Sittings · Document
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
Committee on Legal Affairs
Amendment 63
Daniel Buda
Proposal for a regulation
Recital 1
| Text proposed by the Commission | Amendment |
| (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. | (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. |
Or. en
Amendment 64
Javier Zarzalejos
Proposal for a regulation
Recital 1
| Text proposed by the Commission | Amendment |
| (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. | (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. |
Or. en
Amendment 65
Marie Toussaint
Proposal for a regulation
Recital 2
| Text proposed by the Commission | Amendment |
| (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. | (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. |
Or. en
Amendment 66
Javier Zarzalejos
Proposal for a regulation
Recital 2 a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Amendment 67
Daniel Buda
Proposal for a regulation
Recital 11
| Text proposed by the Commission | Amendment |
| (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 15 years of exclusivity from the time the medicinal product in question first obtains an authorisation to be placed on the market in the Union. Since the unitary certificate would take effect at the expiry of the basic patent, and in order to take into account discrepancies in national practices regarding the date of expiry of a patent which may result in 1-day differences, this Regulation should clarify when exactly the protection conferred by a unitary certificate should take effect. | (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 14 years of exclusivity from the time the medicinal product in question first obtains an authorisation to be placed on the market in the Union. Since the unitary certificate would take effect at the expiry of the basic patent, and in order to take into account discrepancies in national practices regarding the date of expiry of a patent which may result in 1-day differences, this Regulation should clarify when exactly the protection conferred by a unitary certificate should take effect. |
Or. en
Amendment 68
Daniel Buda
Proposal for a regulation
Recital 16
| Text proposed by the Commission | Amendment |
| (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 by the description of the patent on its filing date. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims provided that each of them is specifically identifiable in the light of all the information disclosed by that patent. | deleted |
Or. en
Amendment 69
Javier Zarzalejos
Proposal for a regulation
Recital 16
| Text proposed by the Commission | Amendment |
| (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 by the description of the patent on its filing date. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims provided that each of them is specifically identifiable in the light of all the information disclosed by that patent. | (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 in light of the description of the patent, on the basis of that person’s general knowledge in the relevant field and of the the prior art at the filing date or priority date of the basic patent. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims provided that each of them is specifically identifiable in the light of all the information disclosed by that patent. |
Or. en
Amendment 70
Javier Zarzalejos
Proposal for a regulation
Recital 17
| Text proposed by the Commission | Amendment |
| (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, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one. | (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, whether for the same therapeutic indication or for a different one. |
Or. en
Amendment 71
Daniel Buda
Proposal for a regulation
Recital 17
| Text proposed by the Commission | Amendment |
| (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, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one. | (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 derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one. |
Or. en
Amendment 72
Daniel Buda
Proposal for a regulation
Recital 19
| Text proposed by the Commission | Amendment |
| (19) To ensure balanced protection, however, a unitary certificate should entitle its holder to prevent a third party from manufacturing not only the product identified in the unitary certificate but also therapeutically equivalent derivatives of that product, such as salts, esters, ethers, isomers, mixtures of isomers or complexes, as well as biosimilars, even where such derivatives are not explicitly mentioned in the product description on the unitary certificate. There is therefore a need to consider that the protection conferred by the unitary certificate extends to such equivalent derivatives, within the limits of the protection conferred by the basic patent. | deleted |
Or. en
Amendment 73
Javier Zarzalejos
Proposal for a regulation
Recital 20
| Text proposed by the Commission | Amendment |
| (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 economically linked. Furthermore, no certificate should be granted to the proprietor of a basic patent in respect of a product which is the subject of an authorisation held by a third party, without that party’s consent. | (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 part of the same undertaking at the time of filing an application for a certificate. Furthermore, no certificate should be granted to the proprietor of a basic patent in respect of a product which is the subject of an authorisation held by a third party, without that party’s consent. |
Or. en
Amendment 74
Daniel Buda
Proposal for a regulation
Recital 21
| Text proposed by the Commission | Amendment |
| (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 therapeutically equivalent products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products. | (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, subject to the limits of the protection conferred by the basic patent, to all biosimilar products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products. |
Or. en
Justification
These clarifications reduce legal uncertainty and clarify the reference to biosimilars.
Amendment 75
Javier Zarzalejos
Proposal for a regulation
Recital 21
| Text proposed by the Commission | Amendment |
| (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 therapeutically equivalent products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products. | (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 biosimilar products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products. |
Or. en
Amendment 76
Marie Toussaint
Proposal for a regulation
Recital 21 a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Amendment 77
Javier Zarzalejos
Proposal for a regulation
Recital 22
| Text proposed by the Commission | Amendment |
| (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, or of being stored in the Union in view of its entry into the Union market upon expiry of the certificate. To avoid discrimination between applicants for certificates under Regulation [COM(2023) 231] and for unitary certificates under this Regulation, similar rights and limitations should be conferred by certificates under Regulation [COM(2023) 231] and by unitary certificates, and therefore that exception should also be available in respect of unitary certificates. The reasons for the introduction for the waiver and the conditions for its application should be applicable for unitary certificates. | (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 market where protection does not exist or has expired, or of being stored in a Member State for a defined period pending the expiry certificate in view of entering the market of any Member State upon expiry of the corresponding certificate. To avoid discrimination between applicants for certificates under Regulation [COM(2023) 231] and for unitary certificates under this Regulation, similar rights and limitations should be conferred by certificates under Regulation [COM(2023) 231] and by unitary certificates, and therefore that exception should also be available in respect of unitary certificates. The reasons for the introduction for the waiver and the conditions for its application should be applicable for unitary certificates. |
Or. en
Amendment 78
Daniel Buda
Proposal for a regulation
Recital 25
| Text proposed by the Commission | Amendment |
| (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 Office. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates. | (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. |
Or. en
Amendment 79
Javier Zarzalejos
Proposal for a regulation
Recital 25
| Text proposed by the Commission | Amendment |
| (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 Office. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates. | (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 Unified Patent Court. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates. |
Or. en
Amendment 80
Javier Zarzalejos
Proposal for a regulation
Recital 26
| Text proposed by the Commission | Amendment |
| (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 matters, located today at national offices only. To ensure an optimal quality of the examination, suitable criteria should be laid down in respect of the participation of specific examiners in the procedure, in particular as regards qualification and conflicts of interest. | (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. |
Or. en
Amendment 81
Marie Toussaint
Proposal for a regulation
Recital 26
| Text proposed by the Commission | Amendment |
| (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 matters, located today at national offices only. To ensure an optimal quality of the examination, suitable criteria should be laid down in respect of the participation of specific examiners in the procedure, in particular as regards qualification and conflicts of interest. | (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. |
Or. en
Amendment 82
Javier Zarzalejos
Proposal for a regulation
Recital 26 a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Amendment 83
Javier Zarzalejos
Proposal for a regulation
Recital 28
| Text proposed by the Commission | Amendment |
| (28) To safeguard third parties’ procedural rights and ensure a complete system of remedies, third parties should be able to challenge an examination opinion, by initiating opposition proceedings within a short duration following the publication of that opinion, and that opposition may result in that opinion being amended. | deleted |
Or. en
Amendment 84
Javier Zarzalejos
Proposal for a regulation
Recital 29
| Text proposed by the Commission | Amendment |
| (29) After the completion of the examination of a unitary certificate application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the Office should implement the examination opinion by granting a unitary certificate or rejecting the application, as applicable. | (29) After the completion of the examination of a unitary certificate application, and after the time limits for appeal have expired, or, the case being, after a final decision on the merits has been issued, the Office should implement without undue delay the examination opinion by granting a unitary certificate or rejecting the application, as applicable. |
Or. en
Amendment 85
Javier Zarzalejos
Proposal for a regulation
Recital 30
| Text proposed by the Commission | Amendment |
| (30) Where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed. | (30) To safeguard procedural rights and ensure a complete system of remedies, where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed. |
Or. en
Amendment 86
Marie Toussaint
Proposal for a regulation
Recital 31
| Text proposed by the Commission | Amendment |
| (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account. | (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. |
Or. en
Amendment 87
Javier Zarzalejos
Proposal for a regulation
Recital 31
| Text proposed by the Commission | Amendment |
| (31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account. | (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. |
Or. en
Amendment 88
Javier Zarzalejos
Proposal for a regulation
Recital 32
| Text proposed by the Commission | Amendment |
| (32) Any person may challenge the validity of a unitary certificate by lodging with the Office an application for a declaration of invalidity. | (32) Any person may challenge the validity of a unitary certificate by lodging with the Unified Patent Court an application for a declaration of invalidity. |
Or. en
Amendment 89
Daniel Buda
Proposal for a regulation
Recital 33
| Text proposed by the Commission | Amendment |
| (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 oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act. | (33) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of the paediatric extension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council, as well as other procedural fees such as those for oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act. |
Or. en
Justification
This amendment makes the reference to pediatric extensions more legally sound.
Amendment 90
Javier Zarzalejos
Proposal for a regulation
Recital 33
| Text proposed by the Commission | Amendment |
| (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 oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act. | (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 appeals. The fees charged by the Office should be laid down by an implementing act. |
Or. en
Amendment 91
Daniel Buda
Proposal for a regulation
Recital 35
| Text proposed by the Commission | Amendment |
| (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. | (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. |
Or. en
Justification
The EU is urged to abolish patent linkage to prevent delays in generic and biosimilar drug market entry and to include a disclaimer on the SPC register to ensure it's not used for regulatory decisions, aligning with efforts to promote competition and address anti-competitive practices.
Amendment 92
Daniel Buda
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Justification
The definition of ‘economically linked’ as referred to in recital 20 and articles 3 and 38 is necessary to provide legal certainty and uniform interpretation of the term. It reflects EMA’s definition of this concept in the context of Global Marketing Authorisations.
Amendment 93
Marie Toussaint
Proposal for a regulation
Article 3 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
| (a) the product is protected by that basic patent in force; | (a) the product is protected by that basic patent in force and is already available on the Union market ; |
Or. en
Amendment 94
Marie Toussaint
Proposal for a regulation
Article 3 – paragraph 1 – point b
| Text proposed by the Commission | Amendment |
| (b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004; | (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 ; |
Or. en
Amendment 95
Javier Zarzalejos
Proposal for a regulation
Article 3 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
| 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. | 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 part of the same undertaking at the time of filing an application for a certificate, by a competent national authority or by the Office, as applicable. The same principle shall apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents. |
Or. en
Amendment 96
Marie Toussaint
Proposal for a regulation
Article 5 – paragraph 3 – introductory part
| Text proposed by the Commission | Amendment |
| 3. By way of derogation from paragraph 1, 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: | 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: |
Or. en
Amendment 97
Marie Toussaint
Proposal for a regulation
Article 5 – paragraph 3 – point a – point iii
| Text proposed by the Commission | Amendment |
| (iii) the making, no earlier than 6 months before the expiry of the unitary certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; | (iii) the making, no earlier than 6 months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making, in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the corresponding certificate; |
Or. en
Amendment 98
Marie Toussaint
Proposal for a regulation
Article 5 – paragraph 3 – point a – point iv a (new)
| Text proposed by the Commission | Amendment |
| (iv a) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)]. |
Or. en
Amendment 99
Daniel Buda
Proposal for a regulation
Article 8 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before unitary effect is attributed to the basic patent, the application for a unitary certificate shall be lodged within 6 months of the date on which unitary effect is attributed to the basic patent. | 2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before the basic patent is granted, the application for a unitary certificate shall be lodged within 6 months of the date on which the patent is granted. |
Or. en
Justification
Reference to the date when “unitary effect is attributed” to the basic patent is confusing. Suggest keeping the wording “before the basic patent is granted” (same wording as in the proposed SPC recast regulation)
Amendment 100
Marie Toussaint
Proposal for a regulation
Article 8 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application. |
Or. en
Amendment 101
Adrián Vázquez Lázara
Proposal for a regulation
Article 9 – paragraph 1 – point a – point iv a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Justification
The transparency of the R&D funds received for the development of the product for which an SPC is requested is in line with the proposal included in the revised regulation regarding transferable exclusivity vouchers for novel antimicrobials in the pharmaceutical legislation.
Amendment 102
Daniel Buda
Proposal for a regulation
Article 9 – paragraph 1 – point a – point iv a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Justification
Transparency of the R&D funds received for the development of the product for which an SPC is applied for is in line with the proposal included in the revised Regulation, in relation to transferable exclusivity vouchers for novel antimicrobials, in the pharmaceutical legislation.
Amendment 103
Marie Toussaint
Proposal for a regulation
Article 9 – paragraph 1 – point a a (new)
| Text proposed by the Commission | Amendment |
| (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; |
Or. en
Justification
Such conditions are already required under Regulation (EC) No 847/2000 (Article 2(2)) on Orphan Drugs.
Amendment 104
Marie Toussaint
Proposal for a regulation
Article 9 – paragraph 1 – point d a (new)
| Text proposed by the Commission | Amendment |
| (d a) any information on any direct public financial support received for research related to the development of the product. |
Or. en
Amendment 105
Daniel Buda
Proposal for a regulation
Article 9 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| 1 a. a consent in accordance with Art. 6(2), if applicable. |
Or. en
Justification
The criterion of consent foreseen in art. 6(2) needs to also be included in the application, since it is one of the criteria for obtaining an SPC.
Amendment 106
Daniel Buda
Proposal for a regulation
Article 12 – paragraph 1
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Justification
Timely publication of the application is essential for third parties to be immediately aware of the possibility that an SPC be granted. This is also in line with the strict deadlines foreseen to make third party observations and the following procedures. The language is aligned with the one proposed in the SPC Recast Regulation.
Amendment 107
Javier Zarzalejos
Proposal for a regulation
Article 12 – paragraph 1
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Amendment 108
Adrián Vázquez Lázara
Proposal for a regulation
Article 13 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The Office shall assess the application on the basis of all the conditions in Article 3(1), for all Member States in which the basic patent has unitary effect. | 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. |
Or. en
Justification
The conditions referred to in Art. 3(2) and 6(2) should also be included in the examination of the application
Amendment 109
Daniel Buda
Proposal for a regulation
Article 13 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The Office shall assess the application on the basis of all the conditions in Article 3(1), for all Member States in which the basic patent has unitary effect. | 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. |
Or. en
Amendment 110
Javier Zarzalejos
Proposal for a regulation
Article 13 – paragraph 2
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Amendment 111
Adrián Vázquez Lázara
Proposal for a regulation
Article 13 – paragraph 2
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Justification
The conditions referred to in art. 3(2) and 6(2) should also be included in the examination of the application.
Amendment 112
Daniel Buda
Proposal for a regulation
Article 13 – paragraph 2
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Amendment 113
Daniel Buda
Proposal for a regulation
Article 13 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1) 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. | 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. |
Or. en
Justification
The conditions referred to in art. 3(2) and 6(2) should also be included in the examination of the application. For the sake of transparency, the opinion should be published as soon as possible on the Register.
Amendment 114
Adrián Vázquez Lázara
Proposal for a regulation
Article 13 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1) 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. | 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. |
Or. en
Amendment 115
Adrián Vázquez Lázara
Proposal for a regulation
Article 13 – paragraph 4
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Justification
In order to improve the transparency, the opinion should be published in the register as soon as possible.
Amendment 116
Javier Zarzalejos
Proposal for a regulation
Article 13 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 117
Adrián Vázquez Lázara
Proposal for a regulation
Article 13 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Justification
The timely issuance of an SPC is essential for the safety of applicants and third parties. An SPC cannot fulfil its function of compensating the patent proprietor for (at least part of) the time lost during the approval procedure if it is not granted in time. The grant of a SPC several years before the expiry of the basic patent is necessary so that innovators can plan their business and generic companies can be certain of when the intellectual property will expire and plan accordingly. The proposal provides for the Office to issue an EO within 3 months of the deadline for receipt of third party comments. This will give the Office sufficient time to consider such comments and issue a timely Order within 4 months of publication.
Amendment 118
Adrián Vázquez Lázara
Proposal for a regulation
Article 14 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Third party observations shall be submitted within 3 months after publication of the application in the Register. | 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. |
Or. en
Justification
Third Party Observations are important safeguards when it comes to the issuance of qualitative unitary certificates based on the scientific observations and peer review of qualified individuals or parties.
Amendment 119
Daniel Buda
Proposal for a regulation
Article 14 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Third party observations shall be submitted within 3 months after publication of the application in the Register. | 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. |
Or. en
Amendment 120
Javier Zarzalejos
Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 1 (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 121
Javier Zarzalejos
Proposal for a regulation
Article 15
| Text proposed by the Commission | Amendment |
| [...] | deleted |
Or. en
Amendment 122
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 4 – point c a (new)
| Text proposed by the Commission | Amendment |
| (c a) any evidence that is relied upon by the opponent. |
Or. en
Amendment 123
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 4 a. any evidence that is relied upon by the opponent. |
Or. en
Justification
This additional point is for the sake of transparency and legal certainty.
Amendment 124
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. | 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate 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. |
Or. en
Amendment 125
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. | 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate 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. |
Or. en
Justification
In order to safeguard transparency and legal certainty, this clarification is needed.
Amendment 126
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 8
| Text proposed by the Commission | Amendment |
| 8. A notice of opposition shall be inadmissible where a previous appeal relating to the same subject matter and cause of action has been adjudicated on its merits by the Office, and the decision of the Office on that appeal has acquired the authority of a final decision. | deleted |
Or. en
Amendment 127
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 8
| Text proposed by the Commission | Amendment |
| 8. A notice of opposition shall be inadmissible where a previous appeal relating to the same subject matter and cause of action has been adjudicated on its merits by the Office, and the decision of the Office on that appeal has acquired the authority of a final decision. | deleted |
Or. en
Justification
Para 8 is very unclear and confusing. It cannot refer to an appeal on another opposition on the same examination, since the opposition deadline is too short for this situation to happen.
Amendment 128
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 10
| Text proposed by the Commission | Amendment |
| 10. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. | 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. |
Or. en
Amendment 129
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 10
| Text proposed by the Commission | Amendment |
| 10. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. | 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. |
Or. en
Justification
The clarification in para 10 is for the sake of transparency and legal certainty.
Amendment 130
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 10 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Justification
A new paragraph 10a would ensure efficiency, uniformity and legal certainty in the work of the Office.
Amendment 131
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 10 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 132
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 12
| Text proposed by the Commission | Amendment |
| 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 mention this in the Register. | 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 publish its full decision in the Register. |
Or. en
Amendment 133
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 12
| Text proposed by the Commission | Amendment |
| 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 mention this in the Register. | 12. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition, and the Office shall publish its full decision in the Register. |
Or. en
Amendment 134
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 13 a (new)
| Text proposed by the Commission | Amendment |
| 13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. |
Or. en
Justification
New Paragraph 13a: this measure would ensure the highest possible level of transparency of the process.
Amendment 135
Raffaele Stancanelli
Proposal for a regulation
Article 15 – paragraph 13 a (new)
| Text proposed by the Commission | Amendment |
| 13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. |
Or. en
Amendment 136
Javier Zarzalejos
Proposal for a regulation
Article 16 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more applications for unitary certificates. | 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. |
Or. en
Amendment 137
Marie Toussaint
Proposal for a regulation
Article 16 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 138
Javier Zarzalejos
Proposal for a regulation
Article 16 – paragraph 5
| Text proposed by the Commission | Amendment |
| 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, opposition and invalidity proceedings. Each such competent national authority shall update that list in the event of a change. | 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 proceedings. Each such competent national authority shall update that list in the event of a change. |
Or. en
Amendment 139
Javier Zarzalejos
Proposal for a regulation
Article 17 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The assessments under Articles 13, 15, 19 and 23 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 16(1) from two different participating competent national authorities, under supervision of the Office. | 1. The assessments under Articles 13 and 19 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 16(1) from two different participating competent national authorities, under supervision of the Office. |
Or. en
Amendment 140
Daniel Buda
Proposal for a regulation
Article 17 – paragraph 3 – introductory part
| Text proposed by the Commission | Amendment |
| 3. When setting up an examination panel, the Office shall ensure the following: | 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. |
Or. en
Justification
In order to ensure the highest quality examination and, ultimately, SPC, appointment procedures should be based on hiring meritorious, highly qualified examiners and should not discriminate against applicants from any particular Member State. In the interest of timely patient access to medicines, no political or geographical criteria should potentially frustrate the quality of granting procedures and, ultimately, of SPCs.
Amendment 141
Marie Toussaint
Proposal for a regulation
Article 17 – paragraph 3 – point -a (new)
| Text proposed by the Commission | Amendment |
| (-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates; |
Or. en
Amendment 142
Adrián Vázquez Lázara
Proposal for a regulation
Article 17 – paragraph 3 – point a
| Text proposed by the Commission | Amendment |
| (a) geographical balance amongst the participating offices; | deleted |
Or. en
Justification
Ensuring a high quality examination is crucial. Any appointment procedure must be based on hiring meritorious, highly qualified examiners. Any applicant from any Member State should be discriminated. No political or geographical criteria should apply on this question.
Amendment 143
Javier Zarzalejos
Proposal for a regulation
Article 17 – paragraph 3 – point a a (new)
| Text proposed by the Commission | Amendment |
| (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; |
Or. en
Amendment 144
Marie Toussaint
Proposal for a regulation
Article 17 – paragraph 3 – point c
| Text proposed by the Commission | Amendment |
| (c) no more than one examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231]. | (c) that there is no examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231]. |
Or. en
Amendment 145
Javier Zarzalejos
Proposal for a regulation
Article 17 – paragraph 3 – point c
| Text proposed by the Commission | Amendment |
| (c) no more than one examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231]. | (c) no examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231]. |
Or. en
Amendment 146
Javier Zarzalejos
Proposal for a regulation
Article 17 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. The Office shall publish a yearly an overview of the number of procedures, including those for examination, opposition, appeal and invalidity, each competent national authority participated in. | 4. The Office shall publish a yearly an overview of the number of procedures, including those for examination and appeal, each competent national authority participated in. |
Or. en
Amendment 147
Daniel Buda
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
| After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions: | 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 any appeal or opposition (including, where applicable, any appeal to the General Court or the Court of Justice) has been issued, the Office shall take one of the following decisions: |
| a. where the examination opinion is positive, the Office shall grant a unitary certificate; | |
| b. where the examination opinion is negative, the Office shall reject the application for a unitary certificate. |
Or. en
Amendment 148
Marie Toussaint
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
| After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions: | No later than three months after the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions: |
Or. en
Amendment 149
Javier Zarzalejos
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
| Text proposed by the Commission | Amendment |
| After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions: | Immediately after the period during which an appeal may be filed has expired without any appeal being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions: |
Or. en
Amendment 150
Javier Zarzalejos
Proposal for a regulation
Article 18 – paragraph 1 – subparagraph 1 (new)
| Text proposed by the Commission | Amendment |
| The Office shall inform the applicant of its decision without undue delay. |
Or. en
Amendment 151
Daniel Buda
Proposal for a regulation
Article 19 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Third parties may also submit observations in respect of an application for an extension of the duration of a unitary certificate. | 2. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of the unitary certificate. |
Or. en
Justification
The same opposition safeguard as for the SPC application should be applied to the application for an extension of the duration of the certificate.
Amendment 152
Daniel Buda
Proposal for a regulation
Article 22 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
| (a) the certificate was granted contrary to Article 3; | (a) the certificate was granted contrary to Article 3 and 6; |
Or. en
Justification
The addition of Article 6 (prohibition on third party SPCs) reflects the additional paragraph proposed by the Commission in Article 6, which should indeed be a ground for invalidity, as meant in that article.
Amendment 153
Marie Toussaint
Proposal for a regulation
Article 22 – paragraph 1 – point c a (new)
| Text proposed by the Commission | Amendment |
| (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]. |
Or. en
Amendment 154
Marie Toussaint
Proposal for a regulation
Article 22 – paragraph 1 – point c b (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Amendment 155
Daniel Buda
Proposal for a regulation
Article 22 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Justification
The new paragraph aims to reflect changes in the SPC regulation by clarifying that the Unified Patent Court (UPC) will have jurisdiction over patent revocations. It suggests removing references to national courts to avoid confusion, aligning with the proposed amendments to Articles 23 and 24 and Article 15 of the SPC regulation.
Amendment 156
Daniel Buda
Proposal for a regulation
Article 23
| Text proposed by the Commission | Amendment |
| [...] | deleted |
Or. en
Justification
Articles 23 and 24 are recommended for removal because assigning the EUIPO revocation action authority, similar to EU Trademark Regulation, conflicts with the Unified Patent Court's (UPC) role. This could result in inconsistent case law and counter the goal of the new regulations to reduce legal fragmentation. Additionally, there are issues with the current wording and fairness of the rules on lis pendens and res judicata in sections 23(6) and 24.
Amendment 157
Adrián Vázquez Lázara
Proposal for a regulation
Article 23
| Text proposed by the Commission | Amendment |
| [...] | deleted |
Or. en
Justification
With the entry into force of the UPC, which has jurisdiction over SPCs and is a specialized court in Europe, it makes no sense to allow the possibility of invalidity actions before the EUIPO, which is not specialized and opens up the challenge of a bifurcated system with uncoordinated timetables.
Amendment 158
Javier Zarzalejos
Proposal for a regulation
Article 23 – title
| Text proposed by the Commission | Amendment |
| Application for a declaration of invalidity | Action for declaration of invalidity |
Or. en
Amendment 159
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. Any person may file with the Office an application for a declaration of invalidity of a unitary certificate. | 1. Any person may bring an action for declaration of invalidity of a unitary certificate before the Unified Patent Court. |
Or. en
Amendment 160
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 161
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. An application for a declaration of invalidity shall be filed in writing, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid. | deleted |
Or. en
Amendment 162
Marie Toussaint
Proposal for a regulation
Article 23 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. An application for a declaration of invalidity shall be filed in writing, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid. | 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. |
Or. en
Amendment 163
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. The application for a declaration of invalidity shall contain: | deleted |
| (a) the references of the unitary certificate against which that application is filed, the name of its holder, and the identification of the product; | |
| (b) the particulars of the person referred to in paragraph 1 (‘applicant’) and, where applicable, of its representative; | |
| (c) a statement of the grounds on which the application for a declaration of invalidity is based. |
Or. en
Amendment 164
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. The application for a declaration of invalidity shall be examined by an invalidation panel set up by the Office in accordance with the rules applicable to examination panels. However, the invalidation panel shall not include any examiner previously involved in the examination panel that examined the unitary certificate application, nor, the case being, any examiner involved in possible related opposition proceedings, nor in related appeal proceedings. | deleted |
Or. en
Amendment 165
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. An application for a declaration of invalidity shall be inadmissible where an application relating to the same subject matter and cause of action, and involving the same parties, has been adjudicated on its merits, either by the Office or by a competent court as referred to in Article 24, and the decision of the Office or that court on that application has acquired the authority of a final decision. | deleted |
Or. en
Amendment 166
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 7
| Text proposed by the Commission | Amendment |
| 7. If the invalidation panel notes that the application for a declaration of invalidity does not comply with paragraphs 2, 3 or 4, it shall reject that application as inadmissible, and communicate this to applicant. | deleted |
Or. en
Amendment 167
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 8
| Text proposed by the Commission | Amendment |
| 8. The decision to reject an application for a declaration of invalidity as inadmissible shall be communicated to the holder of the unitary certificate, together with a copy of that application. | deleted |
Or. en
Amendment 168
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 9
| Text proposed by the Commission | Amendment |
| 9. Where the application for a declaration of invalidity is not rejected as inadmissible, the Office shall promptly transmit that application to the holder of the unitary certificate, and shall publish it in the Register. If several applications for a declaration of invalidity have been filed, the Office shall promptly communicate them to the other applicants. | deleted |
Or. en
Amendment 169
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 10
| Text proposed by the Commission | Amendment |
| 10. The Office shall issue a decision on the application for a declaration of invalidity within 6 months, unless the complexity of the case requires a longer period. | deleted |
Or. en
Amendment 170
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 11
| Text proposed by the Commission | Amendment |
| 11. If the examination of the application for a declaration of invalidity reveals that the one or more of the conditions set out in Article 22 are met, the unitary certificate shall be declared invalid. Otherwise the application for a declaration of invalidity shall be rejected. The outcome shall be mentioned in the Register. | deleted |
Or. en
Amendment 171
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 12
| Text proposed by the Commission | Amendment |
| 12. The unitary certificate shall be deemed not to have had, as from the outset, the effects specified in this Regulation, to the extent that it has been declared invalid. | 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. |
Or. en
Amendment 172
Javier Zarzalejos
Proposal for a regulation
Article 23 – paragraph 13
| Text proposed by the Commission | Amendment |
| 13. The Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the details of the procedure governing the declaration of invalidity. | deleted |
Or. en
Amendment 173
Daniel Buda
Proposal for a regulation
Article 24
| Text proposed by the Commission | Amendment |
| [...] | deleted |
Or. en
Justification
Articles 23 and 24 are recommended for removal because assigning the EUIPO revocation action authority, similar to EU Trademark Regulation, conflicts with the Unified Patent Court's (UPC) role. This could result in inconsistent case law and counter the goal of the new regulations to reduce legal fragmentation. Additionally, there are issues with the current wording and fairness of the rules on lis pendens and res judicata in sections 23(6) and 24.
Amendment 174
Adrián Vázquez Lázara
Proposal for a regulation
Article 24
| Text proposed by the Commission | Amendment |
| [...] | deleted |
Or. en
Justification
With the entry into force of the UPC, which has jurisdiction over SPCs and is a specialized court in Europe, it makes no sense to allow the possibility of invalidity actions before the EUIPO, which is not specialized and opens up the challenge of a bifurcated system with uncoordinated timetables.
Amendment 175
Javier Zarzalejos
Proposal for a regulation
Article 24 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The competent court of a Member State shall reject a counterclaim for a declaration of invalidity if a decision taken by the Office relating to the same subject matter and cause of action and involving the same parties has already become final. | 2. The competent court of a Member State shall reject a counterclaim for a declaration of invalidity if a decision taken by the Unified Patent Court relating to the same subject matter and cause of action and involving the same parties has already become final. |
Or. en
Amendment 176
Javier Zarzalejos
Proposal for a regulation
Article 24 – paragraph 4
| Text proposed by the Commission | Amendment |
| 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 Office of the date on which the counterclaim was filed. The Office shall record that information in the Register. If an application for a declaration of invalidity of the unitary certificate had already been filed before the Office before the counterclaim was filed, the court shall be informed thereof by the Office and stay the proceedings until the decision on the application is final or the application is withdrawn. | 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 Unified Patent Court of the date on which the counterclaim was filed. If an action for declaration of invalidity of the unitary certificate had already been initiated before the Unified Patent Court before the counterclaim was filed, the court shall be informed thereof by the Unified Patent Court and stay the proceedings until the decision on the action brought before the Unified Patent Court becomes final. |
Or. en
Amendment 177
Javier Zarzalejos
Proposal for a regulation
Article 24 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. The competent court hearing a counterclaim for a declaration of invalidity may stay the proceedings on application by the holder of a unitary certificate and after hearing the other parties and may request the defendant to submit an application for a declaration of invalidity to the Office within a time limit which it shall determine. If the application is not made within the time limit, the proceedings shall continue; the counterclaim shall be deemed withdrawn. Where the competent court of a Member State stays the proceedings it may order provisional and protective measures for the duration of the stay. | deleted |
Or. en
Amendment 178
Adrián Vázquez Lázara
Proposal for a regulation
Article 28 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision. | 3. Notice of appeal shall be filed 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 3 months of the date of notification of the decision. |
| Any written reply to the statement of grounds of appeal shall be submitted no later than 3 months from the statements filing date. The Office shall fix a date for oral proceedings within 3 months following the filing of the reply or within 6 months following the filing of the statement of grounds of appeal, whichever is earlier. The Office will issue a written decision within 3 months from the oral hearing. |
Or. en
Justification
The proposal does not mention the time limits for lodging an appeal at all. In practice, we know that a case referred to the ECJ by a national court can take up to 3 years before there is a decision/reasoned order from the ECJ. As expeditious administration of SPCs is in the interest of all parties in the IP context, a fast and efficient timetable for the appeal process is necessary for the integrity of the proposed system on the part of the Office.
Amendment 179
Daniel Buda
Proposal for a regulation
Article 28 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision. | 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, together with any evidence relied upon, shall be filed within 4 months of the date of notification of the decision. |
Or. en
Justification
For the sake of transparency and legal certainty, the evidence relied upon should also be indicated.
Amendment 180
Marie Toussaint
Proposal for a regulation
Article 28 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision. | 3. Notice of appeal shall be filed in writing 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. |
Or. en
Amendment 181
Javier Zarzalejos
Proposal for a regulation
Article 28 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision. | 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 3 months of the date of notification of the decision. |
Or. en
Amendment 182
Javier Zarzalejos
Proposal for a regulation
Article 28 – paragraph 3 – subparagraph 1 (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 183
Daniel Buda
Proposal for a regulation
Article 28 – paragraph 4 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Justification
The right for the examination and/or opposition panels to be a party to the appeal proceeding is a safeguard that would ensure that all the arguments behind the appealed decisions be fully heard and taken into consideration.
Amendment 184
Marie Toussaint
Proposal for a regulation
Article 28 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards may annul or alter the opinion. | 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards shall annul or alter the opinion. |
Or. en
Amendment 185
Daniel Buda
Proposal for a regulation
Article 28 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. An action may be brought before the General Court of the European Union against a decision of the Boards of Appeal in relation to appeals, within 2 months of the date of notification of that decision, on grounds of infringement of an essential procedural requirement, infringement of the Treaty on the Functioning of the European Union, infringement of this Regulation or of any rule of law relating to their application or misuse of power. The action shall be open to any party to proceedings before the Board of Appeal adversely affected by its decision. The General Court shall have jurisdiction to annul or to alter the contested decision. | 6. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. |
Or. en
Justification
This amendment to paragraph 6 would preserve legal certainty.
Amendment 186
Daniel Buda
Proposal for a regulation
Article 28 – paragraph 8 a (new)
| Text proposed by the Commission | Amendment |
| 8 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation. |
Or. en
Justification
New paragraph 8a: This addition would ensure the highest possible level of transparency of the process.
Amendment 187
Adrián Vázquez Lázara
Proposal for a regulation
Article 29 – paragraph 4
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Justification
The corresponding recitals (31) and (39) have been included in Articles 29.4 and 30.4 to ensure that the members of the Board of Appeal have the necessary competence. The current wording only refers to the EUTM Regulation, which does not take into account the important element of required expertise in SPC matters
Amendment 188
Javier Zarzalejos
Proposal for a regulation
Article 29 – paragraph 4
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Amendment 189
Javier Zarzalejos
Proposal for a regulation
Article 31 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The Office shall charge a fee for appeals, for oppositions, for applications for a declaration of invalidity and for conversions. | 2. The Office shall charge a fee for appeals and for conversions. |
Or. en
Amendment 190
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Amendment 191
Marie Toussaint
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
| Text proposed by the Commission | Amendment |
| (i a) information on any direct public financial support received for research related to the development of the product; |
Or. en
Amendment 192
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
| Text proposed by the Commission | Amendment |
| (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. |
Or. en
Amendment 193
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point j
| Text proposed by the Commission | Amendment |
| (j) the date and a summary of the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect; | (j) any documents from the examination procedure and the date and a copy of the examination opinion in respect of each of the Member States in which the basic patent has unitary effect; |
Or. en
Amendment 194
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point k a (new)
| Text proposed by the Commission | Amendment |
| (k a) where applicable, any third party observation and any related documents; |
Or. en
Amendment 195
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point k a (new)
| Text proposed by the Commission | Amendment |
| (k a) where applicable, any third party observation and any related documents; |
Or. en
Amendment 196
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point l
| Text proposed by the Commission | Amendment |
| (l) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a unitary certificate; | (l) any documents from the examination procedure and the date and a copy of the examination opinion relating to an application for an extension of the duration of a unitary certificate; |
Or. en
Amendment 197
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point l
| Text proposed by the Commission | Amendment |
| (l) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a unitary certificate; | (l) where applicable, the date and a copy of the examination opinion relating to an application for an extension of the duration of a unitary certificate; |
Or. en
Amendment 198
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point l
| Text proposed by the Commission | Amendment |
| (l) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a unitary certificate; | (l) where applicable, the date and a copy of the examination opinion relating to an application for an extension of the duration of a unitary certificate; |
Or. en
Amendment 199
Javier Zarzalejos
Proposal for a regulation
Article 35 – paragraph 1 – point m
| Text proposed by the Commission | Amendment |
| (m) where applicable, the filing of an opposition, and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion; | deleted |
Or. en
Amendment 200
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point m
| Text proposed by the Commission | Amendment |
| (m) where applicable, the filing of an opposition, and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion; | (m) where applicable, the filing of an opposition, its status, any documents from the opposition procedure, and the outcome outcome of the opposition proceedings, a copy of the decision and including where applicable a copy summary of the revised examination opinion; |
Or. en
Amendment 201
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point m
| Text proposed by the Commission | Amendment |
| (m) where applicable, the filing of an opposition, and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion; | (m) where applicable, the filing of an opposition, its status, any documents from the opposition procedure, the outcome outcome of the opposition proceedings, a copy of the decision and, where applicable a copy of the revised examination opinion; |
Or. en
Amendment 202
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point n
| Text proposed by the Commission | Amendment |
| (n) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion; | (n) where applicable, the filing of an appeal, its status, any documents from the appeal proceedings, outcome a copy of the decision and where applicable a copy of the revised examination opinion; |
Or. en
Amendment 203
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point n
| Text proposed by the Commission | Amendment |
| (n) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion; | (n) where applicable, the filing of an appeal, its status, any documents from the appeal proceedings, its outcome, a copy of the decision and where applicable a copy of the revised examination opinion; |
Or. en
Amendment 204
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point r – point 1 (new)
| Text proposed by the Commission | Amendment |
| 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; |
Or. en
Amendment 205
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point r a (new)
| Text proposed by the Commission | Amendment |
| (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; |
Or. en
Amendment 206
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 1 – point r a (new)
| Text proposed by the Commission | Amendment |
| (r a) any documents and communications between the Office and any party in the proceedings. |
Or. en
Amendment 207
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 1 – point r b (new)
| Text proposed by the Commission | Amendment |
| (r b) any documents and communications between the Office and any party in the proceedings. |
Or. en
Amendment 208
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 7 – point b
| Text proposed by the Commission | Amendment |
| (b) maintaining the Register and making it available for inspection by public authorities and economic operators; | (b) maintaining the Register and making it available for inspection by economic operators |
Or. en
Amendment 209
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 7 – point b
| Text proposed by the Commission | Amendment |
| (b) maintaining the Register and making it available for inspection by public authorities and economic operators; | (b) maintaining the Register and making it available for inspection by economic operators; |
Or. en
Amendment 210
Marie Toussaint
Proposal for a regulation
Article 35 – paragraph 8 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 211
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 8 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 212
Raffaele Stancanelli
Proposal for a regulation
Article 35 – paragraph 8 a (new)
| Text proposed by the Commission | Amendment |
| 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. |
Or. en
Amendment 213
Javier Zarzalejos
Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 2
| Text proposed by the Commission | Amendment |
| An employee of a legal person may also represent other legal persons which are economically linked with the legal person being represented by that employee. | An employee of a legal person may also represent other legal persons which are part of the same undertaking at the time of filing an application for a certificate as the legal person being represented by that employee. |
Or. en
Amendment 214
Javier Zarzalejos
Proposal for a regulation
Article 39 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
| (c) deciding on oppositions against examination opinions; | deleted |
Or. en
Amendment 215
Javier Zarzalejos
Proposal for a regulation
Article 39 – paragraph 1 – point d
| Text proposed by the Commission | Amendment |
| (d) deciding on applications for a declaration of invalidity; | deleted |
Or. en
Amendment 216
Adrián Vázquez Lázara
Proposal for a regulation
Article 41 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public. | deleted |
Or. en
Amendment 217
Daniel Buda
Proposal for a regulation
Article 41 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public. | deleted |
Or. en
Amendment 218
Javier Zarzalejos
Proposal for a regulation
Article 41 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public. | 2. Oral proceedings before an examination panel shall not be public. |
Or. en
Amendment 219
Adrián Vázquez Lázara
Proposal for a regulation
Article 41 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Oral proceedings before the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the Boards of Appeal decide otherwise in cases where admission of the public could have serious and unjustified disadvantages, in particular for a party to the proceedings. | 3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings. |
Or. en
Justification
All oral hearings should be public by default in the interests of transparency and legal certainty.
Amendment 220
Daniel Buda
Proposal for a regulation
Article 41 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Oral proceedings before the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the Boards of Appeal decide otherwise in cases where admission of the public could have serious and unjustified disadvantages, in particular for a party to the proceedings. | 3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings. |
Or. en
Justification
Similar to the practice at the EPO, all oral proceedings should be public by default for the sake of transparency and legal certainty.
Amendment 221
Marie Toussaint
Proposal for a regulation
Article 42 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period. | 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. |
Or. en
Amendment 222
Javier Zarzalejos
Proposal for a regulation
Article 46 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article, or in Article 15(1) and (3). | 5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article. |
Or. en
Amendment 223
Javier Zarzalejos
Proposal for a regulation
Article 48 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The losing party in opposition proceedings and proceedings for a declaration of invalidity, including in related appeal proceedings, shall bear the fees paid by the other party. The losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative, within the maximum rates set for each category of costs in the implementing act to be adopted in accordance with paragraph 7. The fees to be borne by the losing party shall be limited to the fees paid by the other party in those proceedings. | 1. The losing party in proceedings for a declaration of invalidity, including in related appeal proceedings, shall bear the fees paid by the other party. The losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative, within the maximum rates set for each category of costs in the implementing act to be adopted in accordance with paragraph 7. The fees to be borne by the losing party shall be limited to the fees paid by the other party in those proceedings. |
Or. en
Amendment 224
Javier Zarzalejos
Proposal for a regulation
Article 50 – paragraph 1 – point 1 – point b
Article 151 – paragraph 1
Article 151 – paragraph 1
| Text proposed by the Commission | Amendment |
| (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], including opposition proceedings, and of applications for unitary certificates under Regulation [COM(2023) 222] and Regulation [COM(2023) 221], including opposition and invalidity proceedings; | (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], of applications for unitary certificates under Regulation [COM(2023) 222] and Regulation [COM(2023) 221]; |
Or. en
Amendment 225
Javier Zarzalejos
Proposal for a regulation
Article 54 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The power to adopt delegated acts referred to in Articles 15(13), 23(13), 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) and 47(3) shall be conferred on the Commission for an indeterminate period of time from XXX [OP please insert the date = date of entry into force]. | 2. The power to adopt delegated acts referred to in Articles 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) and 47(3) shall be conferred on the Commission for an indeterminate period of time from XXX [OP please insert the date = date of entry into force]. |
Or. en
Amendment 226
Javier Zarzalejos
Proposal for a regulation
Article 54 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. The delegation of power referred to in Articles 15(13), 23(13), 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) and 47(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. | 3. The delegation of power referred to in Articles 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) and 47(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. |
Or. en
Amendment 227
Javier Zarzalejos
Proposal for a regulation
Article 54 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. A delegated act adopted pursuant to Article 15(13), 23(13), 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) or 47(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. | 6. A delegated act adopted pursuant to Article 28(8), 30, 34(2), 41(4), 42(6), 43(4), 44(5) or 47(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
Or. en
Amendment 228
Marie Toussaint
Proposal for a regulation
Article 56 – paragraph 1
| Text proposed by the Commission | Amendment |
| 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. | 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] . |
Or. en
Amendment 229
Adrián Vázquez Lázara
Proposal for a regulation
Article 56 – paragraph 1
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en
Justification
The evaluation, with a presentation of the main results to other EU institutions, is a fundamental transparency measure and reflects the provision in the SPC Regulation.
Amendment 230
Daniel Buda
Proposal for a regulation
Article 56 – paragraph 1
| Text proposed by the Commission | Amendment |
| 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. | 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. |
Or. en