Zero Term SPCs: the Dutch decision

The score is now 3:3 for the grant of an SPC for sitagliptin, now that the Netherlands Patent Office (NPO) has decided to grant a zero-term SPC.

For those of you who don't quite master Ruud van Nistelrooy's native language, here is a summary of the key points the NPO argued:

• First, the grounds for refusal included in the SPC regulation appear to be limited.
  
• Secondly from the proposal of the Paediatric Regulation it is clear that the term extension was meant not only as a reward for carrying out mandatory paediatric studies for new marketing authorizations but also as an incentive for companies with existing marketing authorizations to perform such studies. It is repeatedly stated in the proposal that companies will want to develop new formulations, dosage forms and indications for their existing products in order to access the six-month SPC extension (see the references in our decision). Not granting a zero-term SPC would mean that in this case no such incentive exists. That does not seem in line with the purpose of the Paediatric Regulation which is to increase our knowledge on the safety and efficacy of medicines in the paediatric population. Furthermore applicants could also be tempted to delay granting of the marketing authorization in order to qualify for an SPC with a positive duration. Delayed entry of pharmaceuticals onto the market (and available to patients) is obviously not desirable and this is also explicitly stated in the preamble of the Paediatric Regulation (4th recital).

Thanks to Martijn de Lange from the Netherlands Patent Office for informing us on this decision.

SPC Blog seminar

If you aren't able to attend the SPC Blog's seminar tomorrow, but would like to peruse a recording of the talks, please email me here and let me know. Right now it looks as though, subject to the speakers' agreement, we should be able to make a video recording of each of the presentations. The blog also hopes to make the speakers' PowerPoint slides available.

French cases: now we have Bayer too

Last week The SPC Blog posted this item concerning French judicial rulings concerning SPCs, submitted by Florian Leverve. Now John Miles (Potter Clarkson) has kindly sent in both the original French and translated English versions of yet another French decision: Bayer Cropscience AG v INPI, Cour d'appel, 10 September 2003. Thanks, once again, for your efforts to keep the readership of this weblog so well informed.

SPCs and paediatric market exclusivity

Almost two weeks ago, The SPC Blog welcomed Professor Ulrich Gassner as one of its guest team for 2009. The same post carried a link to his recent article, "Ergänzendes Schutzzertifikat und pädiatrische Marktexklusivität" Zeitschrift für Arzneimittelrecht und Arzneimittelpolitik (A&R) 4(2008),269-272. 

This article was published in German but The SPC Blog has now procured, through the kindness of Jeffrey S. Boone, J.D. (Vice President, Intellectual Property, Covidien), an excellent translation of Professor Gassner's article into English. You can read the English version here. The SPC Blog would like to thank both Dr Boone and Professor Gassner for their kindness in creating this translation and allowing its distribution through this weblog.

French SPC decisions

Florian Leverve, a legal researcher at Queen Mary Intellectual Property Research Institute (QMIPRI) and co-author of European Patent Decisions, has sent us the names and URLs of five French SPC decisions, which we reproduce here.  Have we missed any? If so, please email the blog and let us know.  

The cases we know of are these: 

Société Allen et Hanburys c/Société Promedica et société Chiesi Farmaceutici SpA, Cour de Cassation, 24/03/1998 (Supreme Court)

Société Glaxo Operation UK Limited c/ Société Laboratoire Flavelab, Cour d’Appel de Paris 26/03/1999 (Appellate Court)

Sociétés Eli Lilly & Co. c/ Société Flavelab, Cour de Cassation 8/03/2005 (Supreme Court)

Société G Gam c/ Société Pfizer, Cour de Cassation 3/04/2007 (Supreme Court)

Société Chiron c/ INPI, Cour de Cassation 3/04/2007 (Supreme Court)

Hearing fixed for AHP reference

On Thursday 12 February the Second Chamber of the Court of Justice of the European Communities will be hearing arguments in Case C-482/07 AHP Manufacturing BV v Bureau voor de Industriële Eigendom, also operating under the name Octrooicentrum Nederland, a reference for a preliminary ruling from the Rechtbank 's-Gravenhage (Netherlands) lodged on 2 November 2007. The questions referred for a preliminary ruling are as follows:

"1. Does Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as subsequently amended, and more specifically Article 3(1)(c) thereof, preclude the grant of a certificate to the holder of a basic patent for a product for which, at the time of the submission of the application for a certificate, one or more certificates have already been granted to one or more holders of one or more other basic patents?

2. Does Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, as subsequently amended, and more specifically recital 17 and the second sentence of Article 3(2) thereof, give rise to a different answer to Question 1?

3. When answering the previous questions, is it relevant whether the last application submitted, like the previous application or applications, is submitted within the period prescribed by Article 7(1) of Regulation (EEC) No 1768/92 or that prescribed by Article 7(2) of Regulation (EEC) No 1768/92?

4. When answering the previous questions, is it relevant whether the period of protection afforded by the grant of a certificate pursuant to Article 13 of Regulation (EEC) No 1768/92 expires at the same time as, or at a later time than, under one or more certificates already granted for the product concerned?

5. When answering the previous questions, is it relevant that Regulation (EEC) No 1768/92 does not specify the period within which the competent authority, as referred to in Article 9(1) of that Regulation, must process the application for a certificate and ultimately grant a certificate, as a result of which a difference in the speed with which the authorities concerned in the Member States process applications may lead to differences between them as to the possibility of a certificate being granted?"

Gilead article just published in BioSLR

"Extension granted: Gilead obtains its SPC for Combination Antiretrovirals" is the name of the atricle by Jonathan Ball (Norton Rose) which has just been published in vol.9, issue 5, of the Bioscience Law Review. 

This journal, published six times a year by Lawtext, welcomes articles and case notes on all areas of bioscience law and practice, including supplementary protection certificates. You can read Jonathan Ball's note in full by clicking here.

European Commission Pharma Sector Inquiry - Preliminary Report

As most SPC Blog readers will be aware, a year ago, the European Commission kicked off 2008 by launching a sector inquiry into EU pharmaceutical markets under EC competition rules because information relating to innovative and generic medicines suggested that competition in the sector may be restricted or distorted. Some of the things that appear to have motivated the Commission in this endeavour was the apparent decline in innovation (measured by the declining number of new medicines reaching the market - as if producing medicines was an easy task...) as well as the delayed market entry of generic drugs. The preliminary report is out and and all 426 pages of it can be accessed here.

A whole section is devoted to SPCs (paragraphs 245-249), and includes a few words to the Commission's finding that AstraZeneca abused its dominant position by using a later date of marketing authorization (Appeal ongoing).

SPCs are also mentioned briefly under the section on Community Authorisations (paragraph 260), in conjuction with, interestingly, the only mention in the report of the so-called Bolar provision.

The final report is due out in Spring 2009.

Welcome to a guest blogger for 2009

Some of our more observant readers will have noted that this year we have already introduced two Guest Bloggers for the year 2009 (we hope to announce a third soon). This post gives us an opportunity to introduce one of them, Professor Dr Ulrich Gassner. Professor of Public Law in the University of Augsburg's Faculty of Law, he is also Co-Founder-Director of the Institute of Bio Law, Health Law and Medicine Law and Founder-Director of the Institute of Medical Devices Law. Aside from his academic responsibilities he is also Senior European Consultant to law firm Bird & Bird's Munich office.

Professor Gassner is the author of an article on SPCs, "Ergänzendes Schutzzertifikat und pädiatrische Marktexklusivität" A&R 4(2008),269-272.  This article was published last year in Arzneimittel & Recht, Zeitschrift für Arzneimittelrecht und Arzneimittelpolitik (A&R), published by Wissenschaftliche Verlagsgesellschaft mbH (WVG), Birkenwaldstraße 44, 70191 Stuttgart, Germany. The author and publisher have both kindly agreed to the SPC Blog making this article available for the benefit of its readers: you can download it here.

SPC Blog seminar -- a reminder

Just a quick reminder -- if you've not yet registered to attend The SPC Blog seminar, which is coming up on the afternoon of Wednesday 28 January (not Thursday 29), is being hosted by law firm Olswang in its London office. Remarkably, 60 people have registered so far, drawn from the pharma and agrochemical sectors, private practice and academe. We wonder when was the last time that so many people, drawn together by a shared interest in SPCs, will have spent so much time in each other's company in pursuit of a greater understanding of the issues and solutions.

Full details of the programme can be found here; if you'd like to attend but haven't yet said so, you can still RSVP Natalie Smith here.

Sweden: short and sweet

The Swedish Patent and Registration Office (PRV) boasts a bright, efficiently organised bilingual website in Swedish and English. 

Information on SPCs is a little hard to locate, since it's not visible from the site-map, but the operative page has this to say:

 "Background information on supplementary protection for pharmaceuticals

The period of patent protection for inventions is 20 years, from the date of filing for the patent application. However, in the case of patents for pharmaceuticals, the period of protection may be extended by a maximum of 5 years. Any such extension of the period of protection is granted under a Supplementary Protection Certificate (SPC). This protection covers the active compound or compounds that constitute or form part of a pharmaceutical approved in accordance with the EU regulation that applies in Sweden. The period of SPC is calculated from the date of first approval of the pharmaceutical for sale in the EEA and the date of filing of the patent application. The SPC period begins when the period of validity for the patent expires. You can also be granted supplementary protection for plant protection products in the same way as for pharmaceuticals".

A table of SPC-related fees is provided on the Fees page.

Tour of Patent Offices - Germany

For the first posting in 2009, the SPC blog decided it was time to check out the scene in Germany.

Information about patent applications, patents, including status can be obtained from the register website of the German Patent Office (here, https://dpinfo.dpma.de/). Although there is an English language search mask, the results are posted in German. You can however click to a table containing a translation of the terms listed in the search results. The site may be rather slow during peak usage times and refuse to run your search.

The site does provide information on whether an SPC application was filed, but unfortunately, no information on the status of the SPCs can be obtained.

For those interested in reading up on German SPC case law, the website of the German Patent and Trade Mark Court is your place to look (that is, if you want it for free). You can search cases from 2003 onwards by date, case number and term. But a word of warning, you'll have to brush up your German because there isn't an English language site. If the case has gone up to the Federal Supreme Court, you can check out the pages of the Bundesgerichtshof for cases back to 2000. Here again, the site's in German.

Hopefully, short summaries of future cases will be published here in English, for those that don't have a grasp of the lovely language of Goethe.