Changes from plenary report to adopted text

RemovedArticle 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.

Added(9) Considering that certain Member States have not yet joined the unitary patent system, certificates granted by national patent offices should remain available.

RemovedArticle 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.

Added(10) To avoid discrimination between applicants for certificates under Regulation [COM(2023) 223] and for unitary certificates under this Regulation, and distortions of the internal market, the same substantive rules should apply, with appropriate adaptations, to certificates under Regulation [COM(2023) 223] and to unitary certificates, in particular as regards the conditions for grant of a certificate, as well as the duration and effects of a certificate.

RemovedArticle 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;

Added(11) In particular, the duration of the protection granted by a unitary certificate should be identical to the duration provided for as regards national certificates under Regulation [COM(2023) 223]; namely, the holder of both a unitary patent and a unitary certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the plant protection product in question first obtains an authorisation to be placed on the market in the Union. Since the unitary certificate would take effect at the expiry of the basic patent, and in order to take into account discrepancies in national practices regarding the date of expiry of a patent which may result in 1-day differences, this Regulation should clarify when exactly the protection conferred by a unitary certificate should take effect.

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

Added(12) Regulation (EU) No 2017/1001 of the European Parliament and of the Council has established, under its Article 2, a European Union Intellectual Property Office (‘the Office’). In the interest of the internal market, and due to the autonomous nature of the unitary certificate, its examination and grant procedure should be carried out by a single examining authority. This can be achieved by giving the Office the task of examining both applications for unitary certificates in accordance with this Regulation and Regulation [COM(2023) 222] and centralised applications for certificates under Regulations [COM(2023) 231] and [COM(2023) 223].

RemovedArticle 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].

Added(13) In the absence of a centralised marketing authorisation, marketing authorisations are granted at a national level. Accordingly, authorisations in respect of a given plant protection product may have a slightly different scope in different Member States. Nevertheless, a unitary certificate should confer protection to that plant protection product only to the extent that it is duly covered by the marketing authorisations granted in each of the Member States in which the basic patent has unitary effect.

RemovedArticle 18 – paragraph 1 – introductory part: After 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, without undue delay:

Added(14) The fact that marketing authorisations in respect of a given plant protection product may be granted at different dates in different Member States would in many cases make the grant of a unitary certificate for a given plant protection product impossible, if it was required that authorisations must have been granted in all relevant Member States – i.e. those in which the basic patent has unitary effect – by the time of the filing of the application. An applicant should therefore be allowed to file an application for a unitary certificate where marketing authorisations have been applied for in all relevant Member States, provided that such authorisations are granted before the end of the examination process – which for that reason should not be completed earlier than 18 months from the filing of the application. Where no authorisation has been granted in a relevant Member State before the completion of the examination, the unitary certificate should not have any effect in respect of that Member State until a valid authorisation is granted in that Member State. However, that suspensory effect should be lifted where an outstanding authorisation is granted after the grant of the unitary certificate but – to ensure legal certainty – before the expiry of the basic patent, following a request to that end by the holder of the unitary certificate, subject to a verification of that request by the Office.

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

Added(15) An applicant should also be allowed to lodge a ‘combined application’ that would also include the designation of Member States, other than those in which the basic patent has unitary effect, in which the grant of national certificates would be requested as set out in Regulation [COM(2023) 223]. Such a combined application should undergo a single examination procedure.

RemovedArticle 21 – paragraph 1 – point a: (a) the certificate was granted contrary to Articles 3 and 6(2);

Added(16) In such an event, double protection by both a unitary certificate and a national certificate – whether obtained on the basis of a national application or of a centralised application – should be excluded in any Member State.

RemovedArticle 22 – paragraph 12: 12. To the extent that it has been declared invalid, the unitary certificate shall be deemed not to have had, as from the outset, the effects specified in this Regulation.

Added(17) One of the conditions for the grant of a certificate should be that the product should be protected by the basic patent, in the sense that the product should fall within the scope of one or more claims of that patent, as interpreted by the person skilled in the art byin light of the description and drawings of the patent, on the basis of that person’s general knowledge in the relevant field and of the prior art at the on its filing date or priority date of the basic patent. This should not necessarily require that the active substance of the product be explicitly identified in the claims. or, in the event of a preparation, this should not necessarily require that each of its active substances be explicitly identified in the claims, provided that each of themactive substance is specifically identifiable in the light of all the information disclosed by that patent on the basis of the prior art at the filing date or priority date of the basic patent. [Am. 2]

RemovedArticle 26 – 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 the evidence supporting those grounds, shall be filed within 3 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.

Added(18) To avoid overprotection, it should be provided that no more than one certificate, whether national or unitary, may protect the same product in a Member State. Therefore it should be required that the product, or any derivative such as salts, esters, ethers, isomers, mixtures of isomers, or complexes, equivalent to the product from a phytosanitary perspective, should not have already been the subject of a prior certificate, either alone or in combination with one or more additional active ingredients, whether for the same application or for a different one. [Am. 3]

RemovedArticle 26 – 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.

Added(19) Within the limits of the protection conferred by the basic patent, the protection conferred by a unitary certificate should extend only to the product, namely the active substance or combinations thereof, covered by the authorisation to place it 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.

RemovedArticle 27 – 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.

Added(20) To ensure balanced protection, however, a unitary certificate should entitle its holder to prevent a third party from manufacturing not only the product identified in the unitary certificate but also derivatives of that product, such as salts, esters, ethers, isomers, mixtures of isomers, or complexes, equivalent to the product from a phytosanitary perspective, even where such derivatives are not explicitly mentioned in the product description on the unitary certificate. There is therefore a need to consider that the protection conferred by the unitary certificate extends to such equivalent derivatives, within the limits of the protection conferred by the basic patent.

RemovedArticle 27 – paragraph 4 a (new): 4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to Boards of Appeal in matters regarding unitary certificates.

Added(21) As a further measure to ensure that no more than one certificate may protect the same product in any Member State, the holder of more than one patent for the same product should not be granted more than one certificate for that product. However, where two patents protecting the product are held by two holders, one certificate for that product should be allowed to be granted to each of those holders, where they can demonstrate that they are not economically linked. Furthermore, no certificate should be granted to the proprietor of a basic patent in respect of a product which is the subject of an authorisation held by a third party, without that party’s consent.

RemovedArticle 32 – paragraph 1: 1. Communications addressed to the Office shall be effected by electronic means. The Executive Director shall determine to what extent and under which technical conditions those communications are to be submitted electronically.

Added(22) As regards unitary certificate applications for plant protection products, the condition for grant relating to the authorisation being the first one should be fulfilled on a country-by-country basis.

RemovedArticle 33 – paragraph 1 – point i: (i) 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;

Added(23) To ensure alignment with the rules applicable to unitary patents, a unitary certificate as an object of property should be dealt with, in its entirety and in all Member States in which it has effect, as a national certificate of the Member State determined in accordance with the law that applies to the basic patent.

RemovedArticle 33 – paragraph 1 – point k: (k) 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;

Added(24) To guarantee a fair and transparent process, ensure legal certainty and reduce the risk of subsequent validity challenges, third parties should have the possibility, after the publication of the unitary certificate application, to submit within 3 months observations to the Office while the centralised examination is being performed. These third parties allowed to submit observations should also include Member States. This, however, should not affect the rights of third parties to initiate subsequent invalidity proceedings before the Office. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.

RemovedArticle 33 – paragraph 1 – point l: (l) 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;

Added(25) The examination of an application for a unitary certificate should be conducted, under supervision of the Office, by an examination panel including one member of the Office as well as two examiners employed by the national patent offices. This would ensure that optimal use be made of expertise in supplementary protection certificates and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the Office and the competent national authorities should make sure that designated examiners have the relevant expertise and sufficient experience in the assessment of supplementary protection certificates. Additional suitable criteria should be laid down in respect of the participation of specific examiners in the procedure, in particular as regards qualification and conflicts of interest. [Am. 4]

RemovedArticle 40 – 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.

Added(26) The Office should examine the application for a unitary certificate and issue an examination opinion. That opinion should state the reasons for which it is positive or negative.

RemovedArticle 51 – paragraph 1: By … [OJ: 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 and the Council. As part of that evaluation, the Commission shall assess the feasibility and benefits of establishing a central authorisation procedure for plant protection products under the European Food Safety Authority.

Added(27) To safeguard third parties’ procedural rights and ensure a complete system of remedies, third parties should be able to challenge an examination opinion, by initiating opposition proceedings within a short duration following the publication of that opinion, and that opposition may result in that opinion being amended.