Changes from plenary report to adopted text

Added(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.

RemovedArticle 5 – paragraph 3 – point a – point i: (i) the making of a product, or a medicinal product containing that product, for the purpose of export to third countries;or

Added(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.

RemovedArticle 5 – paragraph 3 – point a – point ii: (ii) any related act that is strictly necessary for that making in the Union or for the actual export itself; or

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) 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.

RemovedArticle 5 – paragraph 3 – point a – point iii: (iii) making, no earlier than 6 months before the expiry of the unitary certificate, a product, or a medicinal product containing that product, for the purpose of storing it in the Member State of making in order to place that product, or a medicinal product containing that product, on the market of Member States after the expiry of the certificate; or

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 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.

RemovedArticle 5 – paragraph 3 – point a – point iv: (iv) any related act that is strictly necessary for the making in the Union as referred to in point (iii), or for the actual storing itself, provided that such related act is carried out no earlier than 6 months before the expiry of the certificate.

Added(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 or Regulation (EU) 2019/6 of the European Parliament and of the Council 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.

RemovedArticle 8 – paragraph 4 a (new): 4a. The application for a unitary certificate shall be lodged electronically, using the formats made available by the Office.

Added(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.

RemovedArticle 9 – paragraph 1 – point a – point iv a (new): (iva) information on any direct public financial support received for research related to the development of the product for which the SPC is requested.

Added(14a) To avoid unnecessary administrative and financial burden both for the pharmaceutical industry and for the national authorities and the Office, certain streamlining measures should be introduced. Electronic applications for unitary and combined applications for supplementary protection certificates should be made possible. Applications submitted to the Office should follow the ‘digital by default’ principle and hence be submitted to the Office in electronic form. Applications should be assessed on the basis of the file submitted by the applicant in accordance with this Regulation. [Am. 3]

RemovedArticle 9 – paragraph 1 – point d a (new): (da) where applicable, the consent of the third party referred to in Article 6(2) of this Regulation.

Added(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.

RemovedArticle 10 – paragraph 1: The application for a unitary certificate and, where applicable, the application for an extension of the duration of a unitary certificate, shall be lodged in electronic form with the Office. / The Office shall put the necessary arrangements in place in order to ensure that exchanges of data and information are done electronically and that the commercially confidential nature of the information exchanged is protected. Such arrangements shall be without prejudice to the provisions on regulatory protection.

Added(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 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 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 themactive ingredient 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. 4]

RemovedArticle 12 – paragraph 1: If the application for a unitary certificate complies with Article 11(1), or if an application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall publish the application in the Register without undue delay and no later than five working days after the application was lodged.

Added(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. [Am. 5]

RemovedArticle 13 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Articles 3 and 6(2), for all Member States in which the basic patent has unitary effect.

Added(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.

RemovedArticle 13 – paragraph 2: 2. Where the application for a unitary certificate and the product to which it relates comply with Articles 3 and 6(2) for each of the Member States referred to in paragraph 1, the Office shall issue a reasoned positive examination opinion in respect of the grant of a unitary certificate. The Office shall notify that opinion to the applicant via the electronic platform and publish it in the Register without undue delay.

Added(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.

RemovedArticle 13 – paragraph 3: 3. Where the application for a unitary certificate and the product to which it relates does not comply with Articles 3 and 6(2) in respect of one or more of those Member States, the Office shall issue a reasoned negative examination opinion on the grant of a unitary certificate. The Office shall notify that opinion to the applicant via the electronic platform and publish it in the Register without undue delay.

Added(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.

RemovedArticle 13 – paragraph 4: 4. The Office shall translate the examination opinion in the official languages of all designated Member States. The Office may use verified machine translation to that effect. The Office shall publish the examination opinion in the Register as soon as possible after it is issued.

Added(20a) For the purposes of ensuring a broad supply of products protected by supplementary protection certificates, holders of unitary supplementary protection certificates are encouraged to exercise their rights under such certificates in a way that allows the supply of products in markets where they do not have the intention to launch any product. In that respect, holders might reach voluntary agreements to licence the unitary supplementary protection certificate rights in those markets. The objective is to allow the supply of products by licensees where the holders of unitary supplementary protection certificates decide not to put any product on the market. [Am. 6]

RemovedArticle 13 – paragraph 5: 5. The Commission is empowered to adopt implementing acts laying down rules on procedures relating to the filing, and procedures regarding the way in which examination panels examine applications for unitary certificates and prepare examination opinions, as well as the issuance of examination opinions by the Office in electronic form. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

Added(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 productsbiosimilars 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. [Am. 7]

RemovedArticle 13 – paragraph 5 a (new): 5a. The Office shall issue an examination opinion within six months of publication of the application for a unitary certificate. Without prejudice to Articles 14, 25 and 28, whenever duly justified for reasons of urgency, the applicant may submit a request for an expedited procedure. Where the request for an expedited examination procedure is deemed justified, the Office shall issue an examination opinion within four months from the publication of the application for a unitary certificate.

Added(21a) The timely entry of generics and biosimilars onto the Union market is important, in particular to increase competition, to reduce prices and to ensure both the sustainability of national healthcare systems and better access to affordable medicines for patients in the Union. The importance of such timely entry was underlined by the Council in its conclusions of 17 June 2016 on strengthening the balance in the pharmaceutical systems in the Union and its Member States. On the other hand, it should be borne in mind that intellectual property rights remain one of the cornerstones of innovation, competitiveness and growth in the internal market. [Am. 8]

RemovedArticle 14 – paragraph 1: 1. Any natural or legal person may submit written observations to the Office concerning the eligibility for supplementary protection of the product to which the application relates, in one or more of the Member States in which the basic patent has unitary effect. Such written observations shall be submitted to the Office electronically.

Added(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 market, where protection does not exist or has expired or of being made and stored in the Union in view of its entry into the Unionentering the market of any Member State upon expiry of the corresponding certificate (EU ‘Day-one’ entry) and any acts related thereto. 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. [Am. 9]

RemovedArticle 14 – paragraph 3 – subparagraph 2 (new): Whenever the expedited procedure applies in accordance with Article 13(5a), observations shall be submitted within six weeks after publication of the application in the Register.

Added(22a) In those specific and limited circumstances, and in order to create a level playing field between Union-based makers and third country makers, the protection conferred by a supplementary protection certificate in accordance to Regulation (EU) 2019/933 should be restricted so as to allow making for the exclusive purpose of export to third countries and any related acts in the Union strictly necessary for the making or for the actual export itself, where such acts would otherwise require the consent of a certificate holder (‘related acts’). For instance, related acts could include the possession, supply, offering to supply, import, use or synthesis of an active ingredient for the purpose of making a medicinal product containing that product, or temporary storage of the product or advertising for the exclusive purpose of export to third country destinations. The exception should also apply to related acts performed by third parties who are in a contractual relationship with the maker. [Am. 10]

RemovedArticle 14 – paragraph 4: 4. Any observations by a third party shall be submitted electronically in one of the official languages of the Union and state the grounds on which they are based.

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 15 – paragraph 4 – point c a (new): (ca) any evidence the opponent relies on in support of the opposition.

Added(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 should also be available for unitary certificates. For this purpose that Regulation should be amended.

RemovedArticle 15 – paragraph 6: 6. If the opposition panel notes that the notice of opposition does not comply with paragraphs 2, 3 or 4, it shall reject the opposition as inadmissible, and communicate its decision as well as the reasoning for its decision to the opponent as soon as practicable after the filing of the notice of opposition, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

Added(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.

RemovedArticle 15 – paragraph 9 a (new): 9a. In cases where several oppositions have been filed against an examination opinion, the Office shall deal with the oppositions jointly and issue one single decision in respect of all oppositions filed

Added(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 and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, 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. 11]

RemovedArticle 15 – paragraph 10: 10. The Office shall issue a decision on the opposition, including a detailed reasoning for that decision, within 6 months, unless the complexity of the case requires a longer period.

Added(26a) To guarantee an effective protection of innovation, in certain urgent situations, including where the expiry of the basic patent is imminent, an expedited examination procedure might be necessary, notwithstanding the possibility for third parties to submit observations and make use of other remedies provided under this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be provided. [Am. 12]

RemovedArticle 15 – paragraph 12: 12. If the opposition panel considers that at least one ground for opposition prejudices the maintenance of the examination opinion, it shall adopt an amended opinion, and the Office shall publish its full decision in the Register.

Added(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.

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(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.

RemovedArticle 15 – paragraph 12 b (new): 12b. All exchanges between the Office, the holder and the opponent shall take place electronically.

Added(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 without undue delay the examination opinion by granting a unitary certificate or rejecting the application, as applicable. [Am. 13]

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(30) To safeguard procedural rights and ensure a complete system of remedies, 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. [Am. 14]

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(31) When appointing members of the Boards of Appeal in matters regarding applications for unitary certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account. [Am. 15]

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

Added(32) Any person may challenge the validity of a unitary certificate by lodging with the Office an application for a declaration of invalidity.

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(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 offor paediatric medicinal products in accordance with Article 86 of Directive (EU) .../... [2023/0132(COD)], 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. [Am. 16]

RemovedArticle 18 – paragraph 1: 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: