Overwegingen bij COM(2023)222 - Aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen - Hoofdinhoud
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| dossier | COM(2023)222 - Aanvullende beschermingscertificaat met eenheidswerking voor geneesmiddelen. |
|---|---|
| document | COM(2023)222  |
| datum | 27 april 2023 |
(2)The period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal 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 certificate protection within the internal market, or at least a significant part thereof, should feature amongst the legal instruments which pharmaceutical undertakings have at their disposal.
(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’ 21 , 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, as well as a centralised procedure for obtaining marketing authorisations for medicinal products. In addition, the unitary patent as laid down in Regulation (EU) No 1257/2012 of the European Parliament and of the Council 22 enters into force in June 2023 in respect of the 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 medicinal 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 a centralised authorisation; it 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. Consequently, a unitary certificate should only be transferred or revoked, or expire, in respect of all those Member States.
(8)Regulation [COM(2023) 231] replaces Regulation (EC) No 469/2009 of the European Parliament and of the Council 23 , and includes new provisions establishing a centralised procedure for the examination of supplementary protection certificates for medicinal products.
(9)Considering that products authorised under procedures other than the centralised one should still be able to enjoy supplementary protection, and 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) 231] 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) 231] 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) 231]; 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 medicinal 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 Council 24 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 the Office being given the task of examining both applications for unitary certificates in accordance with this Regulation and Regulation [COM(2023) 221] and centralised applications for certificates under Regulations [COM(2023) 231] and [COM(2023) 223]. To ensure consistency with this Regulation, Regulation (EU) No 2017/1001 should be amended.
(13)A unitary certificate for a medicinal product should be based only on a centralised marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council 25 or Regulation (EU) 2019/6 of the European Parliament and of the Council 26 only. These authorisations refer to human medicinal and veterinary medicinal products respectively. Such an authorisation, unlike national authorisations, relates to the same medicinal product throughout the Union, and this would thus facilitate the examination of applications for unitary certificates.
(14)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) 231]. Such a combined application should undergo a single examination procedure.
(15)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.
(16)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 ingredient of the product be explicitly identified in the claims. Or, in the event of a combination product, this should not necessarily require that each of its active ingredients 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.
(17)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 therapeutically equivalent derivative such as salts, esters, ethers, isomers, mixtures of isomers, complexes or biosimilars, 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 therapeutic indication or for a different one.
(18)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 ingredient or combinations thereof, covered by the authorisation to place it on the market and for any use of the product as a medicinal product that has been authorised before the expiry of the unitary certificate.
(19)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 therapeutically equivalent derivatives of that product, such as salts, esters, ethers, isomers, mixtures of isomers or complexes, as well as biosimilars, 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.
(20)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.
(21)Where the marketing authorisation submitted in support of the application for a certificate for a biological medicinal product identifies that product by means of its International Nonproprietary Name (INN), the protection conferred by the certificate should extend to all therapeutically equivalent products having the same International Nonproprietary Name as the product referred to in the marketing authorisation, irrespective of possible minor differences between a subsequent biosimilar and the product authorised, which are usually unavoidable given the nature of biological products.
(22)Regulation [COM(2023) 231] provides for an exception according to which, under narrowly defined circumstances and subject to various safeguards, the protection conferred by a national supplementary protection certificate for medicinal products does not extend to a product that would be manufactured in the Union by a person other than the holder of that certificate, where it is manufactured for the purpose of being exported to a third country, or of being stored in the Union in view of its entry into the Union market upon expiry of the certificate. To avoid discrimination between applicants for certificates under Regulation [COM(2023) 231] and for unitary certificates under this Regulation, similar rights and limitations should be conferred by certificates under Regulation [COM(2023) 231] and by unitary certificates, and therefore that exception should also be available in respect of unitary certificates. The reasons for the introduction for the waiver and the conditions for its application should be applicable for unitary certificates.
(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 avoid discrimination between applicants for national certificates under Regulation [COM(2023) 231] and applicants for unitary certificates under this Regulation, an extension of the duration of a certificate as defined by Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council 27 should also be available for unitary certificates. For this purpose that Regulation should be amended.
(25)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.
(26)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.
(27)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.
(28)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.
(29)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.
(30)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.
(31)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.
(32)Any person may challenge the validity of a unitary certificate by lodging with the Office an application for a declaration of invalidity.
(33)The Office should have the possibility to charge a fee for the application for a unitary certificate and for an application for the extension of duration of a unitary certificate in the case of paediatric medicinal products, 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.
(34)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.
(35)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.
(36)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.
(37)Financial provision should be made to ensure competent national authorities that participate in the centralised procedure are adequately remunerated for their participation.
(38)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.
(39)To ensure that Regulation (EU) No 608/2013 of the European Parliament and of the Council 28 also covers unitary certificates, that Regulation should be amended.
(40)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. 29 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.
(41)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 Council 30 .
(42)The Commission should regularly report on the operation of this Regulation, in coordination with that required in Regulation [COM(2023) 231]. The Commission should regularly evaluate the impact of unitary supplementary protection on access to medicines.
(43)This Regulation respects fundamental rights and observes the principles recognised 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 35 and 47 of the Charter. This also applies to the above-mentioned exception, which maintains the core rights of the certificate, by being limited to the making of a product, or a medicinal product containing that product, only for the purpose of export outside the Union or for the purpose of storing for a limited period of time with a view to entry into the Union market upon expiry of the protection, and to the acts strictly necessary for such making or for the actual export or the actual storing. In the light of those fundamental rights and principles, the exception does not go beyond what is necessary and appropriate in the light of its overall objective, which is to promote the competitiveness of the Union by avoiding relocation and allowing makers of generics and biosimilars established in the Union to compete, on the one hand, on fast-growing global markets where protection does not exist or has already expired, and on the other, on the Union market upon expiry of the certificate.
(44)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 certificate 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.
(45)The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 31 and delivered an opinion on XXX [OP, please add reference once available].
(46)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.