Pharmaceuticals Policy and Law

The purpose of this paper is to set out and discuss the recent jurisdictional developments in the European Court of Justice (ECJ) with respect to supplementary protection certificates (SPCs) including paediatric extensions. During the past five years the ECJ has been particularly active and has clarified a number of highly controversial legal ambiguities, such as the availability of negative term SPCs.

Supplementary protection certificates for medicinal products for human use (SPC) and data exclusivity are legal instruments that provide protection for pharmaceuticals. They differ, however, with respect to the rationale, requirements and scope of their protection.

An SPC does not prolong the basic patent, but extends protection conferred by the basic patent, within the limits prescribed by the marketing authorization for a given medicinal product, which is usually different from the scope of protection granted by the basic patent. The aim is to provide an additional period of protection in the case where a pharmaceutical marketing authorization process was particularly long. This is to allow a pharmaceutical company that holds the basic patent to recoup the investment made in research and development of the pharmaceutical. An SPC rewards a product – a patented active ingredient or a combination of active ingredients, as opposed to the first submitted regulatory data as in the case of data exclusivity.

Data exclusivity is a “quasi” – intellectual property right which prevents health authorities responsible for granting marketing authorizations from relying on the original data submitted by the first market entrant as well as preventing subsequent applicants from cross-referring to the original data. Data exclusivity should be distinguished from market exclusivity. Market exclusivity means that a subsequent market entrant may not market a particular product on which a marketing authorization has been issued, irrespective of the fact whether he refers to data submitted by the first market entrant or he has generated the data himself. Data exclusivity should neither be confused with data protection, as there are other legal instruments, such as trade secrets, which serve to protect undisclosed, confidential know-how.

Complex relationships between SPCs, data exclusivity and market exclusivity may occur i.e. the scope and period of protection conferred by them may overlap or complement each other. In the latter case they enhance the overall protection for a given medicinal product. They are even more important during the period when no other type of protection is available, and there is only data exclusivity or SPC protection. Due to the interesting interrelations between SPCs and data exclusivity they are both worth a profound analysis. The paper aims to touch upon the importance of data exclusivity in the light of other legal protection instruments available, such as an SPC.

The priority review voucher scheme is a strong market-driven incentive which complements existing incentives for pharmaceutical research on neglected diseases. Contrary to other market based incentives, the PRV reconciles the need for innovation with generic manufacturers’ business plans – since the PRV scheme does not delay generic competition while extending effective patent life.