50 Amendments of Marie TOUSSAINT related to 2023/0127(COD)
Amendment 65 #
Proposal for a regulation
Recital 2
Recital 2
(2) The period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. Whereas such considerations, governing the grant of supplementary certificate protection, according to Regulation (EEC) No 1768/92, should still apply regardless of its territorial scope.
Amendment 65 #
Proposal for a regulation
Recital 2
Recital 2
(2) The period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research. Whereas such considerations, governing the grant of supplementary certificate protection, according to Regulation (EEC) No 1768/92, should still apply regardless of its territorial scope.
Amendment 76 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) The timely entry of generics and biosimilars onto the Union market is key for public health purposes, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines for patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States.
Amendment 76 #
Proposal for a regulation
Recital 21 a (new)
Recital 21 a (new)
(21 a) The timely entry of generics and biosimilars onto the Union market is key for public health purposes, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines for patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in pharmaceutical systems in the Union and its Member States.
Amendment 81 #
Proposal for a regulation
Recital 26
Recital 26
(26) The examination of an application for a unitary certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the procedure, in particular as regards qualification and conflicts of interest.
Amendment 81 #
Proposal for a regulation
Recital 26
Recital 26
(26) The examination of an application for a unitary certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the procedure, in particular as regards qualification and conflicts of interest.
Amendment 86 #
Proposal for a regulation
Recital 31
Recital 31
(31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 86 #
Proposal for a regulation
Recital 31
Recital 31
(31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 93 #
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) the product is protected by that basic patent in force and is already available on the Union market ;
Amendment 93 #
Proposal for a regulation
Article 3 – paragraph 1 – point a
Article 3 – paragraph 1 – point a
(a) the product is protected by that basic patent in force and is already available on the Union market ;
Amendment 94 #
Proposal for a regulation
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive (EU) ... [2023/0132 (COD)], with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004, as appropriate ;
Amendment 94 #
Proposal for a regulation
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive (EU) ... [2023/0132 (COD)], with Regulation (EU) 2019/6, or with the centralised procedure under Regulation (EC) No 726/2004, as appropriate ;
Amendment 96 #
Proposal for a regulation
Article 5 – paragraph 3 – introductory part
Article 5 – paragraph 3 – introductory part
3. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met:
Amendment 96 #
Proposal for a regulation
Article 5 – paragraph 3 – introductory part
Article 5 – paragraph 3 – introductory part
3. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met:
Amendment 97 #
Proposal for a regulation
Article 5 – paragraph 3 – point a – point iii
Article 5 – paragraph 3 – point a – point iii
(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;
Amendment 97 #
Proposal for a regulation
Article 5 – paragraph 3 – point a – point iii
Article 5 – paragraph 3 – point a – point iii
(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;
Amendment 98 #
Proposal for a regulation
Article 5 – paragraph 3 – point a – point iv a (new)
Article 5 – paragraph 3 – point a – point iv a (new)
(iv a) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)].
Amendment 98 #
Proposal for a regulation
Article 5 – paragraph 3 – point a – point iv a (new)
Article 5 – paragraph 3 – point a – point iv a (new)
(iv a) any act in accordance with Article 85 of Directive (EU) ... [2023/0132 (COD)].
Amendment 100 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.
Amendment 100 #
Proposal for a regulation
Article 8 – paragraph 4 a (new)
Article 8 – paragraph 4 a (new)
4 a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.
Amendment 103 #
Proposal for a regulation
Article 9 – paragraph 1 – point a a (new)
Article 9 – paragraph 1 – point a a (new)
(a a) the appropriate documentation containing the following information: (i) data on all costs that the applicant has incurred in the course of developing the medicinal product subject to the application for unitary certificate; (ii) details of any grants, public financial support, tax incentives or other cost recovery provisions received either within the Union or in third countries; (iii) in cases where the medicinal product is already authorised for any indication or where the medicinal product is under investigation for one or more other indications, a clear explanation of and justification for the method that is used to apportion the development costs among the various indications shall be provided; (iv) a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for designation shall be provided; (v) a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur during the first 10 years that the medicinal product is authorised shall be provided; (vi) an estimate and justification for the expected revenues from sales of the medicinal product in the Union during the first 10 years after authorisation; (vii) all cost and revenue data shall be determined in accordance with generally accepted accounting practices and shall be certified by a registered accountant in the Union;
Amendment 103 #
Proposal for a regulation
Article 9 – paragraph 1 – point a a (new)
Article 9 – paragraph 1 – point a a (new)
(a a) the appropriate documentation containing the following information: (i) data on all costs that the applicant has incurred in the course of developing the medicinal product subject to the application for unitary certificate; (ii) details of any grants, public financial support, tax incentives or other cost recovery provisions received either within the Union or in third countries; (iii) in cases where the medicinal product is already authorised for any indication or where the medicinal product is under investigation for one or more other indications, a clear explanation of and justification for the method that is used to apportion the development costs among the various indications shall be provided; (iv) a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for designation shall be provided; (v) a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur during the first 10 years that the medicinal product is authorised shall be provided; (vi) an estimate and justification for the expected revenues from sales of the medicinal product in the Union during the first 10 years after authorisation; (vii) all cost and revenue data shall be determined in accordance with generally accepted accounting practices and shall be certified by a registered accountant in the Union;
Amendment 104 #
Proposal for a regulation
Article 9 – paragraph 1 – point d a (new)
Article 9 – paragraph 1 – point d a (new)
(d a) any information on any direct public financial support received for research related to the development of the product.
Amendment 104 #
Proposal for a regulation
Article 9 – paragraph 1 – point d a (new)
Article 9 – paragraph 1 – point d a (new)
(d a) any information on any direct public financial support received for research related to the development of the product.
Amendment 137 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1 a. Once a national competent authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and independence, and whether they have sufficient experience for the centralised examination procedure.
Amendment 137 #
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Article 16 – paragraph 1 a (new)
1 a. Once a national competent authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and independence, and whether they have sufficient experience for the centralised examination procedure.
Amendment 141 #
Proposal for a regulation
Article 17 – paragraph 3 – point -a (new)
Article 17 – paragraph 3 – point -a (new)
(-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 141 #
Proposal for a regulation
Article 17 – paragraph 3 – point -a (new)
Article 17 – paragraph 3 – point -a (new)
(-a) relevant expertise, independence and sufficient experience in the examination of patents and supplementary protection certificates;
Amendment 144 #
Proposal for a regulation
Article 17 – paragraph 3 – point c
Article 17 – paragraph 3 – point c
(c) no more than onethat 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].
Amendment 144 #
Proposal for a regulation
Article 17 – paragraph 3 – point c
Article 17 – paragraph 3 – point c
(c) no more than onethat 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].
Amendment 148 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
Amendment 148 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
Amendment 153 #
Proposal for a regulation
Article 22 – paragraph 1 – point c a (new)
Article 22 – paragraph 1 – point c a (new)
(c a) the centralised marketing authorisation has been withdrawn in accordance with Article 14 or there has been a suspension of marketing, a withdrawal from the market of a medicinal product or a withdrawal of a marketing authorisation by the marketing authorisation holder in accordance with Article 24 [revised Regulation (EC) No 726/2004].
Amendment 153 #
Proposal for a regulation
Article 22 – paragraph 1 – point c a (new)
Article 22 – paragraph 1 – point c a (new)
(c a) the centralised marketing authorisation has been withdrawn in accordance with Article 14 or there has been a suspension of marketing, a withdrawal from the market of a medicinal product or a withdrawal of a marketing authorisation by the marketing authorisation holder in accordance with Article 24 [revised Regulation (EC) No 726/2004].
Amendment 154 #
Proposal for a regulation
Article 22 – paragraph 1 – point c b (new)
Article 22 – paragraph 1 – point c b (new)
(c b) the medicinal product is not placed on all Member States market covered by the unitary certificate or combined centralised supplementary protection certificate; where a medicinal product is not placed on a Member State market covered by the unitary certificate or the combined centralised supplementary protection certificate, the applicant shall waive the supplementary protection certificate rights for markets where the medicinal product has not been launched.
Amendment 154 #
Proposal for a regulation
Article 22 – paragraph 1 – point c b (new)
Article 22 – paragraph 1 – point c b (new)
(c b) the medicinal product is not placed on all Member States market covered by the unitary certificate or combined centralised supplementary protection certificate; where a medicinal product is not placed on a Member State market covered by the unitary certificate or the combined centralised supplementary protection certificate, the applicant shall waive the supplementary protection certificate rights for markets where the medicinal product has not been launched.
Amendment 162 #
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. An application for a declaration of invalidity shall be filed in writing or electronically, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid.
Amendment 162 #
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
3. An application for a declaration of invalidity shall be filed in writing or electronically, and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid.
Amendment 180 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Notice of appeal shall be filed in writing or electronically at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision.
Amendment 180 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Notice of appeal shall be filed in writing or electronically at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal shall be filed within 4 months of the date of notification of the decision.
Amendment 184 #
Proposal for a regulation
Article 28 – paragraph 5
Article 28 – paragraph 5
5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards mayshall annul or alter the opinion.
Amendment 184 #
Proposal for a regulation
Article 28 – paragraph 5
Article 28 – paragraph 5
5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards mayshall annul or alter the opinion.
Amendment 191 #
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
Article 35 – paragraph 1 – point i a (new)
(i a) information on any direct public financial support received for research related to the development of the product;
Amendment 191 #
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
Article 35 – paragraph 1 – point i a (new)
(i a) information on any direct public financial support received for research related to the development of the product;
Amendment 210 #
Proposal for a regulation
Article 35 – paragraph 8 a (new)
Article 35 – paragraph 8 a (new)
8 a. By way of derogation from Article 35(7), point (b), public authorities shall not use the information provided for in the register for practices of patent linkage, and no regulatory or administrative decisions related to generics or biosimilars shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.
Amendment 210 #
Proposal for a regulation
Article 35 – paragraph 8 a (new)
Article 35 – paragraph 8 a (new)
8 a. By way of derogation from Article 35(7), point (b), public authorities shall not use the information provided for in the register for practices of patent linkage, and no regulatory or administrative decisions related to generics or biosimilars shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.
Amendment 221 #
Proposal for a regulation
Article 42 – paragraph 3
Article 42 – paragraph 3
3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summoned, it shall be verified that that expert is not subject to any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period.
Amendment 221 #
Proposal for a regulation
Article 42 – paragraph 3
Article 42 – paragraph 3
3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summoned, it shall be verified that that expert is not subject to any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period.
Amendment 228 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament and to the Council. Special emphasis shall be given to the effects of longer exclusivity periods to recover R&D investments in the light of Directive (EU) No XXX/XX [COM(2023)192] .
Amendment 228 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
By xxxxxx [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European Parliament and to the Council. Special emphasis shall be given to the effects of longer exclusivity periods to recover R&D investments in the light of Directive (EU) No XXX/XX [COM(2023)192] .