Forthcoming event with SPC content

Belgian patent attorney firm De Clercq Brants & Partners is organizing a one-day seminar on 14 November 2008 on "Patent Warming, Patent Warning? Patenting Life Sciences and Today’s Challenges in Patent Law and Practice”. Speakers in what is a very stimulating programme include Christophe Ronse (Altius), who is discussing the enforcement of pharmaceutical patents in Belgium and giving an update of SPC case law.

Full details of the seminar programme and registration form are available here. Bookings should be made before 31 October 2008, if possible.

Commercial and economic literature on patent term extension

While there is quite a lot of accessible literature on the legal requirements that govern the extension of the duration of the patent monopoly, I've had less luck finding current and readable material on the commercial and economic impact of patent term extension, whether in Europe's SPC zone or outside it.

In order to build up a useful reading list, I am again asking readers of this blog if they can make any recommendations -- whether articles, chapters of books, websites or anything else. All recommendations will of course be shared with readers of The SPC Blog. Please email The SPC Blog here.

BioScience Forum SPC PowerPoints

In an earlier post ("SPCs: a hot topic for the BIA") this blog mentioned the then-forthcoming Annual BioScience Forum of the BioIndustry Association (BIA), which takes place today in Central London. One of the intellectual property "hot topics" is SPCs.

I have in my possession the PowerPoint presentation that accompanies the talk, which is given by Michael Burdon. If anyone would like to receive a copy of the PowerPoints, can he or she just email me here.

SPCs in Switzerland

The Swiss Patent Office (the IGE) has information on its website in its three official working languages -- French, German and Italian -- as well as English. The page providing information on SPCs, last updated in June of this year, summarises the need for supplementary patent protection quite succinctly:

"Patented inventions for medicines (pharmaceuticals) and pesticides require federal approval before they can be put on the market (Swissmedic, BVet, BLW). Since it can take up to ten years to finally get federal approval, and the time limit of the patent protection is running, a supplementary certificate of protection can be requested".

Curiously, the multilingual nature of the site is not maintained to a uniform standard. The form for requesting a Supplementary Protection Certificate is available only in German and French versions and a notice concerning changes in procedure is available only in German.

SPCs in Hungary

A selection of Hungarian legal materials, translated into English, can be obtained from the SPC page of the Hungarian Patent Office, as well as the English languages texts of the relevant EU legislation.

Provisions of Hungarian law supplied here are as follows:

* Article 22/A of Act XXXIII of 1995 on the protection of inventions by patents;
* Decree No. 19/2005. (IV. 12.) GKM on the Fees for Administrative Services in Industrial Property Procedures before the Hungarian Patent Office;
* Decree No. 26/2004 (II. 26.) Korm. on the rules necessary for the implementation of the European Community Regulations concerning the creation of a supplementary protection for certain products;
* Government Decree 26/2004. (II. 26.)

Again, the site does not appear to carry any explanation as to what exactly an SPC is, why one should need them or what are the reasons for its conditions and limitations.

SPCs in Slovenia

The SPC Blog is proposing to make occasional visits to the websites of the European Union's patent-granting authorities in order to see what information they have on supplementary protection certificates. Today we start with the website of the Republic of Slovenia's Intellectual Property Office (SIPO).

The SIPO site provides an English-language option that embraces all IP rights; there is a dedicated webpage for SPC law and practice, which also lists the current filing fee (420 euro). The forms available include a pdf form, in Slovenian and English, for the authorisation of a local representative when making an SPC application. There is little in the way of general information concerning SPCs. Thus the FAQs on the SPC page relate to patents in general rather than to SPCs, their strengths, weaknesses or degree of use.

IPI report on SPCs: special offer

Last winter the Intellectual Property Institute, London, published Extending Rewards for Innovative Drug Development - A Report on Supplementary Certificates for Pharmaceutical Products. According to the Institute:

"This report contains an analysis of the impact of Supplementary Protection Certificates for medicinal products since their introduction in 1993. In particular, it assesses whether SPCs are still "fit for purpose" for the modern pharmaceutical industry. The Report contains a discussion of the aims of the SPC regime for medicinal products. Some of the significant cases for the drug development industry are placed in context, including the recent MIT/Gliadel and Yissum decisions and there is an overview of the new six month paediatric extensions for SPCs. The Report concludes with an assessment of the effect of SPCs on incentives to invest in pharmaceutical R&D".

This report, specially prepared for the Institute by Duncan Curley, can be purchased directly from it in one of two formats: as a pdf version at £30 or in hard copy format at £48.

Following a request from the SPC Blog, the Institute has kindly agreed to make both the hard copy of this report and the pdf version available to SPC Blog readers at a handsome reduction, i.e. at £24 (in the case of hard copies, that's £24 plus P&P). If you would like to take advantage of this offer, email Anne Goldstein here and quote the special offer code "THESPCBLOG".

New Irish SPC Regulations enacted

Last month a new set of SPC regulations was enacted in the Republic of Ireland, the European Communities (Supplementary Certificate) Regulations SI 307 of 2008. Notice of the making of these new regulations was published in the Iris Oifigiuil--the official journal-- on 8 August 2008. These regulations lay down the fees (95 euro in each case) and procedural requirements which apply to requests for SPCs, to requests for extensions of the duration of SPCS, to certificates granted and to extensions of the duration of certificates granted. They give full effect to Council Regulation 1768/92, Regulation 1610/96 and Regulation 1901/2006 with effect from 26 July 2008. There is no explicit provision for the electronic filing of requests for SPCs or extensions of certificates.

For the record, these regulations revoke the earlier Statutory Instrument No. 125 of 1993. They provide that a certificate issued under the 1993 Regulations and in force immediately before these regulations entered into force will continue to operate as if it were a certificate under these regulations.

Italian SPCs

Our attention was drawn this week to an article in the June 2008 issue of EPI Information, the journal of the Institute of Professional Representatives before the European Patent Office.

In this issue, F. de Benedetti of Italy reports the passing of a bill in the Italian Parliament which clarifies the calculation of the six month annual reduction of the term of SPCs applied for in Italy before 2 January 1993.

Prior to the harmonization of SPC regulations in Europe by Council Regulation 1768/92, Italy enacted its own SPC scheme: the duration of the certificate was equal to the period between filing the patent application and the date of first marketing authorization in Italy as long as this term did not exceed 18 years after the end of the lawful term of the patent. Moreover, this term was to begin on the date of marketing authorization. This patentee friendly scheme was changed in 2002 when a new law was enacted that provided for an annual six month reduction to the term of these pre-1992 SPCs. It however remained unclear how to calculate the term reduction when the remaining term was less than one year.

On 23 February 2008 the Italian Parliament passed a bill containing a provision to clarify calculation of this term reduction. This provision calls for the reduction to be applied to the last year. For example, should the last year's remaining term be less than 6 months, the SPC would expire on 31 December of the previous year. Should the remaining term be more than 6 months, then it will be reduced by 6 months.

According to Mr. de Benedetti, although this provision clarifies an important point of law, there are other points which still remain unclear:

A small number of said SPCs were not yet in force in 2004, when the system
reducing the term by 6 months for each calendar year started to be
applied. It remains to be seen for these cases, whether the subtraction of
6 months should count in any case from the year 2004 or from the year when, upon
the patents expiry, the SPC entered into force.

The SPC blog would be interested in getting a rough estimate of how many SPCs with abnormally long terms are still lurking around in Italy…