Sittings · Document
Supplementary protection certificate for medicinal products (recast)
Committee on Legal Affairs
Amendment 45
Marie Toussaint
Proposal for a regulation
Recital 3
| Text proposed by the Commission | Amendment |
| (3) Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. | deleted |
Or. en
Amendment 46
Daniel Buda
Proposal for a regulation
Recital 3
| Text proposed by the Commission | Amendment |
| (3) Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. | (3) Medicinal products, especially . in particular . those that are the result of long, costly research will not continue to be developed in 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 47
Marie Toussaint
Proposal for a regulation
Recital 5
| Text proposed by the Commission | Amendment |
| (5) 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. | deleted |
Or. en
Amendment 48
Daniel Buda
Proposal for a regulation
Recital 5
| Text proposed by the Commission | Amendment |
| (5) 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. | (5) That this situation leads to a lack of protection which penalises pharmaceutical research , and there is a risk that research centres situated in the Member States relocate to countries that offer greater protection, despite it is challenging to establish a clear link between SPC protection and the location of R&D. |
Or. en
Amendment 49
Daniel Buda
Proposal for a regulation
Recital 8
| Text proposed by the Commission | Amendment |
| (8) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art by the description of the patent on its filing date. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims, provided that each of them is specifically identifiable in the light of all the information disclosed by that patent. | deleted |
Or. en
Justification
The existing jurisprudence is very complex and not fully reflecting what is described in this recital. It is impossible to perfectly describe the existing jurisprudence in a few lines, therefore this article should be deleted.Any attempt to describe the content of the jurisprudence may risk to deviate from the exact meaning of the jurisprudence, just creating legal uncertainty.Alternatively, if reference should be made to the jurisprudence, it could be amended: “The Unitary SPC should build on the existing case law”. But this would be anyway implicit.
Amendment 50
Javier Zarzalejos
Proposal for a regulation
Recital 8
| Text proposed by the Commission | Amendment |
| (8) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art by the description of the patent on its filing date. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims, provided that each of them is specifically identifiable in the light of all the information disclosed by that patent. | (8) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art in light of the description of the patent on the basis of that person’s general knowledge in the relevant field and on 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 51
Javier Zarzalejos
Proposal for a regulation
Recital 9
| Text proposed by the Commission | Amendment |
| (9) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one. | (9) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, whether for the same therapeutic indication or for a different one. |
Or. en
Amendment 52
Daniel Buda
Proposal for a regulation
Recital 9
| Text proposed by the Commission | Amendment |
| (9) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one. | (9) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product, in a Member State. Therefore it should be required that the product, or any derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, 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
Justification
“therapeutically equivalent” should be removed since it has to be interpreted and could potentially end up contradicting the actual objective of this recital (ie. by creating overprotection).This is a necessary clarification that reduces legal uncertainty and the possibility to misinterpret the scope of the SPC.
Amendment 53
Daniel Buda
Proposal for a regulation
Recital 11
| Text proposed by the Commission | Amendment |
| (11) To ensure balanced protection, however, a certificate should entitle its holder to prevent a third party from manufacturing not only the product identified in the 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 certificate. There is therefore a need to consider that the protection conferred by the certificate extends to such equivalent derivatives, within the limits of the protection conferred by the basic patent. | deleted |
Or. en
Justification
This recital is confusing since it refers to the doctrine of equivalent, which is different country by country and is hard to unify it here in a recital. The current wording broadens the scope of protection of the patent. To avoid legal uncertainty, this recital should be deleted.
Amendment 54
Javier Zarzalejos
Proposal for a regulation
Recital 12
| Text proposed by the Commission | Amendment |
| (12) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not 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. | (12) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not 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 55
Daniel Buda
Proposal for a regulation
Recital 13
| Text proposed by the Commission | Amendment |
| (13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all therapeutically equivalent products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products. | (13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend, 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 56
Javier Zarzalejos
Proposal for a regulation
Recital 13
| Text proposed by the Commission | Amendment |
| (13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all therapeutically equivalent products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products. | (13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all biosimilars 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 57
Daniel Buda
Proposal for a regulation
Recital 15
| Text proposed by the Commission | Amendment |
| (15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 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 . | (15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 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 . |
Or. en
Justification
A maximum length of exclusivity of 14 years rather 15 years is aligned with the maximum length foreseen in other jurisdictions, like the United States and in China. This is important for ensuring a level playing field and preserving the competitiveness of the EU manufacturing industry.
Amendment 58
Daniel Buda
Proposal for a regulation
Recital 17
| Text proposed by the Commission | Amendment |
| (17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 15 years and the maximum period of validity of the certificate of 5 years where the paediatric extension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council22 applies. | (17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 14 years and the maximum period of validity of the certificate of 5 years where the paediatric extension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council22 applies. |
| _________________ | _________________ |
| 22 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1). | 22 Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 378, 27.12.2006, p. 1). |
Or. en
Justification
A maximum length of exclusivity of 14 years rather 15 years is aligned with the maximum length foreseen in other jurisdictions, like the United States and in China. This is important for ensuring a level playing field and preserving the competitiveness of the EU manufacturing industry.
Amendment 59
Daniel Buda
Proposal for a regulation
Recital 24
| Text proposed by the Commission | Amendment |
| (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act. | (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of the paediatric 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 a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act. |
Or. en
Justification
This amendment makes the reference to paediatric extensions more legally sound.
Amendment 60
Marie Toussaint
Proposal for a regulation
Recital 24
| Text proposed by the Commission | Amendment |
| (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act. | (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, in accordance with Article [86] of Directive (EU) .../... [2023/0132(COD)], as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act. |
Or. en
Amendment 61
Javier Zarzalejos
Proposal for a regulation
Recital 24
| Text proposed by the Commission | Amendment |
| (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act. | (24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, as well as other procedural fees such as a fee for appeal. The fees charged by the Office should be laid down by an implementing act. |
Or. en
Amendment 62
Daniel Buda
Proposal for a regulation
Recital 28
| Text proposed by the Commission | Amendment |
| (28) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates. | (28) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the centralised application, to submit within 3 months observations to the Office while the centralised examination is being performed. Third parties should have the possibility to make observations also in opposition and appeal proceedings. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates. |
Or. en
Justification
Third Party Observations (TPOs) constitute important safeguards to ensure the issuance of qualitative unitary certificates based on the scientific observations and peer review of qualified individuals or parties. They offer interested parties a chance to share a rigorous evaluation of applications for monopoly rights that may seriously damage patients if granted erroneously. TPOs should be possible also in opposition and appeal proceedings.
Amendment 63
Javier Zarzalejos
Proposal for a regulation
Recital 30
| Text proposed by the Commission | Amendment |
| (30) The examination of a centralised application for a certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates matters, located today at national offices only. To ensure an optimal quality of the examination, suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest. | (30) The examination of a centralised application for a certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the Office and the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest. |
Or. en
Amendment 64
Javier Zarzalejos
Proposal for a regulation
Recital 32
| Text proposed by the Commission | Amendment |
| (32) 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 65
Javier Zarzalejos
Proposal for a regulation
Recital 32 a (new)
| Text proposed by the Commission | Amendment |
| (32 a) To guarantee an effective protection of innovation, in certain urgent situations, including where the expiry of the basic patent is imminent, an expedited examination procedure may be needed, notwithstanding the possibility for third parties to submit observations and other remedies provided for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be foreseen. |
Or. en
Amendment 66
Javier Zarzalejos
Proposal for a regulation
Recital 33
| Text proposed by the Commission | Amendment |
| (33) After the completion of the examination of a centralised application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the opinion should be transmitted to the respective national patent offices of the designated Member States. | (33) After the completion of the examination of a centralised application, and after the time limits for appeal have expired, or, the case being, after a final decision on the merits has been issued, the opinion should be transmitted to the respective national patent offices of the designated Member States. The Office must ensure the transmission takes place within a timeframe allowing national patent offices to grant the certificate or reject the application, upon the case, before the expiry of the basic patent. |
Or. en
Amendment 67
Javier Zarzalejos
Proposal for a regulation
Recital 38
| Text proposed by the Commission | Amendment |
| (38) Where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed. | (38) To safeguard procedural rights and ensure a complete system of remedies, where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed. |
Or. en
Amendment 68
Javier Zarzalejos
Proposal for a regulation
Recital 39
| Text proposed by the Commission | Amendment |
| (39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account. | (39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account. |
Or. en
Amendment 69
Marie Toussaint
Proposal for a regulation
Recital 41 a (new)
| Text proposed by the Commission | Amendment |
| (41 a) The timely entry of generics and biosimilars onto the Union market is key for public health purposes, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States. |
Or. en
Amendment 70
Marie Toussaint
Proposal for a regulation
Recital 60
| Text proposed by the Commission | Amendment |
| (60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. | (60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. However, the information provided for within the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generic or biosimilars should be based on information provided for in the register, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the supplementary protection certificate. |
Or. en
Amendment 71
Daniel Buda
Proposal for a regulation
Recital 60
| Text proposed by the Commission | Amendment |
| (60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. | (60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. The register shall not be used for practices of patent linkage, such as conditioning any regulatory or administrative decisions related to generic or biosimilar medicinal product, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC. |
Or. en
Justification
The EU is expected to abolish patent linkage to prevent the delay of generic and biosimilar market entry and must clearly state in the SPC Register that it should not influence regulatory decisions. This change is part of broader pharmaceutical legislation revisions to promote competition and prevent the misuse of patent systems.
Amendment 72
Daniel Buda
Proposal for a regulation
Article 2 – paragraph 1 – point 12 a (new)
| Text proposed by the Commission | Amendment |
| (12 a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that (i) one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder, (ii) that the different holders have concluded tacit or explicit agreements in relation to the basic patents, in relation to applications for a certificate on the product or in relation to an authorisation to place the product on the market as a medicinal product or (iii) that they otherwise exercise concerted practices concerning the placing of the product on the market as a medicinal product. |
Or. en
Justification
The definition of ‘economically linked’ as referred to in recital 12 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 73
Javier Zarzalejos
Proposal for a regulation
Article 3 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders, where they are not economically linked. | 3. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders, where they are not part of the same undertaking at the time of filing an application for a certificate. 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 74
Daniel Buda
Proposal for a regulation
Article 5 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. | 1. Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations. |
Or. en
Amendment 75
Marie Toussaint
Proposal for a regulation
Article 5 – paragraph 2 – introductory part
| Text proposed by the Commission | Amendment |
| 2. By way of derogation from paragraph 1, the certificate shall not confer protection against certain acts which would otherwise require the consent of the the certificate holder, if all of the following conditions are met: | 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the certificate shall not confer protection against certain acts which would otherwise require the consent of the the certificate holder, if all of the following conditions are met: |
Or. en
Amendment 76
Marie Toussaint
Proposal for a regulation
Article 5 – paragraph 2 – 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 77
Marie Toussaint
Proposal for a regulation
Article 7 – 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 78
Daniel Buda
Proposal for a regulation
Article 8 – paragraph 1 – point a a (new)
| Text proposed by the Commission | Amendment |
| (a a) information on all direct financial support received for research related to the development of the product for which the SPC is applied for. |
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 79
Marie Toussaint
Proposal for a regulation
Article 8 – paragraph 1 – point d a (new)
| Text proposed by the Commission | Amendment |
| (d a) information on any direct public financial support received for research related to the development of the product. |
Or. en
Amendment 80
Daniel Buda
Proposal for a regulation
Article 8 – paragraph 1 – point d a (new)
| Text proposed by the Commission | Amendment |
| (d 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 81
Marie Toussaint
Proposal for a regulation
Article 11 – paragraph 1 – point f a (new)
| Text proposed by the Commission | Amendment |
| (f a) information on any direct public financial support received for research related to the development of the product. |
Or. en
Amendment 82
Daniel Buda
Proposal for a regulation
Article 11 – paragraph 1 a (new)
| Text proposed by the Commission | Amendment |
| 1 a. information on all direct financial support received for research related to the development of the product for which the SPC is applied for. |
Or. en
Justification
This transparency measure is in line with the amendment in art 8 and in the proposal for a revised Regulation in the pharmaceutical legislation, in relation to transferable exclusivity vouchers for novel antimicrobials.
Amendment 83
Daniel Buda
Proposal for a regulation
Article 15 – paragraph 1 – point a
| Text proposed by the Commission | Amendment |
| (a) the certificate was granted contrary to Article 3; | (a) the certificate it was granted contrary to the provisions of Articles 3 or 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.16Article
Amendment 84
Marie Toussaint
Proposal for a regulation
Article 15 – paragraph 1 – point c a (new)
| Text proposed by the Commission | Amendment |
| (c a) the marketing authorisation has been withdrawn or revoked in accordance with Directive (EU) .../... [2023/0132(COD)]. |
Or. en
Amendment 85
Daniel Buda
Proposal for a regulation
Article 16 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent. | 2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent or before a competent court of a Member State. |
Or. en
Justification
Reference to “competent court of a Member State” was introduced in Article 15, therefore it has to be included also in Article 16.
Amendment 86
Daniel Buda
Proposal for a regulation
Article 18 – paragraph 2 a (new)
| Text proposed by the Commission | Amendment |
| 2 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 2a: This addition would ensure the highest possible level of transparency of the process.
Amendment 87
Marie Toussaint
Proposal for a regulation
Article 20 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply. | 1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted, as appropriate, in accordance with Directive (EU) .../... [EC2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply. |
Or. en
Amendment 88
Daniel Buda
Proposal for a regulation
Article 23 – paragraph 1
| Text proposed by the Commission | Amendment |
| If the centralised application complies with Article 22, or if an application for an extension of the duration of certificates complies with Article 33(2), the Office shall publish the application, without undue delay, in the Register. | If the centralised application complies with Article 22, or if an application for an extension of the duration of certificates complies with Article 33(2), the Office shall publish the application, without undue delay, in the Register and anyway no later than five working days after. |
Or. en
Justification
Immediate publication ensures transparency, legal certainty and predictability.
Amendment 89
Daniel Buda
Proposal for a regulation
Article 24 – 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 each of the designated Member States. | 1. The Office shall assess the application on the basis of all the conditions in Articles 3(1), 3(3) and 6(2) for each of the designated Member States. |
Or. en
Amendment 90
Daniel Buda
Proposal for a regulation
Article 24 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. | 2. Where the centralised application for a certificate and the product to which it relates comply with Articles 3(1), 3(3) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. |
Or. en
Amendment 91
Daniel Buda
Proposal for a regulation
Article 24 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. | 3. Where the centralised application for a certificate and the product to which it relates does not comply with Articles 3(1), 3(3) and 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant. and publish it on the Register immediately and anyway no later than five working days after the opinion is issued. |
Or. en
Amendment 92
Javier Zarzalejos
Proposal for a regulation
Article 24 – paragraph 5 a (new)
| Text proposed by the Commission | Amendment |
| 5 a. The Office shall adopt an examination opinion within 6 months after publication of the centralised application in the Register. | |
| Without prejudice to Articles 25, 26 and 28 of this Regulation, whenever duly justified for reasons of urgency, the applicant may submit a request for an expedited procedure. Where the request for an expedited examination procedure is deemed justified, the Office shall adopt an examination opinion within 4 months from the publication of the application for a unitary certificate. |
Or. en
Amendment 93
Daniel Buda
Proposal for a regulation
Article 25 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register. | 3. Third party observations shall be submitted within 3 months after publication of the centralised application in the Register. Third party observations may also be submitted in opposition and appeal proceedings. |
Or. en
Justification
Third Party Observations (TPOs) constitute important safeguards to ensure the issuance of qualitative unitary certificates based on the scientific observations and peer review of qualified individuals or parties. They offer interested parties a chance to share a rigorous evaluation of applications for monopoly rights that may seriously damage patients if granted erroneously. TPOs should be possible also in opposition and appeal proceedings.
Amendment 94
Javier Zarzalejos
Proposal for a regulation
Article 25 – paragraph 3 – subparagraph 1 (new)
| Text proposed by the Commission | Amendment |
| Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within 1 month after publication of the application in the Register. |
Or. en
Amendment 95
Javier Zarzalejos
Proposal for a regulation
Article 26
| Text proposed by the Commission | Amendment |
| [...] | deleted |
Or. en
Amendment 96
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 are not fulfilled for one or more of the designated Member States. | 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Articles 3 or 6 are not fulfilled for one or more of the designated Member States. |
Or. en
Justification
The new requirement of Art. 6 on third party SPCs must be a ground for opposition since it is a newly introduced condition.
Amendment 97
Daniel Buda
Proposal for a regulation
Article 26 – 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
Justification
This additional point is for the sake of transparency and legal certainty.
Amendment 98
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1. | 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate 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 99
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 7 – subparagraph 2
| Text proposed by the Commission | Amendment |
| 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
The second sentence of para 7 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. It should therefore be removed since it may otherwise suggest that if the grounds of opposition are the same as grounds raised in an initial negative examination opinion but overturned in an appeal by the applicant, the opposition is inadmissible.
Amendment 100
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 9
| Text proposed by the Commission | Amendment |
| 9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. | 9. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. The decision shall include detailed reasons. |
Or. en
Justification
The clarification in para 9 is for the sake of transparency and legal certainty.
Amendment 101
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 9 a (new)
| Text proposed by the Commission | Amendment |
| 9 a. If more than one opposition is filed in respect of the same examination opinion, the Office shall hear the oppositions jointly and issue a common decision. |
Or. en
Justification
A new paragraph 9a would ensure efficiency, uniformity and legal certainty in the work of the Office.
Amendment 102
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 11
| Text proposed by the Commission | Amendment |
| 11. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall mention this in the Register. | 11. 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 103
Daniel Buda
Proposal for a regulation
Article 26 – paragraph 12 a (new)
| Text proposed by the Commission | Amendment |
| 12 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation. |
Or. en
Amendment 104
Javier Zarzalejos
Proposal for a regulation
Article 27 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications. | 1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications, on the basis of their relevant expertise and experience in the field . |
Or. en
Amendment 105
Javier Zarzalejos
Proposal for a regulation
Article 27 – 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 and opposition 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 106
Javier Zarzalejos
Proposal for a regulation
Article 28 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The assessments under Articles 24, 26 and 33 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 27(1) from two different participating competent national authorities. | 1. The assessments under Articles 24 and 33 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 27(1) from two different participating competent national authorities. |
Or. en
Amendment 107
Marie Toussaint
Proposal for a regulation
Article 28 – 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 108
Daniel Buda
Proposal for a regulation
Article 28 – paragraph 3 – point a
| Text proposed by the Commission | Amendment |
| (a) geographical balance amongst the participating offices; | deleted |
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 109
Javier Zarzalejos
Proposal for a regulation
Article 28 – paragraph 3 – point a a (new)
| Text proposed by the Commission | Amendment |
| (a a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one of them has a minimum of 5 years of experience in patent and supplementary protection certificate examination; |
Or. en
Amendment 110
Marie Toussaint
Proposal for a regulation
Article 28 – paragraph 3 – point c
| Text proposed by the Commission | Amendment |
| (c) no more than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). | (c) that there is no examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). |
Or. en
Amendment 111
Javier Zarzalejos
Proposal for a regulation
Article 28 – paragraph 3 – point c
| Text proposed by the Commission | Amendment |
| (c) no more than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). | (c) no examiner employed by a competent national authority making use of the exemption laid down in Article 10(5). |
Or. en
Amendment 112
Javier Zarzalejos
Proposal for a regulation
Article 28 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. The Office shall publish a yearly overview of the number of procedures, including those for examination, opposition and appeal, each competent national authority participated in. | 4. The Office shall publish a yearly overview of the number of procedures, including those for examination and appeal, each competent national authority participated in. |
Or. en
Amendment 113
Daniel Buda
Proposal for a regulation
Article 29 – 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 114
Javier Zarzalejos
Proposal for a regulation
Article 29 – 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 115
Javier Zarzalejos
Proposal for a regulation
Article 29 – 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 the notification of the statement setting out the grounds of appeal. A date for oral hearing shall be set by the Office within 3 months after the filing of the reply to the grounds of appeal or within 6 months of the filing of grounds of appeal, whichever is earlier. | |
| A written decision of the Office shall issue within 3 months after the date of the oral hearing. |
Or. en
Amendment 116
Daniel Buda
Proposal for a regulation
Article 29 – 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
Amendment 117
Marie Toussaint
Proposal for a regulation
Article 29 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards may annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. | 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. |
Or. en
Amendment 118
Daniel Buda
Proposal for a regulation
Article 29 – paragraph 5
| Text proposed by the Commission | Amendment |
| 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards may annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. | 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States. |
Or. en
Amendment 119
Javier Zarzalejos
Proposal for a regulation
Article 30 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001. | 4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account. |
Or. en
Amendment 120
Javier Zarzalejos
Proposal for a regulation
Article 32 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall transmit the examination opinion and its translations to the competent national authority of each designated Member State. | 1. 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 transmit the examination opinion and its translations to the competent national authority of each designated Member State. Such transmission shall take place without undue delay within a timeframe allowing the competent national authorities of each designated Member State to grant or reject a certificate, as applicable, according to applicable national procedures, before the expiry of the basic patent. |
Or. en
Amendment 121
Daniel Buda
Proposal for a regulation
Article 32 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall transmit the examination opinion and its translations to the competent national authority of each designated Member State. | 1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits any appeal or opposition (including, where applicable, any appeal to the General Court or the Court of Justice) has been issued, the Office shall transmit the final examination opinion and its translations to the competent national authority of each designated Member State. |
Or. en
Justification
Suggested amendment consistent with suggested amendment of Recital 33.
Amendment 122
Daniel Buda
Proposal for a regulation
Article 33 – paragraph 4
| Text proposed by the Commission | Amendment |
| 4. Third parties may also submit observations in respect of a centralised application for an extension of the duration of certificates. | 4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates |
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 123
Javier Zarzalejos
Proposal for a regulation
Article 34 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The Office shall charge a fee for an appeal, and for an opposition. | 2. The Office shall charge a fee for an appeal. |
Or. en
Amendment 124
Javier Zarzalejos
Proposal for a regulation
Article 35 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The Office shall develop, keep and maintain an electronic Register, providing up-to-date information regarding the status of all published centralised applications, and of all centralised applications for an extension of the duration of certificates. | 1. The Office shall develop, keep and maintain an electronic, searcheable and public Register, providing up-to-date information regarding the status of all published centralised applications, and of all centralised applications for an extension of the duration of certificates. |
Or. en
Amendment 125
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point j a (new)
| Text proposed by the Commission | Amendment |
| (j a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for. |
Or. en
Justification
This transparency measure is in line with the amendment in art 8 and in the proposal for a revised Regulation in the pharmaceutical legislation, in relation to transferable exclusivity vouchers for novel antimicrobials.
Amendment 126
Marie Toussaint
Proposal for a regulation
Article 35 – paragraph 2 – point j a (new)
| Text proposed by the Commission | Amendment |
| (j a) information on any direct public financial support received for research related to the development of the product; |
Or. en
Amendment 127
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point j b (new)
| Text proposed by the Commission | Amendment |
| (j b) where applicable, any third party observation and any related documents; |
Or. en
Amendment 128
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point k
| Text proposed by the Commission | Amendment |
| (k) the date and a summary of the examination opinion in respect of each of the designated Member States; | (k) any documents from the examination procedure and the date and a copy summary of the examination opinion in respect of each of the designated Member States; |
Or. en
Amendment 129
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point m
| Text proposed by the Commission | Amendment |
| (m) where applicable, the date and a summary of the examination opinion relating to an application for an extension of the duration of a certificate; | (m) where applicable, the date and a copy of the examination opinion relating to an application for an extension of the duration of the certificates; |
Or. en
Amendment 130
Javier Zarzalejos
Proposal for a regulation
Article 35 – paragraph 2 – point n
| Text proposed by the Commission | Amendment |
| (n) where applicable, the filing of an opposition, and its outcome, including where applicable a summary of the revised examination opinion; | deleted |
Or. en
Amendment 131
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point n
| Text proposed by the Commission | Amendment |
| (n) where applicable, the filing of an opposition, and its outcome, including where applicable a summary of the revised examination opinion; | (n) where applicable, the filing of an opposition, its status, any documents from the opposition procedure, its outcome, a copy of the decision and where applicable a copy of the revised examination opinion; |
Or. en
Amendment 132
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point o
| Text proposed by the Commission | Amendment |
| (o) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion; | (o) where applicable, the filing of an appeal, its status, any documents from the appeal proceedings, its outcome, a copy of the decision and where applicable a of the revised examination opinion; |
Or. en
Amendment 133
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – 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 134
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 2 – point s a (new)
| Text proposed by the Commission | Amendment |
| (s a) any documents and communications between the Office and any party in the proceedings. |
Or. en
Justification
A new para (sa) reflects the current practice of transparency at the EPO in relation to patents.
Amendment 135
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 9 – 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
Justification
Before the EU's SPC Register can list granted SPCs, patent linkage must be abolished to ensure that such a list does not affect decisions on generics or biosimilars. A disclaimer to this effect is required on the register's website. Upcoming pharmaceutical legislation revisions aim to ban patent linkage, preventing brand-name drug owners from using patents to delay generic drug market entry, continuing efforts from a 2012 EC directive proposal.
Amendment 136
Marie Toussaint
Proposal for a regulation
Article 35 – paragraph 11 a (new)
| Text proposed by the Commission | Amendment |
| 11 a. By way of derogation from Article 35(9), point (b), public authorities shall not use the information provided for in the register for practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilars shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids |
Or. en
Amendment 137
Daniel Buda
Proposal for a regulation
Article 35 – paragraph 11 a (new)
| Text proposed by the Commission | Amendment |
| 11 a. The existence on the Register of a granted or applied for supplementary protection certificate shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products. |
Or. en
Amendment 138
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 139
Javier Zarzalejos
Proposal for a regulation
Article 39 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The combined application shall undergo a single centralised examination procedure, as well as a single opposition or appeal procedure, where it has been filed against an opinion or decision in respect of both the centralised application and the unitary certificate application. | 2. The combined application shall undergo a single centralised examination procedure, as well as a single appeal procedure, where it has been filed against an opinion or decision in respect of both the centralised application and the unitary certificate application. |
Or. en
Amendment 140
Javier Zarzalejos
Proposal for a regulation
Article 40 – paragraph 1 – point c
| Text proposed by the Commission | Amendment |
| (c) deciding on oppositions against examination opinions; | deleted |
Or. en
Amendment 141
Daniel Buda
Proposal for a regulation
Article 44 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Oral proceedings before an examination panel or opposition panel shall not be public. | deleted |
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 142
Javier Zarzalejos
Proposal for a regulation
Article 44 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. Oral proceedings before an examination panel or opposition panel shall not be public. | 2. Oral proceedings before an examination panel shall not be public. |
Or. en
Amendment 143
Daniel Buda
Proposal for a regulation
Article 44 – 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
Amendment 144
Marie Toussaint
Proposal for a regulation
Article 45 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period. | 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summoned, it shall be verified that that expert is free of any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period. |
Or. en
Amendment 145
Javier Zarzalejos
Proposal for a regulation
Article 49 – 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 26(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 146
Javier Zarzalejos
Proposal for a regulation
Article 51 – paragraph 1
| Text proposed by the Commission | Amendment |
| 1. The losing party in opposition proceedings, including in related appeal proceedings, shall bear the fees paid by the other party. The losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative, within the maximum rates set for each category of costs in the implementing act to be adopted in accordance with paragraph 7. The fees to be borne by the losing party shall be limited to the fees paid by the other party in those proceedings. | 1. The losing party in 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 147
Javier Zarzalejos
Proposal for a regulation
Article 55 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. The power to adopt delegated acts referred to in Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation. | 2. The power to adopt delegated acts referred to in Articles 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation. |
Or. en
Amendment 148
Javier Zarzalejos
Proposal for a regulation
Article 55 – paragraph 3
| Text proposed by the Commission | Amendment |
| 3. The delegation of power referred to in Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. | 3. The delegation of power referred to in Articles 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force. |
Or. en
Amendment 149
Javier Zarzalejos
Proposal for a regulation
Article 55 – paragraph 6
| Text proposed by the Commission | Amendment |
| 6. A delegated act adopted pursuant to Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. | 6. A delegated act adopted pursuant to Articles 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council. |
Or. en
Amendment 150
Daniel Buda
Proposal for a regulation
Article 57 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter III. | 2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the other provisions of Chapter I and II as well as of the application of Chapter III. and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. The evaluation should assess in particular whether the objectives of those provisions have been achieved, with particular regard to whether research centres situated in the Member States relocate and medicinal products, especially those that are the result of long, costly research continue to be developed in the Union. |
Or. en
Justification
It is of utmost importance to regularly evaluate whether the SPC regulation has achieved the objectives it was introduced for, since SPCs have a huge impact on national healthcare budgets and on patient access to medicines.
Amendment 151
Marie Toussaint
Proposal for a regulation
Article 57 – paragraph 2
| Text proposed by the Commission | Amendment |
| 2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter III. | 2. By [OP, please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter III and present a report on the main findings to the European Parliament and to the Council. |
Or. en
Amendment 152
Javier Zarzalejos
Proposal for a regulation
Article 60 – paragraph 2
| Text proposed by the Commission | Amendment |
| Articles 20 to 53 and 55 to 57 shall apply from xxxxx [OP: please insert: the first day of the 12th month after the entry into force]. | Articles 20 to 53 and 55 to 57 shall apply from xxxxx [OP: please insert: the first day of the 24th month after the entry into force]. |
Or. en