Source: http://thespcblog.blogspot.com/2014/
Timestamp: 2019-04-20 04:56:20+00:00

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Seattle Genetics and an alternative question -- but will the CJEU answer it?
The SPC Blog has received further news from our friend Mike Snodin (Park Grove IP) that he has published another article in Scrip Regulatory Affairs. This latest article, entitled “Supplementary Protection Certificates: the Court of Justice of the EU will have its day after all” (a copy of which can be obtained here), relates to the questions referred to the Court of Justice of the European Union (CJEU) in Case C-471/14 Seattle Genetics [on which see earlier SPC Blogpost here].
As regular readers of this blog will know, the questions referred by the Oberlandesgericht Wien in Seattle Genetics relate to the issue of whether longer term should be awarded to certain SPCs by relying upon the date of notification of a “centralised” Marketing Authorisation instead of the (earlier) date of the European Commission’s decision to issue the Authorisation.
Mike’s article discusses and analyses the questions referred to the CJEU and highlights potential problems with regard to the framing of those questions. In an attempt to clear away any confusion that could be caused by the manner in which the questions referred have been framed, Mike presents an alternative question that is more precisely adapted to the facts underlying Seattle Genetics. He concludes by expressing the hope that the CJEU decides to answer such an alternative question, and by outlining reasons why, in his view, that alternative question should be answered in favour of using the date of notification for “centralised” MAs.
News has reached us that a regular contributor to this blog -- and one of the speakers at the recent SPC Blog seminar (Mike Snodin, Park Grove IP) -- has published a new article in Scrip Regulatory Affairs. A copy of the article, entitled “Supplementary Protection Certificates: the never-ending saga of Article 3(a)”, which was first published online by Scrip Regulatory Affairs on 1 December 2014, can be viewed via this link.
Mike’s article explains why the ruling of the High Court, England and Wales, of July 2014 in Eli Lilly v HGS may well provide what the SPC community has sought for years, namely a test for compliance with Article 3(a) of Regulation 469/2009 that is not only simple and robust but which is also relatively straightforward to apply in a wide variety of cases. However he also explains why, in his view, this is unlikely to be the end of the saga relating to Article 3(a). In this respect, Mike’s article discusses two alternative interpretations of Article 3(a) that have been proposed by some commentators and that could muddy the waters for a number of years to come. While one of those alternative interpretations is perhaps not fundamentally inconsistent with the extent of protection test used by the High Court, Mike’s view is that the same cannot be said for the other -- which is based upon an unusual reading of the CJEU’s ruling in Queensland and which appears to be impossible to reconcile with the conclusions reached by the High Court. Fortunately, however, Mike also outlines in his article the reasons why he believes that more challenging interpretation must be wrong and why the High Court’s extent of protection test must prevail –- at least for now.
We have received notification of a new case referred to the Court of Justice of the European Union (CJEU): C-471/14: A request for a preliminary ruling concerning the supplementary protection certificate for medicinal products.
1. Is the date for the first authorisation to place the product on the market, pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law, or does that provision refer to the date on which the authorisation takes effect in the law of the Member State in question?
2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?
If you would like to comment on this case please e-mail policy@ipo.gov.uk by 01 December 2014.
We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on CJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.
You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing.
If you are aware of any references to the Court of Justice that are not currently included on our website, you are also welcome to send us your views. If you choose to do this, please include clear information about the case to help us to identify it.
Further information on intellectual property CJ cases can be found on our website https://www.gov.uk/government/publications/references-to-the-european-court-of-justice.
Let no-one accuse The SPC Blog of being slow to being you the news. Only a few minutes ago a new publication was launched, which may be of great interest and relevance to most of this blog's readers. It's titled Ergänzende Schutzzertifikate - Patent Term Extensions: USA, Japan, EU, Germany, Korea, Taiwan, Switzerland, Australia, Israel, Russia and Singapore and it's a bilingual text put together for our benefit by Dr Arne Markgraf. It's published for the very modest sum -- for a specialist law book -- of 134 euro. Oh, yes, and you can order it from the website of publishers Nomos here.
Patent term extensions are the most important instrument for securing rights to innovative medicines after expiry of the regular patent term. The new manual comments on all relevant provisions including the relevant case law in the U.S., Japan and Europe. In addition, it presents corresponding extension opportunities in Australia, Israel, Korea, Russia, Switzerland, Singapore, Taiwan and in the free trade agreement between the U.S. and the Central American countries. It also comments on the current state of negotiations on the Free Trade Agreement between the European Union and Canada. So the manual covers all important markets, which offer the possibility of a patent term extension. It is aimed at lawyers from pharmaceutical companies and international law firms.
Its bilingual German/English synoptic structure is tailored to support the global development of innovative medicines. It facilitates the decision-making in international project teams through a rapid and easy access to all relevant information. It also assists to find uniform argumentation during grant or revocation proceedings across borders.
The SPC Blog looks forward to reviewing this book in due course.
The PowerPoints for the various sessions, together with the speakers' biographical details, have already been uploaded for your delectation and can be accessed here.
Michael Factor (of the IP Factor weblog) has drawn our attention to a recent blogpost of his own, here, on in Ruling Concerning Patent term extension to IL 120701 to Wyeth, 3 November 2014. This is a somewhat strange tale involving Israel's recently amended patent law. In short, Wyeth filed a request to correct an error in the patent extension order for Bazedoxifene. The Commissioner for Patents did not allow the amendment but cancelled the patent term extension altogether as a "wrongfully given bureaucratic decision". Having established that it was null and void, he ordered that the patent term extension application be subjected to accelerated re-examination under the amended law.
Michael's post contains all the details.
The PowerPoints and speakers' biographical details for yesterday's seminar, "SPC Law and Practice 2014: All you need to know" are now available for your delectation. You can read them online by clicking here or download them by clicking here.
WARNING! It's a big 2.56 MB file, running to some 143 pages, so think twice before printing it in full -- particularly if your ink cartridge is coming up for replacement.
the dawning of the Age of Aquarium ...?
the seminar has been recorded on video, which should be processed and published more swiftly than on previous occasions, on the basis that Olswang LLP (the host firm -- thanks!) has had more practice at video-recording seminars than it did when last an SPC seminar was held there.
This year a variety of topics were discussed, with a first-ever mention of the phenomenon of SPC for fish vaccines and the prospects of shoal immunity. But that's another matter and, if you want to know what was said about this and other issues, you shouldn't have long to wait.
Apart from Olswang (whose London office staff also provided the logistics and processed the refreshments), gratitude is also expressed to all of the speakers and participants for giving of their time and effort, and to the Court of Justice of the European Union for their possibly inadvertent contribution by providing so much content for us to analyse and discuss -- a contribution that shows no signs of abating.
Do please be patient: all items will be made available as soon as possible, so there's no need to chase!
The defendant (Orifarm) had imported a pharmaceutical product, MSD’s Singulair, from Poland during the term of the paediatric extension of the SPC. The plaintiff brought interlocutory injunction proceedings, claiming that such imports could be prohibited relying upon the "Specific Mechanism".
As its primary line of defence, the defendant held that the paediatric extension did not prolong the protection conferred by the "Specific Mechanism". As its second line of defence, the defendant held that, even if such protection could be conferred by a paediatric extension, such extension would only be applicable to those of the plaintiff's products which -- by their strength -- were indicated for children.
The Bailiff's Court (the court of first instance) held that the patent, the SPC and the paediatric extension thereof were to be considered as a single coherent right that covers all products and not just the ones authorized for the treatment of children. Accordingly, the Bailiff's Court found for the plaintiff.
The Maritime and Commercial Court agreed with the Bailiff's Court, stating that the expression "such protection" under the Specific Mechanism as stated in the Treaty of Accession is to be interpreted as the patent protection being one continuous string of protection. The Maritime and Commercial Court added that the paediatric extension is not dependent on a product being indicated for the treatment of children, but only on whether or not the drug is tested for children.
The protection would not therefore terminate until the paediatric extension had expired.
The judgement (in Danish) can be found here.
Thanks, Martin, for this really helpful summary.
New has reached The SPC Blog of the latest publication by Mike Snodin of Park Grove IP (a copy of which can be viewed here). On this occasion, Mike’s article (“The CJEU – for supplementary protection certificates, who needs it?”) discusses the arguments for and against the use of Notification Date for “centralised” marketing authorisations (MAs) and explains why the arguments against, as typified by a decision of the Danish Patent Office, are fatally flawed.
Mike concludes that it is acte clair that the SPC legislation requires the use of the date of validity of a MA to calculate the duration of an SPC. How the date of validity is calculated will depend upon the type of MA involved – but for “centralised” MAs it will involve use of the Notification Date.
In the light of his analysis of the legislation, Mike concludes that it is not necessary for patent offices to refer this matter to the CJEU in order to accept arguments in favour of the use of the Notification Date. Mike’s article was published too late to persuade the Oberlandesgericht Wien not to make a reference on this point. However, Mike hopes that his article will help the CJEU quickly grasp the key points of the matter. He also hopes that they will forgive the title that the publishers chose for his article!
Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?
1. Is the date of the first authorisation to place the product on the market in the Community under Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products determined under Community law, or does the Regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?
2. If the CJEU affirms that the date under question 1 is determined under Community law: which is the relevant date – that of the authorisation or that of the notification?
The need for a referral in this area has been clear, particularly since the UKIPO’s change of practice a year ago to use the date of notification rather than the date of the decision to calculate the SPC term based on centralised authorisations (BL O/418/13 – GENZYME). This approach typically results in a few extra days of term, which can be very valuable. Belgium, Slovenia and most recently Portugal use a similar approach, but other national patent offices have resisted, arguing either that the SPC regulations make it clear that the date of the decision is the relevant date, or that in the absence of a CJEU ruling on the matter there is no need for them to change their practice.
The referral is based on Austrian SPC application no. SZ 39/2012 (“Brentuximab vedotin or pharmaceutically acceptable salts thereof”). The applicant (Seattle Genetics) applied for the SPC based on EP 1 545 613 and Takeda’s authorisation EU/1/12/794/001 for Adcetris (Brentuximab vedotin). The authorisation is dated 25th October 2012, but was notified 5 days later, on 30th October 2012. In calculating the SPC term, the Austrian patent office used the decision date of the authorisation, but Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30th October 2027. In its reasoning, Seattle Genetics referred to the practice in the UK, Belgium, Slovenia and Portugal, as well as Art. 13 and Recital 9 of the Regulation, and the authorisation itself which states that the authorisation is valid from the date of notification. The Austrian Oberlandesgericht seems to think that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date.
Thanks so much, Daniel, for taking the trouble to share this with us.
Just over a year ago, the Court of Appeal for England and Wales made a reference for a preliminary ruling to the Court of Justice of the European Union (CJEU) in Case C-539/13, Merck Canada Inc., Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals PLC (as noted by The SPC Blog, here). The questions referred are somewhat wordy and relate to the Specific Mechanism -- a derogation from the principle of free movement of goods which was appended to the Act of Accession when a whole batch of new members -- the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and the Slovak Republic -- joined the European Union.
This Special Mechanism allowed the owner of a pharma patent or an SPC to prevent the parallel importation of the patented product from one of the accession states if, at the time of filing, such protection was unavailable in that accession state; anyone who intended to import such a product was required to demonstrate to the relevant national authority that he had given notice of that intention to the holder or beneficiary of the protection.
1 May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so?
(c) is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?
A holder of a patent or a supplementary protection certificate, or his beneficiary, duly notified of an intention to import and market pharmaceutical products covered by the Specific Mechanism ... is required to respond to the notification, so as to demonstrate an intention to oppose the proposed importation and placing on the market, within the period prescribed in the second paragraph of the Specific Mechanism, in order to be entitled to enforce any restriction on the import and marketing of the products concerned. A holder of a patent or a supplementary protection certificate, or his beneficiary, is precluded from relying upon his rights with respect to any import and marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights.
It is now for the CJEU to decide whether to adopt this Opinion, on which it is expected to give a ruling in the next few months.
There's a recent blogpost on Michael Factor's IP Factor weblog, "Israel Patent Office Shortens Patent term Extension for Ezetimibe", which provides a detailed analysis of Re 110956 Association of Israel Industrialists v Schering and Mercke, decided by Asa Kling on 18 September 2014. This ruling deals with, among other things, the retroactive effect of Israeli legislation on patent term.
A decision of the Intellectual Property Court (IP Court) granting a Supplementary Protection Certificate (SPC) on a second medical use, despite the existence of a previous SPC for the same product and the same basic patent, contradicting the practice of the Portuguese Patent Office (PTO), was published in the IP Bulletin.
Boehringer applied for the SPC No. 511 referring to the medicine Pradaxa (dabigatran etexilate in the form of a mesylate) and respecting the basic patent EP1485094, to protect the medical use of dabigatran etexilate for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation.
The PTO refused SPC 511 by sustaining that it does not comply with the requirements of Article 3(d) of Regulation 469/2009 (SPC Regulation), alleging that this SPC is not associated with the first marketing authorization (MA) for the same product, since a SPC based on the same patent and on the same active ingredient had already been applied for (SPC 490).
Boehringer filed a judicial appeal against the decision of refusal of the PTO claiming that SPC 490 was applied for the use of the active ingredient dabigatran etexilate (as mesylate) for primary prevention of venous thromboembolic events in adults who have undergone an operation to replace the hip or knee, while SPC 511 is intended to protect the use of the same active ingredient for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation. Consequently, Boehringer concluded that since the therapeutic use is different, it cannot be said that there is more than one SPC for the same basic patent.
The IP Court allowed Boehringer’s appeal and revoked the decision of refusal of the PTO.
In the aforementioned decision, the IP Court quoted the jurisprudence of CJEU, namely Case 130/2011 Neurim [on which see earlier SPC Blog posts here]), according to which "like a patent protecting a ‘product’ or a patent protecting a process by which a ‘product’ is obtained, a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product".
Considering the teachings of the CJEU, the IP Court held that since the new therapeutic use of the drug Pradaxa -- prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation -- comprises the active ingredient protected by the basic patent of the SPC 511, it should be understood that this therapeutic use is not covered by any previous MA and therefore SPC 511 must be granted.
This decision shows the harmonization of Portuguese jurisprudence with the jurisprudence of the CJEU regarding SPC and shall serve as an important precedent for the PTO to change its practice relating to SPC on second medical uses".
Novartis's VALSARTAN appeal: French Cour de Cassation says "non!"
Valsartan HCT France: the end of ex parte preliminary injunctions in France?
NOVARTIS filed an appeal before the French Supreme Court against this judgment, raising three grounds. In its decision issued on September 16, 2014, the French Supreme Court dismissed NOVARTIS's appeal in whole.
NOVARTIS argued that judges must apply the principle that both sides must be heard. Therefore, according to NOVARTIS, the Court of appeal couldn’t raise ex officio the question of whether the circumstances justified ex parte interim measures without inviting the opposing parties to submit their comments.
However, in its ruling, the French Supreme Court considered that since the Court of Appeal was asked to rescind an ex parte order, it could verify whether the circumstances justified asking for ex parte interim measures, without having to invite the parties to present their observations, such a verification being not a point of law raised ex officio.
* The loss of market share, a price war, parallel imports and the disincentive to innovation simply cannot be reparable by the payment of damages.
the Court could rightly, and in the exercise of its sole discretion, determine that the conditions to order ex parte interim measures were not met.
NOVARTIS argued that since SANOFI detained the generic medicinal products and that it has declared that the product was already marketed, the proof of imminent harm was sufficiently established to order interim measures.
However, the French Supreme Court ruled that this ground was irrelevant since the Court of appeal had ruled that conditions to grant ex parte interim measures weren’t met.
This decision (in the original French) can be downloaded here or accessed online here.
João Jorge (Raul-Cesar Ferreira) has kindly sent us some hot news from the Portuguese Intellectual Property Court in Case 457/12.7YHLSB, which is being published today although it was reflected even yesterday on the court's online database. This decision concerns the date used to calculate the term of SPC 474.
Takeda Pharmaceutical Company Ltd. filed the application for the SPC on 26/03/2012, having EP 1718641 as the base patent and based on the MA for azilsartan medoxomil -- Edarbi. The marketing authorization (MA) for Edarbi was granted by Decision C(2011)9280 of 07/12/2011, with publication in the Official Journal of European Union dated 24/02/2012, where the date of notification to the owner is identified has being 09/12/2011, two days after the date of the Decision.
With this, the expected validity end was 07/12/2026 instead of 09/12/2026.
After publication of the Decision from the PTMO, Takeda appealed from said Decision to the Portuguese Intellectual Property Court requiring that the date to be used in the calculation should be the date of the Notification.
“…the relevant date to determine the validity period of the certificate consists of the starting date of the marketing authorisation associated therewith. It is from that date that the medicament can start to be commercialized. This does not occur with the pronunciation of the marketing authorisation decision but with the effective validity of that authorisation”.
“It is provided in Article 297 of the Treaty on the Functioning of the European Union, which replaces the Treaty Establishing the European Community, that decisions that are not a legislative act and mentioning a addressee are notified to him/her and producing effects upon that notification.
From this it results that the decision to grant a marketing authorisation only has effect from the notification date, for which reason the common practice is to make reference to it by publication in the Official Journal of the mention of the date of the decision and of the date of notification to its addressee.
* the administrative act which grants an authorisation could not have effect before its applicant had been notified.
This decision is in agreement with the previous decision BL O/418/13 of the UKIPO [on which see Mike Snodin's earlier contribution on this blog here].
It is still to be seen what will be the understanding of the PTMO of this decision and if it will apply it (to future cases or, even, to previous cases) or if the PTMO will maintain its practice waiting for a referral to the CJEU on this matter.
Earlier news from was posted by João on The SPC Blog here this April.
The just-published current issue of the Bio-Science Law Review (six times a year from Lawtext Publishing, Oxford),vol.14, issue 1, pp 21-24, contains a case note, "The meaning of 'Active Ingredient' for SPC Protection is again uncertain: Bayer CropScience AG (Case 11/13)" by our friend Paul England (Taylor Wessing LLP's London office).
Paul incidentally furnished a note for this blog on the Advocate General's Opinion in this case which was not initially published in English. The SPC Blog's note on the ruling can be found here.
SPC Blog Seminar 2014: at last, the invitation!
With a lot of effort from blog team member Rob Stephen and the kind support once again of host firm Olswang LLP, The SPC Blog is delighted -- and not a little relieved -- to announce that the programme for this year's annual seminar is now published. For full details and registration, just click here.
There will be plenty of time for questions and a drink afterwards.
Do join us once again! You are very welcome.
The SPC Blog is once again delighted to inform readers that our good friend Alice de Pastors has produced yet another of her excellent reports: SPC News 28 – September 2014 is now available to read here or to download here. As usual, it's full of information which includes statistics on SPC applications in Europe between 1991 and December 2013. A sample table is shown above.
Alice adds that it also notes discrepancies in SPC protection in European countries which are due to differences in interpretation of the EC Regulation and/or in policy as between national patent offices.
Thanks, Alice! Your efforts are much appreciated.
The SPC Blog has received a note from our friend and occasional correspondent Mike Snodin which informs us that the firm that he founded in July 2014, Park Grove IP, now has a fully functional website. Blog readers may wish to know that this website contains, among other things, a copy of the most recent of Mike’s publications (an article entitled “Every cloud has a silver lining: Portugal's loss may be the UK's gain”, which was published by Scrip Regulatory Affairs in June 2014). A copy of that article can be viewed by clicking here.
(b) an additional day's term for some SPCs in certain countries (such as the UK).
The SPCs that may be affected are those for which less than 10 years have elapsed between the filing date of patent upon which the SPC is based and the date of the first authorisation in the European Economic Area for the “product” defined in respect of the SPC.
In the Genzyme case that Mike argued before the UK IPO in 2013 (BL O/418/13), the Hearing Officer declined a request (based upon the provisions of the Euratom treaty) to award an additional day’s term to just such an SPC. However, Mike is of the view that the ruling in C-555/13 would appear to undermine the Hearing Officer’s reasons for refusing that request. Therefore, Mike’s Euratom argument may yet rise again!
(ii) what are known as “AR 16 licences” granted by the Irish Department of Agriculture, Food and the Marine pursuant to the Irish Statutory Instrument No 144/2007 European Communities (Animal Remedies) Regulations 2007 part III “Exceptional authorisation”, point 16?
2. If question 1 is answered in the affirmative, is such a product outside the scope of the SPC Regulation and is an SPC granted on the basis of such a product therefore invalid?
3. Concerning the interpretation of Article 2 of the SPC Regulation, should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 (or Directive 2001/82) within the meaning of Article 2?
4. (a) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b)?
(b) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute a first authorisation to place the product on the market as a medicinal product in Norway within the meaning of Article 3(d)?
5. When the medicinal product is a virus vaccine, can the scope of protection under the SPC cover not only the specific strain of the virus that is included in the medicinal product and covered by the basic patent, but also other strains of the virus that are covered by the basic patent?
a) such other strains have an equivalent therapeutic effect to the virus strain included in the medicinal product or whether the therapeutic effect is not immediately equivalent?
b) a medicinal product based on such other strain will have to be the subject of a separate marketing authorisation with requirements for documentation of safety and effect?
b) will the SPC be valid; such, however, that the scope of protection pursuant to Article 4 does not extend beyond the specific virus strain authorised to be placed on the market as a medicinal product?
This request was received from the Oslo District Court on 23 July. The deadline for written observations from Governments and relevant institutions is Monday, 13 October 2014.
"I am doing research concerning SPCs and, in particular, on the implications of special approval exemptions for medicine (to be sold on the market, at the request of a doctor/vet, prior to marketing authorisation) for SPC applications. In a nutshell, I am looking for case law and articles that may have touched on this issue: does a special approval exemption under Directive 2001/82 [on the Community Code Relating to Veterinary Medicinal Products] or Directive 2001/83 [on the Community Code Relating to Medicinal Products for Human Use], granted for many consecutive years, constitute a de facto marketing authorisation, thereby disqualifying the product in question from applying for a SPC?
If you happen to have information on this topic, I would greatly appreciate it if you could share it with me".
Well, readers -- this is your chance! Do please post any useful reading suggestions below and let's see what we can come up with.
It's always good to keep an eye on other weblogs, since they do feature patent term extension news from time to time. One such blog is Michael Factor's IP Factor blog, which has just posted a piece, "Israel Patent Number 94634, Extending and Shortening Patent Term Extensions", here, on The Association of Israeli Pharmacists v Sir Roy Calne and Wyeth, Ruling Asa Kling 13, July 2014.
The post is quite long and a bit complex, so we thank Michael for getting this case online while packing for his holiday. That's enthusiasm for you!
In Leibniz-Institut für Neue Materialien Gemeinnützige GmbH, BL O/328/14, a UK Intellectual Property Office decision of 29 July, hearing officer Lawrence Cullen held that a medical device, the marketing authorisation for which was governed by Directive 93/42 -- the Medical Devices Directive -- was not a basis for granting an application for an SPC under Regulation 469/2009 in respect of the “aqueous dispersion of iron oxide nanoparticles” . According to the Institute the authorisation procedure under the Medical Devices Directive was the equivalent of an authorisation to place the product on the market as a medicinal product, granted under the administrative procedure laid down in Directive 2001/83 (the Medicinal Products Directive). Following a careful examination of all the relevant legislation and case law, the hearing officer held that a product which had not been subject to the administrative procedure in the Medicinal Products Directive is actually excluded by Article 2 of the SPC Regulation from being granted an SPC.
The 45 page ruling can be read in its entirety here.
"I would like to report a recent case before the Supreme Administrative Court of Bulgaria regarding an SPC application for Atripla, a drug for treatment of HIV infection.
“a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analog having biological activity against HIV reverse transcriptase”.
Although efavirenz was found to be a compound of Formula I and emtizitabine -- a nucleoside analogue -- the court held that the claim envisaged only combinations of two active ingredients, while the applied product consisted of three. Further, the court confirmed that the third ingredient, tenofovir disoproxil fumarate, was also outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics. As a result the Supreme Court reversed the decision of the court of first instance and instead upheld the decision of the Patent Office to reject the application of Merck Sharp & Dohme Inc.
In its detailed analysis the Supreme Court touched on a number of important topics of the SPC domain. It provided guidance on the methods of interpretation of patent claims, on the applicability of the infringement test and the significance of the Medeva and Eli Lilly decisions. It also commented on decisions of other jurisdictions which had been put forward by the parties in support of their arguments. Therefore, in my opinion the Atripla case resulted in a milestone decision of the Bulgarian case law with respect to the application of the SPC Regulation.
If you can cope with the original Bulgarian text of the judgment, Dimitar has kindly provided a link to it here.
"the term for patent protection of medicinal and plant products (which are subjects of marketing authorizations), can be prolonged up to 5 years depending on the time spent on completing the marketing authorization process (equivalent to SPC)".
This is unlikely to be done before all current EU Member States have approved the Association Agreements, but it's at least a step in the right direction.
SPC Blog Seminar 2014: save the date!
Save the date! Thursday 6 November has now been fixed for this year's SPC Blog seminar. Following readers' suggestions we look forward to having presentations on medical device SPCs, some Intellectual Property Office input -- at least from the UK and ideally from the Netherlands too -- plus biotech SPC considerations, a general case review, and probably a few short topics.
More details, and registration instructions, will be posted as soon as possible.
Article 3(a) of Regulation 469/2009 requires that a product which is the subject of an application for an SPC must be “protected by a basic patent in force”. This was held by the Court of Justice of the European Union (the “CJEU”) in Medeva (Case C-322/10 [noted on this weblog here]) to mean that the active ingredient must be “specified” in the wording of the claims.
In October 2012 the Patents Court for England and Wales (Warren J) in Eli Lilly and Company Ltd v Human Genome Sciences, Inc. referred further questions to the CJEU regarding the interpretation of Article 3(a). In December 2013 the CJEU handed down its judgment in the Lilly case (C-493/12), holding that it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Article 3(a) does not, in principle, preclude the grant of an SPC where the active ingredient is covered by a functional claim provided that “the claims relate, implicitly but necessarily and specifically” to the active ingredient in question.
The case returned to the Patents Court (Warren J) in May and June 2014. The judgment provides important guidance as to the interpretation of the CJEU’s decision and the circumstances in which SPCs may be obtained for products based on claims defined in functional terms.
“An isolated antibody or portion thereof that binds specifically to (a) the full length Neutrokine-α polypeptide … or (b) the extracellular domain of the Neutrokine-α polypeptide …”.
Eli Lilly and Company Ltd (“Lilly”) wishes to market, in due course, a product containing an antibody (known as tabalumab) that binds specifically to Neutrokine-α. Lilly has not yet received a marketing authorisation (“MA”) for tabalumab.
Lilly issued a claim against HGS seeking a declaration from the Patents Court that any SPC granted to HGS in respect of the patent and based upon any MA for tabalumab would be invalid.
Lilly’s case was that tabalumab is not “protected by” the patent for the purposes of Article 3(a) as tabalumab is not specified in the wording of the claims. That, Lilly submitted, would require a structural definition of the active ingredient in the claims of the patent.
Lilly had originally sought to argue a further ground on which any SPC would be invalid, namely that HGS would not be able to obtain an SPC based on the HGS Patent and an MA held by a third party (Lilly) – the “Third Party Issue”. Lilly discontinued this aspect of the claim before the CJEU hearing in September 2013.
HGS’s case was that tabalumab fell within the scope of protection of claim 13 (as interpreted by section 125 of the UK Patents Act, Article 69 of the European Patent Convention (“EPC”) and the Protocol on the Interpretation of Article 69) and that that claim related “implicitly but necessarily and specifically” to tabalumab, as required by the CJEU.
As with other decisions of the CJEU in relation to the SPC Regulation, regrettably the guidance given is not clear. This is reflected by the fact that both Lilly and HGS had applied to the Patents Court for judgment in their favour on the basis of the CJEU’s decision. The Court also observed that “one thing the [CJEU decision] does not give is the clear guidance which the reference was designed to obtain” (paragraph 4).
In dismissing Lilly’s claim for declaratory relief, the Court explains (paragraph 67) that the CJEU has clearly held that functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent. This is on the condition that the “claims relate implicitly but necessarily and specifically” to the active ingredient.
The Court held at paragraph 70 that the correct reading of the CJEU’s judgment required an application of the relevant rules (i.e. Article 69 EPC or Section 125 Patents Act 1977) to ascertain the extent of the invention and what the claims relate to. If the active ingredient in question is covered by the claims, it is protected for the purposes of Article 3(a) – subject to a proviso.
This proviso is explained at paragraph 66 of the Judgment and is necessary to reflect the approach of the CJEU in Medeva in relation to products containing combinations of active ingredients. A product is not protected within the meaning of Article 3(a) solely by virtue of a claim containing general wording that extends the claim beyond its principle scope (such as “comprises”). However, in the absence of such extending words, the Court held that “the claims have a focused scope and the question is simply whether the product falls within the scope of the claims” (paragraph 66). Lilly had conceded during the course of these proceedings that tabalumab falls within the scope of claim 13 of the patent, and the proviso did not apply since there were no extending words. Tabalumab was therefore “protected by” the patent within the meaning of Article 3(a).
Finally, the Court considered (at paragraphs 44-54 of the judgment) that paragraph 43 of the CJEU’s decision, which relates to whether a patent owner has made any investment in the research leading to the MA, is more relevant to the discontinued Third Party Issue than to the test under Article 3(a). However, the Court made clear that SPCs are intended to be available without discrimination for the type, or stage, of research leading to the grant of the basic patent.
The judgment provides welcome guidance on the interpretation of Article 3(a) and confirms the availability of SPCs for products based on functional claim language (such as for antibodies defined by their binding target). On Friday Lilly was been granted leave to appeal, so the issues will be reviewed further in due course.
"The purpose of this paper is to set out and discuss the recent jurisdictional developments in the European Court of Justice (ECJ) with respect to supplementary protection certificates (SPCs) including paediatric extensions. During the past five years the ECJ has been particularly active and has clarified a number of highly controversial legal ambiguities, such as the availability of negative term SPCs".
You can check out the contents of the issue in which this article appears here, where you will spot the names and contributions of quite a few of our friends and blog-readers.
As readers will know, we've not yet been able to sort out a date for this year's SPC Blog Seminar but we are aiming for late October, a rather lovely time of year to be in London, in all its autumnal splendour. Further details will be posted as soon as available.
Meanwhile, blog team member Robert Stephen is amenable to suggestions for topics and speakers. If you have suggestions for either, can you please email Rob at Robert.Stephen@olswang.com and let him know.
The lengthy, complex and controversial litigation in Italy over Xalatan and Pfizer's attempts to preserve its market in Italy has been chronicled on this weblog (see earlier SPC Blog posts, listed here). It is also being written up in the legal literature. Here's news of two recent case notes.
"The Highest Italian Administrative Court has the Final Word on the Xalatan Case and Reinstates the Original Infringement Decision of the Italian Competition Authority", by Michele Giannino (Desogus Law Office) appears in the current issue of the Bio-Science Law Review (BSLR) which, incidentally, has a 20% reduction offer for new subscribers that finishes today.
"Pfizer's misuse of patent/SPC rights results in an abuse of dominant position", by Gian Paolo Di Santo (Studio Legale Pavia e Ansaldo) appears in the July 2014 issue of the Journal of Intellectual Property Law & Practice (JIPLP), Gian Paolo having acted in this case for Assogenerici and some of the original plaintiffs against Pfizer.
Almost two years ago to the day, The SPC Blog reported on the fate of the unhappy fate of the SPC for Telmisartan + hctz in Spain (see "Telmisartan + hctz: combination SPC revoked in Spain", 26 June 2012, here, and "Telmisartan + hctz: combination SPC in Spain -- now in English" (8 July 2012, here.
This decision, invalidating the SPC, has now been upheld on appeal: see "Navarra Court of Appeal confirms invalidity of Spanish SPC for telmisartan + hctz", written for today's International Law Office release by Sara Pelaz (Grau & Angulo), here. This helpful note adds that Boehringer still has the option of lodging an appeal with the Spanish Supreme Court.

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