SPCS on the syllabus and in print

Two snippets of news:

1. This blog thought it might be handy to compile a list of institutions that include SPCs within the purview of their patent law syllabuses (see previous post). First to respond is our friend and correspondent Professor Ulrich M. Gassner, who together with two colleagues, teaches a specialised course at the Munich Intellectual Property Law Center (MIPLC) under the title of "Pharmaceuticals and IP". This course also covers SPCs, though Professor Gassner informs us that the infomation on the center's website is somewhat outdated. Phillip Johnson has also reported that SPCs are covered on the Queen Mary (University of London) MSc course from this academic year, as well as on Professor Johanna Gibson's IP Aspects of Medicine course at the same institution.


2. This blog recently asked for information about features on Supplementary Protection Certificates. It has learned that Patent World has commissioned a piece that will appear in its February 2009 issue. Written by some lawyers from Howrey LLP, it is entitled "SPCs - is the law any clearer?" and will compare three jurisdictions: UK, Germany and the Netherlands.

SPCs on the syllabus

This blog notes with pleasure that Supplementary Protection Certificates are part of the Patent Law syllabus taught by Irish barrister Glen Gibbons, whose IP Law Ireland law blog has just come to my attention. Since patent law is a difficult subject and SPCs are regarded as a fringe element of it, not all courses cover it -- so well done Glen. Frustratingly, the blog does not state the institution in which this course is offered.

If readers are sufficiently interested, this blog will seek to compile a list of institutions that do cover SPCs in their intellectual property syllabuses.

SPCs -- Current Litigation Issues

This blog is one of the sponsors of C5's forthcoming conference on Pharma & Bio Patent Litigation, 17-18 February 2009 in Amsterdam (full details and booking form available here). One of the speakers is Duncan Curley (Innovate Legal), who will be reviewing current litigation issues involving SPCs. Guesting for the blog this morning, Duncan gives a foretaste of his talk:

"As readers of this blog will know, the active pharmaceutical ingredient (API) in many blockbuster drug products will usually have been discovered and patented a long time before the highly profitable years of peak sales. SPCs can prolong these “golden years” with a period of extra legal exclusivity, based upon the extension of a patent monopoly that must be designated in the application for a SPC.

Most small molecule APIs that are now being targeted for generic competition in Europe will have been subject to protection by a SPC at some point. When an API is protected by a claim in the basic patent to the chemical compound itself, the criteria for the grant of a SPC are often easy to fulfil and there will usually be little scope for an attack on the validity of a certificate.

Drug discovery programmes have changed considerably since 1993, when SPCs first became available. In recent years, pharmaceutical companies have focused more on the development of new forms of drug administration to the patient population, including reformulations of existing drugs, combination therapies (including co-administration of two or more drugs), optimised dosage regimes and novel drug delivery systems. Companies have sought patent protection for these innovations. In some cases they have applied for SPCs, but these applications may not always be as straightforward as SPCs based on patent claims covering simple, small molecule APIs. For example, the Gilead Sciences case (here) earlier this year concerned an appeal from the rejection by the UK IPO of a certificate for the combination product Truvada®. In the Yissum case (here), the patent claims were for a new use of an old API, calcitriol – and the application for a certificate was rejected.

Generic drug producers recognise the weaknesses in the existing system for the grant of certificates and SPCs are now becoming an increasing focus of litigation in the pharma and biotech sectors. We have just seen another legal challenge to the validity of a certificate in the levofloxacin decision of the Patents Court - and there are other cases in the pipeline. The growing trend of generic industry attacks on SPCs and many other burning legal issues will be explored in detail at the C5 Pharma & Bio Patent Litigation conference - sponsored by The SPC Blog - in Amsterdam, next February".

Another SPC article ...

"Changes in supplementary protection certificates can mean a difference of millions of euros per month for the value of pharmaceutical products", say Dr Martin Huenges and Dr Dirk Bühler of Maiwald. This is how Managing Intellectual Property introduced the authors' article "Patent term extensions", which appeared in that journal's April issue.

The SPC Blog is pleased to have received permission from the journal to make this article available to its readers. You can download it by clicking here.

Italia and the Certificati Complementari di Protezione

The tour of European countries with SPCs continues. this time reaching Italy: the country with the exceptionally long SPCs which are still alive and well.

Right: Italy leading the pack

As most seasoned readers will be aware, the Certificati Complementari di Protezione (CCP) were introduced in Italy first via Italian law by law number 349/91 (October 1991), and were subsequently replaced by European Regulation 1768/92 (2 January 1993).

The intial Italian CCPs provided for a maximum duration of protection of a whopping 18 years from the date on which the patent reaches the end of its life. It is estimated that between October 1991 and January 1993 roughly 400 active compounds received CCP protection and roughly 190 are still in force. The last CCPs are expected to expire in 2011. Omeprazole still appears to benefit from a CCP (which is set to expire in 2010).

Information on deposited and granted SPCs can be obtained from this website on the website of the Italian Patent Office, unfortunately all in Italian.

Managing generic competition and patent strategies

In April of this year the Journal of Intellectual Property Law and Practice (JIPLP) published an article, "Managing generic competition and patent strategies in the pharmaceutical industry", written by the three-man team of Brian Whitehead, Stuart Jackson and Richard Kempner (all of Addleshaw Goddard). Since one of the issues it addresses is that of SPCs, The SPC Blog has sought to make it available to its readership. Thanks to JIPLP's publishers, Oxford University Press, and thanks also to the authors, you can access the article in full here.

If readers can identify further articles, conference papers and other items of relevance to SPCs -- in any language -- this blog will be very pleased to make mention of them and will be pleased to seek the necessary copyright permissions in order to bring this about.

Literature on SPCs

Back in September I asked readers of The SPC Blog if they could recommend any good reading on the commercial and economic aspects of supplementary protection certificates. There hasn't been much of a response as yet, though I've been sent copies of two short articles by Mike Snodin and John Miles of (formerly Eric) Potter Clarkson. Both pieces are published in RAJ Pharma and they share the same title: "Making the Most of Paediatric SPC Extensions".

* The July 2007 article (RAJ Pharma, 18(7), 459-463, (2007)) discusses three possible models for calculating the term of "extended" SPCs. Two of the three models involve the new concept of applying for SPCs that, without the six-month extension, would have no term (or even a negative term). The authors add:

"The conclusions that we reach could have a significant impact upon strategies for product lifecycle management. ... [I]f paediatric trials are to be conducted on a product, then it may always be worth applying for an SPC, even if fewer than five years have elapsed between patent filing and the grant of the marketing authorisation".

* The June 2008 article (RAJ Pharma, 19(6), 387-388, (2008)) is a two-page note on a UK IPO decision on whether it is possible to obtain a zero or negative-term SPC in order to base a paediatric extension on it (see the earlier SPC Blog post here). The authors conclude:

"It remains to be seen whether it will be possible to persuade a patent office (or a national court or the European Court of Justice) to accept a calculation of extended SPC term".

The first article can be accessed here; the second article can be accessed here. Many thanks, Mike and John, for letting us know about these.

More on Switzerland

The SPC Blog welcomes this contribution from Professor Ulrich M. Gassner, which builds on the blog's earlier posting on SPCs in Switzerland. Professor Gassner is attached to the Institute of Medical Devices Law in the University of Augsburg's Faculty of Law. You can contact him by email here. Writes Professor Gassner:

"Being neither an EU member nor an EEA country, Switzerland has set up its own SPC legislation. It is deliberately modelled on the EC Regulations in order to keep pace with the EC standards of protecting innovative products and research activities.

Consequently Swiss Patent Law provides inter alia for the same duration of the certificate. The only big difference is that the certificate may be granted only if a marketing authorization of the product in Switzerland has been issued. A first authorization in the EU does not count in this respect. Apart from that, there are no significant differences between the mode of operation of SPCs in Switzerland and in the jurisdictions that belong to the EU.

Note that the content of the notice on the website of theSwiss Federal Institute of Intellectual Property (IGE), available only in German, is also laid down in Article 140c para 3 of the Swiss Patent Act."

February conference: more news

Last month this blog announced the forthcoming Pharma/Biotech Patent Litigation Conference in Amsterdam next February. Because this blog is a sponsor, readers are entitled to a 10% discount on the booking fee. The colour version brochure of the programme is now available here, for anyone interested.

Duncan Curley (Innovate Legal), who will be speaking on "Analysing the Growing Trend of Generic Industry Attacks on SPCs" in this event, has promised to write a short piece for The SPC Blog on his current thoughts on the subject -- so watch this space.

While on the subject of this conference, there's a competition for which the prize is FREE REGISTRATION (see the earlier blog for rules and deadline). Entry involves submitting your best cocktail recipe. So far, very few entries have been received. Don't be shy: you can either send it to The SPC Blog or directly to me here.