Activities of Javier ZARZALEJOS related to 2023/0127(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the 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
Amendments (62)
Amendment 64 #
Proposal for a regulation
Recital 1
Recital 1
(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.
Amendment 66 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(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.
Amendment 69 #
Proposal for a regulation
Recital 16
Recital 16
(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 byin light of the description of the patent, on its filing datethe 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.
Amendment 70 #
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 73 #
Proposal for a regulation
Recital 20
Recital 20
(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 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 75 #
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 equivalentbiosimilar 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 77 #
Proposal for a regulation
Recital 22
Recital 22
(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 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.
Amendment 79 #
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. 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 OfficeUnified Patent Court. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
Amendment 80 #
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 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.
Amendment 82 #
Proposal for a regulation
Recital 26 a (new)
Recital 26 a (new)
(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.
Amendment 83 #
Proposal for a regulation
Recital 28
Recital 28
Amendment 84 #
Proposal for a regulation
Recital 29
Recital 29
(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 without undue delay the examination opinion by granting a unitary certificate or rejecting the application, as applicable.
Amendment 85 #
Proposal for a regulation
Recital 30
Recital 30
(30) 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 the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed.
Amendment 87 #
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 and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.
Amendment 88 #
Proposal for a regulation
Recital 32
Recital 32
(32) Any person may challenge the validity of a unitary certificate by lodging with the OfficeUnified Patent Court an application for a declaration of invalidity.
Amendment 90 #
Proposal for a regulation
Recital 33
Recital 33
(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 invalidityappeals. The fees charged by the Office should be laid down by an implementing act.
Amendment 95 #
Proposal for a regulation
Article 3 – paragraph 2 – subparagraph 2
Article 3 – paragraph 2 – subparagraph 2
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 applicablepart 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.
Amendment 107 #
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.
Amendment 110 #
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) 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.
Amendment 116 #
Proposal for a regulation
Article 13 – paragraph 5 a (new)
Article 13 – paragraph 5 a (new)
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.
Amendment 120 #
Proposal for a regulation
Article 14 – paragraph 3 – subparagraph 1 (new)
Article 14 – paragraph 3 – subparagraph 1 (new)
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.
Amendment 121 #
Proposal for a regulation
Article 15
Article 15
Amendment 136 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – 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 applications for unitary certificates, on the basis of their relevant expertise and experience in the field.
Amendment 138 #
Proposal for a regulation
Article 16 – paragraph 5
Article 16 – 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, opposition and invalidity proceedings. Each such competent national authority shall update that list in the event of a change.
Amendment 139 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The assessments under Articles 13, 15, 19 and 2319 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.
Amendment 143 #
Proposal for a regulation
Article 17 – paragraph 3 – point a a (new)
Article 17 – paragraph 3 – point a a (new)
(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;
Amendment 145 #
Proposal for a regulation
Article 17 – paragraph 3 – point c
Article 17 – paragraph 3 – point c
(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].
Amendment 146 #
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Office shall publish a yearly an overview of the number of procedures, including those for examination, opposition, appeal and invalidity and appeal, each competent national authority participated in.
Amendment 149 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
Amendment 150 #
Proposal for a regulation
Article 18 – paragraph 1 – subparagraph 1 (new)
Article 18 – paragraph 1 – subparagraph 1 (new)
The Office shall inform the applicant of its decision without undue delay.
Amendment 158 #
Proposal for a regulation
Article 23 – title
Article 23 – title
Applicaction for a declaration of invalidity
Amendment 159 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
1. Any person may file with the Office an applicabring an action for a declaration of invalidity of a unitary certificate before the Unified Patent Court.
Amendment 160 #
Proposal for a regulation
Article 23 – paragraph 2 a (new)
Article 23 – paragraph 2 a (new)
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.
Amendment 161 #
Proposal for a regulation
Article 23 – paragraph 3
Article 23 – paragraph 3
Amendment 163 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
Amendment 164 #
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
Amendment 165 #
Proposal for a regulation
Article 23 – paragraph 6
Article 23 – paragraph 6
Amendment 166 #
Proposal for a regulation
Article 23 – paragraph 7
Article 23 – paragraph 7
Amendment 167 #
Proposal for a regulation
Article 23 – paragraph 8
Article 23 – paragraph 8
Amendment 168 #
Proposal for a regulation
Article 23 – paragraph 9
Article 23 – paragraph 9
Amendment 169 #
Proposal for a regulation
Article 23 – paragraph 10
Article 23 – paragraph 10
Amendment 170 #
Proposal for a regulation
Article 23 – paragraph 11
Article 23 – paragraph 11
Amendment 171 #
Proposal for a regulation
Article 23 – paragraph 12
Article 23 – paragraph 12
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, to the extent that it has been declared invalid.
Amendment 172 #
Proposal for a regulation
Article 23 – paragraph 13
Article 23 – paragraph 13
Amendment 175 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The competent court of a Member State shall reject a counterclaim for a declaration of invalidity if a decision taken by the OfficeUnified Patent Court relating to the same subject matter and cause of action and involving the same parties has already become final.
Amendment 176 #
Proposal for a regulation
Article 24 – paragraph 4
Article 24 – paragraph 4
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 OfficeUnified Patent Court of the date on which the counterclaim was filed. The Office shall record that information in the Register. If an applicaction for a declaration of invalidity of the unitary certificate had already been filinitiated before the OfficeUnified Patent Court before the counterclaim was filed, the court shall be informed thereof by the OfficeUnified Patent Court and stay the proceedings until the decision on the application is final ction brought before the application is withdrawnUnified Patent Court becomes final.
Amendment 177 #
Proposal for a regulation
Article 24 – paragraph 6
Article 24 – paragraph 6
Amendment 181 #
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 shall be filed within 43 months of the date of notification of the decision.
Amendment 182 #
Proposal for a regulation
Article 28 – paragraph 3 – subparagraph 1 (new)
Article 28 – 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 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.
Amendment 188 #
Proposal for a regulation
Article 29 – paragraph 4
Article 29 – paragraph 4
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.
Amendment 189 #
Proposal for a regulation
Article 31 – paragraph 2
Article 31 – paragraph 2
2. The Office shall charge a fee for appeals, for oppositions, for applications for a declaration of invalidity and for conversions.
Amendment 199 #
Proposal for a regulation
Article 35 – paragraph 1 – point m
Article 35 – paragraph 1 – point m
Amendment 213 #
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 214 #
Proposal for a regulation
Article 39 – paragraph 1 – point c
Article 39 – paragraph 1 – point c
Amendment 215 #
Proposal for a regulation
Article 39 – paragraph 1 – point d
Article 39 – paragraph 1 – point d
Amendment 218 #
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public.
Amendment 222 #
Proposal for a regulation
Article 46 – paragraph 5
Article 46 – paragraph 5
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).
Amendment 223 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
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.
Amendment 224 #
Proposal for a regulation
Article 50 – paragraph 1 – point 1 – point b
Article 50 – paragraph 1 – point 1 – point b
Article 151 – paragraph 1
Article 151 – paragraph 1
(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;
Amendment 225 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
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].
Amendment 226 #
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
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.
Amendment 227 #
Proposal for a regulation
Article 54 – paragraph 6
Article 54 – paragraph 6
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.