49 Amendments of Daniel BUDA related to 2023/0127(COD)
Amendment 63 #
Proposal for a regulation
Recital 1
Recital 1
(1) Pharmaceutical research plays a decisive role in the continuing improvement in public health. Medicinal products, in particular those that are the result of long, costly research will not continue to be developed in the Union unless they are covered by favourable rules that provide for sufficient protection to encourage such research. However, it is challenging to establish a clear link between SPC protection and the location of R&D, because many other factors unrelated to the SPC play a significant role in the location of R&D.
Amendment 67 #
Proposal for a regulation
Recital 11
Recital 11
(11) In particular, the duration of the protection granted by a unitary certificate should be identical to the duration provided for as regards national certificates under Regulation [COM(2023) 231]; namely, the holder of both a unitary patent and a unitary certificate should be able to enjoy an overall maximum of 154 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.
Amendment 68 #
Proposal for a regulation
Recital 16
Recital 16
Amendment 71 #
Proposal for a regulation
Recital 17
Recital 17
(17) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one.
Amendment 72 #
Proposal for a regulation
Recital 19
Recital 19
Amendment 74 #
Proposal for a regulation
Recital 21
Recital 21
(21) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all therapeutically equivalent, 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.
Amendment 78 #
Proposal for a regulation
Recital 25
Recital 25
(25) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the unitary certificate application, to submit within 3 months observations to the Office while the centralised examination is being performed. Third parties should have the possibility to make observations also in opposition and appeal proceedings. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate subsequent invalidity proceedings before the Office. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 89 #
Proposal for a regulation
Recital 33
Recital 33
(33) The Office should have the possibility to charge a fee for the centralised application for a unitary certificate and for an application for the extension of duration of a unitary certificates in the case of the paediatric medicinal productsextension 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.
Amendment 91 #
Proposal for a regulation
Recital 35
Recital 35
(35) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. The register should be available in all official languages of the Union. The register shall not be used for practices of patent linkage, such as conditioning any regulatory or administrative decisions related to generic or biosimilar medicinal product, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC.
Amendment 92 #
Proposal for a regulation
Article 2 – paragraph 1 – point 9 a (new)
Article 2 – paragraph 1 – point 9 a (new)
(9 a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that (i) one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder, (ii) that the different holders have concluded tacit or explicit agreements in relation to the basic patents, in relation to applications for a certificate on the product or in relation to an authorisation to place the product on the market as a medicinal product or (iii) that they otherwise exercise concerted practices concerning the placing of the product on the market as a medicinal product.
Amendment 99 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
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 is granted, the application for a unitary certificate shall be lodged within 6 months of the date on which unitary effect is attributed to the basic patentthe patent is granted.
Amendment 102 #
Proposal for a regulation
Article 9 – paragraph 1 – point a – point iv a (new)
Article 9 – paragraph 1 – point a – point iv a (new)
(iv a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for.
Amendment 105 #
Proposal for a regulation
Article 9 – paragraph 1 a (new)
Article 9 – paragraph 1 a (new)
1 a. a consent in accordance with Art. 6(2), if applicable.
Amendment 106 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay and anyway no later than five working days after.
Amendment 109 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. The Office shall assess the application on the basis of all the conditions in Article 3(1), 3(2) and 6(2) for all Member States in which the basic patent has unitary effect.
Amendment 112 #
Proposal for a regulation
Article 13 – paragraph 2
Article 13 – paragraph 2
2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1), 3(2) and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant.
Amendment 113 #
Proposal for a regulation
Article 13 – paragraph 3
Article 13 – paragraph 3
3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1), 3(2) and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant. and publish it on the Register immediately and anyway no later than five working days after the opinion is issued.
Amendment 119 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Third party observations shall be submitted within 3 months after publication of the application in the Register. Third party observations may also be submitted in opposition and appeal proceedings.
Amendment 123 #
Proposal for a regulation
Article 15 – paragraph 4 a (new)
Article 15 – paragraph 4 a (new)
4 a. any evidence that is relied upon by the opponent.
Amendment 125 #
Proposal for a regulation
Article 15 – paragraph 6
Article 15 – paragraph 6
6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate this to the opponent with reasons as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.
Amendment 127 #
Proposal for a regulation
Article 15 – paragraph 8
Article 15 – paragraph 8
Amendment 129 #
Proposal for a regulation
Article 15 – paragraph 10
Article 15 – paragraph 10
10. The Office shall issue a decision on the opposition within 6 months, unless the complexity of the case requires a longer period. The decision shall include detailed reasons.
Amendment 130 #
Proposal for a regulation
Article 15 – paragraph 10 a (new)
Article 15 – paragraph 10 a (new)
10 a. If more than one opposition is filed in respect of the same examination opinion, the Office shall hear the oppositions jointly and issue a common decision.
Amendment 133 #
Proposal for a regulation
Article 15 – paragraph 12
Article 15 – paragraph 12
12. If the opposition panel considers that at least oneno ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinreject the opposition, and the Office shall mention thispublish its full decision in the Register.
Amendment 134 #
Proposal for a regulation
Article 15 – paragraph 13 a (new)
Article 15 – paragraph 13 a (new)
13 a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.
Amendment 140 #
Proposal for a regulation
Article 17 – paragraph 3 – introductory part
Article 17 – paragraph 3 – introductory part
3. When setting up an examination panel, the Office shall ensure the following: a. the respective workload of the examiners is taken into account; b. no more than one examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of Regulation [COM(2023) 231.
Amendment 147 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
Grant of a unitary certificate or rejection of the application for a unitary certificate After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions: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.
Amendment 151 #
Proposal for a regulation
Article 19 – paragraph 2
Article 19 – paragraph 2
2. Third parties may also submit observations or an opposition in respect of an centralised application for an extension of the duration of athe unitary certificate.
Amendment 152 #
Proposal for a regulation
Article 22 – paragraph 1 – point a
Article 22 – paragraph 1 – point a
(a) the certificate was granted contrary to Article 3 and 6;
Amendment 155 #
Proposal for a regulation
Article 22 – paragraph 1 a (new)
Article 22 – paragraph 1 a (new)
Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent, or before a competent court of a Member State.
Amendment 156 #
Proposal for a regulation
Article 23
Article 23
Amendment 173 #
Proposal for a regulation
Article 24
Article 24
Amendment 179 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, together with any evidence relied upon, shall be filed within 4 months of the date of notification of the decision.
Amendment 183 #
Proposal for a regulation
Article 28 – paragraph 4 a (new)
Article 28 – paragraph 4 a (new)
4 a. The examination and/or opposition panels should also be amenable to representing themselves and defending their examination opinion as a party to the appeal proceedings.
Amendment 185 #
Proposal for a regulation
Article 28 – paragraph 6
Article 28 – paragraph 6
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 decisWhere an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination, 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 rpinion and is remitted to the Office, the decision of the Boards shall annule 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 decisionr alter that opinion before transmitting it to the competent national authorities of the designated Member States.
Amendment 186 #
Proposal for a regulation
Article 28 – paragraph 8 a (new)
Article 28 – paragraph 8 a (new)
8 a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.
Amendment 192 #
Proposal for a regulation
Article 35 – paragraph 1 – point i a (new)
Article 35 – paragraph 1 – point i a (new)
(i a) information on all direct financial support received for research related to the development of the product for which the unitary SPC is applied for.
Amendment 193 #
Proposal for a regulation
Article 35 – paragraph 1 – point j
Article 35 – paragraph 1 – point j
(j) the date and a summarany documents from the examination procedure and the date and a copy of the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect;
Amendment 194 #
Proposal for a regulation
Article 35 – paragraph 1 – point k a (new)
Article 35 – paragraph 1 – point k a (new)
(k a) where applicable, any third party observation and any related documents;
Amendment 198 #
Proposal for a regulation
Article 35 – paragraph 1 – point l
Article 35 – paragraph 1 – point l
(l) where applicable, the date and a summarcopy of the examination opinion relating to an application for an extension of the duration of a unitary certificate;
Amendment 200 #
Proposal for a regulation
Article 35 – paragraph 1 – point m
Article 35 – paragraph 1 – point m
(m) where applicable, the filing of an opposition, and thits 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;
Amendment 203 #
Proposal for a regulation
Article 35 – paragraph 1 – point n
Article 35 – paragraph 1 – point n
(n) where applicable, the filing of an appeal, and the outcome of the appeal proceedings, includingits status, any documents from the appeal proceedings, its outcome, a copy of the decision and where applicable a summarcopy of the revised examination opinion;
Amendment 204 #
Proposal for a regulation
Article 35 – paragraph 1 – point r – point 1 (new)
Article 35 – paragraph 1 – point r – point 1 (new)
1) where applicable, the filing of an action to the General Court or the Court of Justice of the European Union, its status, a copy of the decision and where applicable a copy of the revised examination opinion;
Amendment 206 #
Proposal for a regulation
Article 35 – paragraph 1 – point r a (new)
Article 35 – paragraph 1 – point r a (new)
(r a) any documents and communications between the Office and any party in the proceedings.
Amendment 208 #
Proposal for a regulation
Article 35 – paragraph 7 – point b
Article 35 – paragraph 7 – point b
(b) maintaining the Register and making it available for inspection by public authorities and economic operators;
Amendment 211 #
Proposal for a regulation
Article 35 – paragraph 8 a (new)
Article 35 – paragraph 8 a (new)
8 a. The existence on the Register of a granted or applied for supplementary protection certificate shall not be a valid ground to refuse, suspend, delay, withdraw or revoke decisions relating to marketing authorisations, the price of a medicinal product or its inclusion within the public health insurance system, or the public and private procurement of medicinal products.
Amendment 217 #
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
Amendment 220 #
Proposal for a regulation
Article 41 – paragraph 3
Article 41 – paragraph 3
3. Oral proceedings before an examination panel, an opposition panel or the Boards of Appeal, including delivery of the decision and, as the case may be, of a revised opinion, shall be public, unless the examination panel, the opposition panel or the Boards of Appeal decide otherwise in cases where admission of the public to all or a part of the oral proceedings could have serious and unjustified disadvantages, in particular for a party to the proceedings.
Amendment 230 #
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, the Council and the European Economic and Social Committee.