a regulation Article 7 – paragraph 4 a (new) 4 a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.
Amendment 78 #
Proposal for a regulation Article 8 – paragraph 1 – point a a (new) (a a) information on all direct financial support received for research related to the development of the product for which the SPC is applied for.
Amendment 78 #
Proposal for a regulation Article 8 – paragraph 1 – point a a (new) (a a) information on all direct financial support received for research related to the development of the product for which the SPC is applied for.
Amendment 79 #
Proposal for a regulation Article 8 – paragraph 1 – point d a (new) (d a) information on any direct public financial support received for research related to the development of the product.
Amendment 79 #
Proposal for a regulation Article 8 – paragraph 1 – point d a (new) (d a) information on any direct public financial support received for research related to the development of the product.
Amendment 80 #
Proposal for a regulation Article 8 – paragraph 1 – point d a (new) (d a) a consent in accordance with Art. 6(2), if applicable.
Amendment 80 #
Proposal for a regulation Article 8 – paragraph 1 – point d a (new) (d a) a consent in accordance with Art. 6(2), if applicable.
Amendment 81 #
Proposal for a regulation Article 11 – paragraph 1 – point f a (new) (f a) information on any direct public financial support received for research related to the development of the product.
Amendment 81 #
Proposal for a regulation Article 11 – paragraph 1 – point f a (new) (f a) information on any direct public financial support received for research related to the development of the product.
Amendment 82 #
Proposal for a regulation Article 11 – paragraph 1 a (new) 1 a. information on all direct financial support received for research related to the development of the product for which the SPC is applied for.
Amendment 82 #
Proposal for a regulation Article 11 – paragraph 1 a (new) 1 a. information on all direct financial support received for research related to the development of the product for which the SPC is applied for.
Amendment 83 #
Proposal for a regulation Article 15 – paragraph 1 – point a (a) the certificate it was granted contrary to the provisions of Articles 3 or 6;
Amendment 83 #
Proposal for a regulation Article 15 – paragraph 1 – point a (a) the certificate it was granted contrary to the provisions of Articles 3 or 6;
Amendment 84 #
Proposal for a regulation Article 15 – paragraph 1 – point c a (new) (c a) the marketing authorisation has been withdrawn or revoked in accordance with Directive (EU) .../... [2023/0132(COD)].
Amendment 84 #
Proposal for a regulation Article 15 – paragraph 1 – point c a (new) (c a) the marketing authorisation has been withdrawn or revoked in accordance with Directive (EU) .../... [2023/0132(COD)].
Amendment 85 #
Proposal for a regulation Article 16 – paragraph 2 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.
Amendment 85 #
Proposal for a regulation Article 16 – paragraph 2 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.
Amendment 86 #
Proposal for a regulation Article 18 – paragraph 2 a (new) 2 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
Amendment 86 #
Proposal for a regulation Article 18 – paragraph 2 a (new) 2 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
Amendment 87 #
Proposal for a regulation Article 20 – 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 (EU) .../... [EC2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.
Amendment 87 #
Proposal for a regulation Article 20 – 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 (EU) .../... [EC2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.
Amendment 88 #
Proposal for a regulation Article 23 – 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, without undue delay, in the Register and anyway no later than five working days after.
Amendment 88 #
Proposal for a regulation Article 23 – 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, without undue delay, in the Register and anyway no later than five working days after.
Amendment 89 #
Proposal for a regulation Article 24 – paragraph 1 1. The Office shall assess the application on the basis of all the conditions in Articles 3(1), 3(3) and 6(2) for each of the designated Member States.
Amendment 89 #
Proposal for a regulation Article 24 – paragraph 1 1. The Office shall assess the application on the basis of all the conditions in Articles 3(1), 3(3) and 6(2) for each of the designated Member States.
Amendment 90 #
Proposal for a regulation Article 24 – paragraph 2 2. Where the centralised application for a certificate and the product to which it relates comply with Articles 3(1), 3(3) and 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.
Amendment 90 #
Proposal for a regulation Article 24 – paragraph 2 2. Where the centralised application for a certificate and the product to which it relates comply with Articles 3(1), 3(3) and 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.
Amendment 91 #
Proposal for a regulation Article 24 – paragraph 3 3. Where the centralised application for a certificate and the product to which it relates does not comply with Articles 3(1), 3(3) and 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 it on the Register immediately and anyway no later than five working days after the opinion is issued.
Amendment 91 #
Proposal for a regulation Article 24 – paragraph 3 3. Where the centralised application for a certificate and the product to which it relates does not comply with Articles 3(1), 3(3) and 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 it on the Register immediately and anyway no later than five working days after the opinion is issued.
Amendment 92 #
Proposal for a regulation Article 24 – paragraph 5 a (new) 5 a. 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 92 #
Proposal for a regulation Article 24 – paragraph 5 a (new) 5 a. 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 93 #
Proposal for a regulation Article 25 – paragraph 3 3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register. Third party observations may also be submitted in opposition and appeal proceedings.
Amendment 93 #
Proposal for a regulation Article 25 – paragraph 3 3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register. Third party observations may also be submitted in opposition and appeal proceedings.
Amendment 94 #
Proposal for a regulation Article 25 – paragraph 3 – subparagraph 1 (new) Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within 1 month after publication of the application in the Register.
Amendment 94 #
Proposal for a regulation Article 25 – paragraph 3 – subparagraph 1 (new) Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within 1 month after publication of the application in the Register.
Amendment 96 #
Proposal for a regulation Article 26 – paragraph 2 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Articles 3 or 6 are not fulfilled for one or more of the designated Member States.
Amendment 96 #
Proposal for a regulation Article 26 – paragraph 2 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Articles 3 or 6 are not fulfilled for one or more of the designated Member States.
Amendment 97 #
Proposal for a regulation Article 26 – paragraph 4 – point c a (new) (c a) any evidence that is relied upon by the opponent.
Amendment 97 #
Proposal for a regulation Article 26 – paragraph 4 – point c a (new) (c a) any evidence that is relied upon by the opponent.
Amendment 98 #
Proposal for a regulation Article 26 – paragraph 6 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 the opponent with reasons as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.
Amendment 98 #
Proposal for a regulation Article 26 – paragraph 6 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 the opponent with reasons as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.
Amendment 99 #
Proposal for a regulation Article 26 – paragraph 7 – subparagraph 2 Amendment 99 #
Proposal for a regulation Article 26 – paragraph 7 – subparagraph 2 source: 756.105
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2024-10-19Show (19) Changes | Timetravel
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|
| committees/3/opinion |
False
|
2023-06-02Show (1) Changes | Timetravel
| commission |
|
2023-06-01Show (1) Changes | Timetravel
| committees/2/opinion |
False
|
2023-05-25Show (1) Changes | Timetravel
| committees/4/rapporteur |
|
2023-05-24Show (1) Changes | Timetravel
| committees/3/opinion |
False
|
2023-05-12Show (2) Changes
| docs/0 |
|
| events/0/summary |
|