Changes from report parliamentary committee draft to plenary report

AddedArticle 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 .../... [2023/0132(COD)], through the centralised procedure under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6, the procedure in this Chapter shall apply.

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ChangedArticle 2423 – paragraph 3: 3.1: WhereIf the centralised application for a certificate and the product to which it relates does not complycomplies with Article 3(1)22, andor (3)if andan Articleapplication 6(2)for inan respectextension of all orthe someduration of thecertificates designatedcomplies Memberwith States,Article 33(2), the Office shall adopt a reasoned negativepublish examinationthe opinionapplication, in respect of such Member States. The Office shall notify thatthe opinionRegister towithout theundue applicantdelay and publish itno onlater thethan Registerfive withoutworking unduedays delay.after.

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

AddedArticle 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 and publish the opinion on the dedicated register without undue delay.

AddedArticle 24 – paragraph 3: 3. Where the centralised application for a certificate and the product to which it relates does not 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 negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant and publish the opinion on the dedicated register without undue delay.

AddedArticle 24 – paragraph 5 a (new): 5a. 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.

AddedArticle 25 – paragraph 3 a (new): 3a. Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within six weeks after publication of the application in the Register.

AddedArticle 26 – paragraph 2: 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 or 6 are not fulfilled for one or more of the designated Member States.

Article 26 – paragraph 4 – point c a (new): (ca) any evidence the opponent relies on in support of the opposition.

Article 26 – paragraph 6: 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate its decision as well as the reasoning for its decision to the opponent, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

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ChangedArticle 26 – paragraph 9: 9. The Office shall issue a decision on the opposition including a detailed reasoning for itsthat decision within 6 months, unless the complexity of the case requires a longer period.

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ChangedArticle 26 – paragraph 9 a (new): 9a. In cases where several oppositions have been filed against an examination opinion, the Office shall deal with the oppositions jointly and issue one single decision in respectregards ofto all oppositions filed.

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ChangedArticle 26 – paragraph 10: 10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition,opposition and notify the opponent of its decisiondecision, and the Office shall mention this in the Register.

Change 13

RemovedArticle 28 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates;

AddedArticle 26 – paragraph 12 a (new): 12a. Full transparency shall be ensured throughout the whole opposition proceeding, which shall be open, whenever possible, to public participation.

RemovedArticle 28 – paragraph 3 – point c: (c) that there is no examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).

AddedArticle 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 of their experience in the field.

RemovedArticle 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, including corresponding evidence relied on, shall be filed within 4 months of the date of notification of the decision.

AddedArticle 28 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one examiner has a minimum of five years of experience in the examination of patents and supplementary protection certificates;

AddedArticle 28 – paragraph 3 – point a a (new): (aa) where possible, geographical balance amongst the participating offices;

AddedArticle 28 – paragraph 3 – point c: (c) that there is no examiner employed by a competent national authority making use of the exemption set out in Article 10(5) of this Regulation.

AddedArticle 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, including corresponding evidence relied on, shall be filed within 3 months of the date of notification of the decision

AddedArticle 29 – paragraph 3 a (new): 3a. Any reply to statement of the grounds of appeal shall be submitted in writing within three months from the date of the notification of the statement of the grounds of appeal. Where applicable, the Office shall set a date for an oral hearing within three months after the filing of the reply to the grounds of appeal or within six months of the filing of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable.

Article 29 – paragraph 5: 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States.

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

AddedArticle 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.

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ChangedArticle 3330 – paragraph 4: 4.4 Thirda parties(new): may4a. alsoArticle submit166(9) observationsof orRegulation oppositions(EU) in2017/1001 respectshall ofapply ato centralisedBoards applicationof forAppeal anin extensionmatters ofregarding thecentralised durationapplications offor certificates.

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AddedArticle 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.

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

AddedArticle 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.

AddedArticle 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.

Article 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;

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

Article 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;

Article 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;

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ChangedArticle 35 – paragraph 11 a (new): 11a. By way of derogation fromof Article 35(9), point (b),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 biosimilarsbiosimilar shall be based on information provided for in the register and be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations,authorisation, pricing and reimbursement decisions or tender bids.

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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 it shall be verified that that expert 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.

AddedArticle 44 – paragraph 2: deleted

RemovedArticle 57 – paragraph 2: 2. By [OP, 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 and to the Council.

AddedArticle 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.

AddedArticle 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.

AddedArticle 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.