Changes from plenary report to adopted text

Added(a) the product is protected by that basic patent in force;

Added(b) a valid authorisation to place the product on the market as a plant protection product has been granted in accordance with Regulation (EC) No 1107/2009 in at least one of the Member States in which that basic patent has unitary effect; [Am. 9]

Added(c) the product has not already been the subject of a certificate, nor of a unitary certificate;

Added(d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a plan protection product.

Added2. The holder of more than one patent for the same product shall not be granted more than one certificate or unitary certificate for that product for any given Member State.

AddedWhere two or more applications, whether national or centralised applications for certificates, or applications for unitary certificates, concerning the same product and submitted by two or more holders of different patents are pending for a given Member State, one certificate or unitary certificate for that product may be granted to each of those holders, where they are not economically linked, by a competent national authority or by the Office, as applicable. The same principle shall apply mutatis mutandis to applications submitted by the holder concerning the same product for which one or more certificates or unitary certificates have been previously granted to other different holders of different patents. [Am. 10]

Added3. A unitary certificate shall also be granted for a given plant protection product if the following conditions are fulfilled:

Added(a) at the date of the application, in each of the Member States in which the basic patent has unitary effect, an authorisation to place the product on the market as a plant protection product has been applied for in accordance with Regulation (EC) No 1107/2009, but an authorisation has not yet been granted in at least one of these Member States;

Added(b) before the examination opinion is adopted, valid authorisations have been granted in each of the Member States in which the basic patent has unitary effect.

Added4. Where the condition set out in paragraph 3, point (a), is fulfilled, the examination opinion shall not be adopted earlier than 18 months after the application was filed.

Added5. By way of derogation from paragraph 3, where only the condition set out in paragraph 3, point (a), is fulfilled in respect of a Member State in which the basic patent has unitary effect, a unitary certificate shall be granted, but shall not have effect in that Member State.

AddedWhere a unitary certificate is granted in accordance with the first subparagraph, the applicant may submit to the Office a marketing authorisation subsequently granted in that Member State before the expiry of the basic patent, together with a request for the effect of the unitary certificate to resume in that Member State. The Office shall assess whether the conditions set out in paragraph 1 are fulfilled in respect of that Member State, and shall issue a decision on whether the effect shall resume.

AddedArticle 4 Scope of the protection

AddedWithin the limits of the protection conferred by the basic patent, the protection conferred by a unitary certificate shall extend only to the product covered, in each of the Member States in which that basic patent has unitary effect, by an authorisation to place the corresponding plant protection product on the market and for any use of the product as a plant protection product that has been authorised before the expiry of the unitary certificate.

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.

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 first authorisation referred to in Article 3(1), point (b), to place the product on the market as a plant protection product was granted in one of the Member States in which the basic patent has unitary effect.

Added2. Notwithstanding paragraph 1, where an authorisation to place the product on the market are granted in a Member State in which the basic patent has unitary effect, 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.

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(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 Part A, Section 1, points 1.1 to 1.7, of Commission Regulation 283/2013 or Part B, Section 1, points 1.1 to 1.4.3, of that Regulation or in equivalent national laws of the Member State in which the application was lodged;

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(ca) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation. [Am. 11]

Added2. The application referred to in this Article shall be filed by using a specific application form.

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 50.

AddedArticle 10 Lodging of an application for a unitary certificate

AddedThe application for a unitary certificate shall be lodged with the Office.

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

Added1. The Office shall examine the following:

Added(a) whether the application for a unitary certificate complies with Article 9;

Added(b) whether the application complies with Article 8;

Added(c) whether the application fee referred to in Article 29(1) has been paid within the prescribed period.

Added2. Where the centralised application does not satisfy the requirements referred to in paragraph 1, the Office shall request the applicant to take the measures necessary to satisfy those requirements, and shall set a deadline for such compliance.

Added3. Where the fee referred to in paragraph 1, point (c), has not been paid or has not been paid in full, the Office shall inform the applicant accordingly.

Added4. If the applicant does not satisfy the requirements referred to in paragraph 1 within the deadline referred to in paragraph 2, the Office shall reject the application for a unitary certificate.

AddedArticle 12 Publication of the application

AddedIf the application for a unitary certificate complies with Article 11(1), the Office shall publish the application in the Register without undue delay. [Am. 12]

AddedArticle 13 Examination of the application for a unitary certificate

Added1. The Office shall assess the application on the basis of all the conditions in Article 3(1),3 for all Member States in which the basic patent has unitary effect. [Am. 13]

Added2. Where the application for a unitary certificate and the product to which it relates comply with Article 3(1)Articles 3 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 and publish it in the Register without undue delay. [Am. 14]

Added3. Where the application for a unitary certificate and the product to which it relates does not comply with Article 3(1)Articles 3 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 and publish it in the Register without undue delay. [Am. 15]

Added4. The examination opinion shall be translated in the official languages of all Member States in which the basic patent has unitary effect. The Office may use verified machine translation to that effect.

Added5. 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. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 50.

AddedArticle 14 Observations by third parties

Added1. 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.

Added2. A natural or legal person that has submitted the written observations in accordance with paragraph 1 shall not be a party to the proceedings.

Added3. Third party observations shall be submitted within 3 months after publication of the application in the Register.

Added4. Any observations by a third party shall be submitted in writing in one of the official languages of the Union and state the grounds on which they are based.