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PART X SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS Chapter 1 Scope of Application 127a. Scope of Application (1) This Part shall apply to supplementary protection certificates for medicinal products. (2) The other provisions of this Ordinance shall be applicable except where Part VII of the Law or this Part provide otherwise. Chapter 2 Application for Certificate 127b. Application; Fee (1) The application shall contain: (a) a request for grant of a certificate; (b) a copy of the first official authorization to market the product in Switzerland, including: 1. a copy of the certificate of registration; 2. a copy of the information concerning the medicinal product as authorized by the competent authority; (c) where appropriate, the powers of the representative. (2) The filing fee shall be paid within the time limit laid down by the Institute. 127c. Content of the Request The request for grant of a certificate shall contain the following: (a) The name or business name of the applicant together with his address; (b) Where appropriate, the name and address of the representative; (c) The number of the patent on which the application is based (basic patent); (d) The title of the invention protected by the basic patent; (e) The date of the first official authorization to market the product in Switzerland; (f) An identification of the product designated by the authorization to market together with its registration number; (g) The signature of the applicant or his representative. 127d. Publication of a Notice of Application (1) A notice of the application shall be published. (2) The following particulars shall be published: (a) The name or business name of the applicant together with his address; (b) Where appropriate, the name and address of the representative; (c) The filing date of the application; (d) The number of the basic patent; (e) The title of the invention protected by the basic patent; (f) The date of the first official authorization to market the product in Switzerland; (g) A designation of the product covered by the authorization together with its registration number. (3) Publication shall be made after completion of the examination under Article 127e. Chapter 3 Examination of Application 127e. Examination on Filing of the Application (1) On receiving the application, the Office shall examine whether it has been filed within the required period of time and whether it satisfies the conditions set out in Articles 127b and 127c. (2) If the application does not satisfy the conditions set out in subsection (1), the Institute shall allow the applicant a period of two months to remedy it. (3) If the latter time limit is not complied with, the Institute shall declare the application to be inadmissible. 127f. Examination of the Conditions for Issuing a Certificate (1) The Institute shall examine whether the conditions required for the issue of a certificate (Articles 140a(2) and 140b of the Law) have been satisfied. (2) If the conditions have not been satisfied, the Institute shall reject the application. Chapter 4 Grant of Certificate 127g. Grant of Certificate (1) If the conditions for grant of a certificate have been satisfied, the Institute shall grant a certificate and enter it in the Patent Register. (2) The grant of a certificate shall be published together with the following information: (a) The number of the basic patent together with an addition; (b) The name or business name of the holder of the certificate together with his address; (c) Where appropriate, the name and address of the representative; (d) Filing date of the application; (e) The number of the basic patent; (f) The title of the invention protected by the basic patent; (g) The date of the first official authorization to market the product in Switzerland; (h) A designation of the product covered by the authorization together with its registration number; (i) The date of expiry of the term of protection of the certificate. Chapter 5 Publication of Rejection of the Application for a Certificate, of the Premature Lapse of the Certificate, of its Invalidity or of its Suspension 127h. Publication of Rejection of the Application for a Certificate, of the Premature Lapse of the Certificate, of its Invalidity or of its Suspension (1) The rejection of an application for a certificate, the premature lapse of a certificate, its invalidity or its suspension shall be published. (2) The following information shall be published: (a) the number of the basic patent together with an addition, except where the application for a certificate has been rejected; (b) the name or business name of the applicant or of the holder of the certificate together with his address; (c) the number of the basic patent; (d) the title of the invention protected by the basic patent; (e) the date of the first official authorization to market the product in Switzerland; (f) a designation of the product covered by the authorization together with its registration number; (g) the date of the rejection of the application for a certificate, the premature lapse of the certificate, its invalidity or its suspension. Chapter 6 File and Register 127i. File (1) The file of the certificate shall be annexed to the file of the basic patent. (2) The file of the certificate may be freely consulted. (3) The certificate shall be given the number of the basic patent together with an addition. 127k. Register (1) Entries concerning a certificate shall be shown on the page of the register that concerns the basic patent. (2) The following information shall be shown thereon: (a) The number of the basic patent together with an addition; (b) The name or business name of the holder of the certificate together with his address; (c) Where appropriate, the name and address of the representative; (d) The filing date of the application; (e) The number of the basic patent; (f) The title of the invention protected by the basic patent; (g) The date of the first official authorization to market the product in Switzerland; (h) A designation of the product covered by the authorization together with its registration number; (i) The date of grant of the certificate; (k) The date of expiry of the term of protection of the certificate; (l) Any rights assigned and any restrictions on the right of disposal ordered by the courts or by the enforcement authorities; (m) Amendments concerning the existence of the certificate or of the right to a certificate; (n) Changes of domicile or place of business of the holder of a certificate; (o) Changes of representative or of his domicile or place of business. (3) The Institute may provisionally or definitively enter other particulars as it deems necessary. (4) Entries concerning rights assigned in the basic patent or any restrictions to the right to dispose of the patent ordered by the courts or by the enforcement authorities shall be presumed valid for the certificate to the same extent as for the basic patent. Chapter 7 Fees 127l. Annual Fees Where an annual fee to be paid does not concern a full year, its amount shall be the equivalent, for each full or commenced month of the term of the certificate, of one-twelfth of the annual fee that would be due for the year concerned, rounded up to the nearest franc. 127m. Refund of Annual Fees (1) In the event of invalidity of a certificate, the annual fees shall be refunded for the duration that has elapsed between the time the declaration of invalidity becomes final and the date on which the certificate would have expired. (2) In the event of renunciation of a certificate, the annual fees shall be refunded as a proportion of the duration for which the holder has renounced the certificate. (3) Where the official authorization to market a product is canceled, the annual fees shall be reimbursed as a proportion of the duration of the certificate for which the authorization is canceled. (4) Where the official authorization to market the product is suspended, the annual fees shall be reimbursed as a proportion of the period for which the authorization is suspended. (5) In all cases, only full annual fees shall be refunded. (6) Fees shall only be refunded on request; the request shall be submitted within two months from: (a) the declaration of invalidity of the certificate; (b) renunciation of the certificate; (c) cancellation of the official authorization under subsection (3); (d) the end of the suspension of the official authorization under subsection (4).

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