Changes from plenary report to adopted text

Added(40) Any person may challenge the validity of a certificate granted following the centralised procedure before a competent court of a Member State, which includes the Unified Patent Court where the conditions are met.

RemovedArticle 32 – paragraph 1 – subparagraph 1 a (new): 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.

Added(41) To reduce administrative burden and costs for certificate holders, there is a need for the centralised procedure to provide for a swift way of applying for, and granting, an extension of the duration of a set of equivalent certificates for a given medicinal product, granted under the new centralised procedure, in accordance with Regulation (EC) No 1901/2006. As for certificates, such extensions should be granted by competent national authorities, subject to a positive examination of the centralised application for an extension of the duration.

RemovedArticle 32 – paragraph 5 a (new): 5a. The competent national authority shall inform the applicant of its decision without undue delay.

Added(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. [Am. 12]

RemovedArticle 33 – paragraph 4: 4. Third parties may also submit observations or an opposition in respect of a centralised application for an extension of the duration of certificates.

Added(42) In 2019, the Union introduced an exception in Regulation (EU) 2019/933 of the European Parliament and of the Council from the protection granted to holders of supplementary protection certificates for medicinal products. It noted the absence of any exception to the protection conferred by the certificate has had the unintended consequence of preventing makers of generics and biosimilars established in the Union from making generics and biosimilars in the Union, even for the purpose of export to third country markets in which protection does not exist or has expired or for the purpose of storing with a view to day-one placement on the Union market entry. Those circumstances put makers of generics and biosimilars established in the Union at a significant competitive disadvantage in comparison with makers based in third countries that offer less or no protection. The reasons for the introduction for the waiver and the conditions for its application remain applicable at the present time.

RemovedArticle 35 – paragraph 1: 1. The Office shall develop, keep and maintain an electronic, searchable 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.

Added(43) A balance should be struck between restoring a level playing field between makers of generics and biosimilars established in the Union and makers based in third countries that offer less or no protection and ensuring that the essence of the exclusive rights of holders of certificates (‘certificate holders’) is guaranteed in relation to the Union market.

RemovedArticle 35 – paragraph 2 – point j a (new): (ja) information on any direct public financial support received for research related to the development of the product;

Added(44) Makers of generics and biosimilars established in the Union should be allowed to make and store products, or medicinal products containing those products, in a Member State for a defined period pending the expiry of the certificate, for the purpose of entering the market of any Member State upon expiry of the corresponding certificate, thereby helping those makers to compete effectively in the Union immediately after protection has expired (‘EU day-one entry’).

RemovedArticle 35 – paragraph 2 – point k: (k) the date and the examination opinion in respect of each of the designated Member States;

Added(45) In those specific and limited circumstances, and in order to create a level playing field between Union-based makers established in the Union and third-countryand third country makers, it is appropriate to provide for an exception to the protection conferred by a supplementary protection certificate in accordance to Regulation (EU) 2019/933 should be restricted, so as to allow the making of a product, or a medicinal product containing that product, for the exclusive purpose of export to third countries or of storing, and any related acts in the Union strictly necessary for that making or for the actual export or the actual storing (‘related acts’) itself, where such acts would otherwise require the consent of the a certificate holder(‘related acts’). For instance, such related acts could include the possessing the, possession, supply, offering to supply, supplying, importing, using or synthesising of import, use or synthesis of an active ingredient for the purpose of making a medicinal product. They could also consist of containing that product, or temporary storingstorage of the product or advertising of the product for the exclusive purpose of export to third-countrythird country destinations. The exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker. [Am. 13]

RemovedArticle 35 – paragraph 2 – point n: (n) where applicable, the filing of an opposition, its status and its outcome, including where applicable a summary of the revised examination opinion;

Added(46) The exception should apply to a product, or a medicinal product containing that product, protected by a certificate and should cover the making of the product protected by the certificate in the territory of a Member State and the making of the medicinal product containing that product.

RemovedArticle 35 – paragraph 2 – point o: (o) where applicable, the filing of an appeal, its status and the outcome of the appeal proceedings, including where applicable a summary of the revised examination opinion;

Added(47) The exception should not cover placing a product, or a medicinal product containing that product, which is made for the purpose of export to third countries or of storing with a view to EU day-one entry, on the market of a Member State where a certificate is in force, either directly or indirectly after export, nor should it cover re-importation of such a product, or medicinal product containing that product, into the market of a Member State in which a certificate is in force. Moreover, it should not cover any act or activity carried out for the purpose of import of products, or medicinal products containing those products, into the Union merely for the purposes of repackaging and re-exporting. In addition, the exception should not cover any storing of products, or medicinal products containing those products, for any purposes other than those set out in this Regulation.

RemovedArticle 35 – paragraph 11 a (new): 11a. By way of derogation of Article 35(9)(b) public authorities shall not use the information provided for in the register for practices of patent linkage and no regulatory or administrative decisions related to generics or biosimilar shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisation, pricing and reimbursement decisions or tender bids.

Added(48) By limiting the scope of the exception to the making of a product, or a medicinal product containing that product, for the purpose of export outside the Union or to making for the purpose of storing, and to acts strictly necessary for such making or for the actual export or the actual storing, the exception will not conflict with the normal exploitation of the product, or the medicinal product containing that product, in the Member State in which the certificate is in force, namely with the core exclusive right of the certificate holder to make that product for the purpose of placing it on the Union market during the term of the certificate. In addition, that exception should not unreasonably prejudice the legitimate interests of the certificate holder, whilst taking account of the legitimate interests of third parties.

RemovedArticle 44 – paragraph 2: deleted

Added(49) Effective and proportionate safeguards should apply in relation to the exception in order to increase transparency, to help the certificate holder to enforce its protection in the Union and check compliance with this Regulation, and to reduce the risk of illicit diversion onto the Union market during the term of the certificate.

RemovedArticle 44 – 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.

Added(50) To ensure better transparency and legal certainty, it is necessary to impose an information obligation on the maker, namely the person established in the Union, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export or storing, is carried out. That obligation should apply also where the making is directly carried out by the maker .

RemovedArticle 45 – paragraph 3: 3. If the Office or the relevant panel considers it necessary for a party, witness or expert to give evidence orally, it shall issue a summons to the person concerned to appear before it. Where an expert is summonsed, the Office or the relevant panel, as applicable, shall verify that the person is free of any conflict of interest. The period of notice provided in such summons shall be at least 1 month, unless they agree to a shorter period.

Added(51) It should be the responsibility of the maker established in the Union to verify that protection does not exist or has expired in a country of export, or whether that protection is subject to any limitations or exemptions in that country.

RemovedArticle 57 – paragraph 2: 2. By … [OJ: please insert: five years after the date of application], and every 5 years thereafter, the Commission shall also carry out an evaluation of the application of Chapter III, and present a report on the main findings to the European Parliament, the Council and the European Economic and Social Committee. The evaluation should assess in particular whether the objectives of the provisions in that Chapter have been achieved.

Added(52) Certain due diligence requirements should be imposed on the maker as a condition to use the exception , so as to ensure better transparency and legal certainty . The holder of the relevant certificate will , therefore, be entitled to enforce its rights under the certificate, while having due regard to the general obligation, provided for in Directive 2004/48/EC of the European Parliament and of the Council, not to engage in abusive litigation.