Activities of Adrián VÁZQUEZ LÁZARA related to 2023/0127(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the unitary supplementary certificate for medicinal products, and amending Regulation (EU) 2017/1001, Regulation (EC) No 1901/2006 as well as Regulation (EU) No 608/2013
Amendments (15)
Amendment 101 #
Proposal for a regulation
Article 9 – paragraph 1 – point a – point iv a (new)
Article 9 – paragraph 1 – point a – point iv a (new)
(iv a) Data and information regarding any direct financial support received for research contributing to the development of the product for which the single SPC is requested.
Amendment 108 #
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) 3(2) and 6(2), for all Member States in which the basic patent has unitary effect.
Amendment 111 #
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), 3(2) and 6(2) 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 114 #
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), 3(2) and 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.
Amendment 115 #
Proposal for a regulation
Article 13 – paragraph 4
Article 13 – paragraph 4
4. The Office shall translate the examination opinion in the official languages of all designated Member States. The Office may use verified machine translation to that effect and publish the examination opinion on the Register as soon as possible after it is issued.
Amendment 117 #
Proposal for a regulation
Article 13 – paragraph 5 a (new)
Article 13 – paragraph 5 a (new)
5 a. The Office will issue a decision on examination within 6 months following the publication date of the application for a unified certificate. A request for accelerated processing may be filed at any point subsequent to the publication of the application for a Unified Certificate. Upon receipt of a request for accelerated processing, the Office will issue a decision on the examination within 4 months.
Amendment 118 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. Third party observations shall be submitted within 3 months after publication of the application in the Register. Third party observations may also be admissible in the course of appeal proceedings.
Amendment 142 #
Proposal for a regulation
Article 17 – paragraph 3 – point a
Article 17 – paragraph 3 – point a
Amendment 157 #
Proposal for a regulation
Article 23
Article 23
Amendment 174 #
Proposal for a regulation
Article 24
Article 24
Amendment 178 #
Proposal for a regulation
Article 28 – paragraph 3
Article 28 – paragraph 3
3. Notice of appeal shall be filed electronically 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. Any written reply to the statement of grounds of appeal shall be submitted no later than 3 months from the statements filing date. The Office shall fix a date for oral proceedings within 3 months following the filing of the reply or within 6 months following the filing of the statement of grounds of appeal, whichever is earlier. The Office will issue a written decision within 3 months from the oral hearing.
Amendment 187 #
Proposal for a regulation
Article 29 – paragraph 4
Article 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.
Amendment 216 #
Proposal for a regulation
Article 41 – paragraph 2
Article 41 – paragraph 2
Amendment 219 #
Proposal for a regulation
Article 41 – paragraph 3
Article 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.
Amendment 229 #
Proposal for a regulation
Article 56 – paragraph 1
Article 56 – paragraph 1
By xxxxxx [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 Parliament, the Council and the European Economic and Social Committee.