Activities of Javier ZARZALEJOS related to 2023/0126(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary protection certificate for plant protection products
Amendments (63)
Amendment 26 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2 a) That situation leads to a lack of protection which penalises plant protection research and the competitiveness of the sector.
Amendment 27 #
Proposal for a regulation
Recital 14
Recital 14
(14) The fact that marketing authorisations in respect of a given plant protection product may be granted at different dates in different Member States would in many cases make the grant of a unitary certificate for a given plant protection product impossible, if it was required that authorisations must have been granted in all relevant Member States – i.e. those in which the basic patent has unitary effect – by the time of the filing of the application. An applicant should therefore be allowed to file an application for a unitary certificate where a marketing authorisations have been applied for in all relevant Member States, provids granted that such authorisations are granted before the end of the examination process – which for that reason should not be completed earlier than 18 months from the filing of the applicationleast in one Member State. Where no authorisation has been granted in a relevant Member State before the completion of the examination, the unitary certificate should not have any effect in respect of that Member State until a valid authorisation is granted in that Member State. However, that suspensory effect should be lifted where an outstanding authorisation is granted after the grant of the unitary certificate but – to ensure legal certainty – before the expiry of the basic patent, following a request to that end by the holder of the unitary certificate, subject to a verification of that request by the Office.
Amendment 28 #
Proposal for a regulation
Recital 17
Recital 17
(17) One of the conditions for the grant of a certificate should be that the product should be 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 substance of the product be explicitly identified in the claims. Or, in the event of a preparation, this should not necessarily require that each of its active substances 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 29 #
Proposal for a regulation
Recital 18
Recital 18
(18) 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, or complexes, equivalent to the product from a phytosanitary perspective, 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 application or for a different one.
Amendment 30 #
Proposal for a regulation
Recital 21
Recital 21
(21) 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 31 #
Proposal for a regulation
Recital 24
Recital 24
(24) 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 32 #
Proposal for a regulation
Recital 25
Recital 25
(25) 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, 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 33 #
Proposal for a regulation
Recital 27
Recital 27
Amendment 34 #
Proposal for a regulation
Recital 28
Recital 28
(28) 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 35 #
Proposal for a regulation
Recital 29
Recital 29
(29) 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 37 #
Proposal for a regulation
Recital 30
Recital 30
(30) 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 38 #
Proposal for a regulation
Recital 31
Recital 31
(31) 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 39 #
Proposal for a regulation
Recital 32
Recital 32
(32) The Office should have the possibility to charge a fee for the application for a unitary certificate, 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 40 #
Proposal for a regulation
Article 3 – paragraph 1 – introductory part
Article 3 – paragraph 1 – introductory part
1. A unitary certificate shall be granted by the Office on the basis of a basic patent if, in each of the Member States in which that basic patent has unitary effect, at the date of the application, all of the following conditions are fulfilled:
Amendment 41 #
Proposal for a regulation
Article 3 – paragraph 1 – point a a (new)
Article 3 – paragraph 1 – point a a (new)
(a a) the product is approved in accordance with Article 4 of Regulation (EC) No 1107/2009;
Amendment 42 #
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 plant protection product has been granted in accordance with Regulation (EC) No 1107/2009, in at least one of the Member States in which that basic patent has unitary effect;
Amendment 43 #
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 for 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 44 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Amendment 45 #
Proposal for a regulation
Article 3 – paragraph 4
Article 3 – paragraph 4
Amendment 46 #
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1
Article 3 – paragraph 5 – subparagraph 1
Amendment 47 #
Proposal for a regulation
Article 9 – paragraph 1 – point a – point iii a (new)
Article 9 – paragraph 1 – point a – point iii a (new)
(iii a) the number and date of the approval of the product, as referred to in Article 3(1), point (aa);
Amendment 49 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
If the application for a unitary certificate complies with Article 11(1), the Office shall publish the application in the Register without undue delay.
Amendment 50 #
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), for all Member States in which the basic patent has unitary effect.
Amendment 51 #
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.
Amendment 52 #
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) 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 without undue delay.
Amendment 53 #
Proposal for a regulation
Article 15
Article 15
Amendment 54 #
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 56 #
Proposal for a regulation
Article 17 – paragraph 1
Article 17 – paragraph 1
1. The assessments under Articles 13, 15 and 22 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 58 #
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 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 60 #
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) 223].
Amendment 61 #
Proposal for a regulation
Article 17 – paragraph 4
Article 17 – paragraph 4
4. The Office shall publish a yearly overview of the number of procedures, including those for examination, opposition, appeal and invalidity and appeal, each competent national authority participated in.
Amendment 63 #
Proposal for a regulation
Article 18 – paragraph 1 – introductory part
Article 18 – paragraph 1 – introductory part
Amendment 64 #
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 65 #
Proposal for a regulation
Article 22 – paragraph 1
Article 22 – 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 66 #
Proposal for a regulation
Article 22 – paragraph 2 a (new)
Article 22 – 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 67 #
Proposal for a regulation
Article 22 – paragraph 3
Article 22 – paragraph 3
Amendment 68 #
Proposal for a regulation
Article 22 – paragraph 4
Article 22 – paragraph 4
Amendment 69 #
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
Amendment 70 #
Proposal for a regulation
Article 22 – paragraph 6
Article 22 – paragraph 6
Amendment 71 #
Proposal for a regulation
Article 22 – paragraph 7
Article 22 – paragraph 7
Amendment 72 #
Proposal for a regulation
Article 22 – paragraph 8
Article 22 – paragraph 8
Amendment 73 #
Proposal for a regulation
Article 22 – paragraph 9
Article 22 – paragraph 9
Amendment 74 #
Proposal for a regulation
Article 22 – paragraph 10
Article 22 – paragraph 10
Amendment 75 #
Proposal for a regulation
Article 22 – paragraph 11
Article 22 – paragraph 11
Amendment 76 #
Proposal for a regulation
Article 22 – paragraph 12
Article 22 – 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 77 #
Proposal for a regulation
Article 22 – paragraph 13
Article 22 – paragraph 13
Amendment 78 #
Proposal for a regulation
Article 23 – paragraph 2
Article 23 – 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 79 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – 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 80 #
Proposal for a regulation
Article 23 – paragraph 6
Article 23 – paragraph 6
Amendment 81 #
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – 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 82 #
Proposal for a regulation
Article 26 – paragraph 3 – subparagraph 1 (new)
Article 26 – 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 84 #
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – 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 85 #
Proposal for a regulation
Article 29 – paragraph 2
Article 29 – paragraph 2
2. The Office shall charge a fee for appeals, for oppositions, for applications for a declaration of invalidity and for conversions.
Amendment 87 #
Proposal for a regulation
Article 33 – paragraph 1 – point k
Article 33 – paragraph 1 – point k
Amendment 88 #
Proposal for a regulation
Article 36 – paragraph 2 – subparagraph 2
Article 36 – 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 89 #
Proposal for a regulation
Article 37 – paragraph 1 – point c
Article 37 – paragraph 1 – point c
Amendment 90 #
Proposal for a regulation
Article 37 – paragraph 1 – point d
Article 37 – paragraph 1 – point d
Amendment 91 #
Proposal for a regulation
Article 39 – paragraph 2
Article 39 – paragraph 2
2. Oral proceedings before an examination panel, opposition panel or invalidity panel shall not be public.
Amendment 93 #
Proposal for a regulation
Article 44 – paragraph 5
Article 44 – 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 94 #
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – 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 95 #
Proposal for a regulation
Article 49 – paragraph 2
Article 49 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 15(13), 22(13), 26(8), 28, 32(2), 39(4), 40(6), 41(4), 42(5) and 45(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 96 #
Proposal for a regulation
Article 49 – paragraph 3
Article 49 – paragraph 3
3. The delegation of power referred to in Articles 15(13), 22(13), 26(8), 28, 32(2), 39(4), 40(6), 41(4), 42(5) and 45(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 97 #
Proposal for a regulation
Article 49 – paragraph 6
Article 49 – paragraph 6
6. A delegated act adopted pursuant to Articles 15(13), 22(13), 26(8), 28, 32(2), 39(4), 40(6), 41(4), 42(5) and 45(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.