Changes from plenary report to adopted text

Added5. The Commission is empowered to adopt implementing acts to determine the criteria in the ways the panels are to be set up and the criteria for the selection of examiners. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55.

AddedArticle 18 Grant of a unitary certificate or rejection of the application for a unitary certificate

AddedAfter 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:: [Am. 51]

Added(a) where the examination opinion is positive, the Office shall grant a unitary certificate;

Added(b) where the examination opinion is negative, the Office shall reject the application for a unitary certificate.

AddedThe Office shall inform the applicant of its decision without undue delay. [Am. 52]

AddedArticle 19 Grant of an extension of the duration of a unitary certificate

Added1. After ensuring that the application for an extension of the duration of a unitary certificate complies with Article 9(3), the Office shall assess that application on the basis of the conditions laid down in Article 36 of Regulation (EC) No 1901/2006.

Added2. Third parties may also submit observations or oppositions in respect of an application for an extension of the duration of a unitary certificate. [Am. 53]

Added3. Where the application for an extension of the duration complies with the conditions referred to in paragraph 1, the Office shall grant an extension of the duration of the unitary certificate.

Added4. Where the application for an extension of the duration does not comply with the conditions referred to in paragraph 1, the Office shall reject that application.

AddedArticle 20 Duration of the unitary certificate

Added1. The unitary certificate shall take effect at the end of the lawful term of the basic patent, namely on the twentieth anniversary of the filing date of the application for that patent, for a period equal to the period which elapsed between the date on which the application for the basic patent was lodged and the date of the first authorisation to place the product on the market in the Union, reduced by a period of 5 years.

Added2. The duration of the unitary certificate may not exceed 5 years from the date on which it takes effect.

Added3. The periods laid down in paragraphs 1 and 2 shall be extended by 6 months in the case where Article 36 of Regulation (EC) No 1901/2006 applies. In that case, the duration of the period laid down in paragraph 1 of this Article may be extended only once.

AddedArticle 21 Expiry of the unitary certificate

AddedThe unitary certificate shall lapse in any of the following events:

Added(a) at the end of the period provided for in Article 20;

Added(b) if the unitary certificate holder surrenders it;

Added(c) if the annual fee laid down in accordance with Article 31(3) is not paid in time;

Added(d) if and as long as the product covered by the unitary certificate may no longer be placed on the market following the withdrawal of the appropriate authorisation to place on the market in accordance with Regulation (EC) No 726/2004 or Regulation (EU) 2019/6.

AddedFor the purposes of the first subparagraph, point (d), the Office may decide on the lapse of the certificate either of its own motion or at the request of a third party.

AddedArticle 22 Invalidity of the unitary certificate

AddedThe unitary certificate shall be invalid in any of the following events:

Added(a) the certificate was granted contrary to Article 3Articles 3 and 6(2); [Am. 54]

Added(b) the basic patent has lapsed before its lawful term expires;

Added(c) the basic patent is revoked or limited to the extent that the product for which the unitary certificate was granted would no longer be protected by the claims of the basic patent or, after the basic patent has expired, grounds for revocation exist which would have justified such revocation or limitation.

AddedArticle 23 Application for a declaration of invalidity

Added1. Any person may file with the Office an application for a declaration of invalidity of a unitary certificate.

Added2. An application for a declaration of invalidity may only be filed on the grounds that one or more of the conditions set out in Article 22 are not fulfilled for one or more of the Member States in which the basic patent has unitary effect.

Added3. An application for a declaration of invalidity shall be filed in writing,electronically and shall specify the grounds on which it is made. It shall not be considered as duly filed until the related fee has been paid. [Am. 55]

Added4. The application for a declaration of invalidity shall contain:

Added(a) the references of the unitary certificate against which that application is filed, the name of its holder, and the identification of the product;

Added(b) the particulars of the person referred to in paragraph 1 (‘applicant’) and, where applicable, of its representative;

Added(c) a statement of the grounds on which the application for a declaration of invalidity is based.

Added5. The application for a declaration of invalidity shall be examined by an invalidation panel set up by the Office in accordance with the rules applicable to examination panels. However, the invalidation panel shall not include any examiner previously involved in the examination panel that examined the unitary certificate application, nor, the case being, any examiner involved in possible related opposition proceedings, nor in related appeal proceedings.

Added6. An application for a declaration of invalidity shall be inadmissible where an application relating to the same subject matter and cause of action, and involving the same parties, has been adjudicated on its merits, either by the Office or by a competent court as referred to in Article 24, and the decision of the Office or that court on that application has acquired the authority of a final decision.

Added7. If the invalidation panel notes that the application for a declaration of invalidity does not comply with paragraphs 2, 3 or 4, it shall reject that application as inadmissible, and communicate this to applicant.

Added8. The decision to reject an application for a declaration of invalidity as inadmissible shall be communicated to the holder of the unitary certificate, together with a copy of that application.

Added9. Where the application for a declaration of invalidity is not rejected as inadmissible, the Office shall promptly transmit that application to the holder of the unitary certificate, and shall publish it in the Register. If several applications for a declaration of invalidity have been filed, the Office shall promptly communicate them to the other applicants.

Added10. The Office shall issue a decision on the application for a declaration of invalidity within 6 months, unless the complexity of the case requires a longer period.

Added11. If the examination of the application for a declaration of invalidity reveals that the one or more of the conditions set out in Article 22 are met, the unitary certificate shall be declared invalid. Otherwise the application for a declaration of invalidity shall be rejected. The outcome shall be mentioned in the Register.

Added12. The unitary certificate shall be deemed not to have had, as from the outset, the effects specified in this Regulation, to the extent that it has been declared invalid.

Added13. The Commission is empowered to adopt delegated acts in accordance with Article 54 to supplement this Regulation by specifying the details of the procedure governing the declaration of invalidity.

AddedArticle 24 Counterclaim for the invalidity of a certificate

Added1. A counterclaim for a declaration of invalidity may only be based on the grounds for invalidity set out in Article 22.

Added2. The competent court of a Member State shall reject a counterclaim for a declaration of invalidity if a decision taken by the Office relating to the same subject matter and cause of action and involving the same parties has already become final.

Added3. If the counterclaim is brought in a legal action to which the holder of the unitary certificate is not already a party, that holder shall be informed thereof and may be joined as a party to the action in accordance with the conditions applicable before the competent court.

Added4. The competent court of a Member State with which a counterclaim for a declaration of invalidity of the unitary certificate has been filed shall not proceed with the examination of the counterclaim, until either the interested party or the court has informed the Office of the date on which the counterclaim was filed. The Office shall record that information in the Register. If an application for a declaration of invalidity of the unitary certificate had already been filed before the Office before the counterclaim was filed, the court shall be informed thereof by the Office and stay the proceedings until the decision on the application is final or the application is withdrawn.

Added5. Where the competent court of a Member State has given a judgment which has become final on a counterclaim for a declaration of invalidity of a unitary certificate, a copy of the judgment shall be sent to the Office without delay, either by the court or by any of the parties to the national proceedings. The Office or any other interested party may request information about such transmission. The Office shall mention the judgment in the Register and shall take the necessary measures to comply with its operative part.

Added6. The competent court hearing a counterclaim for a declaration of invalidity may stay the proceedings on application by the holder of a unitary certificate and after hearing the other parties and may request the defendant to submit an application for a declaration of invalidity to the Office within a time limit which it shall determine. If the application is not made within the time limit, the proceedings shall continue; the counterclaim shall be deemed withdrawn. Where the competent court of a Member State stays the proceedings it may order provisional and protective measures for the duration of the stay.

AddedArticle 25 Revocation of an extension of the duration of a unitary certificate for a medicinal product

Added1. The Office may revoke an extension of the duration if it was granted contrary to Article 36 of Regulation (EC) No 1901/2006.

Added2. Any person may submit an application for revocation of the extension of the duration to the Office.

AddedArticle 26 Notification of lapse or invalidity

Added1. Where the unitary certificate lapses in accordance with Article 21, point (b), (c) or (d), or is invalid in accordance with Article 22 and 23, the Office shall promptly publish a notification thereof.

Added2. Where the extension of the duration is revoked in accordance with Article 25, the Office shall promptly publish a notification thereof.

AddedArticle 27 Conversion

Added1. Where the unitary effect of the basic patent is revoked while the application for a unitary certificate is still pending, the holder of that application may, subject to a fee, request the conversion of that application into a centralised application for certificates.

Added2. Where the unitary effect of the basic patent is revoked after the unitary certificate has been granted, the holder of that certificate may, subject to a fee, request the conversion of that unitary certificate into national certificates.