Regulatory affairs and intellectual property protection in the pharmaceutical industry

This training program is addressed to regulatory officers, patent attorneys and in-house lawyers, as well as public servants working in public health organizations, who must navigate through the several legal domains of relevance in pharmaceutical research, development and innovation.

Teaching language: English

The topics addressed:

• The interface between regulatory and IP exclusivities: Regulatory Data Protection and the role of Marketing Authorisations

This module focuses on the protection that may be accorded to data and information submitted for the grating of certain types of marketing authorisations for medicinal products for human use. 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. The approach of the European Medicines Agency (EMA) towards reactive and proactive transparency, including, the manner in which it handles data and information pertaining to medicinal products will be discussed and analysed.

• Supplementary Protection CertificatesSupplementary Protection Certificates

This module explores the legislative background and litigation strategies concerning Supplementary Protection Certificates (SPCs) in the European Union. Participants will become familiarized with timelines, where to apply for SPCs, substantive requirements, and the scope of protection during the term of protection awarded by an SPC. Controversial areas, such as which is the product protected by the basic patent and the relationship between SPCs and patent claims drafting, will be explored in this session.

• Orphan drugs exclusivity and Paediatric Extensions

The final day is devoted to orphan market exclusivity and paediatric exclusivity extensions. Orphan market exclusivity in terms of its nature, effects and interaction with other exclusivities will be discussed, along with conditions for applying for paediatric extensions. Lecturers will address aspects such as how to obtain orphan market exclusivity, situations of mixed orphan/non-orphan indications for the same active pharmaceutical ingredient, the scope of orphan drugs eclusivity, and enforcement (strategies for breaking protection).

An attestation of completion shall be delivered upon full attendance of the participant to the training.

Professionals:

• 1 650 € TTC (early bird) before July 25.
• 1 850 €  TTC  (full price) for all registrations after July 25.

Students:

• 515 € TTC * (initial training)

*subject to validation by the university authorities

Registrations close on September 6. Spaces limited. 

The program has a total duration of 18 hours, distributed in three days.

The seminar takes place between 9am and 6pm on weekdays, and between 9am and 1pm on Saturdays.

These times are indicative and subject to change.

On site in Strasbourg as well as remotely.

The program is jointly designed and directed by:

• Peter Thomsen, Senior Patent Counsel IP Policy & Litigation, Novartis International AG
• Alexander Meier, VP, Head, Legal Regulatory Strategy and Global Regulatory Policy at Moderna
• Pierick Rousseau, Former Intellectual Property Director at Pierre Fabre
• Thomas Lemieux, Lecturer at CEIPI