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.