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

Friday, 24 October 2014

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.

Sunday, 19 October 2014

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.

Monday, 6 October 2014

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".

Thursday, 2 October 2014

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.

Wednesday, 24 September 2014

Calculation of dates in Portugal: notification of MA

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.

During prosecution, Takeda filed a note with the PTMO with their arguments in favour of using the Notification date (09/12/2011) instead of the Decision date (07/12/2011) for the calculation of the SPC expiry dates. This SPC was granted on 25/09/2012 with the duration being calculated using the Decision date. The Patent Office argument was the following: 
“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.

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”
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:
* the decision of grant of a Marketing Authorisation has effect as from its date of Notification, not from the Decision date;
* 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.

Friday, 19 September 2014

Bayer CropScience: case note published

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.


Wednesday, 10 September 2014

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.

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 LLP
• “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…
There will be plenty of time for questions and a drink afterwards.

Do join us once again! You are very welcome.

Tuesday, 9 September 2014

The Pastors Report 2014: now published

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.

Monday, 8 September 2014

Merck-y ruling has a silver lining ...

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.

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 and
(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!

Wednesday, 20 August 2014

Pharmaq AS v Intervet International BV

Of immediate relevance to the blogpost that appeared earlier this afternoon is this announcement from the EFTA Court (reproduced in full below):
EFTA COURT

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)

A request has been made to the EFTA Court by a letter dated 17 July 2014 from Oslo tingrett (Oslo District Court), which was received at the Court Registry on 23 July 2014, for an Advisory Opinion in the case of Pharmaq AS v Intervet International BV, on the following questions:

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, or

(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?

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?

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?
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,
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?
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.