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.

Compliance with Article 3(a): will Eli Lilly help? Here's a new article

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.

Seattle "Relevant date" reference: UKIPO seeks comments

Back in October The SPC Blog posted a this item from Daniel J. Wise (Carpmaels & Ransford), "Austria refers Seattle Genetics to CJEU: is "relevant date" for EU or national law?". The UK Intellectual Property Office is now seeking comments on this reference, with a view to advising the UK government as to whether it wishes to make representations in this reference. According to the UKIPO's media release:

CJ case: C-471/14: SEATTLE GENETICS

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.

The questions referred to the Court of Justice (CJ) for a preliminary ruling are:

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?

This case and the questions referred to the Court can also be viewed on our website at:

https://www.gov.uk/government/publications/references-to-the-european-court-of-justice/references-to-the-european-court-of-justice-2014

If you would like to comment on this case please e-mail policy@ipo.gov.uk by 01 December 2014.

The UKIPO provides further information about its solicitation of comments:

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. 

Patent term extensions: a new book, hot off the press

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.

According to the abstract

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.

Many of the contributors of chapters will be known to readers of this blog. Apart from the editor himself you will encounter the efforts of

• Cheol-Gyoon Ahn, Senior Korean Patent Attorney, Seoul, Korea 
• Eran Bareket, Attorney at law, Tel-Aviv, Israel 
• Chen Ben Dori-Alkan, Attorney at Law, Tel-Aviv, Israel
• Ronnie Benshafrut, Patent Attorney, Tel-Aviv, Israel 
• Ruth Fang, Attorney at law, Taipei, Taiwan 
• Dr. Nicolai von Füner, Patent Attorney, Munich, Germany
• Dr. Siegfried Grimm, Patent Attorney, Zürich, Switzerland 
• Brion P. Heaney, Patent Attorney, Arlington, USA 
• In-Hwan Kim, Senior Foreign Legal Counsel, Seoul, Korea 
• Peter Maddigan, Barrister, Sydney, Australia 
• Dr. Arne Markgraf, Attorney at law, Berlin, Germany 
• Dr. Olaf Meiselmann, Munich, Germany 
• Kristian Robinson, Patent Attorney, Singapore 
• Dr. Regula Rüedi, Patent Attorney, Zürich, Switzerland 
• Harry B. Shubin, Patent Attorney, Arlington, USA 
• Damian Slizys, Patent Attorney, Melbourne, Australia 
• Yoichi Watanabe, Patent Attorney, Tokyo, Japan 
• Paul Whenman, Patent Attorney, Sydney, Australia

The SPC Blog looks forward to reviewing this book in due course.

SPC Blog Seminar presentations: now available online

Here, in record time thanks to the efficiency of our friends at Olswang LLP, are the video links to the seven speaker presentations from ""SPC Law and Practice: All You Need to Know", this year's SPC Blog Seminar:

Review and analysis of pending CJEU referrals and recent CJEU decisions (Dr Robert Stephen, Olswang LLP) here 

Amending and attacking SPCs (Dr Dorothea von Renesse, König Szynka Tilmann von Renesse) here 

What’s up?” from the perspective of the IPOs   

• Patrick Purcell,  UK IPO here

• Dr Oliver Werner, German Patent Office here

• Dr Martijn de Lange, Dutch Patent Office here

SPCs involving medical devices (Charlotte Teall, Forresters) here 

SPCs for biologics (Mike Snodin, ParkGrove IP) here 

The PowerPoints for the various sessions, together with the speakers' biographical details, have already been uploaded for your delectation and can be accessed here.  

The seminar's SPC Law and Practice 2014 - Q&A session can be viewed here

Israel's Commissioner acts on "wrongfully given bureaucratic decision" on Bazedoxifene

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.

SPC Blog PowerPoints and biographies now available

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 SPC Bog seminar 2014

SPCs for fish vaccines? Or is this
the dawning of the Age of Aquarium ...?

This is just a quick note to let readers know that

• the speakers' PowerPoints and notes will all be made available on this weblog in the near future;
• 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!

Specific Mechanism applies to paediatric extensions, says Danish Court

From Martin Dræbye Gantzhorn (Partner, Head of Life Science & Healthcare, Horten Advokatpartnerselskab, Copenhagen) comes this swift, short note to inform readers of The SPC Blog that in October the Danish Maritime and Commercial Court rendered a very rare decision on the scope of the "Specific Mechanism". The proceedings concerned the question whether a paediatric extension to a SPC will also prolong the patentee's protection under the "Specific Mechanism". In short:

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.

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.

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.

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.

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.

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.

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!

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.

Special approval exemptions in a nutshell: a request for help

This blog has recently received a request for assistance from an enthusiastic young student who writes:

"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.

Patent term extension in Israel: a recent ruling

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!

Medical Devices Directive authorisation no good for SPC

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.

A Bulgarian milestone as Supreme Court rules on Atripla application

From our friend Dimitar Batakliev (IP Attorney, Bulgaria) comes the following news:

"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.

In a decision of 8 June 2014 the Court held that the claimed product, consisting of efavirenz, emtricitabine and tenofovir disoproxil fumarate, was not protected by the basic patent BG 62612 and therefore did not meet the requirements of Article 3 of the SPC Regulation. According to the court, this combination was outside the scope of claim 8 which protected 

“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.

EU Association Agreements with Ukraine, Georgia and Moldova: impact on patent term

A recent Petosevic News & Resources post contains an item, "Ukraine, Georgia, Moldova Sign EU Association Agreements" which mentions, among other things, the amendments to domestic intellectual property law which those three countries will be expected to make in return for closer trading ties with the European Union. One such requirement is that

"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.

SPCs based on functional claims, tabalumab and Neutrokine-α

The decision of Mr Justice Warren in Eli Lilly v Human Genome Sciences Ltd [2014] 2404 EWHC (Pat) in the Patents Court, England and Wales, was handed down on Friday. While it's still not available on BAILII, this judgment is currently being kindly hosted by our friends at Powell Gilbert LLP who represented HGS (now part of GSK) in these proceedings. Powell Gilbert have also furnished us with the following note on this ruling which, with minor edits, we reproduce in full:

Lilly v HGS – Article 3(a) SPC Regulation – Guidance on obtaining SPCs based on functional claims

Summary

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.

Background

Human Genome Sciences, Inc. (“HGS” – now owned by GlaxoSmithKline) is the proprietor of European Patent (UK) No 0 939 804 which relates to and claims a novel protein called Neutrokine-α and antibodies which bind specifically to it. The patent has been held to be valid by the UK Courts (including the Court of Appeal and Supreme Court) and the Technical Board of Appeal of the European Patent Office. Of particular importance is the wording of claim 13 which claims:

“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.  

The judgment of Warren J

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. 

What next?

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.