Changes from plenary report to adopted text

AddedArticle 5 Effects of the unitary certificate

Added1. The unitary certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations, in all Member States in which the basic patent has unitary effect.

Added2. A unitary certificate shall have a unitary character. It shall provide uniform protection and shall have equal effect in all Member States in which the basic patent has unitary effect. The unitary certificate may only be limited, transferred or revoked, or lapse, in respect of all those Member States.

Added3. By way of derogation from paragraph 1 and in accordance with Regulation (EU) .../... [2023/0130(COD)], the unitary certificate shall not confer protection against certain acts which would otherwise require the consent of the unitary certificate holder, if all of the following conditions are met: [Am. 21]

Added(a) the acts comprise any of the following:

Added(i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries; or [Am. 22]

Added(ii) any related act that is strictly necessary for thethat making, in the Union, referred to in point (i), or for the actual export itself; or [Am. 23]

Added(iii) the making, no earlier than 6 months before the expiry of the unitary certificate, of 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 corresponding certificate; or [Am. 24]

Added(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 unitary certificate. [Am. 25]

Added(b) the maker, through appropriate and documented means, notifies the Office, and the competent industrial property office of the respective Member State, and informs the unitary certificate holder, of the information referred to in paragraph 6 no later than 3 months before the start date of the making in that Member State, or no later than 3 months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by a unitary certificate, whichever is the earlier;

Added(c) if the information referred to in paragraph 6 of this Article changes, the maker notifies the Office and the competent industrial property office of the respective Member State, and informs the certificate holder, before those changes take effect;

Added(d) in the case of products, or medicinal products containing those products, made for the purpose of export to third countries, the maker ensures that a logo, in the form set out in Annex I, is affixed to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;

Added(e) the maker complies with paragraph 10 of this Article and, if applicable, with Article 31(4).

Added4. Paragraph 3 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the Union merely for the purpose of repackaging, re-exporting or storing.

Added5. The information provided to the unitary certificate holder for the purposes of paragraph 3, points (b) and (c), shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.

Added6. For the purposes of paragraph 3, point (b), the maker shall provide all of the following information:

Added(a) the name and address of the maker;

Added(b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;

Added(c) the Member State in which the making and, if applicable, also the storing is to take place, and the Member State in which the first related act, if any, prior to that making is to take place;

Added(d) the number of the unitary certificate having effect in the Member State of making, and the number of the certificate or unitary certificate granted in the Member State of the first related act, if any, prior to that making;

Added(e) for medicinal products to be exported to third countries, the reference number of the marketing authorisation, or the equivalent of such authorisation, in each third country of export, as soon as it is publicly available.

Added7. For the purposes of the notifications to the Office and to the competent industrial property office referred to in paragraph 3, points (b) and (c), the maker shall use the standard form for notification set out in Annex II.

Added8. Failure to provide the information referred to in paragraph 6, point (e), with regard to a third country shall only affect exports to that third country, and those exports shall not benefit from the exception laid down in paragraph 3.

Added9. The maker shall ensure that medicinal products made pursuant to paragraph 3, point (a)(i), do not bear an active unique identifier within the meaning of Delegated Regulation (EU) 2016/161.

Added10. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker that performs acts falling under paragraph 3, point (a), is fully informed and aware of all of the following:

Added(a) that those acts are subject to paragraph 3;

Added(b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in paragraph 3, point (a)(i), or the placing on the market of the product, or the medicinal product containing that product, referred to in paragraph 3, point (a)(iii), could infringe the unitary certificate referred to in that paragraph where, and for as long as, that certificate applies.

AddedArticle 6 Entitlement to the unitary certificate

Added1. The unitary certificate shall be granted to the holder of the basic patent or to the successor in title of that holder.

Added2. Notwithstanding paragraph 1, where a basic patent has been granted in respect of a product that is the subject of an authorisation held by a third party, a unitary certificate for that product shall not be granted to the holder of the basic patent without the consent of that third party.

AddedArticle 7 The unitary certificate as an object of property

AddedA unitary certificate or an application for a unitary certificate as an object of property shall be treated in its entirety, in each Member State in which the basic patent has unitary effect, in accordance with the national law applicable to the basic patent as an object of property.

AddedArticle 8 Application for a unitary certificate

Added1. The application for a unitary certificate shall be lodged within 6 months of the date on which the authorisation referred to in Article 3(1), point (b), to place the product on the market as a medicinal product was granted.

Added2. Notwithstanding paragraph 1, where the authorisation to place the product on the market is granted before unitary effect is attributed to the basic patent, the application for a unitary certificate shall be lodged within 6 months of the date on which unitary effect is attributed to the basic patent.

Added3. The application for an extension of the duration may be lodged at the same time when lodging the application for a unitary certificate or when the application for the unitary certificate is pending and the appropriate requirements of Article 9(1), point (d), or Article 9(2), respectively, are fulfilled.

Added4. The application for an extension of the duration of a unitary certificate already granted shall be lodged not later than 2 years before the expiry of the unitary certificate.

Added4a. The application for a unitary certificate shall be lodged electronically, using the formats made available by the Office. [Am. 26]

AddedArticle 9 Content of the application for a unitary certificate

Added1. The application for a unitary certificate shall contain the following:

Added(a) a request for the grant of a unitary certificate, stating the following information:

Added(i) the name and address of the applicant;

Added(ii) if the applicant has appointed a representative, the name and address of that representative;

Added(iii) the number of the basic patent and the title of the invention;

Added(iv) the number and date of the first authorisation to place the product on the market, as referred to in Article 3(1), point (b) and, if this authorisation is not the first authorisation for placing the product on the market in the Union, the number and date of that authorisation;

Added(iva) information on any direct public financial support received for research related to the development of the product for which the SPC is requested; [Am. 27]

Added(b) a copy of the authorisation to place the product on the market, as referred to in Article 3(1), point (b), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC of the European Parliament and of the Council or Article 35 of Regulation (EU) 2019/6;

Added(c) where the authorisation referred to in point (b) is not the first authorisation for placing the product on the market as a medicinal product in the Union, information regarding the identity of the product thus authorised and the legal provision under which the authorisation procedure took place, together with a copy of the notice publishing the authorisation in the appropriate official publication or, in the absence of such a notice, any other document proving that the authorisation has been issued, the date on which it was issued and the identity of the product authorised.

Added(d) where the application for a unitary certificate for a medicinal product includes a request for an extension of the duration:

Added(i) a copy of the statement indicating compliance with an agreed completed paediatric investigation plan as referred to in Article 36(1) of Regulation (EC) No 1901/2006;

Added(ii) where necessary, in addition to the copy of the authorisation to place the product on the market as referred to in point (b), proof of possession of authorisations to place the product on the market of all other Member States, as referred to in Article 36(3) of Regulation (EC) No 1901/2006;

Added(da) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation. [Am. 28]

Added2. Where an application for a unitary certificate is pending, an application for an extension of the duration in accordance with Article 8(3) shall include the documents referred to in paragraph 1, point (d) of this Article and a reference to the application for a certificate already lodged.

Added3. The application for an extension of the duration of a unitary certificate already granted shall contain the documents referred to in paragraph 1, point (d), and a copy of the certificate already granted.

Added4. The applications referred to in this Article shall be filed by using specific application forms.

AddedThe Commission is empowered to adopt implementing acts laying down rules on the application form to be used. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

AddedArticle 10 Lodging of an application for a unitary certificate

AddedThe application for a unitary certificate and, where applicable, the application for an extension of the duration of a unitary certificate, shall be lodged in electronic form with the Office.

AddedThe Office shall put the necessary arrangements in place in order to ensure that exchanges of data and information are done electronically and that the commercially confidential nature of the information exchanged is protected. Such arrangements shall be without prejudice to the provisions on regulatory protection. [Am. 29]

AddedArticle 11 Examination of the admissibility of an application for a unitary certificate