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
Sunday, 21 March 2010
Thursday, 18 March 2010
Tuesday, 16 March 2010
The German FPC overturned the decision of the GPTO. They found that under the specific circumstances of the present case the certificates CE 500 749 and CE 501 532 are to be considered as certificates granted analogously to Directive 65/65/EEC (now replaced by 2001/83/EC in the version of Directive 2004/27/EC). "
Sunday, 14 March 2010
"The SPC has proven an effective instrument in protecting innovation for medicinal products. The most important difference with the instrument of RDP is the duration of the protection. Both RDP and SPC use the first marketing authorisation date as the starting point for the protection period, but RDP is limited to 10 or 11 years, and an SPC can stay valid until 15 years have elapsed.
A disadvantage of both SPC and RDP is that both use the first original marketing authorisation for a specific medicinal product as the basis for protection. The major importance of incremental development of medicinal products after their first marketing is not recognised by either protection mechanism. This may lead to ‘orphaning’ of medicinal products, which could have been extremely useful for different applications other than the one they were originally authorised for, because it is difficult for industry to invest in know-how that will not lead to additional returns".
Friday, 5 March 2010
The fees prescribed in the Regulations are revised on an annual basis following consultation and are based on an assessment of the costs associated with the functions in association with which fees are charged.
You might be forgiven for not spotting it, but there's a tiny reference to paediatric extensions and supplementary protection certificates hidden away in paragraph 10(4) of Schedule V ("Waiver, Reduction or Refund of Capital Fees"). You can spend the first half of your weekend looking for it and the second half wondering what it all means ...
Thursday, 4 March 2010
"The extreme complexities of the legal system underpinning the grant and validity of SPCs is highlighted by the wealth of case law originating from appeals from national patent offices. Those complexities, and the commercial importance of rights afforded by SPCs, are also giving rise to an increased number of disputes in which the validity of SPCs are being challenged independently of the validity of the underlying patent and that trend is likely to continue".
"Pediatric Exclusivities in Europe -- a Quest for the Grail?", an article by Geneviève Michaux (of Counsel. Covington & Burling LLC, Brussels, Belgium), originally published in 64 Food and Drug Law Journal, 631-662 (2009), has now been republished in issue 1 (2010) of the respected Intellectual Property Quarterly (IPQ), a journal which is associated with the Intellectual Property Institute, London. For the abstract of this article (nb the IPQ does not publish abstracts) click here.