Opinion of Advocate General out on joined referrals C-650/17 (Royalty Pharma) and C-114/18 (Sandoz v Searle)

The Opinion of Advocate General Hogan on CJEU joined referrals C-650/17 (Royalty Pharma) and C-114/18 (Sandoz v Searle) has now been published on the Curia website (here).

As you may recall, the questions referred in the Royalty Pharma (C-650/17) were:

Is a product protected by a basic patent in force pursuant to Article 3(a) of Regulation (EC) No 469/2009 only if it forms part of the subject matter of protection defined by the claims and is thus provided to the expert as a specific embodiment? 

Is it not therefore sufficient for the requirements of Article 3(a) of Regulation (EC) No 469/2009 if the product in question satisfies the general functional definition of a class of active ingredients in the claims, but is not otherwise indicated in individualised form as a specific embodiment of the method protected by the basic patent? 

Is a product not protected by a basic patent in force under Article 3(a) of Regulation (EC) No 469/2009 if it is covered by the functional definition in the claims, but was developed only after the filing date of the basic patent as a result of an independent inventive step?

The questions referred to in the Sandoz v Searle case (C-114/18) were:

Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?

The Advocate General proposes that the questions are answered as follows:

The two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and in the operative part of that judgment applies both to products consisting of a single active ingredient and products composed of several active ingredients;

The concept of the ‘core inventive advance’ of the patent does not apply and is of no relevance in the context of Article 3(a) of Regulation No 469/2009; 

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products does not preclude the grant of a supplementary protection certificate for an active ingredient which is covered by a functional definition or a Markush formula provided, however, that the two-part test set out in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and in the operative part of that judgment is satisfied; 

The two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and in the operative part of that judgment must be applied from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent; 

The first part of the two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and the operative part of that judgment is not satisfied and an SPC may not be granted in respect of a product if, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent, the claims in a patent in relation to that product are not required for the solution of the technical problem disclosed by a patent; 

The second part of the two-part test referred to in paragraph 57 of the judgment of 25 July 2018, Teva UK and Others (C‑121/17, EU:C:2018:585) and the operative part of that judgment requires that it be established that a person skilled in the art would have been able, in the light of all the information contained in a patent, on the basis of the prior art at the filing date or priority date of the patent in question, to derive the product in question. This is not the case where, in the light of all the information contained in a patent, a product or constituent element of the product remains unknown to a person skilled in the art on the basis of the prior art at the filing date or priority date of the patent in question.

Many thanks to Oswin Ridderbusch and Alex von Uexküll (Vossius and Partner) for pointing this opinion out to us. 

The SPC Blog Seminar 2019 is open for registration!

This year's seminar run by The SPC Blog, "SPC Law and Practice 2019”, is now open for registration. After a year with our SPC feet up, the new referrals have re-opened some issues and we’ll be taking the usual focussed look at the evolving case law and practice with speakers from private practice and the IPOs.  This event will take place at CMS in London, located at 78 Cannon Street on the afternoon of Friday 20 September 2019.

The link to the registration form can be found here



The planned agenda (allowing for some evolution!) is:



1          Introduction and review of pending CJEU referrals (C354/19, C239-19, C114/18, C650/17  - Gareth  Morgan,  CMS

2          C-443/17 - Abraxis CJEU Judgement   - Daniel Wise, Carpmaels & Ransford

3          The Santen referral (C-673/18) -  Thomas Bouvet, Jones Day, Paris

4          Comments on implementation of recent decisions and hot topics- Representatives of the national IPOs

5          Manufacturing waiver – all systems are now go – Robert Stephen, CMS

6          Medical device SPCs – Nick Fischer and Andrew Hutchinson, Simmons & Simmons

7          Q&A



We hope that you can join us.

Update on the SPC export and stockpiling waiver

Following its approval by the European Parliament in April, the final legislation amending SPC Regulation EC/469/2009 – Regulation (EU) 2019/933 of 20 May 2019 – was published in the Official Journal of the EU on 11 June 2019, and will now enter into force on 01 July 2019

Thank you to Andrew Hutchinson and Nicholas Fischer of Simmons & Simmons for passing this on and providing some commentary on the new legislation, which is available here.

New SPC reference to the CJEU on Article 3(c) – Novartis (C-354/19)

Carpmaels & Ransford and Awa have kindly prepared the following summary on a recent SPC reference to the CJEU:

"The Swedish Patent and Market Appeal Court has made a reference to the CJEU relating to the interpretation of Article 3(c) of the SPC Regulation for Medicinal Products, in light of Article 3(2) of the SPC Regulation for Plant Protection Products. In brief, the court is asking whether, in a case such as the present, an SPC to a new therapeutic indication is available where the applicant has an earlier SPC to the same active ingredient.

Article 3(c) of the Medicinal Products Regulation states that one of the requirements for SPC grant is that “the product has not already been the subject of a certificate” in the same member state and at the date of the SPC application. Article 3(2) of the Plant Protection Regulation provides that “[t]he holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders”, while Recital 17 of the Plant Protection Regulation suggests that Article 3(2) is also valid for the interpretation of Article 3 of the Medicinal Products Regulation.

The Swedish SPC application underlying this reference is based on Novartis’s marketing authorisation for the medicinal product Ilaris®, which contains the anti-IL1beta antibody canakinumab. The marketing authorisation supporting the SPC application is a decision from 2013 which for the first time authorises canakinumab for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a serious condition responsible for high childhood mortality and severe morbidity. The corresponding basic patent is limited to the use of antibodies such as canakinumab in the treatment of juvenile rheumatoid arthritis.

Novartis has an earlier granted SPC based on a separate patent which protects the canakinumab antibody per se. The SPC is supported by a marketing authorisation for canakinumab in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which is a different indication from SJIA and which falls outside of the scope of the patent that supports the later SPC application.

In view of the existence of the earlier SPC, the Swedish court is asking whether Article 3(c) in light of Article 3(2) precludes the grant of the later SPC application, which relates to a new therapeutic indication protected specifically by its own basic patent. The Swedish court has therefore referred the following question to the CJEU (our translation):

Against the background of the basic objective that supplementary protection for medicinal products aims to accommodate and which consists of stimulating pharmaceutical research in the Union, does Article 3(c) of the Regulation concerning Supplementary Protection Certificates for medicinal products, considering Article 3(2) of the Regulation concerning the creation of a Supplementary Protection Certificate for plant protection products, constitute an obstacle against an applicant, that has previously been granted a Supplementary Protection Certificate concerning a product which is protected by a basic patent in force for the product as such, being granted a Supplementary Protection Certificate concerning a new use of the product in a case such as the present where the new use constitutes a new therapeutic indication which is protected specifically by a new basic patent?

Carpmaels & Ransford represents Novartis AG in respect of its Ilaris® product. AWA represented Novartis AG before the Swedish patent office and courts in relation to the Swedish SPC application."

Free SPC Seminar in London tomorrow!

Daniel Wise of Carpmaels & Ransford has written in to the Blog to say that there are a few last places available for Carpmaels’ annual “SPC Summer Review” event taking place tomorrow, Wednesday, 12th June 2019, from 17:30 (for a 18:00 start) at their offices in central London (One Southampton Row, WC1B 5HA).  The seminar will focus on this year’s CJEU referrals and national court decisions, including the ongoing debates on the meaning of Article 3(a) and the validity of SPCs filed on competitors’ products.  Dr Oliver Werner from the German Patent Office will also be on the panel to discuss the new SPC manufacturing waiver.  Drinks and canapés will be served afterwards.  If you would like to join, please send an email to kirstie.mcclumpha@carpmaels.com, with the subject line “I would like to attend the SPC Summer Review 2019”.  Attendance is free of charge.

C-443/17 - Abraxis CJEU Judgement

The CJEU has today handed down judgment in the case C-443/17 (Abraxis Bioscience), link here (English version). Thank you to Andrew Hutchinson and Nicholas Fischer of Simmons & Simmons for providing some commentary on the decision.

The CJEU’s full answer is as follows:

“Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, read in conjunction with Article 1(b) of that regulation, must be interpreted as meaning that the marketing authorisation referred to in Article 3(b) of that regulation, relied on in support of an application for a supplementary protection certificate concerning a new formulation of an old active ingredient, cannot be regarded as being the first marketing authorisation for the product concerned as a medicinal product in the case where that active ingredient has already been the subject of a marketing authorisation as an active ingredient.”

The decision follows the AG Opinion in December 2018 (covered on the SPC blog here and also by Andrew and Nicholas here). The decision is quite short, and the main points are that:

• MAs for “new formulations” of ‘old’ active ingredients do not qualify for “first MAs” under Article 3(d) (or 3(b));
• Unlike the AG Opinion, the CJEU did not go so far as to overrule Neurim; and
• The CJEU does not state that Neurim is limited to its facts (i.e. veterinary-to-human), but the reasoning indicates that the direction of travel is a very narrow approach.

Overall, the decision avoids giving full and definitive guidance on the scope of the Neurim exception. In particular, a considerable portion of the judgment is spent emphasising that Abraxane is paclitaxel and not a new “product” under Article 1(b) (which was not in issue having been decided by the UKIPO and affirmed by Arnold J, and so not referred). However, what seems clearer is that “new formulations” will not succeed and the reasoning emphasises that the CJEU will adopt a narrow approach under Article 3(d). This raises question marks for strategies that have been deployed seeking SPCs in reliance on Neurim, in particular those that do not have the veterinary-to-human facts. We may know more on this issue soon given the pending referral from the French courts in Santen (C-673/18).

Forum Institut SPC Seminar 2019

From Rechtassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of an SPC-related seminar which he is organising:

'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2019 and on how to understand the decisions and which practical consequences we may expect for the future. A half-day pre-course will be offered for attendees without prior SPC knowledge/education.

Date: 10 May 2019 (pre-course: 9 May 2019); venue: Amsterdam.

More information is available here. 

To register, just forward this blogpost to Jean-Claude at jc.alexandreho@forum-institut.de or click here.

Darunavir in Swedish Preliminary Injunction Proceedings

Recently, the Paris High Court decided for a preliminary injunction against the commercialisation of Darunavir by Sandoz, the SPC Blog report can be found here. In parallel proceedings, the Swedish Patent and Market Appeal Court has come to the opposite conclusion, and found that that the contested SPC would most likely be found invalid and thus denied a request for a preliminary injunction. Hampus Rystedt from Zacco has kindly provided the following summary of the case.

The first instance Patent and Market Court, which is quite experienced in SPC appeals originating from the examination at the Swedish Patent Office, granted a preliminary injunction. The Patent and Market Appeal Court however reversed the decision. The PMAC specifically referenced the Teva case from the CJEU (C-121/17; EU:C:2018:585) and found that the criteria set out in Teva should be applied when assessing the plausibility that an SPC will be considered valid. The PMAC finds that darunavir is not specifically identified in the claims, and indeed appears to have been first synthesized only after the priority date. The PMAC therefore finds that it is likely that the SPC will be considered invalid in the main proceedings and that a preliminary injunction cannot be granted.

Of interest to note is that the decision in PMAC was split 3 to 2, with the chairwoman and the only chemical expert dissenting. The two dissenting judges found that the case law is not clear on how Art 3(a) of 469/2009 should be applied when the basic patent defines the invention by means of a Markush-formula. These judges were thus of the opinion that it had not been sufficiently shown that the SPC would likely be held invalid, and that the preliminary injunction granted by the lower court should be upheld.

The main proceedings will now continue in the first instance court.

Many thanks Hampus!

Update on SPCs in China

Following our short post last May (here) about patent term extensions in China, Michael Lin and Xiaoyang Yang of Marks & Clerk have recently published an update on the progress for introducing supplementary term certificates in China, as well as patent linkage and data protection, in the Newsletter of the AIPLA Chemical Practice Committee (here).

In short:

"On January 4, 2019, the Standing Committee of the National People’s Congress (hereinafter the “SCNPC”) released the draft amendments to the Chinese Patent Law for public comment.  Article 43 of the draft amendments allows for SPC, and provides that innovative drugs introduced to the Chinese market concurrently with overseas market could be eligible for a maximum of five-years extension to the patent term, wherein the remaining patent term after the extension should be no greater than fourteen years.
It is likely that the draft amendments would be reviewed by the SCNPC at least once more, and so it remains to be seen whether the SPC provisions will be sustained and/or revised. "

Many thanks to Michael Lin, Xiaoyang Yang and Roy Isaac (AIPLA) for allowing us to share this update with SPC Blog readers. 

No more launch at risk in France?

Recently, the Paris High Court decided for a preliminary injunction against the commercialization of Darunavir by Sandoz.  A copy of the decision is available here.  Matthieu Dhenne from Dhenne Avocat has kindly provided the below summary for the case. 

A recent decision of the Paris High Court (January 11, 2019) decided preliminary injunctions against the Darunavir commercialization by Sandoz (Prezista generic). The SPC was found to be presumably valid and thus infringed by Sandoz.  

The question was: how should we applied article 3(a) SPC Regulation (Regulation (EC) No. 469/2009)?  We must beforehand recall that the CJEU has never ruled on how article 3(a) should be applied with respect to a Markush claim. Thus, should darunavir be considered as being “specified in the wording of the claims” (Medeva)? Or should we hold that the claim “relates, implicitly but necessarily and specifically“ to darunavir (Eli Lilly)? But maybe those questions are irrelevant since the claim is not a functional one? 

Firstly, the Paris High Court analyzed the CJEU case law about SPC and concluded that the Eli Lilly test was not applicable to a Markush claim:

“It should be noticed that, in Eli Lilly, the case concerned a functional claim, so that the CJEU insisted on a double condition of necessity and specificity. In the present case, the claims of the basic patent are structural and better allow the skilled person to determine in view of the claims whether the active compound protected by the SPC was covered by the basic patent.” 

Secondly, following the examination of the formula of claim 1 of the patent and the various meanings of the variable groups in this claim and some of the dependent claims, the Judge concluded that: 

“Thus darunavir is identified by the skilled person as being implicitly but necessarily and specifically protected by the EP’209 patent in view of the substituents identified in the claims, in keeping with the requirements of article 3(a) of the EC Regulation and of the CJEU case law.” 

Therefore, the judge considered that the defendant did not prove that the SPC was manifestly invalid. Accordingly, a preliminary injunction was ordered, under a 50,000 euro-penalty per violation of the injunction. The judge also ordered a seizure of the infringing drugs, as well as a product recall. 

The recent French case law (and the reform of nullity actions limitation period with PACTE Law?) send a clear sign to the drug manufacturers: launch at risk should now be avoided in France.

Thank you Matthieu!

Recent developments to the SPC manufacturing waiver proposal

As most SPC Blog readers will know, in May 2018, the European Commission published its proposal to amend the SPC Regulation (Regulation (EC) 469/2009) to introduce a manufacturing waiver, i.e. an exception to allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals to export outside the EU during the SPC term (see here for SPC Blog post). 

Recently the Council of the European Union has published its final mandate (here) for negotiations with the European Parliament on this proposal. 

Andrew Hutchinson and Nicholas Fischer have summarized where things now stand with this proposal in an article, which can be accessed here.  Thanks Andrew and Nicholas!