Jurisdiction(s):
United Kingdom

Key definition

Originator definition

What does Originator mean? In pharmaceutical regulatory practice, originator describes the first authorised branded medicine used as the comparator for later generics and biosimilars. The term is descriptive (not a defined statutory term) and is used interchangeably with reference medicinal product. Under Directive 2001/83/EC, the reference medicinal product is one holding a marketing authorisation supported by a complete, stand‑alone dossier under Article 8(3) (not an abridged dossier under Articles 10a, 10b or 10c). Generic applications under Article 10 rely on demonstrating bioequivalence to the originator; biosimilar applications demonstrate biosimilarity to a reference biological. The originator matters because it: - identifies the lawful comparator for...

EU pharmaceutical exclusivities and incentives: SPCs, regulatory data and market protection, orphan and paediatric regimes; interactions, key case law, SPC waiver and unitary SPC, and pending legislative reforms

Published by a LexisNexis Life Sciences expert

Practice notes

What are pharmaceutical incentives?

In the EU, protection mechanisms and incentives for medicinal products, grouped under the term pharmaceutical incentives (PIs), are in place. PIs comprise legislative measures that give originator pharmaceutical companies (originators) a degree of advantage over companies selling medicines with the same active substance at far lower prices (generic or biosimilar companies)-ranging from market protection (MP), through extensions of patent rights, to several years of market exclusivity for a medicinal product.

Rationale behind PIs

PIs were introduced in the EU to encourage and support originators in discovering and developing new medicinal products. While innovation and discovery typically require considerable time and financial investment, only limited effort is needed to use the knowledge generated afterwards. When a generic or biosimilar company reproduces an invention, it often does not bear the substantial research and development (R&D) costs of creating it and can therefore sell the resulting medicinal product at a price well below the originator’s. The prospect of this may discourage originators, who cannot recover the initial outlay incurred during the R&D process. PIs help originators in maintaining certain benefits and...

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Tine Carmeliet

A&O Shearman

Tine heads A&O Shearman’s Belgian life sciences team. She specializes in life sciences patents litigation and advises clients on regulatory issues and commercial transactions in the life science sector. Her litigation experience includes both representing clients before the Belgian and European courts and assisting clients with multi-jurisdictional proceedings. She advices multinational companies and start-ups as well as research institutes in the pharmaceutical, biotech and medical devices sectors on a variety of complex matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, MDR and IVDR, digital health solutions, artificial intelligence, real world data and transparency regulations. She regularly assists clients with drafting and negotiating high value IP licenses, R&D collaborations, tech transfer and spin-out deals and has particular expertise with cell and gene therapy products. In addition, Tine has extensive experience advising on agro(bio)tech and food and feed...

Eveline Van Keymeulen

Latham & Watkins

Eveline Van Keymeulen is a partner in Latham & Watkins’ Brussels and Paris offices and a member of the firm’s healthcare and life sciences practice. Ms Van Keymeulen advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, regulatory incentives, market access, promotion and advertising, post-market obligations, and general compliance matters. In addition, Ms Van Keymeulen has extensive experience advising on medical cannabis and hemp-based product regulations. She successfully challenged the legality of French hemp regulations in the first case related to cannabidiol (CBD) products before the Court of Justice of the European Union (Case C-663/18, Kanavape). This landmark judgment had a major impact on the development of the European CBD industry. Ms Van Keymeulen is ranked in Chambers for Life...

Jeanne Fabre

Latham & Watkins

Jeanne Fabre is an associate in the Paris office of Latham & Watkins and a member of the firm’s healthcare and life sciences practice. She advises multinational companies and start-ups in the pharmaceutical, biotech, medical devices, cosmetics, and food and beverage sectors on a broad variety of complex European, domestic and cross-border regulatory matters, including clinical trials, product approvals, market access, promotion and advertising, post-market obligations, contracts and general compliance matters. Ms Fabre has significant experience working in pharmaceutical companies. Since her Master’s in Life Sciences Law, she has worked for more than three years for several companies, both for local affiliates and parent companies. She was seconded for 18 months part-time to a pharmaceutical company specialising in rare diseases, and a further three months for another pharmaceutical company. During that time she advised on a wide range of day-today regulatory topics (such as...

Web page updated on 28/05/2026

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