The Lazio Regional Administrative Court stated in favor of access to the list of names of manufacturers of generic pharmaceutical products asking for MA

The Lazio Regional Administrative Court, by the judgment no. 6838/12 of last July 19, annulled the decision of April 20, 2012 of the Italian Medicines Agency ("AIFA") which had deferred the access of the company Sanofi Aventis Spa ("Sanofi") to the list of names of manufacturers of generic pharmaceutical products who had applied for marketing authorization ("MA") for drugs equivalent to anti-hypertensive original pharmaceutical products of Sanofi. The active ingredients of the drugs in question were covered by complementary protection certificates ("CCP") not yet due. For this reason, in view of the commencement of procedures for MA granting for the corresponding generic products, Sanofi had made an application for access to the names of generic pharmaceutical companies who had initiated the proceedings in question and this in order to emphasize to said companies that the marketing of generic drugs before the expiration date of CCPs on their active ingredients, would have represented an act of infringement. Fearing delays in the administrative procedure of MA granting, AIFA had denied to Sanofi the access to the list of those names, stating that it would be allowed only at the end of the preliminary investigation relating to the MA granting for generic pharmaceutical products. The Lazio Regional Administrative Court, by the judgment in question, had instead declared illegal such postponement and ordered to AIFA to allow the access to the names in question. The Administrative Court has stressed that the ratio of the instance of Sanofi was not to delay the entry into the market of generics, but to point out to generics pharmaceutical companies that such entry can not be earlier than the day following the expiration date of the CCPs.


10/31/2012 | Courts