Regulatory affairs and intellectual property protection in the pharmaceutical industry

CEIPI has been offering since 2019, in Strasbourg, a new advanced training program, a unique educational proposal targeting regulatory and intellectual property professionals in the pharmaceutical sector. The three days of training have revolved around the interface between patent law, supplementary protection certificates and test data protection.

When it comes to pharmaceutical products, branches of law of administrative nature become tied to private law. The interfaces between pharmaceutical law, intellectual property law, competition law and consumer law are numerous. Patents, supplementary protection certificates and regulatory exclusivities, notably test data protection, make up a sophisticated legal framework of overlapping exclusivities that impact both on innovation and competition.

The topics addressed:

• The interface between regulatory and IP exclusivities

This module focuses on the protection given to test data submitted for the grating of pharmaceutical marketing authorization. The pharmaceutical dossier, the types of information protected, key concepts, the duration of the protection and the acts against which the information is protected will be discussed. Likewise, EMA policies relating disclosure of test data, the specificities for biological products, and litigation strategies impacting test data protection will also be the object of analysis,

• Supplementary Protection Certificates

This module explores the legislative background and litigation strategies concerning Supplementary Protection Certificates in the European Union. EC Regulation 469/2009 will allow to discuss time lines, where to apply, substantive requirements, and scope of protection during term of protection awarded by the SPC. Controversial areas such as which is the product protected by the basic patent, pediatric extensions and the relationship with patent claims drafting will be explored in this session.

• Orphan drugs exclusivity

The final day is devoted to orphan drugs exclusivity, its nature, effects and interaction with other exclusivities. Lecturers will address aspects such as how to obtain this exclusivity, situations of mixed orphan/non-orphan indications for the same active pharmaceutical ingredient, scope and breaking protection of orphan drugs exclusivity, how to enforce orphan drugs exclusivity.