Text · Amendment list
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
Document JURI-AM-756103 · COM(2023)0222 – C90148/2023 – 2023/0127(COD)
- Kind
- Amendment list JURI-AM-756103
- Date
- 13 November 2023
- Committee
- Committee on Legal Affairs
- Dossier
- 2023-0127
More facts (2)
- Formats
- Official page PDF Word
- Reference
- COM(2023)0222 – C90148/2023 – 2023/0127(COD)
Text
The text as parsed from the official Word file. Every paragraph has a link (¶) and can be saved to a project as a passage.
Jump to an amendment (168)
- Amendment 63
- Amendment 64
- Amendment 65
- Amendment 66
- Amendment 67
- Amendment 68
- Amendment 69
- Amendment 70
- Amendment 71
- Amendment 72
- Amendment 73
- Amendment 74
- Amendment 75
- Amendment 76
- Amendment 77
- Amendment 78
- Amendment 79
- Amendment 80
- Amendment 81
- Amendment 82
- Amendment 83
- Amendment 84
- Amendment 85
- Amendment 86
- Amendment 87
- Amendment 88
- Amendment 89
- Amendment 90
- Amendment 91
- Amendment 92
- Amendment 93
- Amendment 94
- Amendment 95
- Amendment 96
- Amendment 97
- Amendment 98
- Amendment 99
- Amendment 100
- Amendment 101
- Amendment 102
- Amendment 103
- Amendment 104
- Amendment 105
- Amendment 106
- Amendment 107
- Amendment 108
- Amendment 109
- Amendment 110
- Amendment 111
- Amendment 112
- Amendment 113
- Amendment 114
- Amendment 115
- Amendment 116
- Amendment 117
- Amendment 118
- Amendment 119
- Amendment 120
- Amendment 121
- Amendment 122
- Amendment 123
- Amendment 124
- Amendment 125
- Amendment 126
- Amendment 127
- Amendment 128
- Amendment 129
- Amendment 130
- Amendment 131
- Amendment 132
- Amendment 133
- Amendment 134
- Amendment 135
- Amendment 136
- Amendment 137
- Amendment 138
- Amendment 139
- Amendment 140
- Amendment 141
- Amendment 142
- Amendment 143
- Amendment 144
- Amendment 145
- Amendment 146
- Amendment 147
- Amendment 148
- Amendment 149
- Amendment 150
- Amendment 151
- Amendment 152
- Amendment 153
- Amendment 154
- Amendment 155
- Amendment 156
- Amendment 157
- Amendment 158
- Amendment 159
- Amendment 160
- Amendment 161
- Amendment 162
- Amendment 163
- Amendment 164
- Amendment 165
- Amendment 166
- Amendment 167
- Amendment 168
- Amendment 169
- Amendment 170
- Amendment 171
- Amendment 172
- Amendment 173
- Amendment 174
- Amendment 175
- Amendment 176
- Amendment 177
- Amendment 178
- Amendment 179
- Amendment 180
- Amendment 181
- Amendment 182
- Amendment 183
- Amendment 184
- Amendment 185
- Amendment 186
- Amendment 187
- Amendment 188
- Amendment 189
- Amendment 190
- Amendment 191
- Amendment 192
- Amendment 193
- Amendment 194
- Amendment 195
- Amendment 196
- Amendment 197
- Amendment 198
- Amendment 199
- Amendment 200
- Amendment 201
- Amendment 202
- Amendment 203
- Amendment 204
- Amendment 205
- Amendment 206
- Amendment 207
- Amendment 208
- Amendment 209
- Amendment 210
- Amendment 211
- Amendment 212
- Amendment 213
- Amendment 214
- Amendment 215
- Amendment 216
- Amendment 217
- Amendment 218
- Amendment 219
- Amendment 220
- Amendment 221
- Amendment 222
- Amendment 223
- Amendment 224
- Amendment 225
- Amendment 226
- Amendment 227
- Amendment 228
- Amendment 229
- Amendment 230
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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.
| 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. |
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.
| 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 ; |
| 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 ; |
| 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. |
| 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: |
| 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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (iv a) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)]. |
| 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. |
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)
| 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. |
| 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. |
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.
| 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. |
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.
| 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; |
Such conditions are already required under Regulation (EC) No 847/2000 (Article 2(2)) on Orphan Drugs.
| 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1 a. a consent in accordance with Art. 6(2), if applicable. |
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.
| 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. |
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.
| 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. |
| 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. |
The conditions referred to in Art. 3(2) and 6(2) should also be included in the examination of the application
| 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. |
| 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. |
| 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. |
The conditions referred to in art. 3(2) and 6(2) should also be included in the examination of the application.
| 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. |
| 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. |
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.
| 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. |
| 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. |
In order to improve the transparency, the opinion should be published in the register as soon as possible.
| 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. |
| 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. |
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.
| 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. |
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.
| 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. |
| 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c a) any evidence that is relied upon by the opponent. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4 a. any evidence that is relied upon by the opponent. |
| 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. |
| 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. |
| 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 |
| 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 |
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.
| 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. |
| 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. |
| 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. |
A new paragraph 10a would ensure efficiency, uniformity and legal certainty in the work of the Office.
| 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. |
| 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. |
| 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. |
| 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. |
New Paragraph 13a: this measure would ensure the highest possible level of transparency of the process.
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| (-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) geographical balance amongst the participating offices; | deleted |
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.
| 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; |
| 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]. |
| 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]. |
| 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. |
| 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. |
| 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: |
| 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: |
| Text proposed by the Commission | Amendment |
|---|---|
| The Office shall inform the applicant of its decision without undue delay. |
| 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. |
The same opposition safeguard as for the SPC application should be applied to the application for an extension of the duration of the certificate.
| 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; |
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.
| 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]. |
| 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. |
| 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. |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| Application for a declaration of invalidity | Action for declaration of invalidity |
| 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. |
| 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. |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 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 |
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
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.
| Text proposed by the Commission | Amendment |
|---|---|
| [...] | deleted |
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.
| 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. |
| 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. |
| 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 |
| 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. |
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.
| 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. |
For the sake of transparency and legal certainty, the evidence relied upon should also be indicated.
| 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. |
| 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. |
| 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. |
| 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. |
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.
| 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. |
| 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. |
| 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. |
New paragraph 8a: This addition would ensure the highest possible level of transparency of the process.
| 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. |
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
| 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. |
| 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. |
| 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. |
| 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; |
| 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. |
| 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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (k a) where applicable, any third party observation and any related documents; |
| Text proposed by the Commission | Amendment |
|---|---|
| (k a) where applicable, any third party observation and any related documents; |
| 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; |
| 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; |
| 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; |
| 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 |
| 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; |
| 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; |
| 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; |
| 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; |
| 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; |
| 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; |
| Text proposed by the Commission | Amendment |
|---|---|
| (r a) any documents and communications between the Office and any party in the proceedings. |
| Text proposed by the Commission | Amendment |
|---|---|
| (r b) any documents and communications between the Office and any party in the proceedings. |
| 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 |
| 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; |
| 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. |
| 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. |
| 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. |
| 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. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) deciding on oppositions against examination opinions; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) deciding on applications for a declaration of invalidity; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public. | deleted |
| 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. |
| 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. |
| 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. |
Similar to the practice at the EPO, all oral proceedings should be public by default for the sake of transparency and legal certainty.
| 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. |
| 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. |
| 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. |
| 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]; |
| 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]. |
| 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. |
| 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. |
| 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] . |
| 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. |
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.
| 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. |
Connections
The dossier, the decisions on this text and its other versions.
No connections found for this item.
Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2023). “AMENDMENTS 63 - 230 - Draft report 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”. Text, 13 November 2023. docId JURI-AM-756103. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/JURI-AM-756103 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/JURI-AM-756103 (CC BY 4.0).
BibTeX
@misc{epw-text-juri-am-756103,
author = {{European Parliament}},
title = {{AMENDMENTS 63 - 230 - Draft report 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}},
year = {2023},
date = {2023-11-13},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/JURI-AM-756103}},
url = {https://news.eu-parl.st-solutions.dev/texts/JURI-AM-756103},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId JURI-AM-756103. Data: EP Open Data API: document record (CC BY 4.0)}
}