R&D incentives for patents and SPCs in Belgium

Writing on the IP Finance weblog this morning, Tom Swinnen (Thompson Hine LLP, Brussels) explains that, for the 2008 tax year, a new tax incentive has been introduced in Belgium which leads to a maximum effective tax rate of 6.8% on patent income. This is the Patent Income Deduction (PID) scheme which, he maintains, results in the lowest effective European tax rate on income derived from the licensing of patents or the use of patented products. The PID is available only in respect of patents and supplementary protection certificates, but not any other intellectual property rights. You can read Tom's piece in full here.

Tour of Patent Offices: Bulgaria

This week, it's off to Bulgaria, thanks to the kind information from Ventsi Stoilov, a Bulgarian IP specialist.

The Bulgarian Patent Office (BPO) website can be accessed here and searches on their database can be done on the BPO On-line website here. However, the database appears to be limited to trademarks, industrial design and case law - unfortunately not much help to those interested in patents. While researching this I noticed I was visitor no. 201,070 to the site. By the time I had done 3 searches, I was visitor no. 201,073...

SPCs and Wikipedia

Last week the Wikipedia entry for Supplementary Protection Certificates was updated again. Wikipedia is an increasingly popular (and indeed relied-upon) source of information for members of the general public. What's more, Google and Yahoo! (but not Cuil) searches of the term "supplementary protection certificate" put the Wikipedia entry at the top of its 'hit' list.

Since Wikipedia is open to amendment and correction by all responsible readers who take the trouble to edit it themselves, it seems prudent for all readers of this weblog who value the accuracy of information concerning SPCs and their public image to monitor the Wikipedia entry regularly in order to ensure that it is acceptable.

Tour of Patent Offices: Portugal

This week the SPC Blog is takes a look at the Portuguese Patent Office.

Similarly to its Spanish counterpart, the Portuguese Patent Office's website is a colourful site. Information is available to the user both in Portuguese as well as in English.

Under the section devoted to patents, there is a subsection on SPCs containing the usual information. The legal basis for SPCs is found in another section. However, the legal basis for plant protection products (EC Regulation 1610/96) is missing from the list...

And last but not least, and in no way related to SPCs but nevertheless interesting, the INPI has made an effort to reach out to young people on IP issues by using comics. Click here for some Portuguese IP-related comics (but then again, how many kids out there still read comics instead of being glued to a virtual entertainment device?)

Mark your diaries

The colourful and rather exotic Italian English-language weblog Catch Us If You Can !!! carries a short post by Mauro Turrini, "Pharmaceuticals for paediatric use". This item summarises the effect of Regulation 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and reminds readers that there is a significant SPC-related calendar date next month:

"The Paediatric Regulation introduces the requirement to include information about paediatric studies in the Marketing Authorisation (MA) application. This requirement, already mandatory for new medicinal products as from 26 July 2008, will start soon to be compulsory also for previously authorised medicinal products covered by a supplementary protection certificate (SPC) or a patent, which qualifies for the granting of the SPC (as from 26 January 2009)".

SPC seminar coming up!

"Supplementary Protection Certificates" is the surprise choice of title for The SPC Blog's first seminar on the subject, which is coming up on 28 January 2009. The seminar, which occupies the whole of Wednesday afternoon (with drinks to follow), will look at hot topics in the field of SPC law and practice, examining in particular any differences that arise between practice in France, Germany and the United Kingdom. Speakers are European Patent Attorneys Michèle Lavé (Cabinet Alice de Pastors, Paris) and Niels Hoelder (Germany), plus Deputy Director of the UK Intellectual Property Office Lawrence Cullen. The event is chaired by SPC Blog team member Robert Stephen, a European Patent Attorney at law firm Olswang (which has kindly agreed to host the event).

You can read and download the formal invitation here. If you'd like to attend, email Natalie Smith here and let her know. Space is limited and we can't guarantee to squeeze everyone in, but we hope we won't disappoint anyone.

Tour of Patent Offices: Cyprus

Next in The SPC Blog's tour of inspection of official national patent websites is Cyprus, a jewel in the Crown of the Eastern Mediterranean. Cyprus, it seems, does not have a dedicated Intellectual Property Office; rather, its intellectual property administration and execution of official policy is handled by the The Intellectual and Industrial Property Section of the Ministry of Commerce, Industry and Tourism's Department of Registrar of Companies and Official Receiver.

There's very little intellectual property information available online from this source, and most of what's there deals with trade marks. A site search of the English language version of the text for 'SPC' received no hits at all. "Supplementary protection certificate" fared equally badly. Even "patent" received just nine hits.

If this review has failed to unearth any significant SPC information from this website which is known to any of our readers, can the relevant link be posted by using the Comment facility below.

Tour of Patent Offices: this time it's Lithuania

The SPC Blog's tour of European patent offices takes us next to Lithuania. The website of the State Patent Bureau of the Republic of Lithuania is accessible in the local language and in English. The site is more transparent than many, having a site-counter that tells readers how many visitors the site has received in total, how many have visited that day and how many are online at that precise moment. I was a little surprised to learn that, mid-day on Sunday, I was already the 6,283rd visitor to the site that day -- but perhaps Sunday is a popular day for IP activity in the Baltic region.

The formal structure of the site divides subject-matter between inventions, topographies, trade marks and designs. There is no page or click-through that is devoted to supplementary patent certificates at all. However, a site search for "SPC" throws up one hit -- a 300 page pdf document dated 27 February 2006 which turns out to be the Official Gazette. A word search of that document produces two hits for "SPC" and none at all for "supplementary patent certificate". Site searches for "supplementary protection certificate" fare substantially, producing four hits of which three are in English: two are from the 2oo2 Annual Report, the third being a read-only Word document containing the English translation of the Lithuanian Patent Act as amended to June 2005.

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.

SPCs in Spain

SPCs at the Spanish Patent Office (OEPM)

Considering all the noise the Spanish made to try to stop SPCs in the first place, the Spanish Patent Office (the SPTO) has an pleasantly structured website on SPCs. It provides a step-by-step guide to the whole process of obtaining an SPC including before applying, during the application procedure and reminding you to pay the award fee once the SPC has been granted. And all of this information is available in English.

Spanish Supreme Court Rules on SPCs

While searching for this information the SPC Blog also stumbled on a short report published by the law firm of Amat i Vidal-Quadras about what appears to be the first judgment by the Spanish Supreme Court on SPCs.

In this case, which had to do with the SPC for fosinopril and hydrochlorothiazide, the Spanish Supreme Court established that the administrative courts have jurisdiction to hear appeals against the granting of SPCs. Moreover, the court held that this product did not fall within the scope of the basic patent and therefore overturned the Spanish Patent Office's decision to grant the SPC.

Daiichi decision -- a commercial footnote

Nearly a fortnight ago, in "Mirror, mirror on the wall, what is the first marketing authorization for this enantiomer?" (here), this blog reviewed the judgment of Mr Justice Kitchin in the Patents Court for England and Wales decision in Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2008] EWHC 2413 (Pat). In that case the court showed how the UK courts deal with the issue of whether the marketing authorization for a racemic product counts as the first marketing authorization as required by Article 3(d) of the SPC Regulation.

I've just spotted that this decision has also been noted by a staff reporter for the Pharmaceutical Business Review in an article, "UK court upholds Daiichi Sankyo's levofloxacin SPC". This article doesn't add much to what we already know, but it does add some business background, mentioning that Daiichi Sankyo has granted an exclusive licence to Sanofi-Aventis to make, use and sell pharmaceutical preparations containing levofloxacin in the UK and that Sanofi-Aventis markets levofloxacin products in the UK under the trade name Tavanic.

A conference -- and a competition!

The SPC Blog is pleased to announce that it is sponsoring the forthcoming C5 conference, Pharma/Biotech Patent Litigation, which is being held in Amsterdam from Tuesday, 17 February to Wednesday, 18 February 2009. Preliminary details of this event can be inspected here. Readers of The SPC Blog who would like to attend this event are entitled to a 10% discount on the £1,399 conference registration fee if they book quoting the reference code SPCBLOGREADER. In addition, C5 is offering free registration as a prize for The SPC Blog's competition, which is quite simple. On the premise that the letters "SPC" stand not only for "Supplementary Protection Certificate" but also "Simply Perfect Cocktail", competition entrants are invited to submit their own recipe for the simply perfect cocktail (one recipe per entrant, please). The closing date for the competition is Sunday 25 January and the winner will be announced on this blog on Tuesday 27 January. The best entries will be published too, though readers should note that, while they may have been tested for immediate efficacy, their long-term impact will remain unknown and they will still be in need of market authorisation!

Please email your cocktail entries to The SPC Blog here, marking the subject as "SPC Cocktail Competition".

Interpretation of the Term 'Product' -- new article

The October 2008 issue of the Journal of Intellectual Property Law and Practice (JIPLP), published monthly by Oxford University Press and which I edit, contains a full-length article by SPC Blog team member Catherine Katzka entitled "Interpretation of the Term 'Product' in EU Council Regulations 1768/92 and 1610/96 on Supplementary Protection Certificates". According to the abstract:

"Legal context: In order to compensate for the reduced time to exploit pharmaceutical and agrochemical patents, patent extension schemes were introduced in the 1990s. In Europe, the extension is achieved through supplementary protection certificates (SPC) with Regulation 1768/92 and 1610/96, which provide for up to 5 years additional protection or agrochemical products.

Key points: The SPC Regulations combine aspects of the patent and regulatory systems, which themselves have different aims and approaches leading to problems in definition. This is particularly the case for the definition of ‘product’. This term is defined in Article 1b as ‘the active ingredient or combination of active ingredients of a medicinal product’. However, EU legislation on SPCs does not provide an indication to precisely what is meant by ‘active ingredient’. This has lead to interpretation problems for national patent offices during the SPC application process and during litigation, which have been and continue to be resolved at the national or European level.

Practical significance: This article discusses from a European perspective the issues of what exactly constitutes a product within the meaning of Article 1 of the Regulations and which products are actually protected by an SPC. It reviews the case law of different European jurisdictions that clarify the question of which products are covered by an SPC as well as establishes what constitutes a new product over the subject matter of a previous marketing authorization. It also addresses the implications of the definition of ‘product’ for Pharma and plant protection industries".

If you'd like to access this article, please email me here and let me know. You should have it before the end of the week.

Mirror, mirror on the wall, what is the first marketing authorization for this enantiomer?

In the recently handed-down judgment of Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and another [2008] EWHC 2413 (Pat), Kitchin J has provided an insight on, among other things, how the UK courts deal with the issue of whether the marketing authorization for a racemic product counts as the first marketing authorization as required by Article 3(d) of the SPC Regulation.

In this case, Daiichi Pharmaceutical Co Ltd were the proprietors of European Patent (UK) No. 0206283 and supplementary protection certificate no. SPC/GB97/085. The patent related to the anti-microbial compound levofloxacin, which is the (-) enantiomer of a racemic compound called ofloxacin. The patent for levofloxacin was granted on 27 January 1993. The UK marketing authorization for ofloxacin was granted on 16 March 1990, whereas the marketing authorization for levofloxacin was granted on 6 June 1997.

Generics (UK) sought a declaration of invalidity of (or rectification of the register in respect of) the SPC based on the argument that the UK marketing authorization which were relied upon in support of the application of the SPC were not the first authorizations to place the product on the market as a medicinal product.

Kitchin J disagreed:

• ofloxacin was a recognized anti-microbial agent, known to comprise two enantiomers but, until the EP No. 0206283, the characteristics of the individual enantiomers were not yet known;


• ofloxacin was recognized to be the active ingredient of the medicinal product for which authorizations were sought and granted in 1990. The authorization was to place ofloxacin on the market and not levofloxacin and
  it was known that ofloxacin, levofloxacin and R(+) enantiomer have different properties.

It followed that an authorization to place ofloxacin on the market as a medicinal product cannot be considered as an authorization to place levofloxacin on the market as a medicinal product. Accordingly, the first marketing authorization of levofloxacin was in 1997 and the SPC does fulfill the requirements of Article 3(d) of the SPC Regulation.

Reading this case reminded The SPC Blog of the German Patent Court's rejection in the Fusilade case of the argument raised by the applicant that a racemate and an enantiomer should be considered as separate products for SPC application because they have separate marketing approval. The Court however held that an SPC for an individual enantiomer could potentially be granted if it were the subject of a patent in which it was specifically claimed.

SPCs in Iceland

The SPC Blog has decided to take a quick look into SPCs in Iceland before the complete meltdown of the country into the Atlantic.

A glance at the website of the Icelandic Patent Office leaves us with the impresion that SPCs don't appear to be a burning issue there. The only information available relates to the Patent Act 17/1991 and Regulation 574/1991. Even the Fees page doesn't provide much information - but then again, the little the fees might bring in won't really help the nation from getting out of its hot spot.

The French Patent Office cooks up controversy

The SPC Blog has obtained information from a source in France about several ongoing cases before the Cour d'Appel de Paris regarding appeals to decisions by the Institut National de la Propriété Intellectuelle (INPI - the French Intellectual Property Office) rejecting SPC applications based on "the same previously market authorised product":

The French PTO appears to have taken a very unhelpful and certainly
"technically unaware" stance, and are applying the ECJ decisions of Yissum,
etc, with gusto.

In essence the cases revolve around the distinction between what was marketed
as essentially a sort of "primordial soup", for example, a mix of enzymes or
cell extract where one enzyme is predominant although others present in the soup
influence its activity (this is not the subject-matter of the cases involved),
and the later and subsequently patented isolation of one particular active
substance over all the others which was found to have an enhanced desired
pharmaceutical effect and was stabler in the absence of all the junk that
hindered it previously. Unfortunately, the name of the "primordal soup" product
as previously authorised for marketing happens to be the same as the specific
name of the isolated substance, and so the INPI has refused the SPC applications
on the grounds that it is the "same product".

It should be interesting to see what the French courts make of it providing
the cases go all the way to trial, especially since there are political
ramifications involved, i.e. one or more state run/owned/shared entities have a
financial stake in the matter.

Proposals for reform in Japan: Samurai writes

The SPC Blog has a friend in Japan who goes by the name Samurai. Writing on the extension of the patent term in Japan and proposals for change, Samurai has this to say:

"The Patent Term Extension (PTE) regime of Japan may be changed drastically according to the IP Strategic Program (IPSP) 2008 (click here for the original Japanese PDF), composed by the Intellectual Property Strategy Headquarters which is chaired by the Prime Minister of Japan.It contains some interesting proposals.

However, before going further, I would like to begin with explaining the current regime, for the convenience of those who are not familiar with Japan's unique PTE system.The guidance for PTE examination will be found here (pdf) and it basically says that the Japanese Patent Office (JPO) will examine the extension application based on whether 'product' or 'use' in the approval is the first or not. This could mean that you can file multiple extension applications whenever you get an additional Marketing Approval (MA) for the same ingredient for the different 'use' (i.e. an additional indication). Moreover, you could extend plural patents based on a single MA due to lack of such limitation in the legislation. As a result, we are enjoying tremendously generous PTEs. These are the basics of Japan's PTE.

Some entities were not satisfied by this and made a greedy attempt to accomplish the extension for the formulation-altered version of the existing drugs. They were Senju (original; English summary), Roche (original; English summary) and Takeda (original; no English summary) and they all lost their actions before the IP High Court. It has therefore been established case law that the formulation patent is not eligible for the extension. Now they seem to be changing their tactics and have utilized the Cabinet instead of courts. Below is a tentative translation of the excerpt from the IPSP 2008 mentioned above (on page 33 of the Japanese text).

Chapter 2: Protection of IPR

I. Adequate protection of intellectual property

1. Ensuring that the new technologies will be properly protected and supporting the creation of new markets

(2) Fundamental review of the Patent Term Extension system

The additional subjects, such as the allowance process in the Cartagena Protocol on Biosafety or the approval process of using biomaterials derived from iPS cells as well as the innovative drugs which differ in terms of revolutionary formulation technologies including DDS will be investigated. In addition, the comprehensive review of the requirements of the extension, the eligible numbers and frequency of patents and the scope of rights of the extended patent, including way for the overall system, also based on international trends, will be conducted. The study, to begin immediately, and reach its conclusion in fiscal 2008. (Ministry of Economy, Trade and Industry, the concerned agencies).

As you can see, it says that they may consider adding the formulation patent as eligible subject matter -- but it also states they may ban Japan's unique multiple extensions (see the phrase 'international trends') at the same time. Of course, the extension of the formulation patent would not be in line with 'international trends'.

As a concerned person, I'm closely of watching the course of action. As is stated in the IPSP, the review has just been started and the reform plan has not yet been finalized. Since the deadline set by IPSP is March 2009, the public comment procedure which will disclose the details of the reform might be expected some time in the beginning of 2009 or earlier. I will keep you updated whenever the status changes".

The SPC Blog thanks Samurai for his contribution and looks forward to hearing of future developments. The blog will also be pleased to receive comments from readers, since some of the points made by Samurai are quite contentious.

SPCSs in Austria

The webpage of the Austrian Patent Office that is dedicated to Supplementary Protection Certificates is certainly an informative one -- though it strikes a somewhat gloomy note. After briefly explaining what the SPC is, it adds:

"This opportunity for extending the life-span of patents for approved pharmaceuticals in the form of a supplementary Protection Certificate was created when Austria joined the European Union in order to make the costly and protracted development of pharmaceuticals and pesticides more financially bearable".

The reader might be forgiven for assuming from the words "more financially bearable" that the SPC was more of a loss-limitation exercise than a means of making profit that a patent-originating pharmaceutical business might factor into its business plans.

The webpage then gives a list of legal provisions, with links: two EU Regulations -- Regulation (EWG) No. 1768/92 (for pharmaceuticals) and Regulation (EWG) No. 1610/96 (for pesticides), followed by Austria's Supplementary Protection Certificates Act (SchZG 1996) and Patentamtsgebührengesetz (effective as of 1 July 2005). Neither of the EU Regulation links work. If they had done, they would have disappointed the English reader, since they would have led to the German texts of the Regulations, not the English ones.

The website also provides links to the SPC application form and guidance as to how to complete it, together with details of application and renewal fees. Visitors to the site are also advised that a Protection Certificate Register is kept by the Austrian Patent Office in which the most important data on Protection Certificates is provided. This Protection Certificate Register may be viewed by anyone. It is also possible to obtain a certified excerpt from the Register. Notes regarding Supplementary Protection Certificates are also published in the Austrian Patent Gazette.

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…

A recent review of the scene in Europe -- and especially France

Alice de Pastors (Cabinet Alice de Pastors) has kindly prepared for this blog a shortened version of her firm's SPC-News 22 -- which was circulated in May of this year -- regarding medicinal SPCs in Europe. Alice writes:

* What is the situation in May 2008?

Supplementary Protection Certificates in Europe are governed
– in the 27 EU countries, Norway and Iceland by EEC Regulation 1768/92, amended by Regulation 1901/2006 of 12 December 2006 relating to medicinal products for paediatric use
– in Switzerland by National law of 3 February 1995.

* Medicinal Product SPCs in Europe from 1991 to 2007

About 10,925 SPC applications for medicinal products regulated by EEC Regulation 1768/92 or National laws were filed in European countries from January 1991 to December 2007, and published up to the end of March 2008. The graph below shows, for each country, the number of SPCs filed from 1991 to 2007, according to their status.

1991-2007 SPCs

M1 = SPC applications
M2 = granted SPCs in force
M3 = granted SPCs not yet in force
M4 = expired, lapsed, invalid SPCs
M5 = rejected or withdrawn SPC applications

The situation differs from one country to another due to the importance of the markets and/or to the applicable laws and/or to the date of entry in force of the EU Regulation:
– fewer than 20 SPCs in force in Bulgaria, Estonia, Lithuania, Malta, Poland, Romania, Slovakia, Czech Republic, Iceland, Slovenia, Hungary, Latvia, Cyprus
– fewer than 100 SPCs in force in Greece, Portugal, Spain, Norway, Finland, Ireland, Denmark
– fewer than 150 SPCs in force in The Netherlands, Germany, Austria, Luxembourg, Switzerland, Sweden, Belgium, UK
– more than 150 SPCs in force in France and Italy.
The graph below shows the number of SPCs filed from 1991 to 2007, according to ATC code (first level) of the products and to the SPC status.

* Medicinal Product SPCs in Europe in 2007

1,245 SPCs filed in 2007 were published at the end of March 2008. The graph below shows the number of SPCs for each country.

Medicinal Product SPCs filed in 2007

The EU SPC Regulation entered in force in Bulgaria and Romania on 1 January 2007. 87 SPCs were filed in 2007 and published in Romania and 23 SPCs in Bulgaria.

Which medicinal products?

The 1,245 SPCs filed in 2007 and published at the end of March 2008 cover about 170 different products (active ingredients, combinations of active ingredients, or formulations).

► Of these 1245 SPCs, about 38% relate to influenza or papillomavirus vaccines, 9% to glucose lowering agents, 6.6% to immunosuppressive agents and 6.3% to veterinary products.
► We noted 33 products, for which at least 10 SPCs were lodged.

Recent French decisions affecting SPCs

Decisions relating to Chiron EP0181150 and EP0318216 patents

Four decisions of Cour de cassation (3/04/2007)

These decisions confirmed the decisions of the Cour d'appel de Paris rejecting Chiron's appeal against the refusal by the French Patent Office of four SPC applications (01C0023, 01C0024, 01C0025, 01C0026) because these applications related to products neither used for treating or preventing disease, nor administered with a view to making a medical diagnosis but to test reactants for in vitro diagnosis.

Decision affecting Triflucan® drugs

Cour de cassation (3/04/2007)

In this decision the Cour de cassation set aside the Cour d'appel de Paris judgment of 12 October 2005 without ordering a new trial; the Cour de cassation considered that National SPC 92C0372 was invalid because the product had already been the subject of the certificate 92C0371.

Decisions affecting Fosamax® and/or Fosavance® drugs

Two decisions of TGI Paris relate to French SPC 96C0032 referring to French patent FR2525223:

TGI Paris (15/02/2008) MSD Somerset Ltd/Teva Classics, Teva Santé
TGI Paris (15/02/2008) Arrow Generiques, EG Labo, Ratiopharm / MSD Somerset Ltd
In these decisions the Court revoked, for lack of inventive step, the claims relating to pharmaceutical compositions suitable for the treatment of urolithiasis and inhibiting the bone reabsorption comprising a biphosphonic acid, and specifically 4-amino-1-hydroxybutan-1,1 biphosphonic acid. If these decisions are confirmed, SPC 960032 will no longer protect Fosamax® and/or Fosavance® drugs (these decisions are open to appeal).

Decision affecting aceclofenac

TGI Paris (22/02/2008) S.A. Laboratorios Almirall, S.A.S. Almirall/Merck Generiques, S.A.S. Qualimed, S.A.S. Pharm’Depo, Merck Farma y Quimica.

In this decision the Court revoked French SPC 98C0017, referring to EP0119332, due to the fact that the SPC was filed by a person other than the owner of the patent at the filing date. In fact Prodes filed SPC 98C0017 in 1998, but Prodes was no longer the owner after 25 January 1985, when the patent was transferred to Prodesfarma SA.

Court invokes "fairness in the administration of the patent system" in rejecting late challenge to patent extension

We are grateful to Antony Taubman (WIPO) for drawing our attention to a decision of the Federal Court of Australia last week, Interpharma Pty Ltd v Commissioner of Patents [2008] FCA 1283.

In short, what happened here was that Lilly held a patent in Australia for difluro nucleoside antivirals. In 2000 Lilly sought and the Commissioner of Patents granted an extension of term for a period of five years ending in March 2009, based on the registrations in the Australian Register of Therapeutic Goods (ARTG) of the commercial product Gemcitabine hydrochloride, approved for use in the treatment of cancer of the lung and pancreas.

Interpharma objected that there was a disconformity between the product registered in the ARTG and that described in Lilly's patent specification. Accordingly Interpharma sought (i) to have the Commissioner's decision to extend the patent set aside and removed from the patent register, (ii) revocation of the patent itself and (iii) damages for false representation under the Trade Practices Act 1974. Lilly cross-claimed for infringement.

Sundberg J dismissed Interpharma's application in its entirety. The claim based on a false representation under the Trade Practices Act 1974 had to fail because that Act only applied in respect of statements made to those with whom one has, or may have, dealings in the course of commerce; this was not the relationship between Lilly and the Commissioner. Interpharma also failed to establish that it was a "person aggrieved" under the Administrative Decisions (Judicial review) Act 1977 with locus standi to challenge the Commissioner's decision since, on the facts, it was not in a position to make the patented product itself. Interpharma's application was also fatally delayed, even if allowance was made for the fact that the company was not incorporated until two years after the decision to extend the patent was taken. The judge concluded, at paragraphs 39 to 40:

"39 Another relevant matter in relation to delay is that the term of a patent is not of interest only to the patentee. As Lilly points out, it is effectively a right in rem, and of significance to all in the patent area who might be interested in trading within or near the subject matter of the patent. For this reason, the Commissioner must publish in the Official Journal a notice that an extension application has been made and is open to public inspection. If an application for extension is accepted, the Commissioner must publish a notice to that effect in the Official Journal. Provision is made for opposition proceedings. If the Commissioner grants an extension, a notice of the grant must be published in the Official Journal. ...

40 I agree with Lilly that once the opposition period has expired and an extension is granted, the patentee and third parties are prima facie entitled to proceed on the basis of the extension. Admittedly, one must take into account that the applicant was not incorporated until nearly two years after the extension. Nevertheless, the public interest to which I have referred is relevant notwithstanding that. As a matter of fairness in the administration of the patent system, it would be extraordinary if extensions could be challenged some eight years after grant. Even taking into account the applicant’s date of incorporation, it would still be extraordinary that a challenge could be made six years after that".

Literature on SPCs: a Google search and other things

While looking for literature on SPCs I thought I'd take a look at the Google Scholar facility. Reputedly Google Scholar is much appreciated by students writing their dissertations and theses, since they can supplement their own slender knowledge of a subject with the fruits of patient research of others (hence the Google Scholar motto "Stand on the shoulders of giants").

Keying in the search term "supplementary protection certificate" I received 312 hits. I had not expected a large number but I had certainly thought that there would be more than this, especially since these hits would include writings that deal with the economic and industrial aspects of SPCs as well as the legal. However, it seems that the database of published research on SPCs is primarily legal, since the addition of the search word "law" only reduces the total hits to 252.

Google Scholar offers to search for research papers and articles published in other EU languages too: its lists French, Portuguese, German and Spanish. Be that as it may, the bias is strongly in favour of English-language materials: for example, a search for "Certificat Complementaire de Protection" retrieved only six hits.

The SPC Blog is hoping to build up a bibliography of useful articles, papers and other materials on SPCs, so that anyone working in the subject -- or approaching it for the first time -- will be able to get to grips with it more easily. If any readers have strong recommendations that they would like to share, can they please email me here and let me know.

New Zealand mulls new patent law -- but there's no room for patent extensions

The Patents Bill 2008 is currently under consideration in New Zealand (you can read a short note here or the full text of the Bill, together with the New Zealand Government's explanatory notes, here). A notable omission is any provision relating to supplementary protection certificates for pharmaceutical or agrochemical substances.

Right: Does New Zealand prioritise the interests of the farmer over that of the pharma ...?

This omission may seem surprising to some when it is borne in mind that "neighbouring" Australia (if any country can be regarded as a neighbour in those parts), which shares much the same legal traditions and business culture, enacted patent extension provisions for pharmaceutical substances in s.70 of its Patents Act 1990. Since New Zealand patent law seems to be treated to a major overhaul about once every 50 or so years, this may be a good time for the innovatory side of the industry to do some lobbying.

Five years ago it was reported by NZ law firm Baldwin Son & Carey that "the Government Minister responsible ... says that the issue of extending the term of pharmaceutical patents will be investigated as part of the review of the Patents Act". Does any reader know what has happened since? Is there a matter of principle involved or is it felt that, since NZ has such a small domestic market, the availability of extension of the patent term for pharma substances is unlikely to play a major part in the investment decisions of pharmaceutical companies?

SPC legislation: past, present and future problems

In the recently-published issue of the Life Sciences Intellectual Property Review 2008 (LSIPR 2008), John Miles of Potter Clarkson LLP provides an overview of some resolved problems and also some unresolved issues regarding the interpretation of the SPC legislation.

Read the article here.
For the full contents of LSIPR 2008, click here.

SPCs a "hot topic" for the BIA

The Annual BioScience Forum of the BioIndustry Association (BIA) takes place on 25 September 2008 in the lovely venue of One Great George Street, London SW1. According to the organisers this event

"combines a cutting-edge agenda with unrivalled networking opportunities. Parallel sessions will focus on

• Translational Medicine
• Intellectual Property Hot Topics
• Business Development Hot Topics
• Talent Management".

The SPC Blog understands that one of the "Intellectual Property Hot Topics" on the BIA's programme will be supplementary protection certificates, which is a good reason for readers of this blog to support this event.

STOP PRESS: Sophie Broster-James (BIA) has emailed to warn us that places at the Forum are limited and that early booking is recommended. You can read the details of the programme and book your place here.

Synergistic combinations of active ingredients doesn't save patent term extension in the US

The aroma of a recent patent term extensions decision by the US PTO has reached this side of the pond with the Patent Baristas report of AstraZeneca's attempt to obtain a patent term extension for Symbicort, an asthma drug comprised of a combination of the active ingredients formoterol fumarate dihydrate and budesonide:

AstraZeneca filed an application for a patent term extension (PTE) of the patent term of U.S. Patent No. 5,674,860 under 35 U.S.C. § 156 in the United States Patent and Trademark Office. They tried to get the extension based the time for FDA review under section 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) of Symbicort®, having the active ingredients, formoterol fumarate dihydrate and budesonide. [n.b. both of these active ingredients were each approved for commercial marketing or use before the approval of Symbicort]

The Patent Office determined that the ‘860 patent was ineligible for patent term extension based upon the regulatory review period because (1) Symbicort does not constitute the first permitted commercial marketing or use of the product Symbicort (formoterol fumarate dihydrate and budesonide) under the provision of law under which such regulatory review period occurred, and (2) the PTE Application was not timely filed.

AstraZeneca had argued that, since Symbicort is a synergistic combination of formoterol fumarate dihydrate and budesonide, it should be considered as a single active ingredient for patent term extension purposes.

The Patent Office disagreed with the synergistic combination argument:

Applicant’s argument is incorrect. The synergistic effect of the active ingredients formoterol fumarate dihydrate and budesonide has no relevance in determining “first permitted commercial marketing or use of the product” as required by 35 U.S.C. § 156(a)(5)(A). The term “product” as used in 35 U.S.C. § 156 includes any new drug or antibiotic drug, “as a single entity or in combination with another active ingredient.” 35 U.S.C. § 156 (f)(2). Section 156(f)(2) says nothing about whether a combination is synergistic. See Arnold Partnership v Dudas, 362 F.3d 1338, 1343 (Fed. Cir. 2004) (”Moreover, this court doubts that synergistic effects are an appropriate distinction for term extension policies, particularly where the statutory language does not distinguish at all between synergistic and nonsynergistic combinations.”).

Read more here.

Although the corresponding SPC for Symbicort (SPC/GB02/033) was granted in the UK in 2003, the patent was revoked in appeal proceedings at the European Patent Office in 2007.

Concern about the future, but demand for extended term is far from unanimous

Via the Cambridge Network comes news of a survey carried out during April and May of this year for UK-based patent and trade mark attorneys Marks & Clerk. The survey, which underpins the findings of that firm's current annual biotechnology report, covered some 500 respondents in the biotech and pharma sectors in Europe, the US and Asia. It reveals (among many other things) that

* 72 per cent of respondents believe that future drug pipelines will become much harder to deliver unless the drug approval process is relaxed;

* extensions to the existing patent term are advocated by 73 per cent of respondents;

* 91 per cent consider the time it now takes for drugs to get through the system is eating into patent protection;

* 78 per cent believe the climate for enabling biotechnology innovation has deteriorated within the past year.

Factors identified as giving rise to concern are the growing caution of the US Food and Drug Administration in the granting of marketing approval for new drugs which, in turn, put added pressure on the patent life, and the likelihood that genuine innovation will take a back seat behind drug modification and late-stage development. In addition to the findings of the survey, the report also highlights key issues relating to IP law and policy. For a copy of the report email Jo Colton here.

One subject worthy of speculation and analysis is why the percentage of respondents who do not advocate an extension of the existing patent term stands at 27%. Is the divide between the pro- and anti-extension lobbies within the industry characterised by differences in national laws, industry sector, perceptions of the worth of new products in the corporate pipeline, job description ... or what?

British court allows Gilead tenofovir appeal

Mr Justice Kitchen (Patents Court, England and Wales) gave his judgment yesterday in Gilead Sciences, Inc's appeal against the Comptroller's refusal of its tenofovir SPC application. The product in question was a combination therapy for HIV and the patent's claims were directed to a class of novel compounds, within which one of the compounds fell. That compound was also specifically disclosed and claimed. As well as compound claims, the patent had a claim directed to a pharmaceutical composition comprising the novel compound "together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients".

The Comptroller's refusal of the SPC application relied heavily on Takeda Chemical Industries Ltd's SPC Applications (No.3) [2004] RPC 1, [2003] EWHC 649 (Pat), where the Patents Court upheld a refusal of SPC applications on lansoprazole in combination with other named antibiotics. The judge held in Takeda that the patent did not protect the combination, but only the lansoprazole element of the combination.

The Comptroller in Gilead indicated that the specification of the patent should at least provide a clear pointer to the specific combination product. Kitchen J rejected this test, holding at para.33 that a clear test applicable to a product comprising a combination of active ingredients

"is to identify the active ingredients of the product which are relevant to a consideration of whether the product falls within the scope of a claim of the basic patent. It is those ingredients, and only those ingredients, which can be said to be protected within the meaning of the Regulation. So, in the case of a product consisting of a combination of ingredients A and B and a basic patent which claims A, it is only A which brings the combination within the scope of the monopoly. Hence it is A which is protected and not the combination of A and B. ... The product comprises two active ingredients... It falls within the scope of claims 1 and 25 only because of the presence of (one of those compounds). Hence, on the Takeda test, claims 1 and 25 do not protect the product within the meaning of the Regulation. However, claim 27 is directed to a composition comprising (the first compound) together with a carrier and optionally other active ingredients. The product falls within this claim too and it does so, in so far as the claim is directed to a combination, as result of the presence of both (compounds)."

The Comptroller has been granted leave to appeal.

Thanks to Helen Jones (Gill, Jennings & Every -- who acted the for appellant, instructing Charlotte May, 8 New Square) for supplying this information.