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Law No. 2011-2012 of December 29, 2011, on the Strengthening of the Safety of Medicines and Health Products, France
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Latest Version in WIPO Lex
Year of Version
2011
Dates
Entry into force:
December 31, 2011
Adopted:
December 29, 2011
Type of Text
IP-related Laws
Subject Matter
Patents (Inventions),
Other
Notes
Title III, Chapter VII, Article 29(X) of Law No. 2011-2012 of December 29, 2011, on Strengthening of the Safety of Medicines and Health Products adds paragraph d bis after paragraph d) of Article 613-5 of the Intellectual Property Code, which states that “d) bis To acts necessary to obtain the visa authorizing advertising mentioned in Article L. 5122-9 of the Public Health Code”.
This amendment provides for a new exception to patent rights, which allows generic producers to apply the procedures necessary for obtaining a mandatory visa that authorizes the advertising of their products, without having to wait for the end of the monopoly granted by the patents related to the corresponding brand name medicines.
Title V, Article 42 of this Law provides that a new Article L. 5121-10-3 is added after L. 5121-10-2 of the Code of Public Health, which states that 'The holder of an intellectual property right protecting the appearance and texture of oral dosage forms of a specialty of reference within the meaning of Article L. 5121-1 may not prohibit oral dosage forms of a generic specialty, which may be substituted for that specialty according to Article L. 5125-23, from presenting an identical or similar appearance and texture'.
Available Texts
Main text(s)
Main text(s)
French
Loi nº 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé
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Related Legislation
Amends (1 text(s))
Amends (1 text(s))
WIPO Lex No.
FR214