Activities of Javier ZARZALEJOS related to 2023/0130(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the supplementary protection certificate for medicinal products (recast)
Amendments (38)
Amendment 50 #
Proposal for a regulation
Recital 8
Recital 8
(8) One of the conditions for the grant of a certificate should be that the product is protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art byin light of the description of the patent on its filing datethe basis of that person’s general knowledge in the relevant field and on the prior art at the filing date or priority date of the basic patent. This should not necessarily require that the active ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients be explicitly identified in the claims, provided that each of them is specifically identifiable in the light of all the information disclosed by that patent.
Amendment 51 #
Proposal for a regulation
Recital 9
Recital 9
(9) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same therapeutic indication or for a different one.
Amendment 54 #
Proposal for a regulation
Recital 12
Recital 12
(12) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not economically linkedpart 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.
Amendment 56 #
Proposal for a regulation
Recital 13
Recital 13
(13) Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all therapeutically equivalentbiosimilars 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 61 #
Proposal for a regulation
Recital 24
Recital 24
(24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.
Amendment 63 #
Proposal for a regulation
Recital 30
Recital 30
(30) The examination of a centralised application for a certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the Office and the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest.
Amendment 64 #
Proposal for a regulation
Recital 32
Recital 32
Amendment 65 #
Proposal for a regulation
Recital 32 a (new)
Recital 32 a (new)
(32 a) To guarantee an effective protection of innovation, in certain urgent situations, including where the expiry of the basic patent is imminent, an expedited examination procedure may be needed, notwithstanding the possibility for third parties to submit observations and other remedies provided for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be foreseen.
Amendment 66 #
Proposal for a regulation
Recital 33
Recital 33
(33) After the completion of the examination of a centralised application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the opinion should be transmitted to the respective national patent offices of the designated Member States. The Office must ensure the transmission takes place within a timeframe allowing national patent offices to grant the certificate or reject the application, upon the case, before the expiry of the basic patent.
Amendment 67 #
Proposal for a regulation
Recital 38
Recital 38
(38) WTo safeguard procedural rights and ensure a complete system of remedies, where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed.
Amendment 68 #
Proposal for a regulation
Recital 39
Recital 39
(39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 73 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for that product may be issued to each of those holders, where they are not economically linkedpart of the same undertaking at the time of filing an application for a certificate. The same principle shall apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents.
Amendment 92 #
Proposal for a regulation
Article 24 – paragraph 5 a (new)
Article 24 – paragraph 5 a (new)
5 a. The Office shall adopt an examination opinion within 6 months after publication of the centralised application in the Register. Without prejudice to Articles 25, 26 and 28 of this Regulation, whenever duly justified for reasons of urgency, the applicant may submit a request for an expedited procedure. Where the request for an expedited examination procedure is deemed justified, the Office shall adopt an examination opinion within 4 months from the publication of the application for a unitary certificate.
Amendment 94 #
Proposal for a regulation
Article 25 – paragraph 3 – subparagraph 1 (new)
Article 25 – paragraph 3 – subparagraph 1 (new)
Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within 1 month after publication of the application in the Register.
Amendment 95 #
Proposal for a regulation
Article 26
Article 26
Amendment 104 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications, on the basis of their relevant expertise and experience in the field .
Amendment 105 #
Proposal for a regulation
Article 27 – paragraph 5
Article 27 – paragraph 5
5. Each competent national authority appointed under this Article shall provide the Office with a list identifying the individual examiners who are available for participation in examination and opposition proceedings. Each such competent national authority shall update that list in the event of a change.
Amendment 106 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. The assessments under Articles 24, 26 and 33 shall be conducted by an examination panel including one member of the Office as well as two examiners as referred to in Article 27(1) from two different participating competent national authorities.
Amendment 109 #
Proposal for a regulation
Article 28 – paragraph 3 – point a a (new)
Article 28 – paragraph 3 – point a a (new)
(a a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one of them has a minimum of 5 years of experience in patent and supplementary protection certificate examination;
Amendment 111 #
Proposal for a regulation
Article 28 – paragraph 3 – point c
Article 28 – paragraph 3 – point c
(c) no more than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).
Amendment 112 #
Proposal for a regulation
Article 28 – paragraph 4
Article 28 – paragraph 4
4. The Office shall publish a yearly overview of the number of procedures, including those for examination, opposition and appeal, each competent national authority participated in.
Amendment 114 #
Proposal for a regulation
Article 29 – paragraph 3
Article 29 – 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 shall be filed within 43 months of the date of notification of the decision.
Amendment 115 #
Proposal for a regulation
Article 29 – paragraph 3 – subparagraph 1 (new)
Article 29 – paragraph 3 – subparagraph 1 (new)
Any written statement in reply to the grounds of appeal shall be filed within 3 months from the date of the notification of the statement setting out the grounds of appeal. A date for oral hearing shall be set by the Office within 3 months after the filing of the reply to the grounds of appeal or within 6 months of the filing of grounds of appeal, whichever is earlier. A written decision of the Office shall issue within 3 months after the date of the oral hearing.
Amendment 119 #
Proposal for a regulation
Article 30 – paragraph 4
Article 30 – paragraph 4
4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001. When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 120 #
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. After the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall transmit the examination opinion and its translations to the competent national authority of each designated Member State. Such transmission shall take place without undue delay within a timeframe allowing the competent national authorities of each designated Member State to grant or reject a certificate, as applicable, according to applicable national procedures, before the expiry of the basic patent.
Amendment 123 #
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. The Office shall charge a fee for an appeal, and for an opposition.
Amendment 124 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. The Office shall develop, keep and maintain an electronic, searcheable and public Register, providing up-to-date information regarding the status of all published centralised applications, and of all centralised applications for an extension of the duration of certificates.
Amendment 130 #
Proposal for a regulation
Article 35 – paragraph 2 – point n
Article 35 – paragraph 2 – point n
Amendment 138 #
Proposal for a regulation
Article 38 – paragraph 2 – subparagraph 2
Article 38 – paragraph 2 – subparagraph 2
An employee of a legal person may also represent other legal persons which are economically linked withpart of the same undertaking at the time of filing an application for a certificate as the legal person being represented by that employee.
Amendment 139 #
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. The combined application shall undergo a single centralised examination procedure, as well as a single opposition or appeal procedure, where it has been filed against an opinion or decision in respect of both the centralised application and the unitary certificate application.
Amendment 140 #
Proposal for a regulation
Article 40 – paragraph 1 – point c
Article 40 – paragraph 1 – point c
Amendment 142 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. Oral proceedings before an examination panel or opposition panel shall not be public.
Amendment 145 #
Proposal for a regulation
Article 49 – paragraph 5
Article 49 – paragraph 5
5. This Article shall not be applicable to the time limits referred to in paragraph 2 of this Article, or in Article 26(1) and (3).
Amendment 146 #
Proposal for a regulation
Article 51 – paragraph 1
Article 51 – paragraph 1
1. The losing party in opposition proceedings, including in related appeal proceedings, shall bear the fees paid by the other party. The losing party shall also bear all costs incurred by the other party that are essential to the proceedings, including travel and subsistence and the remuneration of a representative, within the maximum rates set for each category of costs in the implementing act to be adopted in accordance with paragraph 7. The fees to be borne by the losing party shall be limited to the fees paid by the other party in those proceedings.
Amendment 147 #
Proposal for a regulation
Article 55 – paragraph 2
Article 55 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 148 #
Proposal for a regulation
Article 55 – paragraph 3
Article 55 – paragraph 3
3. The delegation of power referred to in Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect on the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 149 #
Proposal for a regulation
Article 55 – paragraph 6
Article 55 – paragraph 6
6. A delegated act adopted pursuant to Articles 26(13), 29(8), 31, 42(2), 44(4), 45(6), 46(4), 47(5) and 50(3) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Amendment 152 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – paragraph 2
Articles 20 to 53 and 55 to 57 shall apply from xxxxx [OP: please insert: the first day of the 124th month after the entry into force].