"Legal context: Fifteen years after the Council Regulation concerning the creation of a supplementary protection certificate for medicinal products came into force, this article underlines the main goals of its adoption.The SPC Blog is asking the publisher to let it have a PDF of this article for the benefit of the blog's readers. If this request is successful, the PDF will be posted as soon as possible.
Key points: In an international context characterized by a constant increase of costs of research and development, this Regulation was destined to foster pharmaceutical innovation by providing industry with exclusive rights over its inventions, after the end of the general patent protection term. Concerned with the needs of innovative companies, the Community authorities nonetheless desired to preserve the interests of low-income consumers, seeking the swift commercialization of cost-effective drugs.
Practical significance: Reviewing the legislative aims and relevant case law, this paper demonstrates that the European Union was willing to promote pharmaceutical innovation while ensuring the generic industry's general development. It shows that the Regulation can be seen as an illustration of the European model of pharmaceutical law, continually striving to reconcile conflicting imperatives such as the protection of public health and the preservation of economic competitiveness".
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
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"... The Israeli Patent office recently refused H. Lundbeck's application to extend the term of its Israeli patent, covering its blockbuster drug Cipralex® whose active pharmaceutical ingredient is the single (S)-enantiomer (escitalopram) of the racemate Citalopram. The refusal was based on the Israeli Registrar's conclusion that the first registration of a drug containing escitalopram by the Israeli Ministry of Health was the previous registration of the racemate (Citalopram, marketed as Cipramil®)".The newsletter article then goes on to analyse the Patent Office decision which, it concludes, was erroneous.