The SPC blog
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
Sunday, 19 October 2014
Monday, 6 October 2014
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.
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".
Thursday, 2 October 2014
Valsartan HCT France: the end of ex parte preliminary injunctions in France?
The Supreme Court confirms the Paris Court of Appeal, rescinding the ex parte Order of the First Instance Court
previous post of January 11, 2013) reversing the Ruling of the judges in Chamber of the First Instance Court maintaining the ex parte interim measures against the companies SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS ("SANOFI") (post of November 4, 2011)
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's first ground of appeal
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.
NOVARTIS's second ground of appeal
To question the decision issued by the Court of Appeal, NOVARTIS argued that:
* The mere fact that the delay to take interim measures could cause an irremediable harm justified the granting of ex parte interim measures,
* The Court of appeal, to say that the prejudice was not irreparable, ignored the ratio legis of the SPC by ruling that investments to discover the originator product had been compensated by both the patent and the SPC,
* The loss of French market share, an accelerated decrease of the price of the products incorporating Valsartan in France and subsequently in Europe, the launch of other generic medicinal products, the development of parallel imports and the disturbance of the treatments for patients, constitute a very hardly quantifiable prejudice and therefore an irreparable prejudice,
* The loss of market share, a price war, parallel imports and the disincentive to innovation simply cannot be reparable by the payment of damages.
However the French Supreme Court considered that since the Court of Appeal found that:
* The SPC of Novartis expired 17 days after the submission of the application, it was still time to obtain a decision from the judge by complying with the principle of contradiction, by ordering through inter parte proceedings, since there are urgent short-notice summary proceedings;
* There was an uncertainty regarding the imminent marketing of the products on the day of the submission of the application, the prejudice resulting from the marketing of the products 17 days before the supplementary protection certificate expiration was likely to be compensated by the payment of damages it could have obtained inter partes interim measures through urgent short-notice summary proceedings,
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.
“But whereas after having acknowledged that the CCP expired 17 days after the presentation of the petition, the judgment noted that it was still possible on October 27, 2011 to obtain, before Nov. 13, 2011, a decision from the judge respecting the principle of contradiction, through urgent short notice summary proceedings or at a very early date by invoking the emergency; after having also noted that there was a doubt about the imminent commercialization of the products concerned on the date of presentation of the petition, it holds that the harm that would result from the marketing of generic 17 days before the expiration of the CCP was capable of being remedied by the award of damages; that these sovereign findings and assessments, apart from the superfluous reasoning criticized by the first part, the Court of Appeal, which was not bound to follow the parties in the details of their argument, could conclude that the circumstances requiring urgent measures under Article L 615-3 of the Code of intellectual property are taken ex parte were not met; that the plea is unfounded”
NOVARTIS's third ground of appeal
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.
“But whereas the Court of Appeal had held that the requirements to proceed ex parte were not met, the appeal is irrelevant”
Wednesday, 24 September 2014
“The purpose of the present Official Communication is to inform that after analyzing the arguments filed on 06/06/2012 related to Supplementary Protection Certificate (SPC) 474, the date of the Marketing Authorization (MA) that is used to calculate the expiry date is, according to Article 13(1) of Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009, the date written in the MA, in this particular case 07/12/2011.”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 Court decision was based on the following most relevant reasons:
“…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 further clarifies:
“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.Thus, this decision confirmed that the date to be considered in the calculation of the duration of a SPC is the date of notification of the decision. Briefly, the Court decided that:
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.
It would not be understandable how an administrative act granting the authorisation for the practice of a fact could produce effects before its notification to the addressee and how the addressee could know that he/she may legitimately practise that fact without being aware of that decision”
* the decision of grant of a Marketing Authorisation has effect as from its date of Notification, not from the Decision date;
Earlier news from was posted by João on The SPC Blog here this April.* 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.
Friday, 19 September 2014
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.
Wednesday, 10 September 2014
The seminar, held on Thursday 6 November 2014, runs from 1.30 pm until 6 pm. It will address the following topics:
• Review and analysis of pending CJEU referrals and recent CJEU decisions - Robert Stephen, Olswang LLPThere will be plenty of time for questions and a drink afterwards.
• “What’s up?” from the perspective of the IPOs - Various international IPO representatives
• SPCs involving medical devices - Charlotte Teale, Forresters
• SPCs for biologics - Mike Snodin, ParkGrove IP
• Amending and attacking SPCs – Dorothea von Renesse, König Szynka Tilmann von Renesse
• ‘Quick updates’ - notification dates and more…
Do join us once again! You are very welcome.
Tuesday, 9 September 2014
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.
Monday, 8 September 2014
In this article, Mike discusses the decision of the CJEU in Case C-555/13 Merck Canada. While acknowledging the effect that the ruling has in curtailing the term of Portuguese SPCs based upon certain "old law" patents, he argues that the ruling ought to also provide some beneficial side-effects, in the form of:
(a) increased harmonisation of SPC expiry dates across the EU andThe 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.
(b) an additional day's term for some SPCs in certain countries (such as the UK).
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!
Wednesday, 20 August 2014
EFTA COURTThis 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.
Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 16 June 2014 in the case of Pharmaq AS v Intervet International BV (Case E-16/14)
1. Concerning Article 2 of the SPC Regulation, has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC (or Directive 2001/82 EEC) when delivery of the product has taken place in accordance with
(i) “special approval exemptions” granted by the State Medicines Agency to veterinarians and fish health biologists pursuant to Section 3-6 or 3-7 of the Norwegian Regulation of 22 December 1999, alternatively Sections 2-6 or 2-7 of the Norwegian Regulation of 18 December 2009, or2. 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?
(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?
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)?
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?
In answering this question, is it of significance whether
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?6. If an SPC has been granted with a product definition that is not strictly limited to the specific strain of the virus authorised to be placed on the market as a medicinal product,
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?
a) will such an SPC be valid, or
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?
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.