Changes from report parliamentary committee draft to plenary report

Change 15

ChangedArticle 13 – paragraph 2: 2. Where the application4: for4. aThe unitaryOffice certificateshall andtranslate the product toexamination whichopinion itin relatesthe complyofficial withlanguages Articleof 3all anddesignated ArticleMember 6(2)States. forThe eachOffice ofmay theuse Memberverified Statesmachine referredtranslation to in paragraphthat 1,effect. theThe Office shall issue a reasonedpublish positivethe examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicantRegister viaas thesoon registeras andpossible publishafter it on the Register without undueis delay.issued.

Change 16

RemovedArticle 13 – paragraph 3: 3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3 and Article 6(2) 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.

Article 13 – paragraph 5: 5. The Commission is empowered to adopt implementing acts laying down rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine applications for unitary certificates and prepare examination opinions, as well as the issuance of examination opinions by the Office in electronic form. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

Change 17

RemovedArticle 14 – paragraph 1: 1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates, in one or more of the Member States in which the basic patent has unitary effect. Such written observations shall be submitted electronically.

AddedArticle 13 – paragraph 5 a (new): 5a. The Office shall issue an examination opinion within six months of publication of the application for a unitary certificate. Without prejudice to Articles 14, 25 and 28, 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 four months from the publication of the application for a unitary certificate.

AddedArticle 14 – paragraph 1: 1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates, in one or more of the Member States in which the basic patent has unitary effect. Such written observations shall be submitted to the Office electronically.

AddedArticle 14 – paragraph 3 – subparagraph 2 (new): Whenever the expedited procedure applies in accordance with Article 13(5a), observations shall be submitted within six weeks after publication of the application in the Register.

Article 14 – paragraph 4: 4. Any observations by a third party shall be submitted electronically in one of the official languages of the Union and state the grounds on which they are based.

Article 15 – paragraph 4 – point c a (new): (ca) any evidence the opponent relies on in support of the opposition.

Change 18

ChangedArticle 15 – 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,opponent as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

Change 19

ChangedArticle 15 – 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 respect of all oppositions filed.filed

Change 20

ChangedArticle 15 – paragraph 10: 10. The Office shall issue a decision on the oppositionopposition, including a detailed reasoning for that decisiondecision, within 6 months, unless the complexity of the case requires a longer period.

Change 21

RemovedArticle 15 – paragraph 13 a (new): 13a. All exchanges between the Office, the holder and the opponent shall take place electronically.

AddedArticle 15 – paragraph 12: 12. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall publish its full decision in the Register.

RemovedArticle 16 – paragraph 1 a (new): 1a. Once a national competent authority is appointed by the Office as a participating office, it shall appoint its designated examiners based on relevant expertise and whether they have sufficient experience for the centralised examination procedure.

AddedArticle 15 – 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 17 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates;

AddedArticle 15 – paragraph 12 b (new): 12b. All exchanges between the Office, the holder and the opponent shall take place electronically.

AddedArticle 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 based on relevant expertise and sufficient experience required for the centralised examination procedure.

AddedArticle 17 – 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 17 – paragraph 3 – point a a (new): (aa) where possible, geographical balance amongst the participating offices;

Article 17 – 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 Regulation [COM(2023) 231].

Change 22

ChangedArticle 18 – paragraph 1 – introductory part: No later than three months1: afterAfter the period during which an appeal or an opposition may be filed has expired without any appeal nor opposition being filed, or after a final decision on the merits has been issued, the Office shall take one of the following decisions:decisions, without undue delay:

Article 18 – paragraph 1 a (new): The Office shall inform the applicant of its decision without undue delay.

Article 19 – paragraph 2: 2. Third parties may also submit observations or oppositions in respect of an application for an extension of the duration of a unitary certificate.

Change 23

RemovedArticle 22 – paragraph 1 – point c a (new): (ca) the centralised marketing authorisation has been withdrawn in accordance with Article 14 or there has been a suspension of marketing, a withdrawal from the market of a medicinal product or a withdrawal of a marketing authorisation by the marketing authorisation holder in accordance with Article 24 [revised Regulation (EC) No 726/2004].

AddedArticle 22 – paragraph 1 – point a: (a) the certificate was granted contrary to Articles 3 and 6(2);

RemovedArticle 22 – paragraph 1 – point c b (new): (cb) the medicinal product is not placed on all Member States market covered by the unitary certificate or combined centralised supplementary protection certificate; where a medicinal product is not placed on a Member State market covered by the unitary certificate or the combined centralised supplementary protection certificate, the applicant shall waive the supplementary protection certificate rights for markets where the medicinal product has not been launched.

Article 23 – paragraph 3: 3. An application for a declaration of invalidity shall be filed electronically and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid.

Change 24

ChangedArticle 28 – paragraph 3: 3. Notice of appeal shall be filed electronically 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 the supporting evidence forsupporting those grounds, shall be filed electronically within 4three months of the date of notification of the decision. / Any reply to the statement of grounds of appeal shall be submitted in writing no later than three months from the date of the filing of the statement of grounds of appeal. The Office shall, where applicable, fix a date for oral proceedings within three months of the filing of the reply or within six months following the filing of the statement of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the date of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable.

Article 28 – paragraph 5: 5. Where an appeal results in a decision which is not in line with the examination opinion, the decision of the Boards shall annul or alter the opinion.

Change 25

RemovedArticle 29 – paragraph 4 a (new): 4a. The rules set out in Article 166(9) of Regulation (EU) 2017/1001 shall be respected.

AddedArticle 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 concerning applications for unitary certificates, due consideration shall be given to their previous experience in matters concerning supplementary protection certificates or patent law.

AddedArticle 29 – paragraph 4 a (new): 4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to Boards of Appeal in matters regarding unitary certificates.

Article 32 – paragraph 1 a (new): An applicant shall submit an application for a combined centralised application electronically to the Office and in the formats made available by the Office.

Change 26

RemovedArticle 32 – paragraph 1 b (new): The applicant shall be responsible for the accuracy of the information and documentation submitted in respect of its application.

Article 34 – paragraph 1: 1. Communications addressed to the Office shall be effected by electronic means. The Executive Director shall determine under which technical conditions those communications are to be submitted.

Article 35 – paragraph 1 – point i a (new): (ia) information on any direct public financial support received for research related to the development of the product;

Change 27

AddedArticle 35 – paragraph 1 – point j: (j) the date and the examination opinion of the Office in respect of each of the Member States in which the basic patent has unitary effect;

Article 35 – paragraph 1 – point m: (m) where applicable, the filing of an opposition, its status and the outcome of the opposition proceedings, including where applicable a summary of the revised examination opinion;

Article 35 – paragraph 1 – point n: (n) 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;

Change 28

ChangedArticle 35 – paragraph 8 a (new): 8a. By way of derogation from Article 35(7), point (b), publicPublic authorities shall not use the information provided for in the registerRegister for practices of patent linkage, andlinkage. noNo regulatory or administrative decisions related to generics or biosimilars shall be based on information providedin forthe Register. Information in the registerRegistger andshall not be used for refusal, suspension, delay, withdrawal or revocation of marketing authorisations, pricing and reimbursement decisions or tender bids.

Change 29

RemovedArticle 36 – paragraph 2 a (new): 2a. For the purpose of this database the Office shall make public the format for the electronic submission of acts in accordance with Articles 10, 14, 15 and 28 on applications, oppositions, observations and appeals.

Article 40 – paragraph 1: 1. Decisions of the Office under this Regulation shall include examination opinions and shall state the reasons on which they are based. They shall be based only on reasons or evidence on which the parties concerned have had an opportunity to present their comments. Where oral proceedings are held before the Office, the decision may be given orally. Subsequently, the decision or opinion shall be notified electronically to the parties.

Article 40 – paragraph 3: 3. Decisions of the Office under this Regulation which are open to appeal shall be accompanied by a written communication indicating that any notice of appeal is to be filed electronically at the Office within 2 months of the date of notification of the decision in question. That communication shall also draw the attention of the parties to the provisions laid down in Article 28. The parties may not plead any failure on the part of the Office to communicate the availability of appeal proceedings.

Change 30

RemovedArticle 42 – 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 41 – paragraph 2: deleted

AddedArticle 41 – 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 42 – 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 the case may be, shall verify 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.

Article 46 – paragraph 2: 2. The application for re-establishment shall be filed electronically within 2 months of the removal of the obstacle to compliance with the time limit. The omitted act shall be completed within this period. The application shall only be admissible within the year immediately following the expiry of the unobserved time limit.

Change 31

ChangedArticle 56 – paragraph 1: By ... [OP, please insert: five years after the date of application], and every five years thereafter, the Commission shall evaluate the implementation of this Regulation and present a report on the main findings to the European ParliamentParliament, andthe toCouncil and the Council.European Economic and Social Committee. Special emphasis shall be given to the effects of opposition under Article 15 and whether the possibility of opposition leads to significant delays in granting unitary certificates.certificates and to the effects of this Regulation on the recovery of research and development investments in the light of Directive (EU) XXX/XX [COM(2023)192].