Considerations on COM(2023)223 - Supplementary protection certificate for plant protection products (recast) - Main contents
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| dossier | COM(2023)223 - Supplementary protection certificate for plant protection products (recast). |
|---|---|
| document | COM(2023)223  |
| date | April 27, 2023 |
(1) Regulation (EC) No 1610/96 of the European Parliament and of the Council16 has been substantially amended several times17. Since further amendments are to be made, that Regulation should be recast in the interests of clarity.
🡻 1610/96 recital 1
(2) Research into plant protection products contributes to the continuing improvement in the production and procurement of plentiful food of good quality at affordable prices.
🡻 1610/96 recital 2
(3) Plant protection research contributes to the continuing improvement in crop production.
🡻 1610/96 recital 3 (adapted)
(4) Plant protection products, especially those that are the result of long, costly research, will continue to be developed in the Community ⌦ Union ⌫ and in Europe if they are covered by favourable rules that provide for sufficient protection to encourage such research.
🡻 1610/96 recital 4
(5) The competitiveness of the plant protection sector, by the very nature of the industry, requires a level of protection for innovation which is equivalent to that granted to medicinal products by Regulation (EC) No 469/2009 of the European Parliament and of the Council18 [OP, please insert new Regulation reference to COM(2023) 231] Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products(3).
🡻 1610/96 recital 5 (adapted)
(6) at the moment, Tthe period that elapses between the filing of an application for a patent for a new plant protection product and ⌦ the ⌫ authorisation to place the said plant protection product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research and to generate the resources needed to maintain a high level of research.
🡻 1610/96 recital 6
(7) This situation leads to a lack of protection which penalises plant protection research and the competitiveness of the sector.
🡻 1610/96 recital 7 (adapted)
⇨ new
(8) One of the main objectives of the supplementary protection certificate ⌦ (‘certificate’) ⌫ is to place European industry on the same competitive footing as its North American and Japanese counterparts ⇨ third countries ⇦.
🡻 1610/96 recital 8 (adapted)
In its Resolution of 1 February 199319 on a Community programme of policy and action in relation to the environment and sustainable development, the Council adopted the general approach and strategy of the programme presented by the Commission, which stressed the interdependence of economic growth and environmental quality. Improving protection of the environment means maintaining the economic competitiveness of industry. Accordingly, the issue of a supplementary protection certificate can be regarded as a positive measure in favour of environmental protection.
🡻 1610/96 recital 9 (adapted)
(9) A uniform solution at Community ⌦ 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 Community ⌦ Union ⌫ and thus directly affect the functioning of the internal market; whereas this is in accordance with the principle of subsidiarity as defined by Article 3b of the Treaty.
🡻 1610/96 recital 10 (adapted)
⇨ new
(10) Therefore, there is a need to create ⌦ provide for ⌫ a supplementary protection 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. is necessary; whereas a Regulation is therefore the most appropriate legal instrument. ⇨ 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. ⇦
⇩ new
(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 by the description of the patent on its filing date. 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 them is specifically identifiable in the light of all the information disclosed by that patent.
(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.
(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.
(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.
(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.
(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’).
🡻 1610/96 recital 11 (adapted)
(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 fifteen ⌦ 15 ⌫ years of exclusivity from the time the plant protection product in question first obtains authorisation to be placed on the market in the Community ⌦ Union ⌫.
🡻 1610/96 recital 12 (adapted)
⇨ new
(18) All the interests at stake in a sector as complex and sensitive as plant protection must nevertheless ⌦ should ⌫ be taken into account. For this purpose, the certificate cannot be granted for a period exceeding five ⌦ 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.⇦
🡻 1610/96 recital 13 (adapted)
The certificate confers the same rights as those conferred by the basic patent; consequently, where the basic patent covers an active substance and its various derivatives (salts and esters), the certificate confers the same protection.
🡻 1610/96 recital 14 (adapted)
The issue of a certificate for a product consisting of an active substance does not prejudice the issue of other certificates for derivatives (salts and esters) of the substance, provided that the derivatives are the subject of patents specifically covering them.
🡻 1610/96 recital 15 (adapted)
A fair balance should also be stuck with regard to the determination of the transitional arrangements. Such arrangements should enable the Community plant protection industry to catch up to some extent with its main competitors, while making sure that the arrangements do not compromise the achievement of other legitimate objectives concerning the agricultural policy and environment protection policy pursued at both national and Community level.
🡻 1610/96 recital 16 (adapted)
(19) Only action at Community ⌦ Union ⌫ level will ⌦ allow ⌫enable the objective, which consists in 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.
🡻 1610/96, recital 17 (adapted)
(20) The detailed rules ⌦ referred to ⌫ in recitals 13, 14 and 1512, 13 and 14 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 Council Regulation (EC) No 469/2009 [OP please insert new reference to COM(2023) 231].
⇩ new
(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.
(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 Council20 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’).
(23) Therefore, it is necessary to complement the existing national procedures for the grant of certificates for plant protection products with a centralised procedure. That procedure should make it possible, where the basic patent is a European patent, including a unitary patent, to request the grant of national certificates for two or more designated Member States through the filing and examination of a single ‘centralised’ application. Following the grant of certificates under the centralised procedure, these certificates should be equivalent to the certificates granted under national procedures and be subject to the same rules.
(24) Regulation (EU) No 2017/1001 of the European Parliament and of the Council21 has established, under its Article 2, a European Union Intellectual Property Office (‘the Office’). In the interest of the internal market, the centralised procedure should be carried out by a single examining authority. This can be achieved by the Office being given the task of examining applications for certificates under the centralised procedure in accordance with this Regulation.
(25) In order to provide for a simplified examination of a centralised application, its filing should be available only on the basis of a European patent, including a unitary patent. The centralised application should not be available on the basis of a set of independent national patents, as their claims are likely to be different, resulting in greater complexity in examination compared to the situations where the basic patent is a European patent.
(26) Since marketing authorisations for a given plant protection product may be granted at different dates in different Member States, the Member States that could be validly designated in a centralised application for certificates for a certain plant protection product would be severely restricted, if it were to be required that authorisations should have been granted in all Member States designated in the application. The grant of certificates on the basis of such a centralised application should therefore be allowed where marketing authorisations have at least been applied for in all designated Member States, provided that such authorisations are granted before the end of the examination process. For this reason, the examination opinion should not be adopted earlier than 18 months from the filing of the centralised application. Where no authorisation has been granted in a designated Member State before that period has elapsed, however, the Office should, in respect of that Member State, suspend the examination proceedings, and resume them, on request, provided that such an authorisation is eventually granted before the expiry of the basic patent.
(27) The Office should have the possibility to charge a fee for the centralised application for a certificate, as well as other procedural fees such as a fee for opposition or appeal. The fees charged by the Office should be laid down by an implementing act.
(28) An applicant should also be allowed to lodge a ‘combined application’ that would include an application for a unitary certificate as set out in Regulation [COM(2023) 221]. Such a combined application should undergo a single examination procedure.
(29) In order to avoid double protection, it should not be possible to grant certificates – whether national certificates or unitary certificates – for the same product in the same Member State based on both a national application and a centralised application.
(30) 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 centralised 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 invalidity proceedings before the body responsible under national law for the revocation of the corresponding basic patent. These provisions are necessary to ensure involvement of third parties both before and after the grant of certificates.
(31) The Office should examine the centralised application for certificates and issue an examination opinion. That opinion should state the reasons for which it is positive or negative in respect of each of the designated Member States.
(32) The examination of a centralised application for a 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 matters, located today at national offices only. To ensure an optimal quality of the examination, suitable criteria should be laid down in respect of the participation of specific examiners in the centralised procedure, in particular as regards qualification and conflicts of interest.
(33) Where the Office finds that the conditions for grant of a certificate are fulfilled in one or more of the Member States designated in a centralised application, but are not fulfilled in one or more of the other ones, including where in one of the designated Member States the basic European patent has different claims which do not cover the product, the Office should issue a positive opinion for those designated Members States in which the conditions for obtaining a certificate are fulfilled, and a negative opinion for those in which the conditions are not fulfilled.
(34) 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.
(35) After the completion of the examination of a centralised application, and after the time limits for appeal and opposition have expired, or, the case being, after a final decision on the merits has been issued, the opinion should be transmitted to the respective national patent offices of the designated Member States.
(36) Where the examination opinion is positive for one or several Member States, the respective competent national authorities should grant a certificate in accordance with the applicable domestic rules, in particular as regards publication, registration in relevant databases and the payment of annual fees.
(37) Where the examination opinion is negative for one or several Member States, the respective competent national authorities should reject the application in accordance with the applicable domestic rules.
(38) For the sake of coherence and legal certainty, the same substantive provisions should apply to national applications and to centralised applications regarding in particular the scope, the conditions for obtaining certificates, the subject-matter of protection and effect of certificates, and their publication. The centralised procedure would result in the grant of national certificates fully identical to those granted on the basis of national applications.
(39) Since certain competent national authorities may have limited administrative capacity to conduct a full substantive examination of applications for certificates, competent national authorities should remain able to not verify all the conditions for granting a certificate on the basis of a national application. However, to ensure the quality and uniformity of the certificates granted under the centralised procedure, the Office should examine all of the conditions for grant of a certificate under the centralised procedure.
(40) Where the applicant or another party is adversely affected by a decision of the Office, the applicant or that party should have the right, subject to a fee, to file within 2 months an appeal against the decision, before a Board of Appeal of the Office. This also applies to the examination opinion, that may be appealed by the applicant. Decisions of that Board of Appeal should, in turn, be amenable to actions before the General Court, which has jurisdiction to annul or to alter the contested decision. In case of a combined application including a request for a unitary certificate, a common appeal may be filed.
(41) 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 should be taken into account.
(42) Any person may challenge the validity of a certificate granted following the centralised procedure before a competent court of a Member State, which includes the Unified Patent Court where the conditions are met.
(43) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for certificates under the centralised procedure and their status, including on certificates granted on that basis by national offices, which should share with the Office any related information. The register should be available in all official languages of the Union.
(44) Regulation [COM(2023) 221]22 creates a unitary supplementary protection certificate for plant protection products, which may be requested for those Member States in which the basic patent has unitary effect. The request for such a unitary certificate may be made in a combined application for a certificate under the centralised procedure covered by this Regulation. In such a case, the combined application including both requests should be subject to a single centralised examination procedure. Double protection by both a unitary certificate and a certificate granted pursuant to this Regulation should be excluded.
(45) For the tasks conferred on the Office under this Regulation, the languages of the Office should be all official languages of the Union. The Office should accept verified translations, into one of the official languages of the Union, of documents and information. The Office may, if appropriate, use verified machine translations.
(46) Financial provision should be made to ensure that competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.
(47) The necessary set-up costs related to the tasks conferred to the Office, including the costs of new digital systems, should be financed from the Office’s accumulated budgetary surplus.
(48) In order to supplement certain non-essential elements of this Regulation, the power to adopt acts, in accordance with Article 290 of the Treaty on the Functioning of the European Union, should be delegated to the Commission in respect of: (i) specifying the content and form of the notice of appeal and the content and the form of the Boards of Appeal’s decision, (ii) specifying the details concerning the organisation of the Boards of Appeal in proceedings relating to certificates, (iii) specifying the rules on the means of communication, including the electronic means of communication, to be used by the parties to proceedings before the Office and the forms to be made available by the Office, (iv) setting out the detailed arrangements for oral proceedings, (v) setting out the detailed arrangements for the taking of evidence, (vi) setting out the detailed arrangements for notification, (vii) specifying the details regarding the calculation and duration of time limits and (viii) setting out the detailed arrangements for the resumption of proceedings. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.23 In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.
(49) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission as regards: (i) the application forms to be used; (ii) rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine centralised applications and prepare examination opinions, as well as the issuance of examination opinions by the Office, (iii) the criteria in the ways the examination panels are to be set up, and the criteria for the selection of examiners, (iv) the amounts of the applicable fees to be paid to the Office, (v) specifying the maximum rates for costs essential to the proceedings and actually incurred by the successful party, and (vi) rules on the financial transfers between the Office and Member States, the amounts of these transfers, and the remuneration to be paid by the Office regarding the participation of competent national authorities. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council24.
(50) The Commission should regularly report on the operation of the centralised procedure, in coordination with that required in Regulation [COM(2023) 231].
(51) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union (‘the Charter’). The rules in this Regulation should be interpreted and applied in accordance with those rights and principles. In particular, this Regulation seeks to ensure full respect for the right to property and the right to health care and the right to an effective remedy in Articles 17 and 47 of the Charter.
(52) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, with a view to ensuring that the applicable rules and procedures are consistent across the Union, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(53) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 of the European Parliament and of the Council25 and delivered an opinion on XXX [OP, please add reference once available].
(54) Appropriate arrangements should be made to facilitate a smooth transition from the rules provided for in Regulation (EC) No 1610/96 to the rules laid down in this Regulation. To allow for sufficient time for the Office to implement and launch the centralised procedure, the provisions on centralised applications laid down in this Regulation should apply from [OP: please insert - one year after the entry into force of this Regulation],
🡻 1610/96 (adapted)