On December 29 2011 France adopted a new law (2011-2012) on the safety of drugs and health products. The law contains various provisions aimed at strengthening the transparency of the Public Health Code, monitoring drugs and governing health products. Two provisions of this law also introduce exceptions to IP rights on drugs.
The law introduces a new Article L5121-10-3 to the Public Health Code, which provides that:
"the owner of an intellectual property right protecting the appearance and texture of speciality oral pharmaceutical forms…shall not prohibit the oral pharmaceutical forms of a substitutable generic specialty…from showing identical or similar appearance and texture".
These provisions had twice been blocked by the Constitutional Council on the grounds that they were introduced in acts to which they were unrelated. However, this time, the issue has not been referred to the council.
The law further amends Article L613-5 of the Intellectual Property Code by way of a new paragraph which includes a restriction on the scope of rights conferred by a patent. Pursuant to this new paragraph, the rights conferred by a patent do not extend to acts necessary to obtain authorisation required under Article L5122-9 of the Public Health Code for advertising pharmaceuticals to health professionals and granted by the National Safety Agency for Medicines and Health Products.
For further information on this topic please contact Camille Pecnard or Jules Fabre at Hogan Lovells by telephone (+33 1 53 67 47 47), fax (+33 1 53 67 47 48) or email (firstname.lastname@example.org or email@example.com).
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