Changes from report parliamentary committee draft to plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

Changedon the proposal for a regulation of the European Parliament and of the Council on thesupplementarythe supplementary protection certificate for medicinal products (recast)

▸9 unchanged paragraphs

(COM(2023)0231 – C90146/2023 – 2023/0130(COD))

(Ordinary legislative procedure – recast)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2023)0231),

– having regard to Article 294(2) and Article 114(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90146/2023),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 27 September 2023,

– having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts,

– having regard to Rules 110 and 59 of its Rules of Procedure,

Changed– having regard to the report of the Committee on Legal Affairs (A90000/2023),(A9-0022/2024),

▸4 unchanged paragraphs

A. whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1. Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 1

ChangedRecital 2: (2) 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. ItHowever, is,it however,is difficult to establish a direct link between such favourable rules and Union competitiveness because,because while such rules make Union markets more attractive, medicines’ geographical origin and authorised medicines from third countries are equally eligible to receive all Union incentives, just as Union-basedUnion based innovative companies can equally benefit from incentives in third countries.

Recital 3: deleted

Change 2

RemovedRecital 5: deleted

AddedRecital 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 in light of the description and drawings of the patent, on the basis of that person’s general knowledge in the relevant field and of 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 active ingredient is specifically identifiable in the light of all the information disclosed by that patent, on the basis of the prior art at the filing date or priority date of the basic patent.

RemovedRecital 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 biosimilars 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.

AddedRecital 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 derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, should not have already been the subject of a prior certificate, whether for the same therapeutic indication or for a different one.

RemovedRecital 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 in accordance with Article [86] of Directive (EU) .../... [2023/0132(COD)], 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.

AddedRecital 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 biosimilar 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.

RemovedRecital 41 a (new): (41a) The timely entry of generics and biosimilars onto the Union market is important, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines by 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.

AddedRecital 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 in accordance with Article 86 of Directive (EU) .../... [2023/0132(COD)], 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.

RemovedRecital 45: (45) In those specific and limited circumstances, and in order to create a level playing field between Union-based makers and third country makers, it is appropriate to restrict the protection conferred by a supplementary protection certificate in accordance with Regulation (EU) 2019/933 so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for making or for the actual export itself, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, related acts could include the possession, supply, offering to supply, import, using or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third-country destinations. The exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.

AddedRecital 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.

RemovedRecital 60: (60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. However, the information provided for within the register should not be used in relation to practices of patent linkage, and no regulatory or administrative decisions related to generic or biosimilars should be based on information provided for in the register, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the supplementary protection certificate.

AddedRecital 32 a (new): (32a) 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 might be necessary, notwithstanding the possibility for third parties to submit observations and make use of other remedies provided for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be provided.

RemovedArticle 2 – paragraph 1 – point 1: (1) ‘medicinal product’ means any substance or combination of substances that fulfils at least one of the following conditions: / (a) any substance or combination of substances that is presented as having properties for treating or preventing disease in human beings; or / (b) any substance or combination of substances that may be used in or administered to human beings with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis;

AddedRecital 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 shall ensure the transmission takes place within a timeframe allowing national patent offices to grant the certificate or reject the application, as applicable, before the expiry of the basic patent.

AddedRecital 38: (38) To 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.

AddedRecital 39: (39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account.

AddedRecital 41 a (new): (41a) The timely entry of generics and biosimilars onto the Union market is important, 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 the pharmaceutical systems in the Union and its Member States. On the other hand, it should be borne in mind that intellectual property rights remain one of the cornerstones of innovation, competitiveness and growth in the internal market.

AddedRecital 45: (45) In those specific and limited circumstances, and in order to create a level playing field between Union-based makers and third country makers, the protection conferred by a supplementary protection certificate in accordance to Regulation (EU) 2019/933 should be restricted, so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for making or for the actual export itself, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, related acts could include the, possession, supply, offering to supply, import, use or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations. The exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker.

AddedRecital 60: (60) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure, including on certificates granted on that basis by competent national authorities, which should share with the Office any related information. The register should be available in all official languages of the Union. However, the information provided in the register should not be used in regards to practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilars, such as marketing authorisations, pricing and reimbursement decisions or tender bids to the existence of the SPC, should be based on information provided for in the register.

Article 2 – paragraph 1 – point 12 a (new): (12a) ‘economically linked’ means, in respect of different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder.

Change 3

RemovedArticle 5 – paragraph 1: 1. Subject to the provisions of Article 4, the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

AddedArticle 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 .../... [2023/0132(COD)], Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, as appropriate;

RemovedArticle 5 – paragraph 2 – introductory part: 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU) 2019/933, the certificate shall not confer protection against certain acts which would otherwise require the consent of the certificate holder, if all of the following conditions are met:

AddedArticle 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 linked. 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.

RemovedArticle 5 – paragraph 2 – point a – point i: (i) making a product, or a medicinal product containing that product, for the purpose of export to third countries; or

AddedArticle 5 – paragraph 2 – introductory part: 2. By way of derogation from paragraph 1, and in accordance with Regulation (EU).../... [2023/0130(COD)], the certificate shall not confer protection against certain acts which would otherwise require the consent of the certificate holder, if all of the following conditions are met:

AddedArticle 5 – paragraph 2 – point a – point i: (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or

Article 5 – paragraph 2 – point a – point ii: (ii) any related act that is strictly necessary for that making in the Union or for the actual export itself; or

Article 5 – paragraph 2 – point a – point iii: (iii) making, no earlier than 6 months before the expiry of the certificate, 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 certificate; or

Article 5 – paragraph 2 – point a – point iv: (iv) any related act that is strictly necessary for the making in the Union as referred to in point (iii), or for the actual storing itself, provided that such related act is carried out no earlier than 6 months before the expiry of the certificate.

Change 4

ChangedArticle 58 – paragraph 21 – point d a –(new): point(da) ivif aapplicable, (new):the (iva)consent anyof actthe inthird accordanceparty withreferred Articleto [85]in ofArticle Directive6(2) (EU)of .../...this [2023/0132(COD)].Regulation.

Change 5

RemovedArticle 7 – paragraph 4 a (new): 4a. The applicant shall be responsible for the accuracy and completeness of the information and documentation submitted in relation to its application.

RemovedArticle 8 – paragraph 1 – point d a (new): (da) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation;

Article 8 – paragraph 1 – point d b (new): (db) information on any direct public financial support received for research related to the development of the product.

Article 11 – paragraph 1 – introductory part: 1. The authority referred to in Article 9(1) shall publish, without undue delay, notification of the fact that a certificate has been granted. The notification shall contain all of the following information:

Article 11 – paragraph 1 – point f a (new): (fa) information on any direct public financial support received for research related to the development of the product.

Change 6

ChangedArticle 15 – paragraph 1 – point c a (new): (ca)a: if(a) the marketing authorisation has been withdrawn orcertificate revokedwas ingranted accordancecontrary withto DirectiveArticle (EU)3 .../...or [2023/0132(COD)].6(2);

Change 7

RemovedArticle 20 – paragraph 1: 1. Where the basic patent is a European patent, including a unitary patent, and the authorisation to place the product on the market has been granted, as appropriate, in accordance with Directive (EU) .../... [EC2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.

AddedArticle 16 – paragraph 2: 2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent or before a competent court of a Member State.

RemovedArticle 24 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Article 3(1) and (3) and Article 6(2) for each of the designated Member States.

AddedArticle 18 – paragraph 2 a (new): 2a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.

RemovedArticle 24 – paragraph 2: 2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) and (3) and Article 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant.