A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Tuesday, 30 December 2008
Saturday, 20 December 2008
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...
Monday, 15 December 2008
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.
Sunday, 14 December 2008
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?)
Friday, 12 December 2008
"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)".
Monday, 8 December 2008
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.
Saturday, 6 December 2008
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.
Monday, 1 December 2008
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.
Friday, 28 November 2008
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.
Tuesday, 25 November 2008
If readers are sufficiently interested, this blog will seek to compile a list of institutions that do cover SPCs in their intellectual property syllabuses.
Wednesday, 19 November 2008
"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".
Monday, 17 November 2008
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.
Friday, 14 November 2008
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).
Information on deposited and granted SPCs can be obtained from this website on the website of the Italian Patent Office, unfortunately all in Italian.
Thursday, 13 November 2008
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.
Friday, 7 November 2008
* 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.
Tuesday, 4 November 2008
"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."
Monday, 3 November 2008
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.
Friday, 31 October 2008
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.
Wednesday, 29 October 2008
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.
Thursday, 23 October 2008
Please email your cocktail entries to The SPC Blog here, marking the subject as "SPC Cocktail Competition".
Monday, 20 October 2008
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.
"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".
Thursday, 16 October 2008
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.
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.
Friday, 10 October 2008
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.
Monday, 6 October 2008
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.
Friday, 3 October 2008
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.
"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".
Thursday, 2 October 2008
"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.
Monday, 29 September 2008
Full details of the seminar programme and registration form are available here. Bookings should be made before 31 October 2008, if possible.
Friday, 26 September 2008
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.
Thursday, 25 September 2008
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.
Saturday, 20 September 2008
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.
Tuesday, 16 September 2008
Provisions of Hungarian law supplied here are as follows:
* Article 22/A of Act XXXIII of 1995 on the protection of inventions by patents;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.
* 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.)
Friday, 12 September 2008
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.
Monday, 8 September 2008
"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".
Friday, 5 September 2008
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.
Monday, 1 September 2008
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 systemThe SPC blog would be interested in getting a rough estimate of how many SPCs with abnormally long terms are still lurking around in Italy…
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.
Thursday, 28 August 2008
* 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.
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.
Tuesday, 26 August 2008
Court invokes "fairness in the administration of the patent system" in rejecting late challenge to patent extension
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".
Monday, 25 August 2008
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.
Wednesday, 20 August 2008
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?
Thursday, 14 August 2008
Read the article here.
For the full contents of LSIPR 2008, click here.
Tuesday, 12 August 2008
"combines a cutting-edge agenda with unrivalled networking opportunities. Parallel sessions will focus onThe 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.
• Translational Medicine
• Intellectual Property Hot Topics
• Business Development Hot Topics
• Talent Management".
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.
Friday, 8 August 2008
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.”).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.
Read more here.
Wednesday, 6 August 2008
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.
* 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.
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?
Friday, 1 August 2008
The Comptroller's refusal of the SPC application relied heavily on Takeda Chemical Industries Ltd's SPC Applications (No.3)  RPC 1,  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.
Thursday, 31 July 2008
STOP PRESS: it now seems that the "SPCs" mentioned here are themselves a non-standard abbreviation for "Summaries of Product Characteristics", referred to as SmPCs by those who like to distinguish them from supplemtary-protection-certificate-type SPCs . Thanks, Trevor Cook (Bird & Bird) for pointing this out.
Wednesday, 30 July 2008
Under Regulation 1901/2006 companies seeking approval for a new medicinal product, a new indication, route of administration or pharmaceutical form of an existing patent-protected drug must submit a PIP which spells out how they they propose to develop the drug for the various subsets of the paediatric population. If the proposal is approved, the drug's supplementary protection certificate will secure a six-month extension.
Friday, 25 July 2008
This is very topical since tomorrow, 26 July 2008, is the date from which there is imposed an obligation to submit results of studies according to an agreed PIP with applications for (new) marketing authorisations (see Article 7) or a decision granting a waiver or deferral.
The new requirements apply to most products, but not to generics, hybrid applications, biosimilars and well-established medicinal products, or to homeopathic and traditional herbal medicinal products. Different rules govern patented and off-patented medicines, as well as both rewards and incentives for compliance.
For products still under patent, a PIP must be submitted and agreed with the PDCO. If the agreed programme is conducted and the obligations are fulfilled there is the possibility of gaining a 6 months extension of the Supplementary Patent Certificate.
Wednesday, 23 July 2008
Details of the BSLR here, and of Lawtext here.
Sunday, 20 July 2008
Remarkably, the claim is made that the volume of European Union legislation stands at around 85,000 pages. Anyone who regularly reads the Official Journal would be likely to guess that the real figure stood at many times that number.
Readers can review the proposed codified site here.
Wednesday, 9 July 2008
"Finally, the generics industry has fast access to reliable key patent, SPC and data protection expiry information".This access is provided by Pipeline Scope, the latest release from GenericsWeb, which also claims to provide accurate and complete data for over 1,400 international non-proprietary names, across 37 countries, delivered through a user-friendly interface. According to Leighton Howard, Managing Director of GenericsWeb:
"SPC and data exclusivity are critical drivers for generic pharmaceutical development. Existing products lack a logical interface for researching and viewing this information in a way that quickly answers the questions being asked. Scope is developed from the ground up with a perspective of both the patent specialist and the business development executive in mind, allowing fast access to reliable key patent, SPC and data protection expiry information."The SPC-related information concerns protection "in 30 EU states" [at the date of the press release, the number still stood at just 27] plus extensions of term for non-EU countries".