The Court of Justice: who needs it? A new article

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?

From our friend Daniel J. Wise (Partner, Carpmaels & Ransford LLP ) comes the following information about a development from Austria:

On 15 October 2014 the Oberlandesgericht Österreich referred questions to the CJEU on a preliminary ruling regarding the calculation of the SPC term under Article 13 of the SPC regulation.  The case has been assigned the reference number C-471/14 (Seattle Genetics).    The referral not only asks whether under Community law the authorisation’s notification or the decision date should be used to calculate the SPC term, but crucially first asks whether Community law even applies, or whether instead the relevant date should be determined under national law.  The referred questions are (translated from the original German-language decision):  

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.  

It will be interesting to see what the CJEU says.  It would be short-sighted if the CJEU only answered these questions with reference to Article 13, though.  Whatever the answers, SPC applicants will want to know if the same logic applies to Articles 3(d) and 7 as well ... 

Thanks so much, Daniel, for taking the trouble to share this with us.

Merck and the Specific Mechanism: the Advocate General offers some guidance

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.

The questions read as follows:

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? 

2 If the answer to Question 1 is yes:

(a) How must that intention be demonstrated?

(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights? 

3 Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:

(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?

or

(b) Where. as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?;  and

(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?

(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product? 

4 To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:

(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?

or

(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC, or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?

If the answer to Question 4(b) is yes, 

(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?

Yesterday the CJEU's Advocate General offered the following Opinion as to how these questions should be answered:

Questions 1 and 2

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.

Question 3

The notification required under the second paragraph of the aforementioned Specific Mechanism may be carried out by someone other than the potential importer and marketer provided that the identity of the latter is clearly identified by the notifying entity.

Question 4

Prior notification under the second paragraph of the aforementioned Specific Mechanism must be given to a person who has a legal right under national law to bring proceedings to enforce the patent or supplementary protection certificate.

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.

Ezetimibe in Israel: a recent ruling on retroactive effect

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.

Pradaxa in Portugal: IP court trumps Patent Office refusal

A note on Boehringer Ingelheim Pharma GmbH & Co. KG v Instituto Nacional da Propriedade Industrial (Case File No. 300/13.0HYLSB) appears in the most recent BMA Newsflash from the Lisbon, Portugal firm of Baptista, Monteverde & Asociados.  It reads like this:

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!"

From our friends Arnaud Casalonga and Floriane Codevelle of Casalonga et Avocats and Gérard Dossmann, Patent attorney of Casalonga & Associés, whose firms acted as counsel to Sanofi, comes the following information for which The SPC Blog offers its sincere thanks:

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

This post relates to the Appeal before the French Supreme Court concerning the ruling of the Paris Court of Appeal of December 11, 2012 (see our 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. 

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. 

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.

“But whereas the Court of Appeal had held that the requirements to proceed ex parte were not met, the appeal is irrelevant”

This decision (in the original French) can be downloaded here or accessed online here.