Belgian SPC Case

Last November, the Brussels Court of First Instance handed down a decision on the scope of protection conferred by SPCs. The case relates to a vinorelbine tartrate SPC and whether or not the scope of protection conferred by an SPC extends to the use of an active ingredient as such before it is transformed into a medicinal product.

In the case, the defendant,

O is a company that manufactures vinorelbine ditartrate in Belgium in its raw form for export purposes. The substance produced was sold to a company in the United States, which used it to manufacture and market a medicinal product whose therapeutic indication was identical to that for the drug produced by the exclusive licensee of the vinorelbine ditartrate patent, F.

The patent owner, C, and the exclusive licensee, F, pleaded

on the basis of the legislative history to Regulation 1768/92, that the terms “for any use of the product as a medicinal product ” are solely aimed at excluding from the scope of protection of the SPC such uses as do not fall within the pharmaceutical field. These terms therefore have to be construed in their broad sense as covering any use covered by the marketing authorization where what is ultimately concerned is the manufacture of a medicinal product.

The court followed this argument: the protection conferred by article 4 covers not only any use in a medicinal product (finished product), but also any use of the product covered by the patent (active ingredient) where that is destined for use as a medicinal product. The court briefly stated the reasons for its decision as being that the patented product is essential to manufacture of the medicinal product.

O also argued that the words “use of the product as a medicinal product” necessarily mean that the patented product (active ingredient) must be used as a medicinal product in the territory of Belgium for there to be an infringement, because the scope of the Belgian SPC is limited to that territory. According to that interpretation, there is no infringement in Belgium when all one does is manufacture the active ingredient and export it to the United States where it is transformed into a medicinal product.

C and F argued to the contrary that it is sufficient for there to be infringement that O should have manufactured the active ingredient in Belgium, even if for export purposes. In support of this interpretation, they made reference a contrario to EC Regulation 816/2006 which states that manufacture of an active ingredient protected by an SPC in state A with the sole aim of exporting it to state B with public health problems must be accorded a compulsory license. According to them, this regulation confirms that the patent-holder’s consent is necessary for any manufacture of the active ingredient, even if it is manufactured only for export purposes.

After stating very succinct reasoning on this point as well, the court followed the latter interpretation. It pointed out that the manufacture and offering for sale of a product protected by intellectual property rights are regarded as illicit acts and concluded that, for there to be infringement, it is sufficient for a protected product to be manufactured and sold in Belgium and be used in the manufacture of the medicinal product.

Thanks to Fernand de Visscher and Benjamin Docquir at Simont Braun for providing this information. Note: the decision is not yet published.

First paediatric extension application filed in Denmark

In October 2008 the first application for extension of a supplementary protection certificate under Regulation 1901/2006 on Medicinal Products for Paediatric Use was filed in Denmark. The filing took place before the Danish Patent and Trade Mark Office had even issued a request form and formal guidelines regarding supplementary protection for medicinal products for paediatric use, but it was still in accordance with the amended patent regulations that entered into force on 1 May 2008. In addition, the filing took place before the Danish Agency for Governmental Management had approved the official fee for such types of application. 

[Source: note by Casper Struve and Ellen Wetke (Zacco) for Intellectual Asset Management magazine].

Narrower than requested - more cases?

The SPC Blog has received another question from a reader:

"Is anyone aware of any other cases in Europe other than the Flufacenet case in France and the Sumatriptan case in Germany relating to the national patent offices granting SPCs with narrower product descriptions than the applicant requested, and where the patent office was then asked to re-examine the case? Moreover, does someone have an English translation of the Sumatriptan case that can be shared?"

If anyone has knowledge about other cases, please post your information as a comment below.

Two quick questions

The SPC Blog has received two questions from readers. Can you help them?

1. "Are the travaux préparatoires for the SPC Regulation available online -- I've tried finding them on the European Commission's website but have had no luck so far".

2. "Does anyone know whether patent extensions were ever considered for medical devices? And why were they not included within the SPC provisions?"

If you have anything to offer, can you please post your information as a Comment below.

SPC seminar sound-track now available

The sound file containing the various papers delivered at the SPC Blog seminar last month turned out to be vast -- too big by far for hosting on the Google Group server that hosts the blog's email subscription. Olswang has agreed to host it here for the time being, though (thanks!). 

Sitagliptin - NL - negative term

The SPC Blog recently reported the Netherland Patent Office's positive decision to grant an SPC for Sitagliptin. On that occasion, the Blog noted that a zero-term SPC was granted. However, after a more detailed look at the register (and the decision - the Blog isn't fluent in Dutch), it appears that the Netherland Patent Office granted an negative term SPC. So the score is now 2:3:1 (negative term SPC - UK and NL; rejected - PT, SI, DE; zero term SPC - GR) .

Let's see how the other patent offices decide.

Get your paperwork in order, Merck told

The SPC Blog has just received news of Lawrence Cullen's decision last week in Merck & Co., Inc's application, Case O/035/09, 6 February 2009. 

In short, this was an application for an extension to the duration of granted a granted supplementary protection certificate, SPC/GB/02/002. The active ingredient for which the SPC was granted was Caspofungin, an antifungal agent for human use which Merck marketed as Cancidas. This application was made under Article 7 of Regulation 1768/92 to obtain the reward provided under Article 36(1) of Regulation 1901/2006 for completing studies on medicinal products in the paediatric population. 

The preliminary view of the examiner was that this application did not meet the requirements of Article 8(1)(d)(i) of Regulation 1768/92 since it did not include a copy of the statement of compliance with an agreed completed paediatric investigation plan, as referred to in Article 36(1) of EC Regulation 1901/2006. This view was upheld by the Hearing Officer, who considered the relevance of Articles 8, 23, 28 and 36 of Regulation 1901/2006 in deciding if Merck's documents fulfilled the requirement of Article 8(1)(d)(i) of Regulation 1768/92. 

An opinion of the Paediatric Committee of the European Medicines Agency (EMeA) on compliance with an agreed completed paediatric investigation plan was considered not to be sufficient as a statement of compliance with an agreed completed paediatric investigation plan: what is needed is a copy of an updated marketing authorisation granted by a competent authority under Regulation 1901/2006. 

At para 43 of his decision Mr Cullen says:

"In their written submission, the applicant argued that if it was necessary to wait until they could furnish evidence of a granted updated or varied marketing authoristion to apply for the 6 month SPC extension for products that are already covered by an SPC rather than doing so on the basis of the opinion on compliance of the Paediatric Committee, they are in danger of being denied the reward for doing the paediatric studies through no fault of the applicant but rather because of the time taken by the competent authority to process the application and grant the update marketing authorisation. However, in my view the reward is not only based on completing an agreed PIP, it is also based on making sure that information regarding the use of medicinal products in the paediatric population is made available and improved and this achieved by including this information in the marketing authorisation and in the SmPC and, where relevant, the product & labeling information. This is illustrated for example by recital (28) of EC Regulation 1901/2006. Thus there would seem to a valid reason why it is necessary to wait until the varied marketing authorisation is granted. However, I do have some sympathy with the concern expressed by the applicant in relation to the impact of delays beyond their control in obtaining updated granted marketing authorisations from a competent authority and the need make an application for an SPC extension prior to expiry of the original granted SPC. Article 7(4) and 7(5) of EC Regulation 1768/92 require that the application for an extension to the SPC must be lodged before expiry of the original SPC. For the period of 5 years after EC Regulation 1901/2006 enters into force, the application must be made 6 months before the SPC expires, thereafter, the application must be lodged 2 years before the SPC expires. I do not think that it can be one of the intended consequences of this Regulation that the time taken by the competent authority to process the application and grant the update marketing authorisation should prevent an applicant from being able to obtain a reward for carrying out an agreed completed PIP and making the information on its outcomes available".

Merck was allowed a period of time within which to rectify the irregularity in its application.

Business data about SPCs -- a reader asks

In response to a reader's query, The SPC Blog poses the following question:

"I'd like to keep abreast of business information concerning SPCs, rather than just technical legal information about how to get them. For example, news of transactions involving them, challenges to their validity, how their grant affects stock prices, etc. I've tried using Google Alerts but the hits I get from that system seem to consist mainly of links to your blog.

Is there any published source, whether printed or online and in any language, from which business and commercial news abouts SPCs can be gathered?"

If any reader has a useful answer, can he or she please let me know by emailing me here. All suggestions will be posted on this weblog.

SPC cocktail competition

Apologies all round -- The SPC Blog should have announced the winner of its cocktail competition by now, but in all the recent excitement of the seminar last month we quite forgot to do so.

Well done, Lisa Page (Wragge & Co), whose winning entry was her combination of three cocktails, all more or less in accordance with the same recipe:

The Pharma Sector Daiquiri
50ml of white rum
Juice of one half fresh lime (approx 50ml)
Four strawberries
15 ml of sugar syrup

Shake with six ice cubes and pour through the ice into a martini-style cocktail glass.

The SPC Daiquiri uses the same ingredients (of course), with the addition of six ice cubes. All of the ingredients, including the ice, are then blended to produce a frozen cocktail which is a 'longer' drink that expires when the ice melts. Pour into a Margarita-style cocktail glass.

The Exclusive Paediatric Daiquiri is a non-alcoholic version of the SPC frozen Daiquiri and uses 50ml of lemonade instead of the rum

Congratulations, Lisa, and enjoy your prize: complimentary registration for C5's  "Multi-Jurisdictional Pharma/Biotech Patent Litigation" conference in Amsterdam next week. And thanks, too, to our other competitors, for taking the trouble for submitting your entries.

Patent World SPC round-up

With the assistance of her colleagues Tom Carver (London), Birgit Kramer (Gemany) and Claudia Zeri (The Netherlands), patent specialist Marjan Noor (Howrey, London) has written an article on SPC protection in Europe.

Marjan's article, "Prolonging Patent Protection", was published in the February 2009 issue of the ten-times-a-year journal Patent World, which The SPC Blog thanks for permitting it to make Marjan's article available online here.

Dutch zero-term SPCs: original transcript available

On 28 January this blog posted news that the Dutch had recognised zero-term SPCs in the Sitagliptine application. We now have a copy of the Dutch decision, made on 22 January 2009. You can download it here -- but alas it is at present available to us only in Dutch.

The Commission's view on paediatric extensions

Recently, the Commission sent the official records of the 3rd meeting of national SPC experts held on 26 September at the EMEA to national patent offices. This meeting was mainly devoted to the implementation of paediatric extensions. The records are particularly interesting to those who are involved with the administrative implementation of Regulation 1901/2006. Some national patent offices, such as the German PTO, have yet started a consultation procedure to discuss with representatives of industrial pharmaceutical associations administrative issues, such as the format of proofs.

As regards the contents of the records it is somewhat disappointing that, by and large, the Commission takes a rather formalistic approach, even when the wording of the provisions seems to be quite clear. This is especially true with respect to Article 36.3 of Regulation 1901/2006 and Article 8.1.d.ii of Regulation 1768/92. When the wording is somewhat ambiguous, as in Article 36.1 of Regulation 1901/2006 and Article 8.1.d.i of Regulation 1768/92, the result is the same. The Commission seems to apply the maxim "in dubio contra paediatric extension".

Consequently, this basic incentive will be devaluated. Of course, such tendencies of strict interpretation undermine the very aims of the Regulation 1901/2006. It remains to be seen if the national patent offices are able and willing to practise the relevant provisions in a more flexible way, e.g., by using the instrument of Article 10.3 of Regulation 1768/92.

Book review

Participants at last week's SPC Seminar may have enjoyed the chance to chat and perhaps share a pleasant glass of wine with Bird & Bird partner Trevor Cook, whose second edition of Pharmaceuticals Biotechnology and the Law has just been published by LexisNexis. Described by the publishers as "the definitive guide to the law in Europe relating to pharmaceuticals, biotechnology and their related areas such as medical devices", this second edition, arriving some six-and-a-bit years after the first, is an impressive monument to the author's industry and enthusiasm as well as his expertise in the field. 

Sadly for many intellectual property lawyers of the old school, a depressingly large proportion of this book is taken up with regulatory issues: while the need for regulation of the sector is unassailable and its absence unthinkable, when one realises how much in terms of time, effort and resources must be invested in regulatory compliance, it is tempting to speculate as to whether -- if the sector could start again with a clean slate -- a more streamlined and functionally efficient means of regulation could not be devised.

Written primarily from the perspective of harmonised EU law, the book does not neglect those areas which, remaining unharmonised, remain within the realm of English law.  It is well researched, clearly written and handsomely produced.  A special treat for readers of this weblog is that Trevor has kindly devoted some 28 pages to the treatment of SPCs -- for which, many thanks!

Bibliographical details: publication date, January 2009. Hardback. ISBN 9780406914415.  Price £200.  STOP PRESS: the book now has its own web page here.

Seminar slides now available; new patent litigation weblog

The PowerPoint presentations from last Wednesday's seminar are now available here. If you have any problems downloading them, please email me here and let me know.  The video/soundtrack has still to be sorted out so, if you emailed to express your interest in receiving it, please be patient for a little longer.


Readers of The SPC Blog may not yet know of the recent launch of PatLit, a purpose-built weblog covering patent litigation, which went live on Monday morning. While PatLit covers patent dispute resolution generally, it will feature the occasional item on SPCs in court when the opportunity arises. You can inspect PatLit, which has chosen the mythological figure of Puck as its logo, here.

SPC Seminar -- a brief report

The SPC Blog's first SPC seminar got off to a great start yesterday with over 70 SPC aficionados together in the same room for a whole afternoon to listen to SPC perspectives on patent extension law and practice France, Germany and the UK -- and to try to quench their thirst on burning SPC issues.

SPC Blog team member (and seminar chairman) Robert Stephen kicked off the event by providing his view on the current issues in the field.

Rob was then followed by Michèle Lavé (left), from the French patent attorney firm Cabinet Alice de Pastors.  Michèle discussed SPCs in France including SPCs the patent requirements for combination products (Ritonavir, lanzoprazole and emtricitabine combinations), marketing authorization requirements (Flufenacet combination case), definition of the term product (French Timolol and Carmustine decisions) as well as the French position with regard to negative term SPCs.

Matthias Kindler and Niels Hölder of Hoffmann-Eitle (Munich) then took a look at German SPC cases in 2008: they delved into the seemingly unending topic of determining what a first authorization is, especially when the first authorization is one in an EEA member state (the EEA was founded after Regulation 1768/92 entered into force, and the Regulation came into force before, SE, FI and AT acceeded to the EC). This issue was decided by the German Federal Supreme Court (FSC) in the "Pantoprazol" case (X ZB 31/06, 27 May 2008). They also tackled the combination issue ("Anti-helicobacter preparation", FSC X ZB1/08, 8 July 2008) and the problem of having different salts as different active ingredients (FSC X ZB 4/08, 14 October 2008). They then reported on the decision of the German Patent Court to refuse the grant of an SPC with a negative term. This decision has been appealed.

Lawrence Cullen of the Intellectual Property Office addressed SPCs for combinations and the relevant UK case law (Takeda and Gilead). He also spent some time discussing the SPC extension and the Paediatric Regulation as well as the the granting of negative term SPCs. Finally he briefly presented current ECJ references.

The afternoon's PowerPoint presentations should be available soon. Currently The SPC Blog has versions that can neither be copied nor legibly uploaded. Please be patient!

We also have a question, which readers are invited to answer.  Lisa Page asks: 

"In Dr Cullen's presentation he mentioned the possibility that an applicant could benefit from both an six month extension to an SPC under the paediatric regulation and a one year extension to a marketing authorisation for a new clinical indication? In what circumstances can the SPC Blog readers see that this would be a practical benefit to an applicant bearing in mind that they could have selected a one year extension to marketing authorisation under the paediatric regulation in the first instance?"

If you have any bright ideas, please post them as Comments below or email them here