Record of IP Institute's meeting on Paediatric Extensions now available

As you may recall, last year, the IP institute held an informal meeting for patent offices, health authorities and industry to discuss the issue of paediatric extensions (see our posting here). A record of the meeting can now be obtained on the IP Institute's website, here.

Thank you to Martijn de Lange for pointing this out.

Paediatric extensions: another article

The April 2010 issue of Sweet & Maxwell's monthly European Intellectual Property Review (EIPR) contains an article by Dr Ulrich Reese, Dr Claudia Milbradt and Dr Christian Stallberg (Clifford Chance, Dusseldorf) entitled "The Legal Scope and Content of the Right to SPC Extension under the Paediatric Regulation 1901/2006".

This piece is based on a position paper prepared on behalf of the German Association of Research-Based Pharmaceutical Companies (vfa). The authors explain the objectives of the Regulation and seek to clarify the conditions under which such an extension must be granted.

SPC on the basis of an MA for active implantable medical devices

Thanks to Matthias Kindler and Bianca-Lucia Vos (Hoffmann Eitle) for providing the following summary of a recent decision on SPCs for medical devices:

"The German FPC has issued a decision on SPC application 12 2005 000 052 in the name of the Curators of the University of Missouri. The SPC is for “yttrium-90 glass microspheres” and the application had been rejected by the GPTO because the application referred to EC Certificates CE 500 749 and CE 501 532 for the product “TheraSphere(R) yttrium-90 glass microspheres” as relevant MAs. The EC certificates were issued by BSI Product Services according to Council Directive 90/385/EEC relating to active implantable medical devices. The GPTO based the rejection on the ground that only medicinal products and not medical devices were authorized by the legislators as the basis for an SPC.

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). "

A copy of the German decision can be obtained here, and an english translation here.

SPCs and RDP compared

The SPC Blog has just spotted a recent general interest article, "The Supplementary Protection Certificate for Medicinal Products: An Update", written by Carla Schoonderbeek (NautaDutilh) for Who's Who Legal. The article contrasts SPC protection and paediatric extensions with Regulatory Data Protection (RDP) and concludes:

"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".

UK medicines fees change from 1 April

The Medicines (Products for Human Use) (Fees) Regulations 2010, 2010 No. 551, were laid before the British Parliament yesterday and, assuming nothing goes wrong, will become law on 1 April. These Regulations revoke and re-enact in consolidated form, with some amendments, the Medicines (Products for Human Use) (Fees) Regulations 2009 as amended by the Medicines (Products for Human Use) (Amendments relating to Fees for Variations) Regulations 2009 and govern the fees payable under the Medicines Act 1971 and other fees payable in respect of EU obligations relating to marketing authorizations, licences and certificates in respect of medicinal products for human use.

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 ...

Recent articles

"Attacks on Supplementary Protection Certificates" is the title of a challenging piece in the March 2010 issue of Patent World, published ten times a year by Informa. The authors are Hiroshi Sheraton and Andrew Sharples (McDermott Will & Emery), who conclude

"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".

You can see the contents of the current issue of Patent World here.

"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.

Partial Translation of German Sitagliptin Referral

Thanks to Klemens Stratmann (Hoffmann Eitle) for kindly providing a partial translation (here) of the recent German referral on Sitagliptin to the Court of Justice.

New note on DuPont application for losartan

A Current Intelligence note on EI Du Pont Nemours & Co. v United Kingdom Intellectual Property Office [2009] EWCA Civ 966, 17 September 2009, by Sebastian Moore and Jonathan Turnbull (Herbert Smith) and entitled "Paediatric extension applications: substance and timing" appears in the current issue of the Journal of Intellectual Property Law and Practice (JIPLP). You can read this note in full on JIPLP's weblog here.

Summary of the January 2010 SPC Seminar

If you weren't able to make it to the SPC Blog's 2010 seminar, or can't remember all the topics covered, you can now download a summary of the event here. Thanks to John Miles (Potter Clarkson) for reviewing it for accuracy.