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Art. 140a256
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 140tparagraph 1 is available.257 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.258 2 Active ingredients or combinations of active ingredients are referred to in this Section as products.
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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.259
- a medicinal product containing the product is authorised in Switzerland in accordance with Article 9 of the Therapeutic Products Act (TPA) of 15 December 2000.260
2 It is granted based on the first authorisation.261
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Art. 140c
1 The proprietor of the patent has the right to the certificate. 2 Only one certificate shall be granted for each product.262 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.263 262 Inserted by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633). 263 Inserted by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633).
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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.
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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.264 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.265
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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.266
2 In the event that the time limit is not met, the IPI shall refuse the application.
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Art. 140g
The Institute grants the certificate by entering it in the Patent Register.
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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.267 3 …268
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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;
- c.269 all authorisations of medicinal products containing the product are recalled (Art. 16a TPA270).
2 If all authorisations are suspended, the certificate is also suspended. Suspension does not interrupt the term of the certificate.271 3 The Swiss Agency for Therapeutic Products shall notify the IPI of any withdrawal or suspension of the authorisations.272
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Art. 140k
1 The certificate is null and void where: - a.273
- 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. 273 Amended by No I of the FA of 9 Oct. 1998, in force since 1 May 1999 (AS 1999 1363; BBl 1998 1633).
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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.274
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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.
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