Patents Act (PatA)
Inserted by No 1 of the FA of 3 Feb. 1995, in force since 1 Sept. 1995 (AS 1995 2879; BBl 1993 III 706). Amended by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633).
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Supplementary Protection Certificates fo
Inserted by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633).
A. Principle
Art. 140a
1 The Institute shall on application grant a supplementary protection certificate (certificate) for the active ingredients or combination of active ingredients of medicinal products. A certificate will only be issued if no paediatric supplementary protection certificate in accordance with Article 140t paragraph 1 is available. 1bis An active ingredient is a substance of chemical or biological origin contributing to the composition of a medicinal product which has a medicinal effect on the organism. An active ingredient composition is a combination of several substances, all of which have a medicinal effect on the organism. 2 Active ingredients or combinations of active ingredients are referred to in this Section as products.
Art. 140a — Amended by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). Para. 1 — Second sentence inserted by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1bis — Inserted by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
B. Conditions
Art. 140b
1 The certificate is granted if, at the time of the application: a. the product as such, a process for manufacturing it or a use of it is protected by a patent; b. a medicinal product containing the product is authorised in Switzerland in accordance with Article 9 of the Therapeutic Products Act (TPA) of 15 December 2000. 2 It is granted based on the first authorisation.
Para. 1 let. b — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. b — SR 812.21 Para. 2 — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
C. Right
Art. 140c
1 The proprietor of the patent has the right to the certificate. 2 Only one certificate shall be granted for each product. 3 In the event that two or more proprietors of a patent file applications for the same product based on different patents and no certificate has yet been granted, the certificate may be granted to each applicant.
Para. 2 — Inserted by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). Para. 3 — Inserted by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633).
D. Subject-matter of protection and effects
Art. 140d
1 The protection of a certificate extends, within the limits of the scope of protection conferred by the patent, to any use of the product as a medicinal product that has been authorised before the expiry of the certificate. 2 The certificate grants the same rights as the patent and is subject to the same restrictions.
E. Term of protection
Art. 140e
1 The certificate takes effect on expiry of the maximum term of the patent for a period equal to the period which elapses between the date of filing under Article 56 and the date of the first authorisation of the medicinal product containing the product in Switzerland, minus five years. 2 It is valid for no more than five years. 3 The Federal Council may specify that the authorisation of a medicinal product containing the product granted in the European Economic Area (EEA) constitutes the first authorisation within the meaning of paragraph 1 if it is granted earlier than the first authorisation in Switzerland.
Para. 1 — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
F. Time limit for filing the application
Art. 140f
1 The application for the grant of a certificate must be filed: a. within six months of the first authorisation of a medicinal product containing the product in Switzerland; b. within six months of the grant of the patent if this was granted later than the first authorisation. 2 In the event that the time limit is not met, the IPI shall refuse the application.
Para. 1 let. b — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
G. Grant of the certificate
Art. 140g
The Institute grants the certificate by entering it in the Patent Register.
H. Fees
Art. 140h
1 The certificate is subject to the payment of an application fee and renewal fees. 2 The renewal fees must be paid in advance in one single payment for the full term of the certificate. 3 …
Para. 2 — Amended by No I of the FA of 22 June 2007, in force since 1 July 2008 (AS 2008 2551; BBl 2006 1). Para. 3 — Repealed by No I of the FA of 22 June 2007, with effect from 1 July 2008 (AS 2008 2551; BBl 2006 1).
I. Premature lapse and suspension
Art. 140i
1 The certificate lapses where: a. the owner surrenders it by a written declaration to the IPI; b. the annual fees have not been paid in due time; [tab] c. all authorisations of medicinal products containing the product are recalled (Art. 16a TPA). 2 If all authorisations are suspended, the certificate is also suspended. Suspension does not interrupt the term of the certificate. 3 The Swiss Agency for Therapeutic Products shall notify the IPI of any withdrawal or suspension of the authorisations.
Para. 1 let. tab — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 1 let. tab — SR 812.21 Para. 2 — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1). Para. 3 — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
K. Nullity
Art. 140k
1 The certificate is null and void where: a. it was granted contrary to Article 140b, Article 140c paragraph 2, Article 146 paragraph 1 or Article 147 paragraph 1; b. the patent lapses before its maximum term expires (Article 15); c. the patent is declared null and void; 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 the lapse of the patent, grounds exist which would have justified the declaration of nullity of the patent under letter c or a limitation under letter d. 2 Any person may bring an action to have the certificate declared null and void before the authority responsible for declaring the nullity of the patent.
Para. 1 let. a — Amended by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633).
L. Procedure, Register, publications
Art. 140l
1 The Federal Council shall lay down the procedure for the grant of certificates and for their entry in the Patent Register and the IPI’s publications. 2 It shall take account of the regulations of the European Union.
Para. 2 — Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
M. Applicable law
Art. 140m
Insofar as the provisions concerning the certificate do not contain any regulations, the provisions of the first, second, third and fifth Titles of this Act apply by analogy.
Section 2 Extension of the Term of Supplementary P
Inserted by No I of the FA of 9 Oct. 1998 (AS 1999 1363; BBl 1998 1633). Amended by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
A. Requirements
Art. 140n
1 The IPI shall extend the term of protection (Art. 140e) of certificates issued by six months if the authorisation (Art. 9 TPA) of a medicinal product containing the product: a. contains confirmation that the information on the medicinal product reflects the results of all studies performed in accordance with the paediatric test concept (Art. 11 para. 2 let. a no 6 TPA) considered in the authorisation process; and b. was applied for no later than six months after the application for initial authorisation in the European Economic Area of a medicinal product containing the product in which the corresponding medicinal product information reflects the results of all studies performed in accordance with the paediatric test concept considered for the authorisation. 2 A certificate’s term of protection may only be extended once.
Para. 1 — SR 812.21
B. Deadline for submitting an application
Art. 140o
1 An application to extend a certificate’s term of protection may be made with the application for issuance of a certificate at the earliest and two years before the certificate expires at the latest. 2 If the deadline is not respected, the IPI shall reject the application.
C. Extension of term of protection
Art. 140p
The IPI shall extend the term of protection of the certificate by entering this in the Patent Register.
D. Fee
Art. 140q
A fee shall be paid to extend a certificate’s term of protection.
E. Revocation
Art. 140r
1 The IPI may revoke the extension of a certificate’s term of protection if this was granted in contravention of Article 140n or if it subsequently contravenes Article 140n. 2 Any person may lodge a request with the IPI for the extension of a term of protection to be revoked.
F. Procedure, register, publications
Art. 140s
1 The Federal Council shall regulate the procedure for extending the terms of protection of certificates, for registering them in the Patent Register and for publication by the IPI. 2 It shall take into account European Union regulations.
Section 2a Paediatric Supplementary Protection Cer
Inserted by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
A. Requirements
Art. 140t
1 Upon application the IPI shall issue a paediatric supplementary protection certificate (paediatric certificate) for active ingredients or active ingredient compositions of medicinal products with a protection period of six months from the expiry of the longest term of the patent, provided the authorisation (Art. 9 TPA) of a medicinal product containing the product: a. contains confirmation that the information on the medicinal product reflects the results of all studies performed in accordance with the paediatric test concept (Art. 11 para. 2 let. a no 6 TPA) considered in the authorisation process; and b. was applied for no later than six months after the application for initial authorisation in the European Economic Area of a medicinal product containing the product in which the corresponding medicinal product information reflects the results of all studies performed in accordance with the paediatric test concept considered for the authorisation. [tab] 2 A paediatric certificate sh
Para. 1 — SR 812.21
B. Claim
Art. 140u
1 The patent holder has a claim to the paediatric certificate. 2 The paediatric certificate shall be issued once only for each product. 3 If however owing to the existence of different patents several patent holders submit an application for the same product, the paediatric certificate may be issued to each applicant if the addressee’s consent is provided with the confirmation in accordance with Article 140t paragraph 1 letter a.
C. Deadline for submitting an application
Art. 140v
1 The application for the grant of a paediatric certificate may be made two years before the end of the maximum term of the patent at the latest. 2 If the deadline is not respected, the IPI shall reject the application.
D. Fee
Art. 140w
A fee shall be paid for the paediatric certificate.
E. Nullity
Art. 140x
1 The paediatric certificate is null and void when: a. it is issued in contravention of Article 140t or if it subsequently contravenes Article 140t; b. it is issued in contravention of Article 140u paragraph 2; c. the patent lapses before the end of its maximum term (Art. 15); d. the patent is found to be null and void; e. the patent is limited to such an extent that its claims no longer cover the product for which the paediatric certificate was granted; f. after the patent has lapsed, there are grounds which would have justified a declaration of nullity under letter d or a limitation under letter e. 2 Any person may bring an action for the paediatric certificate to be declared null and void before the authority competent to declare the patent null and void.
F. Procedure, register, publications, applicable l
Art. 140y
Articles 140a paragraph 1bis and 2, 140d, 140g, 140i, 140l paragraph 1 and 140m apply mutatis mutandis.
Section 3 Supplementary Protection Certificates fo
Inserted by Annex No 2 of the FA of 18 March 2016, in force since 1 Jan. 2019 (AS 2017 2745, 2018 3575; BBl 2013 1).
Art. 140z
1 The Institute shall on application grant a supplementary protection certificate (certificate) for active ingredients or combination of active ingredients of plant protection products. 2 Articles 140a paragraph 2 and 140b to 140m apply by analogy. 3 Ingredients are substances and microorganisms, including viruses, with a general or specific effect: a. against harmful organisms; b. on plants, parts of plants or plant products.