Considerations on COM(2023)221 - Unitary supplementary protection certificate for plant protection products - Main contents
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| dossier | COM(2023)221 - Unitary supplementary protection certificate for plant protection products. |
|---|---|
| document | COM(2023)221  |
| date | April 27, 2023 |
(2) The period that elapses between the filing of an application for a patent for a new plant protection product and the authorisation to place that product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
(3) Uniform patent and supplementary protection within the internal market, or at least a significant part thereof, should feature amongst the legal instruments which agrochemical undertakings have at their disposal to enhance their competitiveness.
(4) In its Communication of 25 November 2020 entitled ‘Making the most of the EU’s innovative potential – An intellectual property action plan to support the EU’s recovery and resilience’18, the Commission highlighted the need to tackle the remaining fragmentation of the Union’s intellectual property system. In that Communication, the Commission noted that, for medicinal products and plant protection products, supplementary protection is only available at national level. At the same time, there is a centralised procedure for granting European patents. In addition, the ‘unitary patent’ as laid down in Regulation (EU) No 1257/201219 enters into force on 1 June 2023 in respect for all Member States having ratified the Agreement on a Unified Patent Court (‘UPC’).
(5) Regulation (EU) No 1257/2012 has created the possibility to provide unitary patents. However, Regulation (EU) No 1257/2012 does not provide for a unitary supplementary protection certificate (‘unitary certificate’).
(6) In the absence of a unitary certificate, a unitary patent could only be extended by applying for several national certificates in each Member State where protection is sought, preventing the holder of a unitary patent from obtaining unitary protection during the whole combined protection period conferred by that unitary patent and subsequently by these certificates. Therefore, a unitary certificate for plant protection products should be created, that would allow a unitary patent to be extended in a unitary manner. Such a unitary certificate should be applied for on the basis of a unitary basic patent and would have the same legal effects as national certificates in all Member States in which that basic patent has unitary effect. The main feature of such a unitary certificate should be its unitary character.
(7) A unitary certificate should provide uniform protection and have equal effect in all Member States where the basic patent it relies upon has unitary effect, except in the case of temporary suspension of the effect to allow for marketing authorisations granted at different times. Consequently, a unitary certificate should only be transferred or revoked, or expire, in respect of all those Member States.
(8) Regulation [COM(2023) 223] replaces Regulation (EC) No 1610/96 of the European Parliament and of the Council20, and includes new provisions establishing a centralised procedure for the examination of supplementary protection certificates for plant protection products.
(9) Considering that certain Member States have not yet joined the unitary patent system, certificates granted by national patent offices should remain available.
(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.
(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.
(12) 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, 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].
(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.
(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.
(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.
(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.
(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 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.
(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.
(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.
(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.
(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.
(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.
(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.
(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.
(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 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 procedure, in particular as regards qualification and conflicts of interest.
(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.
(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.
(28) After the completion of the examination of a unitary certificate 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 Office should implement the examination opinion by granting a unitary certificate or rejecting the application, as applicable.
(29) 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 the designation of additional Member States with a view to the grant of national certificates, a common appeal may be filed.
(30) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their prior experience in supplementary protection certificate or patent matters should be taken into account.
(31) Any person may challenge the validity of a unitary certificate by lodging with the Office an application for a declaration of invalidity.
(32) The Office should have the possibility to charge a fee for the application for a unitary certificate, as well as other procedural fees such as those for oppositions, appeals and invalidity. The fees charged by the Office should be laid down by an implementing act.
(33) Annual fees in respect of unitary certificates (also known as renewal fees) should be paid to the Office, which should retain a part of them to cover the expenses generated by carrying out tasks in relation to the grant of unitary certificates while the remaining part would be shared with those Member States in which unitary certificates have effect.
(34) To ensure transparency, a register should be set up that can serve as a single access point providing information on applications for unitary certificates as well as granted unitary certificates and their status. The register should be available in all official languages of the Union.
(35) For the tasks conferred on the Office under this Regulation, the languages of the Office should be all official languages of the Union, to enable actors across the Union to easily apply for unitary certificates or submit third party observations and result in optimal transparency for all stakeholders across 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.
(36) Financial provision should be made to ensure that competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.
(37) 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.
(38) 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 2016.22 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.
(39) 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 Council23.
(40) The Commission should regularly report on the operation of this Regulation, in coordination with that required in Regulation [COM(2023) 223].
(41) 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.
(42) Since the objectives of this Regulation cannot be sufficiently achieved by the Member States but can rather, by reason of the autonomous nature of the unitary SPC being independent from national systems, 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.
(43) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/172524 and delivered an opinion on XXX [OP, please add reference once available].
(44) Provision should be made for appropriate arrangements to facilitate a smooth implementation of the rules provided for in this Regulation. To allow for sufficient time for the Office to prepare the operational set-up and launch of the procedure to be used for the grant of unitary certificates, as set out in this Regulation, the application of this Regulation should be deferred.