Changes from plenary report to adopted text

Added(8) One of the main objectives of the supplementary protection certificate (‘certificate’) is to place European industry on the same competitive footing as third countries.

RemovedArticle 27 – 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 centralised applications, on the basis of their relevant expertise and their experience in the field.

Added(9) A uniform solution at Union level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to hinder the free movement of plant protection products within the Union and thus directly affect the functioning of the internal market.

RemovedArticle 28 – 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(10) Therefore, there is a need to provide for a certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national patent or European patent, with or without unitary effect, relating to a plant protection product for which marketing authorisation has been granted. The certificate should provide its holder with an adequate additional period of effective protection subsequent to the expiry of the basic patent. An application for such a certificate should be filed with competent industrial property office (‘competent national authority’) of the Member State concerned.

RemovedArticle 28 – paragraph 3 – point a a (new): (aa) where possible, geographical balance amongst the participating offices;

Added(11) One of the conditions for the grant of a certificate should be that the product is 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 of the patent on itsthe basis of that person’s general knowledge in the relevant field and on the prior art at the 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. 1]

RemovedArticle 28 – paragraph 3 – point c: (c) that there is than one examiner employed by a competent national authority making use of the exemption laid down in Article 10(5).

Added(12) 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. 2]

RemovedArticle 29 – 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 these grounds, shall be filed within three 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 following 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(13) Within the limits of the protection conferred by the basic patent, the protection conferred by a 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 certificate.

RemovedArticle 29 – paragraph 4 a (new): 4a. The Office shall inform the applicant of its decision without undue delay.

Added(14) To ensure balanced protection, however, a certificate should entitle its holder to prevent a third party from manufacturing not only the product identified in the 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 certificate. There is therefore a need to consider that the protection conferred by the certificate extends to such equivalent derivatives, within the limits of the protection conferred by the basic patent.

RemovedArticle 29 – paragraph 5: 5. Where an appeal before the Boards of Appeal of the Office results in a decision which is not in line with the examination opinion and is remitted to the Office, the decision of the Boards shall annul or alter that opinion before transmitting it to the competent national authorities of the designated Member States.

Added(15) 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 30 – paragraph 4: 4. Members of the Boards of Appeal in matters regarding centralised applications for 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 regarding centralised applications for certificates, their prior experience in supplementary protection certificate or patent matters shall be taken into account.

Added(16) In order to ensure maximum flexibility and not unduly discriminate between holders of different types of patents, there should be no limitation on the type of patent on which a national certificate can be applied for before a competent national authority. Therefore, this should continue to be possible on the basis of a national patent or of a European patent, and, in particular, this should also be possible in respect of a European patent with unitary effect (‘unitary patent’).

RemovedArticle 30 – paragraph 4 a (new): 4a. Article 166(9) of Regulation (EU) 2017/1001 shall apply to the Boards of Appeal in matters regarding centralised applications for certificates.

Added(17) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a 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 authorisation to be placed on the market in the Union.

RemovedArticle 34 – paragraph 1 – point j: (j) the date and the examination opinion in respect of each of the designated Member States;

Added(18) All the interests at stake in a sector as complex and sensitive as plant protection should be taken into account. For this purpose, the certificate cannot be granted for a period exceeding 5 years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the market of a Member State as a plant protection product.

RemovedArticle 34 – paragraph 1 – point l: (l) where applicable, the filing of an opposition, its status and its outcome, including where applicable a summary of the revised examination opinion;

Added(19) Only action at Union level will allow ensuring adequate protection for innovation in the field of plant protection, while guaranteeing the proper functioning of the internal market for plant protection products, to be attained effectively.

RemovedArticle 34 – paragraph 1 – point m: (m) 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(20) The detailed rules referred to in recitals 13, 14 and 15 and laid down in in Article 4, Article 8 (1), point (c), and Article 17 (2) of this Regulation are also valid, mutatis mutandis, for the interpretation in particular of recital 9 and Articles 3 and 4, Article 8 (1), point (c), and Article 17 of Regulation (EC) No 469/2009 [OP, please insert new reference to COM(2023)0231].

RemovedArticle 44 – 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 applicable, shall be 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(21) Since the creation of supplementary protection, certificates were only applied for and granted nationally, thus requiring several similar applications to be filed and examined in parallel in a number of Member States. This has resulted in duplication of work for both applicants and competent industrial property offices (‘competent national authorities’) conducting separate examination proceedings in respect of a given product, as well as in occasional discrepancies in the decisions taken by the competent national authorities in different Member States. Such differences usually pertain to the conditions for the grant or refusal of a certificate and include the grant of a certificate in one Member State but the refusal in another Member State regarding the same product or differences in the application of the conditions that apply to prior marketing authorisation or whether the product has already been the subject of a supplementary protection certificate. This leads to legal uncertainty and is inconsistent with the aims of the internal market.

RemovedArticle 56 – paragraph 1: By … [OJ: please insert: five years after the date of application], and every five years thereafter, the Commission shall carry out an evaluation of the application of Chapter III and present a report on the main findings to the European Parliament and to the Council.

Added(22) There is a centralised procedure for granting European patents. In addition, the ‘unitary patent’ as laid down in Regulation (EU) No 1257/2012 of the European Parliament and of the Council is to enter into force on 1 June 2023 in respect for all Member States having ratified the Agreement on a Unified Patent Court (‘UPC’).