What changed between the plenary report and the adopted text

Change 2

Changed:Article(10) 5Within –the paragraphlimits 2of –the pointprotection aconferred –by pointthe iii:basic (iii)patent, making,the noprotection earlierconferred thanby 6a monthscertificate beforeshould theextend expiryonly ofto the certificate, a product, ornamely athe medicinalactive productingredient containingor thatcombinations product,thereof, forcovered by the purposeauthorisation ofto storingplace it inon the Member State ofmarket makingand infor orderany touse placeof thatthe product,product oras a medicinal product containing that product, on the market ofhas Memberbeen Statesauthorised afterbefore the expiry of the certificate; orcertificate.

Change 3

Removed:Article 5 – paragraph 2 – 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:(11) 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 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 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.

Removed:Article 8 – paragraph 1 – point d a (new): (da) if applicable, the consent of the third party referred to in Article 6(2) of this Regulation.

Added:(12) 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.

Removed:Article 8 – paragraph 1 – point d b (new): (db) information on any direct public financial support received for research related to the development of the product.

Added:(13) 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 productsbiosimilar 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. 5]

Removed:Article 11 – paragraph 1 – introductory part: 1. The authority referred to in Article 9(1) shall publish, without undue delay, notification of the fact that a certificate has been granted. The notification shall contain all of the following information:

Added:(14) 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’).

Removed:Article 11 – paragraph 1 – point f a (new): (fa) information on any direct public financial support received for research related to the development of the product.

Added:(15) The duration of the protection granted by the certificate should be such as to provide adequate effective protection. For this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of 15 years of exclusivity from the time the medicinal product in question first obtains an authorisation to be placed on the market in the Union .

Removed:Article 15 – paragraph 1 – point a: (a) the certificate was granted contrary to Article 3 or 6(2);

Added:(16) All the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector should nevertheless be taken into account. For that purpose, it should not be possible to grant a certificate for a period exceeding 5 years. The protection granted should furthermore be strictly confined to the product which obtained authorisation to be placed on the Union market as a medicinal product. In addition, the timely entry of generics and biosimilars into the Union market is also important, particularly in order to increase competition, to reduce prices and to ensure that national healthcare systems are sustainable and that patients in the Union have better access to affordable medicines.

Removed:Article 16 – paragraph 2: 2. Any person may submit an application for revocation of the extension of the duration granted under this Chapter to the body responsible under national law for the revocation of the corresponding basic patent or before a competent court of a Member State.

Added:(17) In order to promote the development of paediatric medicinal products, it should be possible to extend the period of overall maximum exclusivity of 15 years and the maximum period of validity of the certificate of 5 years where the paediatric extension provided for in Article 36 of Regulation (EC) No 1901/2006 of the European Parliament and of the Council applies.

Removed:Article 18 – paragraph 2 a (new): 2a. Full transparency shall be ensured throughout the whole appeal proceeding, which shall be open, whenever possible, to public participation.

Added:(18) 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.

Change 4

Changed:Article(19) 20There –is paragrapha 1:centralised 1.procedure Wherefor thegranting basicEuropean patentpatents, isas well as a Europeancentralised patent,procedure includingfor aobtaining unitarymarketing patent,authorisations andfor themedicinal authorisationproducts. toIn placeaddition, the product‘unitary onpatent’ theas marketlaid hasdown beenin granted,Regulation as(EU) appropriate,No in1257/2012 accordanceof withthe DirectiveEuropean .../...Parliament [2023/0132(COD)],and throughof the centralisedCouncil procedureis underto Regulationenter (EC)into Noforce 726/2004in orJune Regulation2023 (EU)in 2019/6,respect of the procedureMember inStates thishaving Chapterratified shallthe apply.Agreement on a Unified Patent Court (‘UPC’).

Change 5

Removed:Article 23 – paragraph 1: If the centralised application complies with Article 22, or if an application for an extension of the duration of certificates complies with Article 33(2), the Office shall publish the application, in the Register without undue delay and no later than five working days after.

Added:(20) Therefore, it is necessary to complement the existing national procedures for the grant of certificates for medicinal 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, those certificates should be equivalent to the certificates granted under national procedures and be subject to the same rules.

Removed:Article 24 – paragraph 1: 1. The Office shall assess the application on the basis of all the conditions in Articles 3(1) and (3) and Article 6(2) for each of the designated Member States.

Added:(21) 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, 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.

Removed:Article 24 – paragraph 2: 2. Where the centralised application for a certificate and the product to which it relates comply with Article 3(1) and (3) and Article 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned positive examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant and publish the opinion on the dedicated register without undue delay.

Added:(22) 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.

Removed:Article 24 – paragraph 3: 3. Where the centralised application for a certificate and the product to which it relates does not comply with Article 3(1) and (3) and Article 6(2) in respect of all or some of the designated Member States, the Office shall adopt a reasoned negative examination opinion in respect of such Member States. The Office shall notify that opinion to the applicant and publish the opinion on the dedicated register without undue delay.

Added:(23) The centralised procedure should apply only to a medicinal product that is based on a centralised marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council or Regulation (EU) No 2019/6 of the European Parliament and of the Council. 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 will facilitate the examination of centralised applications.

Removed:Article 24 – paragraph 5 a (new): 5a. The Office shall adopt an examination opinion within 6 months after publication of the centralised application in the Register. Without prejudice to Articles 25, 26 and 28 of this Regulation, 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 adopt an examination opinion within 4 months from the publication of the application for a unitary certificate.

Added:(24) The Office should have the possibility to charge a fee for the centralised application for a certificate and for an application for the extension of duration of certificates in the case of paediatric medicinal products in accordance with Article 86 of Directive (EU) .../... [2023/0132(COD)],, 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. [Am. 6]

Removed:Article 25 – paragraph 3 a (new): 3a. Whenever the expedited procedure applies in accordance with to Article 24 (5a), observations shall be submitted within six weeks after publication of the application in the Register.

Added:(25) To ensure consistency amongst the certificates granted based on the same basic patent and for the same product in Member States, to reduce the global examination workload, and to ensure an appropriate application of the conditions for grant in all Member States where protection is sought for a given product, it is necessary that the centralised procedure be the only option available as regards those Member States for which the related requirements are fulfilled, namely that the basic patent be a European patent, including a unitary patent, and that the marketing authorisation be a centralised one. To this end, a national application for a certificate filed with a competent national authority, should be rejected by that national office where the requirements to use the centralised procedure are met. This measure is proportionate considering the risk of divergences, and does not apply to those situations where those requirements do not apply, in which case national applications may still be filed.

Removed:Article 26 – paragraph 2: 2. Opposition may only be filed on the grounds that one or more of the conditions set out in Article 3 or 6 are not fulfilled for one or more of the designated Member States.

Added:(26) 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) 222]. Such a combined application should undergo a single examination procedure.

Removed:Article 26 – paragraph 4 – point c a (new): (ca) any evidence the opponent relies on in support of the opposition.

Added:(27) 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.

Removed:Article 26 – 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, unless these deficiencies have been remedied before expiry of the opposition filing period referred to in paragraph 1.

Added:(28) 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.

Removed:Article 26 – paragraph 9: 9. 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:(29) 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.

Removed:Article 26 – 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 regards to all oppositions filed.

Added:(30) 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 and related patent matters, located today at national offices only. To ensure an optimal quality of the examination, the Office and 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 centralised procedure, in particular as regards qualification and conflicts of interest. [Am. 7]

Removed:Article 26 – paragraph 10: 10. If the opposition panel considers that no ground for opposition prejudices the maintenance of the examination opinion, it shall reject the opposition and notify the opponent of its decision, and the Office shall mention this in the Register.

Added:(31) 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.

Removed:Article 26 – 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:(32) 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.

Removed:Article 27 – paragraph 1: 1. On a request made to the Office, any competent national authority may be appointed by the Office as a participating office in the examination procedure. Once a competent national authority is appointed in accordance with this Article, that authority shall designate one or more examiners to be involved in the examination of one or more centralised applications, on the basis of their relevant expertise and of their experience in the field.

Added:(32a) 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 for in this Regulation. Therefore, a mechanism for applicants to request an expedited examination procedure should be provided. [Am. 8]

Removed:Article 28 – paragraph 3 – point a: (a) relevant expertise and sufficient experience in the examination of patents and supplementary protection certificates, ensuring, in particular, that at least one examiner has a minimum of five years of experience in the examination of patents and supplementary protection certificates;

Added:(33) 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. The Office shall ensure the transmission takes place within a timeframe allowing national patent offices to grant the certificate or reject the application, as applicable, before the expiry of the basic patent. [Am. 9]

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

Added:(34) 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.

Removed:Article 28 – 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 this Regulation.

Added:(35) 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.

Removed:Article 29 – paragraph 3: 3. Notice of appeal shall be filed in writing at the Office within 2 months of the date of notification of the decision. The notice shall be deemed to have been filed only when the fee for appeal has been paid. In case of an appeal, a written statement setting out the grounds of appeal, including corresponding evidence relied on, shall be filed within 3 months of the date of notification of the decision

Added:(36) 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.

Removed:Article 29 – paragraph 3 a (new): 3a. Any reply to statement of the grounds of appeal shall be submitted in writing within three months from the date of the notification of the statement of the grounds of appeal. Where applicable, the Office shall set a date for an oral hearing within three months after the filing of the reply to the grounds of appeal or within six months of the filing of grounds of appeal, whichever is earlier. The Office shall issue a written decision within three months of the oral hearing or of the filing of the reply to the statement of grounds of appeal, as applicable.

Added:(37) 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.

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

Added:(38) 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 a request for a unitary certificate, a common appeal may be filed. [Am. 10]

Change 6

Changed:Article 30 – paragraph 4: 4. Members of the Boards of Appeal in matters regarding centralised applications for certificates shall be appointed in accordance with Article 166 (5) of Regulation (EU) 2017/1001.(39) When appointing members of the Boards of Appeal in matters regarding centralised applications for certificates, their relevant expertise, independence and sufficient prior experience in supplementary protection certificate or patent matters should be taken into account. [Am. 11]

Change 7

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