Regulatory affairs and intellectual property protection in the pharmaceutical industry

The next edition of the training will be held on 12, 13 and 14 January 2023.

Public

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

Programme

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.

Type of training and certification

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

Registration fees

This information will be available later.

Duration

The next edition of the training will be held on 12, 13 and 14 January 2023.

The program has a total duration of 20 hours, distributed in three days.

Timetable

8am to 6pm CET during the week, 8am to 2pm on the Saturday.

This schedule is given on an indicative basis and may slightly change.

Location

On site in Strasbourg as well as remotely.

Heads of studies

The program is jointly designed and directed by:

Natasha Mangal, Education & Scientific Coordinator, Contractual Researcher at CEIPI

Peter Thomsen, Chairman of the Litigation Committee of the Institute of Professional Representatives before the European Patent Office

Pierick Rousseau, Former Intellectual Property Director at Pierre Fabre

Information and registration

Registration for the 2023 edition will soon be open.

Field

Intellectual property Law.