2023/0127(COD) Unitary supplementary certificate for medicinal products
Lead committee dossier:
Progress: Awaiting Council's 1st reading position
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Lead | JURI |
WÖLKEN Tiemo ( S&D)
|
ZARZALEJOS Javier ( EPP),
ZŁOTOWSKI Kosma ( ECR),
SAEIDI Arash ( The Left)
|
| Former Responsible Committee | JURI | ||
| Former Committee Opinion | INTA | ||
| Former Committee Opinion | ENVI | ||
| Former Committee Opinion | IMCO |
Lead committee dossier:
Legal Basis:
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Legal Basis:
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Events
2024/11/18
EP - WÖLKEN Tiemo (S&D) appointed as rapporteur in JURI
2024/11/13
EP - Committee referral announced in Parliament, 1st reading
2024/07/08
European Commission - Commission response to text adopted in plenary
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 unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013.
As a reminder, the proposal lays down rules on the unitary supplementary protection certificate for medicinal products protected by a European patent with unitary effect and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure.
The European Parliament's position adopted at first reading under the ordinary legislative procedure amends the Commission's proposal as follows:
Conditions for obtaining a certificate
The proposal provides that where two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending in a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not economically linked, by a competent national authority or by the Office, as applicable.
According to Members, the same principle should apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents.
Content of the application for a unitary 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 for which the SPC is requested.
The application for a unitary certificate and, where applicable, the application for an extension of the duration of a unitary certificate, should be lodged in electronic form with the Office . The Office should put the necessary arrangements in place in order to ensure that exchanges of data and information are done electronically and that the commercially confidential nature of the information exchanged is protected.
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 publish the notice of examination in the register as soon as possible after it is issued. It 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 an application for a unitary certificate, any person may file with the Office a notice of opposition to that opinion. The notice of opposition should include any evidence the opponent relies on in support of the opposition.
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 respect of all oppositions filed.
Full transparency should be ensured throughout the whole opposition proceeding, which should be open, whenever possible, to public participation.
Examination panels
The assessments should be conducted by an examination panel including one member of the Office as well as two examiners from two different participating competent national 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.
Appeals
Any reply to the statement of grounds of appeal should be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office should, where applicable, fix a date for oral proceedings within three months of the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office should issue a written decision within three months of the date 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 concerning applications for unitary certificates, due consideration should be given to their previous experience in matters concerning supplementary protection certificates or patent law.
Register
Public authorities should not use information in the Register for practices of patent linkage. No regulatory or administrative decisions related to generics or biosimilars should be based on information in the Register. Information in the Register should not be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.
Taking of evidence
If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it should issue a summons to the person concerned to appear before it. Where an expert is summonsed, the Office or the relevant panel, as the case may be, should verify that that expert is free of any conflict of interest .
Evaluation
By five years after the date of application, and every five years thereafter, the Commission should present a report on the main findings. Special emphasis should be given to the effects of opposition and whether the possibility of opposition leads to significant delays in granting unitary certificates and to the effects of this Regulation on the recovery of research and development investments.
Text adopted by Parliament, 1st reading/single reading
Documents
2024/02/28
EP - Results of vote in Parliament
Documents
2024/02/27
EP - Debate in Parliament
Documents
2024/01/31
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 unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013.
As a reminder, the proposal lays down rules on the unitary supplementary protection certificate for medicinal products protected by a European patent with unitary effect and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure.
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:
Application for a unitary certificate
The application for a unitary certificate should be lodged electronically , using the formats made available by the Office.
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 for which the SPC is requested.
The application for a unitary certificate and, where applicable, the application for an extension of the duration of a unitary certificate, should be lodged in electronic form with the Office. The Office should put the necessary arrangements in place in order to ensure that exchanges of data and information are done electronically and that the commercially confidential nature of the information exchanged is protected.
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 an application for a unitary certificate, any person may file with the Office a notice of opposition to that opinion. The notice of opposition should include any evidence the opponent relies on in support of the opposition.
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 respect of all oppositions filed.
Full transparency should be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Examination panels
The assessments should be conducted by an examination panel including one member of the Office as well as two examiners from two different participating competent national 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.
Appeals
Any reply to the statement of grounds of appeal should be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office should, where applicable, fix a date for oral proceedings within three months of the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office should issue a written decision within three months of the date 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 concerning applications for unitary certificates, due consideration should be given to their previous experience in matters concerning supplementary protection certificates or patent law.
Register
Public authorities should not use information in the Register for practices of patent linkage. No regulatory or administrative decisions related to generics or biosimilars should be based on information in the Register. Information in the Register should not be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.
Taking of evidence
If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it should issue a summons to the person concerned to appear before it. Where an expert is summonsed, the Office or the relevant panel, as the case may be, should verify that that expert is free of any conflict of interest.
Evaluation
By five years after the date of application, and every five years thereafter, the Commission should present a report on the main findings. Special emphasis should be given to the effects of opposition and whether the possibility of opposition leads to significant delays in granting unitary certificates and to the effects of this Regulation on the recovery of research and development investments.
Committee report tabled for plenary, 1st reading/single reading
Documents
2024/01/24
EP - Vote in committee, 1st reading
2023/11/13
European Parliament - Amendments tabled in committee
Documents
2023/11/09
DE_BUNDESRAT - Contribution
Documents
2023/10/13
European Parliament - Committee draft report
Documents
2023/09/20
Economic and Social Committee: opinion, report - ESC
Documents
2023/09/11
EP - Committee referral announced in Parliament, 1st reading
2023/04/27
European Commission - Document attached to the procedure
Documents
2023/04/27
European Commission - Legislative proposal
Details
PURPOSE: to simplify the EU Supplementary Protection Certificate (SPC) system and improve its transparency and efficiency, by creating a unitary certificate for medicinal products.
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 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.
There is a clear need to complement the unitary patent (‘European patent with unitary effect’) with a unitary SPC . The proposed creation of a unitary SPC will be fully compatible with the unitary patent system provided for in Regulation (EU) No 1257/2012 and the Unified Patent Court Agreement (UPCA). The unitary patent will enter into force on 1 June 2023, allowing a single patent covering all participating Member States in a unitary manner.
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 centralised procedure for the grant of national certificates for plant protection products, and a unitary certificate for plant products.
CONTENT: this proposal lays down rules on the unitary supplementary protection certificate for medicinal products protected by a European patent with unitary effect and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure.
The proposed SPC reform includes the creation of a unitary SPC , complementing the unitary patent that will enter into force on 1 June 2023. The unitary SPC will also incentivise innovators to use the unitary patent. In the absence of a unitary SPC, a unitary patent could be extended only by means of national SPCs, i.e. in a non-unitary manner, leading to greater administrative burden and costs.
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.
The SPC centralised procedure can be used by any company, start-up, research organisation, innovator, etc. that holds a valid patent on a medicinal product or a plant protection product, and a corresponding marketing authorisation in the EU. Applicants will be able to file a ‘ combined application ' with a view to the grant of both a unitary SPC and national SPC for additional Member States not covered by the unitary patent. This application will be subject to a single examination which, if positive, will result in the grant of a unitary SPC (for those 17 Member States currently participating in the unitary patent system) and of national SPCs in further Member States.
Legislative proposal
Documents
2023/04/27
European Commission - Document attached to the procedure
Documents
2023/04/27
European Commission - Document attached to the procedure
Documents
2023/04/27
EC - Legislative proposal published
Details
PURPOSE: to simplify the EU Supplementary Protection Certificate (SPC) system and improve its transparency and efficiency, by creating a unitary certificate for medicinal products.
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 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.
There is a clear need to complement the unitary patent (‘European patent with unitary effect’) with a unitary SPC . The proposed creation of a unitary SPC will be fully compatible with the unitary patent system provided for in Regulation (EU) No 1257/2012 and the Unified Patent Court Agreement (UPCA). The unitary patent will enter into force on 1 June 2023, allowing a single patent covering all participating Member States in a unitary manner.
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 centralised procedure for the grant of national certificates for plant protection products, and a unitary certificate for plant products.
CONTENT: this proposal lays down rules on the unitary supplementary protection certificate for medicinal products protected by a European patent with unitary effect and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure.
The proposed SPC reform includes the creation of a unitary SPC , complementing the unitary patent that will enter into force on 1 June 2023. The unitary SPC will also incentivise innovators to use the unitary patent. In the absence of a unitary SPC, a unitary patent could be extended only by means of national SPCs, i.e. in a non-unitary manner, leading to greater administrative burden and costs.
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.
The SPC centralised procedure can be used by any company, start-up, research organisation, innovator, etc. that holds a valid patent on a medicinal product or a plant protection product, and a corresponding marketing authorisation in the EU. Applicants will be able to file a ‘ combined application ' with a view to the grant of both a unitary SPC and national SPC for additional Member States not covered by the unitary patent. This application will be subject to a single examination which, if positive, will result in the grant of a unitary SPC (for those 17 Member States currently participating in the unitary patent system) and of national SPCs in further Member States.
Legislative proposal
Documents
Documents
- Commission response to text adopted in plenary: SP(2024)270
- Decision by Parliament, 1st reading: T9-0097/2024
- Results of vote in Parliament: Results of vote in Parliament
- Debate in Parliament: Go to the page
- Committee report tabled for plenary, 1st reading: A9-0019/2024
- Amendments tabled in committee: PE756.103
- Contribution: COM(2023)0222
- Committee draft report: PE753.703
- ESC: CES2306/2023
- Document attached to the procedure: Go to the pageEur-Lex
- Document attached to the procedure: SWD(2023)0119
- Legislative proposal: COM(2023)0222
- Legislative proposal: Go to the pageEur-Lex
- Document attached to the procedure: Go to the pageEur-Lex
- Document attached to the procedure: SWD(2023)0118
- Document attached to the procedure: Go to the pageEur-Lex
- Document attached to the procedure: SWD(2023)0117
- Legislative proposal published: COM(2023)0222
- Legislative proposal published: Go to the page Eur-Lex
- Committee draft report: PE753.703
- Amendments tabled in committee: PE756.103
- Document attached to the procedure: Go to the pageEur-Lex SWD(2023)0119
- Legislative proposal: COM(2023)0222 Go to the pageEur-Lex
- Document attached to the procedure: Go to the pageEur-Lex SWD(2023)0118
- Document attached to the procedure: Go to the pageEur-Lex SWD(2023)0117
- Commission response to text adopted in plenary: SP(2024)270
- Contribution: COM(2023)0222
- ESC: CES2306/2023
Votes
A9-0019/2024 – Tiemo Wölken – Commission proposal #
2024/02/28 Outcome: +: 518, 0: 70, -: 29
PPE
Renew
ID
NI
Verts/ALE| Amendments | Dossier |
| 336 |
2023/0127(COD)
2023/11/13
JURI
336 amendments...
Amendment 100 #
Proposal for a regulation Article 8 – 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 100 #
Proposal for a regulation Article 8 – 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 101 #
Proposal for a regulation Article 9 – paragraph 1 – point a – point iv a (new) (iv a) Data and information regarding any direct financial support received for research contributing to the development of the product for which the single SPC is requested.
Amendment 101 #
Proposal for a regulation Article 9 – paragraph 1 – point a – point iv a (new) (iv a) Data and information regarding any direct financial support received for research contributing to the development of the product for which the single SPC is requested.
Amendment 102 #
Proposal for a regulation Article 9 – paragraph 1 – point a – point iv a (new) (iv 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 102 #
Proposal for a regulation Article 9 – paragraph 1 – point a – point iv a (new) (iv 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 103 #
Proposal for a regulation Article 9 – paragraph 1 – point a a (new) (a a) the appropriate documentation containing the following information: (i) data on all costs that the applicant has incurred in the course of developing the medicinal product subject to the application for unitary certificate; (ii) details of any grants, public financial support, tax incentives or other cost recovery provisions received either within the Union or in third countries; (iii) in cases where the medicinal product is already authorised for any indication or where the medicinal product is under investigation for one or more other indications, a clear explanation of and justification for the method that is used to apportion the development costs among the various indications shall be provided; (iv) a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for designation shall be provided; (v) a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur during the first 10 years that the medicinal product is authorised shall be provided; (vi) an estimate and justification for the expected revenues from sales of the medicinal product in the Union during the first 10 years after authorisation; (vii) all cost and revenue data shall be determined in accordance with generally accepted accounting practices and shall be certified by a registered accountant in the Union;
Amendment 103 #
Proposal for a regulation Article 9 – paragraph 1 – point a a (new) (a a) the appropriate documentation containing the following information: (i) data on all costs that the applicant has incurred in the course of developing the medicinal product subject to the application for unitary certificate; (ii) details of any grants, public financial support, tax incentives or other cost recovery provisions received either within the Union or in third countries; (iii) in cases where the medicinal product is already authorised for any indication or where the medicinal product is under investigation for one or more other indications, a clear explanation of and justification for the method that is used to apportion the development costs among the various indications shall be provided; (iv) a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for designation shall be provided; (v) a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur during the first 10 years that the medicinal product is authorised shall be provided; (vi) an estimate and justification for the expected revenues from sales of the medicinal product in the Union during the first 10 years after authorisation; (vii) all cost and revenue data shall be determined in accordance with generally accepted accounting practices and shall be certified by a registered accountant in the Union;
Amendment 104 #
Proposal for a regulation Article 9 – paragraph 1 – point d a (new) (d a) any information on any direct public financial support received for research related to the development of the product.
Amendment 104 #
Proposal for a regulation Article 9 – paragraph 1 – point d a (new) (d a) any information on any direct public financial support received for research related to the development of the product.
Amendment 105 #
Proposal for a regulation Article 9 – paragraph 1 a (new) 1 a. a consent in accordance with Art. 6(2), if applicable.
Amendment 105 #
Proposal for a regulation Article 9 – paragraph 1 a (new) 1 a. a consent in accordance with Art. 6(2), if applicable.
Amendment 106 #
Proposal for a regulation Article 12 – paragraph 1 If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay and anyway no later than five working days after.
Amendment 106 #
Proposal for a regulation Article 12 – paragraph 1 If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay and anyway no later than five working days after.
Amendment 107 #
Proposal for a regulation Article 12 – paragraph 1 If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay.
Amendment 107 #
Proposal for a regulation Article 12 – paragraph 1 If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay.
Amendment 108 #
Proposal for a regulation Article 13 – paragraph 1 1. The Office shall assess the application on the basis of all the conditions in Article 3(1) 3(2) and 6(2), for all Member States in which the basic patent has unitary effect.
Amendment 108 #
Proposal for a regulation Article 13 – paragraph 1 1. The Office shall assess the application on the basis of all the conditions in Article 3(1) 3(2) and 6(2), for all Member States in which the basic patent has unitary effect.
Amendment 109 #
Proposal for a regulation Article 13 – paragraph 1 1. The Office shall assess the application on the basis of all the conditions in Article 3(1), 3(2) and 6(2) for all Member States in which the basic patent has unitary effect.
Amendment 109 #
Proposal for a regulation Article 13 – paragraph 1 1. The Office shall assess the application on the basis of all the conditions in Article 3(1), 3(2) and 6(2) for all Member States in which the basic patent has unitary effect.
Amendment 110 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant and publish it on the Register without undue delay.
Amendment 110 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant and publish it on the Register without undue delay.
Amendment 111 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1), 3(2) and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 111 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1), 3(2) and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 112 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1), 3(2) and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 112 #
Proposal for a regulation Article 13 – paragraph 2 2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1), 3(2) and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 113 #
Proposal for a regulation Article 13 – paragraph 3 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1), 3(2) and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. 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 113 #
Proposal for a regulation Article 13 – paragraph 3 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1), 3(2) and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. 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 114 #
Proposal for a regulation Article 13 – paragraph 3 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1), 3(2) and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 114 #
Proposal for a regulation Article 13 – paragraph 3 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1), 3(2) and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 115 #
Proposal for a regulation Article 13 – paragraph 4 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 and publish the examination opinion on the Register as soon as possible after it is issued.
Amendment 115 #
Proposal for a regulation Article 13 – paragraph 4 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 and publish the examination opinion on the Register as soon as possible after it is issued.
Amendment 116 #
Proposal for a regulation Article 13 – paragraph 5 a (new) 5 a. The Office shall issue an examination opinion within 6 months after publication of the application for a unitary certificate. Without prejudice to Articles 14, 25 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 issue an examination opinion within 4 months from the publication of the application for a unitary certificate.
Amendment 116 #
Proposal for a regulation Article 13 – paragraph 5 a (new) 5 a. The Office shall issue an examination opinion within 6 months after publication of the application for a unitary certificate. Without prejudice to Articles 14, 25 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 issue an examination opinion within 4 months from the publication of the application for a unitary certificate.
Amendment 117 #
Proposal for a regulation Article 13 – paragraph 5 a (new) 5 a. The Office will issue a decision on examination within 6 months following the publication date of the application for a unified certificate. A request for accelerated processing may be filed at any point subsequent to the publication of the application for a Unified Certificate. Upon receipt of a request for accelerated processing, the Office will issue a decision on the examination within 4 months.
Amendment 117 #
Proposal for a regulation Article 13 – paragraph 5 a (new) 5 a. The Office will issue a decision on examination within 6 months following the publication date of the application for a unified certificate. A request for accelerated processing may be filed at any point subsequent to the publication of the application for a Unified Certificate. Upon receipt of a request for accelerated processing, the Office will issue a decision on the examination within 4 months.
Amendment 118 #
Proposal for a regulation Article 14 – paragraph 3 3. Third party observations shall be submitted within 3 months after publication of the application in the Register. Third party observations may also be admissible in the course of appeal proceedings.
Amendment 118 #
Proposal for a regulation Article 14 – paragraph 3 3. Third party observations shall be submitted within 3 months after publication of the application in the Register. Third party observations may also be admissible in the course of appeal proceedings.
Amendment 119 #
Proposal for a regulation Article 14 – paragraph 3 3. Third party observations shall be submitted within 3 months after publication of the application in the Register. Third party observations may also be submitted in opposition and appeal proceedings.
Amendment 119 #
Proposal for a regulation Article 14 – paragraph 3 3. Third party observations shall be submitted within 3 months after publication of the application in the Register. Third party observations may also be submitted in opposition and appeal proceedings.
Amendment 120 #
Proposal for a regulation Article 14 – paragraph 3 – subparagraph 1 (new) Whenever the expedited procedure applies in accordance with to Article 13 (5a), observations shall be submitted within 1 month after publication of the application in the Register.
Amendment 120 #
Proposal for a regulation Article 14 – paragraph 3 – subparagraph 1 (new) Whenever the expedited procedure applies in accordance with to Article 13 (5a), observations shall be submitted within 1 month after publication of the application in the Register.
Amendment 122 #
Proposal for a regulation Article 15 – paragraph 4 – point c a (new) (c a) any evidence that is relied upon by the opponent.
Amendment 122 #
Proposal for a regulation Article 15 – paragraph 4 – point c a (new) (c a) any evidence that is relied upon by the opponent.
Amendment 123 #
Proposal for a regulation Article 15 – paragraph 4 a (new) 4 a. any evidence that is relied upon by the opponent.
Amendment 123 #
Proposal for a regulation Article 15 – paragraph 4 a (new) 4 a. any evidence that is relied upon by the opponent.
Amendment 124 #
Proposal for a regulation Article 15 – 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 124 #
Proposal for a regulation Article 15 – 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 125 #
Proposal for a regulation Article 15 – 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 125 #
Proposal for a regulation Article 15 – 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 126 #
Proposal for a regulation Article 15 – paragraph 8 Amendment 126 #
Proposal for a regulation Article 15 – paragraph 8 Amendment 127 #
Proposal for a regulation Article 15 – paragraph 8 Amendment 127 #
Proposal for a regulation Article 15 – paragraph 8 Amendment 128 #
Proposal for a regulation Article 15 – paragraph 10 10. 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 128 #
Proposal for a regulation Article 15 – paragraph 10 10. 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 129 #
Proposal for a regulation Article 15 – paragraph 10 10. 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 129 #
Proposal for a regulation Article 15 – paragraph 10 10. 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 130 #
Proposal for a regulation Article 15 – paragraph 10 a (new) 10 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 130 #
Proposal for a regulation Article 15 – paragraph 10 a (new) 10 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 131 #
Proposal for a regulation Article 15 – paragraph 10 a (new) 10 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 131 #
Proposal for a regulation Article 15 – paragraph 10 a (new) 10 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 132 #
Proposal for a regulation Article 15 – paragraph 12 12. 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
Amendment 132 #
Proposal for a regulation Article 15 – paragraph 12 12. 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
Amendment 133 #
Proposal for a regulation Article 15 – paragraph 12 12. If the opposition panel considers that
Amendment 133 #
Proposal for a regulation Article 15 – paragraph 12 12. If the opposition panel considers that
Amendment 134 #
Proposal for a regulation Article 15 – paragraph 13 a (new) 13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 134 #
Proposal for a regulation Article 15 – paragraph 13 a (new) 13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 135 #
Proposal for a regulation Article 15 – paragraph 13 a (new) 13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 135 #
Proposal for a regulation Article 15 – paragraph 13 a (new) 13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 136 #
Proposal for a regulation Article 16 – 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 applications for unitary certificates, on the basis of their relevant expertise and experience in the field.
Amendment 136 #
Proposal for a regulation Article 16 – 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 applications for unitary certificates, on the basis of their relevant expertise and experience in the field.
Amendment 137 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1 a. Once a national competent authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and independence, and whether they have sufficient experience for the centralised examination procedure.
Amendment 137 #
Proposal for a regulation Article 16 – paragraph 1 a (new) 1 a. Once a national competent authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and independence, and whether they have sufficient experience for the centralised examination procedure.
Amendment 138 #
Proposal for a regulation Article 16 – 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 138 #
Proposal for a regulation Article 16 – 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 139 #
Proposal for a regulation Article 17 – paragraph 1 1. The assessments under Articles 13
Amendment 139 #
Proposal for a regulation Article 17 – paragraph 1 1. The assessments under Articles 13
Amendment 140 #
Proposal for a regulation Article 17 – paragraph 3 – introductory part 3. When setting up an examination panel, the Office shall ensure the following: a. the respective workload of the examiners is taken into account; b. no more than one examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231.
Amendment 140 #
Proposal for a regulation Article 17 – paragraph 3 – introductory part 3. When setting up an examination panel, the Office shall ensure the following: a. the respective workload of the examiners is taken into account; b. no more than one examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231.
Amendment 141 #
Proposal for a regulation Article 17 – paragraph 3 – point -a (new) (-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 141 #
Proposal for a regulation Article 17 – paragraph 3 – point -a (new) (-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 142 #
Proposal for a regulation Article 17 – paragraph 3 – point a Amendment 142 #
Proposal for a regulation Article 17 – paragraph 3 – point a Amendment 143 #
Proposal for a regulation Article 17 – paragraph 3 – point a a (new) (a a) relevant expertise and sufficient experience of the examiners, 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 143 #
Proposal for a regulation Article 17 – paragraph 3 – point a a (new) (a a) relevant expertise and sufficient experience of the examiners, 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 144 #
Proposal for a regulation Article 17 – paragraph 3 – point c (c)
Amendment 144 #
Proposal for a regulation Article 17 – paragraph 3 – point c (c)
Amendment 145 #
Proposal for a regulation Article 17 – paragraph 3 – point c (c) no
Amendment 145 #
Proposal for a regulation Article 17 – paragraph 3 – point c (c) no
Amendment 146 #
Proposal for a regulation Article 17 – paragraph 4 4. The Office shall publish a yearly an overview of the number of procedures, including those for examination
Amendment 146 #
Proposal for a regulation Article 17 – paragraph 4 4. The Office shall publish a yearly an overview of the number of procedures, including those for examination
Amendment 147 #
Proposal for a regulation Article 18 – paragraph 1 – introductory part Grant of a unitary certificate or rejection of the application for a unitary certificate 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
Amendment 147 #
Proposal for a regulation Article 18 – paragraph 1 – introductory part Grant of a unitary certificate or rejection of the application for a unitary certificate 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
Amendment 148 #
Proposal for a regulation Article 18 – paragraph 1 – introductory part Amendment 148 #
Proposal for a regulation Article 18 – paragraph 1 – introductory part Amendment 149 #
Proposal for a regulation Article 18 – paragraph 1 – introductory part Amendment 149 #
Proposal for a regulation Article 18 – paragraph 1 – introductory part Amendment 150 #
Proposal for a regulation Article 18 – paragraph 1 – subparagraph 1 (new) The Office shall inform the applicant of its decision without undue delay.
Amendment 150 #
Proposal for a regulation Article 18 – paragraph 1 – subparagraph 1 (new) The Office shall inform the applicant of its decision without undue delay.
Amendment 151 #
Proposal for a regulation Article 19 – paragraph 2 2. Third parties may also submit observations or an opposition in respect of a
Amendment 151 #
Proposal for a regulation Article 19 – paragraph 2 2. Third parties may also submit observations or an opposition in respect of a
Amendment 152 #
Proposal for a regulation Article 22 – paragraph 1 – point a (a) the certificate was granted contrary to Article 3 and 6;
Amendment 152 #
Proposal for a regulation Article 22 – paragraph 1 – point a (a) the certificate was granted contrary to Article 3 and 6;
Amendment 153 #
Proposal for a regulation Article 22 – paragraph 1 – point c a (new) (c a) the centralised marketing authorisation has been withdrawn in accordance with Article 14 or there has been a suspension of marketing, a withdrawal from the market of a medicinal product or a withdrawal of a marketing authorisation by the marketing authorisation holder in accordance with Article 24 [revised Regulation (EC) No 726/2004].
Amendment 153 #
Proposal for a regulation Article 22 – paragraph 1 – point c a (new) (c a) the centralised marketing authorisation has been withdrawn in accordance with Article 14 or there has been a suspension of marketing, a withdrawal from the market of a medicinal product or a withdrawal of a marketing authorisation by the marketing authorisation holder in accordance with Article 24 [revised Regulation (EC) No 726/2004].
Amendment 154 #
Proposal for a regulation Article 22 – paragraph 1 – point c b (new) (c b) the medicinal product is not placed on all Member States market covered by the unitary certificate or combined centralised supplementary protection certificate; where a medicinal product is not placed on a Member State market covered by the unitary certificate or the combined centralised supplementary protection certificate, the applicant shall waive the supplementary protection certificate rights for markets where the medicinal product has not been launched.
Amendment 154 #
Proposal for a regulation Article 22 – paragraph 1 – point c b (new) (c b) the medicinal product is not placed on all Member States market covered by the unitary certificate or combined centralised supplementary protection certificate; where a medicinal product is not placed on a Member State market covered by the unitary certificate or the combined centralised supplementary protection certificate, the applicant shall waive the supplementary protection certificate rights for markets where the medicinal product has not been launched.
Amendment 155 #
Proposal for a regulation Article 22 – paragraph 1 a (new) 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.
Amendment 155 #
Proposal for a regulation Article 22 – paragraph 1 a (new) 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.
Amendment 158 #
Proposal for a regulation Article 23 – title A
Amendment 158 #
Proposal for a regulation Article 23 – title A
Amendment 159 #
Proposal for a regulation Article 23 – paragraph 1 1. Any person may
Amendment 159 #
Proposal for a regulation Article 23 – paragraph 1 1. Any person may
Amendment 160 #
Proposal for a regulation Article 23 – paragraph 2 a (new) 2 a. When the decision taken on the action for declaration of invalidity becomes final, the Unified Patent Court shall without delay send a copy of the judgment to the Office. The Office or any other interested party may request information about such transmission. The Office shall mention the judgment in the Register and shall take the necessary measures to comply with its operative part.
Amendment 160 #
Proposal for a regulation Article 23 – paragraph 2 a (new) 2 a. When the decision taken on the action for declaration of invalidity becomes final, the Unified Patent Court shall without delay send a copy of the judgment to the Office. The Office or any other interested party may request information about such transmission. The Office shall mention the judgment in the Register and shall take the necessary measures to comply with its operative part.
Amendment 161 #
Proposal for a regulation Article 23 – paragraph 3 Amendment 161 #
Proposal for a regulation Article 23 – paragraph 3 Amendment 162 #
Proposal for a regulation Article 23 – paragraph 3 3. An application for a declaration of invalidity shall be filed in writing or electronically, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid.
Amendment 162 #
Proposal for a regulation Article 23 – paragraph 3 3. An application for a declaration of invalidity shall be filed in writing or electronically, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid.
Amendment 163 #
Proposal for a regulation Article 23 – paragraph 4 Amendment 163 #
Proposal for a regulation Article 23 – paragraph 4 Amendment 164 #
Proposal for a regulation Article 23 – paragraph 5 Amendment 164 #
Proposal for a regulation Article 23 – paragraph 5 Amendment 165 #
Proposal for a regulation Article 23 – paragraph 6 Amendment 165 #
Proposal for a regulation Article 23 – paragraph 6 Amendment 166 #
Proposal for a regulation Article 23 – paragraph 7 Amendment 166 #
Proposal for a regulation Article 23 – paragraph 7 Amendment 167 #
Proposal for a regulation Article 23 – paragraph 8 Amendment 167 #
Proposal for a regulation Article 23 – paragraph 8 Amendment 168 #
Proposal for a regulation Article 23 – paragraph 9 Amendment 168 #
Proposal for a regulation Article 23 – paragraph 9 Amendment 169 #
Proposal for a regulation Article 23 – paragraph 10 Amendment 169 #
Proposal for a regulation Article 23 – paragraph 10 Amendment 170 #
Proposal for a regulation Article 23 – paragraph 11 Amendment 170 #
Proposal for a regulation Article 23 – paragraph 11 Amendment 171 #
Proposal for a regulation Article 23 – paragraph 12 12. To the extent that it has been declared invalid, the unitary certificate shall be deemed not to have had, as from the outset, the effects specified in this Regulation
Amendment 171 #
Proposal for a regulation Article 23 – paragraph 12 12. To the extent that it has been declared invalid, the unitary certificate shall be deemed not to have had, as from the outset, the effects specified in this Regulation
Amendment 172 #
Proposal for a regulation Article 23 – paragraph 13 Amendment 172 #
Proposal for a regulation Article 23 – paragraph 13 Amendment 175 #
Proposal for a regulation Article 24 – paragraph 2 2. The competent court of a Member State shall reject a counterclaim for a declaration of invalidity if a decision taken by the
Amendment 175 #
Proposal for a regulation Article 24 – paragraph 2 2. The competent court of a Member State shall reject a counterclaim for a declaration of invalidity if a decision taken by the
Amendment 176 #
Proposal for a regulation Article 24 – paragraph 4 4. The competent court of a Member State with which a counterclaim for a declaration of invalidity of the unitary certificate has been filed shall not proceed with the examination of the counterclaim, until either the interested party or the court has informed the
Amendment 176 #
Proposal for a regulation Article 24 – paragraph 4 4. The competent court of a Member State with which a counterclaim for a declaration of invalidity of the unitary certificate has been filed shall not proceed with the examination of the counterclaim, until either the interested party or the court has informed the
Amendment 177 #
Proposal for a regulation Article 24 – paragraph 6 Amendment 177 #
Proposal for a regulation Article 24 – paragraph 6 Amendment 178 #
Proposal for a regulation Article 28 – paragraph 3 3. Notice of appeal shall be filed electronically 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 178 #
Proposal for a regulation Article 28 – paragraph 3 3. Notice of appeal shall be filed electronically 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 179 #
Proposal for a regulation Article 28 – 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 179 #
Proposal for a regulation Article 28 – 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 180 #
Proposal for a regulation Article 28 – paragraph 3 3. Notice of appeal shall be filed in writing or electronically 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.
Amendment 180 #
Proposal for a regulation Article 28 – paragraph 3 3. Notice of appeal shall be filed in writing or electronically 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.
Amendment 181 #
Proposal for a regulation Article 28 – 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 181 #
Proposal for a regulation Article 28 – 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 182 #
Proposal for a regulation Article 28 – 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 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 be issued within 3 months after the date of the oral hearing.
Amendment 182 #
Proposal for a regulation Article 28 – 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 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 be issued within 3 months after the date of the oral hearing.
Amendment 183 #
Proposal for a regulation Article 28 – 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 183 #
Proposal for a regulation Article 28 – 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 184 #
Proposal for a regulation Article 28 – paragraph 5 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards
Amendment 184 #
Proposal for a regulation Article 28 – paragraph 5 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards
Amendment 185 #
Proposal for a regulation Article 28 – paragraph 6 6.
Amendment 185 #
Proposal for a regulation Article 28 – paragraph 6 6.
Amendment 186 #
Proposal for a regulation Article 28 – paragraph 8 a (new) 8 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
Amendment 186 #
Proposal for a regulation Article 28 – paragraph 8 a (new) 8 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
Amendment 187 #
Proposal for a regulation Article 29 – paragraph 4 4. Members of the Boards of Appeal in matters regarding unitary 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 concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law.
Amendment 187 #
Proposal for a regulation Article 29 – paragraph 4 4. Members of the Boards of Appeal in matters regarding unitary 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 concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law.
Amendment 188 #
Proposal for a regulation Article 29 – paragraph 4 4. Members of the Boards of Appeal in matters regarding unitary 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 unitary certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 188 #
Proposal for a regulation Article 29 – paragraph 4 4. Members of the Boards of Appeal in matters regarding unitary 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 unitary certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 189 #
Proposal for a regulation Article 31 – paragraph 2 2. The Office shall charge a fee for appeals
Amendment 189 #
Proposal for a regulation Article 31 – paragraph 2 2. The Office shall charge a fee for appeals
Amendment 190 #
Proposal for a regulation Article 35 – paragraph 1 – point i a (new) (i 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 190 #
Proposal for a regulation Article 35 – paragraph 1 – point i a (new) (i 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 191 #
Proposal for a regulation Article 35 – paragraph 1 – point i a (new) (i a) information on any direct public financial support received for research related to the development of the product;
Amendment 191 #
Proposal for a regulation Article 35 – paragraph 1 – point i a (new) (i a) information on any direct public financial support received for research related to the development of the product;
Amendment 192 #
Proposal for a regulation Article 35 – paragraph 1 – point i a (new) (i 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 192 #
Proposal for a regulation Article 35 – paragraph 1 – point i a (new) (i 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 193 #
Proposal for a regulation Article 35 – paragraph 1 – point j (j)
Amendment 193 #
Proposal for a regulation Article 35 – paragraph 1 – point j (j)
Amendment 194 #
Proposal for a regulation Article 35 – paragraph 1 – point k a (new) (k a) where applicable, any third party observation and any related documents;
Amendment 194 #
Proposal for a regulation Article 35 – paragraph 1 – point k a (new) (k a) where applicable, any third party observation and any related documents;
Amendment 195 #
Proposal for a regulation Article 35 – paragraph 1 – point k a (new) (k a) where applicable, any third party observation and any related documents;
Amendment 195 #
Proposal for a regulation Article 35 – paragraph 1 – point k a (new) (k a) where applicable, any third party observation and any related documents;
Amendment 196 #
Proposal for a regulation Article 35 – paragraph 1 – point l (l)
Amendment 196 #
Proposal for a regulation Article 35 – paragraph 1 – point l (l)
Amendment 197 #
Proposal for a regulation Article 35 – paragraph 1 – point l (l) where applicable, the date and a
Amendment 197 #
Proposal for a regulation Article 35 – paragraph 1 – point l (l) where applicable, the date and a
Amendment 198 #
Proposal for a regulation Article 35 – paragraph 1 – point l (l) where applicable, the date and a
Amendment 198 #
Proposal for a regulation Article 35 – paragraph 1 – point l (l) where applicable, the date and a
Amendment 199 #
Proposal for a regulation Article 35 – paragraph 1 – point m Amendment 199 #
Proposal for a regulation Article 35 – paragraph 1 – point m Amendment 200 #
Proposal for a regulation Article 35 – paragraph 1 – point m (m) where applicable, the filing of an opposition,
Amendment 200 #
Proposal for a regulation Article 35 – paragraph 1 – point m (m) where applicable, the filing of an opposition,
Amendment 201 #
Proposal for a regulation Article 35 – paragraph 1 – point m (m) where applicable, the filing of an opposition,
Amendment 201 #
Proposal for a regulation Article 35 – paragraph 1 – point m (m) where applicable, the filing of an opposition,
Amendment 202 #
Proposal for a regulation Article 35 – paragraph 1 – point n (n) where applicable, the filing of an appeal,
Amendment 202 #
Proposal for a regulation Article 35 – paragraph 1 – point n (n) where applicable, the filing of an appeal,
Amendment 203 #
Proposal for a regulation Article 35 – paragraph 1 – point n (n) where applicable, the filing of an appeal,
Amendment 203 #
Proposal for a regulation Article 35 – paragraph 1 – point n (n) where applicable, the filing of an appeal,
Amendment 204 #
Proposal for a regulation Article 35 – paragraph 1 – 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 204 #
Proposal for a regulation Article 35 – paragraph 1 – 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 205 #
Proposal for a regulation Article 35 – paragraph 1 – point r a (new) (r a) 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 205 #
Proposal for a regulation Article 35 – paragraph 1 – point r a (new) (r a) 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 206 #
Proposal for a regulation Article 35 – paragraph 1 – point r a (new) (r a) any documents and communications between the Office and any party in the proceedings.
Amendment 206 #
Proposal for a regulation Article 35 – paragraph 1 – point r a (new) (r a) any documents and communications between the Office and any party in the proceedings.
Amendment 207 #
Proposal for a regulation Article 35 – paragraph 1 – point r b (new) (r b) any documents and communications between the Office and any party in the proceedings.
Amendment 207 #
Proposal for a regulation Article 35 – paragraph 1 – point r b (new) (r b) any documents and communications between the Office and any party in the proceedings.
Amendment 208 #
Proposal for a regulation Article 35 – paragraph 7 – point b (b) maintaining the Register and making it available for inspection by
Amendment 208 #
Proposal for a regulation Article 35 – paragraph 7 – point b (b) maintaining the Register and making it available for inspection by
Amendment 209 #
Proposal for a regulation Article 35 – paragraph 7 – point b (b) maintaining the Register and making it available for inspection by
Amendment 209 #
Proposal for a regulation Article 35 – paragraph 7 – point b (b) maintaining the Register and making it available for inspection by
Amendment 210 #
Proposal for a regulation Article 35 – paragraph 8 a (new) 8 a. By way of derogation from Article 35(7), 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 210 #
Proposal for a regulation Article 35 – paragraph 8 a (new) 8 a. By way of derogation from Article 35(7), 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 211 #
Proposal for a regulation Article 35 – paragraph 8 a (new) 8 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 211 #
Proposal for a regulation Article 35 – paragraph 8 a (new) 8 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 212 #
Proposal for a regulation Article 35 – paragraph 8 a (new) 8 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 212 #
Proposal for a regulation Article 35 – paragraph 8 a (new) 8 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 213 #
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 213 #
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 214 #
Proposal for a regulation Article 39 – paragraph 1 – point c Amendment 214 #
Proposal for a regulation Article 39 – paragraph 1 – point c Amendment 215 #
Proposal for a regulation Article 39 – paragraph 1 – point d Amendment 215 #
Proposal for a regulation Article 39 – paragraph 1 – point d Amendment 216 #
Proposal for a regulation Article 41 – paragraph 2 Amendment 216 #
Proposal for a regulation Article 41 – paragraph 2 Amendment 217 #
Proposal for a regulation Article 41 – paragraph 2 Amendment 217 #
Proposal for a regulation Article 41 – paragraph 2 Amendment 218 #
Proposal for a regulation Article 41 – paragraph 2 2. Oral proceedings before an examination
Amendment 218 #
Proposal for a regulation Article 41 – paragraph 2 2. Oral proceedings before an examination
Amendment 219 #
Proposal for a regulation Article 41 – 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 219 #
Proposal for a regulation Article 41 – 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 220 #
Proposal for a regulation Article 41 – 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 220 #
Proposal for a regulation Article 41 – 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 221 #
Proposal for a regulation Article 42 – 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 not subject to 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 221 #
Proposal for a regulation Article 42 – 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 not subject to 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 222 #
Proposal for a regulation Article 46 – paragraph 5 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article
Amendment 222 #
Proposal for a regulation Article 46 – paragraph 5 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article
Amendment 223 #
Proposal for a regulation Article 48 – paragraph 1 1. The losing party in
Amendment 223 #
Proposal for a regulation Article 48 – paragraph 1 1. The losing party in
Amendment 224 #
Proposal for a regulation Article 50 – paragraph 1 – point 1 – point b Article 151 – paragraph 1 Article 151 – paragraph 1 (g) on the basis of requests for participation in the centralised examination procedure, and after giving the Commission an opportunity to comment on them, appointing, by concluding an agreement, those competent national authorities whose examiners will be able to participate in the centralised examination of centralised applications for certificates under Regulations [COM(2023) 231] and [COM(2023) 223],
Amendment 224 #
Proposal for a regulation Article 50 – paragraph 1 – point 1 – point b Article 151 – paragraph 1 Article 151 – paragraph 1 (g) on the basis of requests for participation in the centralised examination procedure, and after giving the Commission an opportunity to comment on them, appointing, by concluding an agreement, those competent national authorities whose examiners will be able to participate in the centralised examination of centralised applications for certificates under Regulations [COM(2023) 231] and [COM(2023) 223],
Amendment 225 #
Proposal for a regulation Article 54 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 225 #
Proposal for a regulation Article 54 – paragraph 2 2. The power to adopt delegated acts referred to in Articles
Amendment 226 #
Proposal for a regulation Article 54 – paragraph 3 3. The delegation of power referred to in Articles
Amendment 226 #
Proposal for a regulation Article 54 – paragraph 3 3. The delegation of power referred to in Articles
Amendment 227 #
Proposal for a regulation Article 54 – paragraph 6 6. A delegated act adopted pursuant to Article
Amendment 227 #
Proposal for a regulation Article 54 – paragraph 6 6. A delegated act adopted pursuant to Article
Amendment 228 #
Proposal for a regulation Article 56 – paragraph 1 By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament and to the Council. Special emphasis shall be given to the effects of longer exclusivity periods to recover R&D investments in the light of Directive (EU) No XXX/XX [COM(2023)192] .
Amendment 228 #
Proposal for a regulation Article 56 – paragraph 1 By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament and to the Council. Special emphasis shall be given to the effects of longer exclusivity periods to recover R&D investments in the light of Directive (EU) No XXX/XX [COM(2023)192] .
Amendment 229 #
Proposal for a regulation Article 56 – paragraph 1 By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee.
Amendment 229 #
Proposal for a regulation Article 56 – paragraph 1 By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee.
Amendment 230 #
Proposal for a regulation Article 56 – paragraph 1 By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation. and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee.
Amendment 230 #
Proposal for a regulation Article 56 – paragraph 1 By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation. and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee.
Amendment 63 #
Proposal for a regulation Recital 1 (1) Pharmaceutical research plays a decisive role in the continuing improvement in public health. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is challenging to establish a clear link between SPC protection and the location of R&D, because many other factors unrelated to the SPC play a significant role in the location of R&D.
Amendment 63 #
Proposal for a regulation Recital 1 (1) Pharmaceutical research plays a decisive role in the continuing improvement in public health. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is challenging to establish a clear link between SPC protection and the location of R&D, because many other factors unrelated to the SPC play a significant role in the location of R&D.
Amendment 64 #
Proposal for a regulation Recital 1 (1) Pharmaceutical research plays a decisive role in the continuing improvement in public health and in ensuring the Union’s competitiveness. 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.
Amendment 64 #
Proposal for a regulation Recital 1 (1) Pharmaceutical research plays a decisive role in the continuing improvement in public health and in ensuring the Union’s competitiveness. 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.
Amendment 65 #
Proposal for a regulation Recital 2 (2) The period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. Whereas such considerations, governing the grant of supplementary certificate protection, according to Regulation (EEC) No 1768/92, should still apply regardless of its territorial scope.
Amendment 65 #
Proposal for a regulation Recital 2 (2) The period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. Whereas such considerations, governing the grant of supplementary certificate protection, according to Regulation (EEC) No 1768/92, should still apply regardless of its territorial scope.
Amendment 66 #
Proposal for a regulation Recital 2 a (new) (2 a) That 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.
Amendment 66 #
Proposal for a regulation Recital 2 a (new) (2 a) That 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.
Amendment 67 #
Proposal for a regulation Recital 11 (11) In particular, the duration of the protection granted by a unitary certificate should be identical to the duration provided for as regards national certificates under Regulation [COM(2023) 231]; namely, the holder of both a unitary patent and a unitary certificate should be able to enjoy an overall maximum of 1
Amendment 67 #
Proposal for a regulation Recital 11 (11) In particular, the duration of the protection granted by a unitary certificate should be identical to the duration provided for as regards national certificates under Regulation [COM(2023) 231]; namely, the holder of both a unitary patent and a unitary certificate should be able to enjoy an overall maximum of 1
Amendment 68 #
Proposal for a regulation Recital 16 Amendment 68 #
Proposal for a regulation Recital 16 Amendment 69 #
Proposal for a regulation Recital 16 (16) 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 69 #
Proposal for a regulation Recital 16 (16) 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 70 #
Proposal for a regulation Recital 17 (17) 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 70 #
Proposal for a regulation Recital 17 (17) 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 71 #
Proposal for a regulation Recital 17 (17) 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 71 #
Proposal for a regulation Recital 17 (17) 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 72 #
Proposal for a regulation Recital 19 Amendment 72 #
Proposal for a regulation Recital 19 Amendment 73 #
Proposal for a regulation Recital 20 (20) 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 73 #
Proposal for a regulation Recital 20 (20) 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 74 #
Proposal for a regulation Recital 21 (21) 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 74 #
Proposal for a regulation Recital 21 (21) 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 75 #
Proposal for a regulation Recital 21 (21) 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 75 #
Proposal for a regulation Recital 21 (21) 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 76 #
Proposal for a regulation Recital 21 a (new) (21 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 for patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States.
Amendment 76 #
Proposal for a regulation Recital 21 a (new) (21 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 for patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States.
Amendment 77 #
Proposal for a regulation Recital 22 (22) Regulation [COM(2023) 231] provides for an exception according to which, under narrowly defined circumstances and subject to various safeguards, the protection conferred by a national supplementary protection certificate for medicinal products does not extend to a product that would be manufactured in the Union by a person other than the holder of that certificate, where it is manufactured for the purpose of being exported to a third country
Amendment 77 #
Proposal for a regulation Recital 22 (22) Regulation [COM(2023) 231] provides for an exception according to which, under narrowly defined circumstances and subject to various safeguards, the protection conferred by a national supplementary protection certificate for medicinal products does not extend to a product that would be manufactured in the Union by a person other than the holder of that certificate, where it is manufactured for the purpose of being exported to a third country
Amendment 78 #
Proposal for a regulation Recital 25 (25) 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 unitary certificate 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 subsequent invalidity proceedings before the Office. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 78 #
Proposal for a regulation Recital 25 (25) 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 unitary certificate 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 subsequent invalidity proceedings before the Office. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 79 #
Proposal for a regulation Recital 25 (25) 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 unitary certificate application, to submit within 3 months observations to the Office while the centralised examination is being performed. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate subsequent invalidity proceedings before the
Amendment 79 #
Proposal for a regulation Recital 25 (25) 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 unitary certificate application, to submit within 3 months observations to the Office while the centralised examination is being performed. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate subsequent invalidity proceedings before the
Amendment 80 #
Proposal for a regulation Recital 26 (26) The examination of an application for a unitary 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 procedure, in particular as regards qualification and conflicts of interest.
Amendment 80 #
Proposal for a regulation Recital 26 (26) The examination of an application for a unitary 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 procedure, in particular as regards qualification and conflicts of interest.
Amendment 81 #
Proposal for a regulation Recital 26 (26) The examination of an application for a unitary 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 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 procedure, in particular as regards qualification and conflicts of interest.
Amendment 81 #
Proposal for a regulation Recital 26 (26) The examination of an application for a unitary 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 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 procedure, in particular as regards qualification and conflicts of interest.
Amendment 82 #
Proposal for a regulation Recital 26 a (new) (26 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 under this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be foreseen.
Amendment 82 #
Proposal for a regulation Recital 26 a (new) (26 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 under this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be foreseen.
Amendment 83 #
Proposal for a regulation Recital 28 Amendment 83 #
Proposal for a regulation Recital 28 Amendment 84 #
Proposal for a regulation Recital 29 (29) After the completion of the examination of a unitary certificate application, and after the time limits for appeal
Amendment 84 #
Proposal for a regulation Recital 29 (29) After the completion of the examination of a unitary certificate application, and after the time limits for appeal
Amendment 85 #
Proposal for a regulation Recital 30 (30)
Amendment 85 #
Proposal for a regulation Recital 30 (30)
Amendment 86 #
Proposal for a regulation Recital 31 (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 86 #
Proposal for a regulation Recital 31 (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 87 #
Proposal for a regulation Recital 31 (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 87 #
Proposal for a regulation Recital 31 (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 88 #
Proposal for a regulation Recital 32 (32) Any person may challenge the validity of a unitary certificate by lodging with the
Amendment 88 #
Proposal for a regulation Recital 32 (32) Any person may challenge the validity of a unitary certificate by lodging with the
Amendment 89 #
Proposal for a regulation Recital 33 (33) The Office should have the possibility to charge a fee for the centralised application for a
Amendment 89 #
Proposal for a regulation Recital 33 (33) The Office should have the possibility to charge a fee for the centralised application for a
Amendment 90 #
Proposal for a regulation Recital 33 (33) The Office should have the possibility to charge a fee for the application for a unitary certificate and for an application for the extension of duration of a unitary certificate in the case of paediatric medicinal products, as well as other procedural fees such as those for
Amendment 90 #
Proposal for a regulation Recital 33 (33) The Office should have the possibility to charge a fee for the application for a unitary certificate and for an application for the extension of duration of a unitary certificate in the case of paediatric medicinal products, as well as other procedural fees such as those for
Amendment 91 #
Proposal for a regulation Recital 35 (35) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. 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 91 #
Proposal for a regulation Recital 35 (35) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. 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 92 #
Proposal for a regulation Article 2 – paragraph 1 – point 9 a (new) (9 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 92 #
Proposal for a regulation Article 2 – paragraph 1 – point 9 a (new) (9 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 93 #
Proposal for a regulation Article 3 – paragraph 1 – point a (a) the product is protected by that basic patent in force and is already available on the Union market ;
Amendment 93 #
Proposal for a regulation Article 3 – paragraph 1 – point a (a) the product is protected by that basic patent in force and is already available on the Union market ;
Amendment 94 #
Proposal for a regulation Article 3 – paragraph 1 – point b (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive (EU) ... [2023/0132 (COD)], with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004, as appropriate ;
Amendment 94 #
Proposal for a regulation Article 3 – paragraph 1 – point b (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive (EU) ... [2023/0132 (COD)], with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004, as appropriate ;
Amendment 95 #
Proposal for a regulation Article 3 – paragraph 2 – subparagraph 2 Where two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending in a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not
Amendment 95 #
Proposal for a regulation Article 3 – paragraph 2 – subparagraph 2 Where two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending in a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not
Amendment 96 #
Proposal for a regulation Article 5 – paragraph 3 – introductory part 3. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met:
Amendment 96 #
Proposal for a regulation Article 5 – paragraph 3 – introductory part 3. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met:
Amendment 97 #
Proposal for a regulation Article 5 – paragraph 3 – point a – point iii (iii) the making, no earlier than 6 months before the expiry of the
Amendment 97 #
Proposal for a regulation Article 5 – paragraph 3 – point a – point iii (iii) the making, no earlier than 6 months before the expiry of the
Amendment 98 #
Proposal for a regulation Article 5 – paragraph 3 – point a – point iv a (new) (iv a) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)].
Amendment 98 #
Proposal for a regulation Article 5 – paragraph 3 – point a – point iv a (new) (iv a) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)].
Amendment 99 #
Proposal for a regulation Article 8 – paragraph 2 2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before
Amendment 99 #
Proposal for a regulation Article 8 – paragraph 2 2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before
source: 756.103
|
History
(these mark the time of scraping, not the official date of the change)
2024-12-18Show (42) Changes | Timetravel
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2024-10-28Show (13) Changes | Timetravel
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2024-10-27Show (13) Changes | Timetravel
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2024-10-26Show (13) Changes | Timetravel
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2024-10-25Show (13) Changes | Timetravel
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2024-10-24Show (13) Changes | Timetravel
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2024-10-23Show (13) Changes | Timetravel
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2024-10-22Show (13) Changes | Timetravel
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2024-10-21Show (13) Changes | Timetravel
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2024-10-20Show (13) Changes | Timetravel
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2024-10-19Show (13) Changes | Timetravel
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2024-10-18Show (13) Changes | Timetravel
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2024-10-17Show (13) Changes | Timetravel
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2024-10-16Show (12) Changes | Timetravel
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2023-09-08Show (4) Changes | Timetravel
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