Coverage – What does undisclosed information encompass?
Any information is capable of protection, provided it fulfills the following conditions: • The information is confidential in the sense that it is not generally known to those in the industrial art within the scope of which the information falls. • The information derives its commercial value from its confidentiality. • The owner of the information has in place measures for keeping the information confidential, i.e. access on a “need-to-know” basis and appropriate non-disclosure agreements with third parties. Protection of undisclosed data or information requested by the Health Authority for marketing approval of pharmaceutical or agrochemical products containing a new chemical entity is particularly addressed in Art. 56 of Law 82/2002.
