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PART VII SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS

A. Principle

Art. 140a

(1) The Federal Institute of Intellectual Property shall issue on request supplementary protection certificates (certificates) for the active ingredients or combinations of active ingredients of medicinal products (products).

(2) A certificate shall be issued once only for any given product.

B. Conditions

Art. 140b

(1) A certificate shall be issued if, at the time of the application:

(a) the product as such, the process for manufacturing the product or its use are protected by a patent;
(b) an official authorization to place the product on the market as a medicinal product has been obtained in Switzerland.

(2) The certificate is granted on the basis of the first authorization.

C. Entitlement

Art. 140c

The certificate shall be granted to the holder of the patent.

D. Subject Matter of Protection and Effects

Art. 140d

(1) Within the limits of the scope of protection afforded by the patent, the certificate shall protect all uses of the product as a medicinal product that have been authorized before the expiry of the certificate.

(2) The certificate shall afford the same rights as the patent and shall be subject to the same restrictions.

E. Term of Protection

Art. 140e

(1) The certificate shall be valid as from the expiry of the maximum term of the patent and for a period corresponding to the time that elapses between the filing date under Article 56 and the date of the first authorization to place the product on the market as a medicinal product in Switzerland, less five years.

(2) It shall be valid for five years at most.

(3) The Federal Council may stipulate that an authorization granted in the European Economic Area (EEA) shall constitute the first authorization within the meaning of paragraph (1) if it precedes that granted in Switzerland.

F. Time Limit for Filing an Application

Art. 140f

(1) The application for a certificate shall be filed:

(a) within a period of six months from the grant of the first authorization to place the product on the market as a medicinal product in Switzerland;
(b) within a period of six months as from the grant of the patent, if that occurs after the grant of the first authorization.

(2) If the above time limits are not complied with, the Federal Institute of Intellectual Property shall declare the application inadmissible.

G. Grant of Certificate

Art. 140g

The Federal Institute of Intellectual Property shall grant the certificate and enter it in the Patent Register.

H. Fees

Art. 140h

(1) The certificate shall be subject to payment of a filing fee and of annual fees.

(2) The annual fees shall be paid in advance in one single payment for the full term of the certificate. They shall become due on the last day of the month during which:

(a) the term of the certificate begins to run;
(b) the certificate is granted where it is granted after the expiry of the maximum term of the patent.

(3) The annual fees shall be paid within a period of six months of their becoming due; if payment is effected during the final three months, a surcharge shall be paid.

I. Premature Lapse; Suspension

Art. 140i

(1) The certificate shall lapse where:

(a) the holder surrenders it by means of a written application addressed to the Federal Institute of Intellectual Property;
(b) the annual fees have not been paid in good time;
(c) the authorization to place the product on the market as a medicinal product is revoked.

(2) Should the authorization be suspended, the certificate shall also be suspended. Suspension shall not interrupt the term of the certificate.

(3) The authority that grants the authorizations shall communicate any revocation or suspension of the authorization to the Federal Institute of Intellectual Property.

K. Invalidity

Art. 140k

(1) The certificate shall be invalid if:

(a) it was granted contrary to Articles 140a(2), 140b, 146(1) or 147(1);
(b) the patent has lapsed before its maximum term expires (Article 15);
(c) the patent is declared invalid;
(d) the patent is limited to the extent that the product for which the certificate was granted is no longer covered by the claims;
(e) after lapse of the patent, grounds for revocation exist which would have justified the declaration of invalidity of the patent under item (c) or a limitation under item (d).

(2) Any person may bring an action for a declaration of invalidity of the certificate before the authority responsible for declaring the patent invalid.

L. Procedure, Register, Publications

Art. 140l

(1) The Federal Council shall lay down the procedure for granting certificates, their entry in the Patent Register and the publications of the Federal Institute of Intellectual Property.

(2) It shall take into account the regulations of the European Community.

M. Applicable Law

Art. 140m

The provisions of Parts I, II, III and V of this Law shall apply mutatis mutandis where the provisions on certificates remain silent.

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