Masterstudiengang "Drug Regulatory Affairs"
Data protection for the development of known drug substances - Changes with the review of EU legislation ***
Dr. Arno Wiehe (Abschlußjahr: 2005)
In April 2004 the EU adopted the Directive 2004/27/EC and the Regulation EC/726/2004. These two pieces of legislation amended and replaced the two basic texts of pharmaceutical legislation for medicinal products for human use, respectively, the Directive 2001/83/EC and the Regulation EEC/2309/93. Thus, the 'Review 2004' has created the new regulatory environment that will be the basis for the marketing authorisation of human medicines in Europe for at least the next decade. The new legislation encompasses provisions related to all aspects of medicinal products for human use, among these are decisive changes with respect to intellectual property. The present master thesis analyses these changes in comparison with the current legislation that will still be in force until the end of 2005. An overview on the present intellectual property regulations is given, with the focus on data exclusivity provisions. Apart from patent protection which is the basic tool to protect innovations data protection can be regarded as the 'second pillar' for this purpose. Data protection becomes especially important in case of long development times and for the protection of innovations related to medicinal products that are already on the market for a considerable period. After mentioning the basic data protection provisions (6/10 years for nationally authorised products and 10 years for centrally authorised products) the specific question of abridged generic applications under the current legislation is discussed, addressing the issue of data protection for line extensions. Those further developments of known drug substances form an important part of the life-cycle of a medicinal product. The ECJ has issued a series of judgements related to this question (C-368/96, C-106/01, C-36/03, and C-74/03) in which a data protection for line extensions of an original medicinal product is rejected. The last part of this overview on the intellectual property provisions mentions the specifics of the market exclusivity granted for Orphan Drugs.
In the second part of the thesis the main provisions related to intellectual property in the new Directive and the new Regulation are summarised. The most important change with respect to patent protection is the introduction of a Roche-Bolar-like clause which significantly facilitates the development of generic medicinal products, which is one of the aims of the new legislation. For data protection, a new 'formula' is introduced (for centrally and nationally authorised medicinal products), the (8 + 2 + 1)-provision, i.e. 8 years of data protection followed by two years of prohibition to market the generic medicinal product, a period that can be extended for another year, if a new indication with significant clinical benefit is developed. Two further data protection incentives are part of Directive 2004/27/EC: a one-year data protection for data on a new indication for a well-established use product and a one-year data protection for the data on a switch from Rx to OTC, both are subject to additional restrictions.
The rejection of a data protection for line extensions of an original medicinal product as expressed by the ECJ has been incorporated in Directive 2004/27/EC with the concept of a 'global' marketing authorisation. The time lines as of which the new regulations apply are given.
In addition, the proposal for a Regulation on medicinal products for the paediatric population (presented by the European Commission in 2004) is mentioned because it will contain important provisions related to intellectual property protection that serve as a strong incentive for the pharmaceutical industry, i.a. here even a data protection for line extensions of existing medicinal products is proposed if they are intended for the paediatric population.
The last part of the thesis briefly discusses possible options for the data protection for the development of known drug substances in this new regulatory environment. It is stressed that the finding of new indications plays an important role for the regulatory strategy, as most extensions of data and market exclusivity under the new legislation are related to new indications or specific patient groups.