Public health and the preservation of competitiveness: the role of the SPC

"Public health and the preservation of economic competitiveness: the European supplementary protection certificate for medicinal products" is the title of an article by Diane Delcourt (Doctor in Law, Université Paul Cézanne, Aix-en-Provence, France), which is published in the June 2009 issue of the Journal of Intellectual Property Law and Practice (JIPLP, published monthly by Oxford University Press and edited by the author of this post). According to the abstract, the article runs along the following lines:

"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.

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".

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.

SPCs in the Black Book

The CIPA Guide to the Patents Acts (aka the Black Book) is a substantial reference manual for anyone dealing with UK patent law, providing the statutory provisions followed by detailed commentary of the case law.

Recently the latest edition of the book, edited by Stephen Jones and Paul Cole, was published. Section 128 A, which is devoted to supplementary protection certificates, was updated and contains an excellent discussion of the issues and UK and ECJ cases on SPCs until late 2008. Tasty topics include: Conditions for obtaining a SPC, definition of "product" for which a SPC can be granted, definition of "basic patent" upon which a SPC can be granted, duration and entitlement, among others.

CIPA Guide to the Patents Acts, 6th Edition, Chartered Institute of Patent Attorneys, ccxiii, 1468 pp, 23 March 2009, Sweet & Maxwell, ISBN: 9780421957404

Enfin possible! Patent and SPC status searches on the INPI website

The Institut National de la Propriété Industrielle (INPI, aka the French Patent Office) recently launched its new patent and SPC information search site- accessible here. And it's free.

You can search by patent (or SPC) publication number for the current status or status history of the patent or SPC application or the granted patent or SPC in France. One nice thing is that if there is an SPC associated with your patent, then its status will be displayed along with that of the patent automatically.

En Anglais? Well, that would be asking too much so you'll have to brush up on your français.

Triptorelin - a salty case

The SPC Blog has come across another decision of the German Federal Patent Court relating to the granting (or refusal to grant) of an SPC on salts of active ingredients - in essence no SPC for a formulation of a salt of an active ingredient if a previous marketing authorisation already exists for a different salt of the active ingredient.

In the case in question, the patent owner applied for an SPC for the peptidic product Triptorelin (as the pamoate salt) based on basic German patent DE3822459 and the marketing authorisation for Triptolrelin Pamoat Dibioclinic 11,25 mg, granted on 16 March 2004. The German Patent and Trademark Office (GPTO) refused the application on the basis that the marketing authorisation cited was not the first marketing authorisation for the peptidic active ingredient. There existed a previous marketing authorisation to the Triptorelin, but for the acetate salt.

The applicant appealed this decision at the German Federal Patent Court (GFPC), arguing that since the different salts have different properties, especially in terms of their solubilities, the marketing authorisations were for different actives.

The GFPC considered that Triptorelin pamoate was not a new product in comparison with Triptorelin acetate, making the marketing authorisation for Triptorelin acetate the first marketing authorisation for the product. An SPC can therefore not be granted because the requirement of Art. 3(d) of Regulation 1768/92 are not satisfied. In a final note, the court mentioned that even if an SPC may be issued for a different salt of an active ingredient according to recital 14 of Regulation 1610/96 (applied to Regulation 1768/92 according to recital 17 of Regulation 1610/96), the requirements of Art. 3 of Regulation 1768/92 still need to be satsified in order for an SPC to be granted for that different salt.

Israel refuses escitalopram SPC

In April the SPC Blog published news of the invalidity of Lundbeck's escitalopram patent and SPC in the Netherlands (see also IPKat post here). Now, via Jeffrey Boone (Covidien), comes information of the fate of escitalopram in Israel, thanks to a newsletter article by the Reinhold Cohn Group. According to that firm,

"... 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.