The SPC blog

SPC blog event in person - October 2024

2024-08-16T14:15:00.006+01:00

If you have not yet moved over to the SPC blog on LinkedIn, you will have missed the heads-up about the next SPC blog event in London on 15th October 2025. So we've reproduced it here....

The invitation to join the SPC blog event at CMS in London on 15 October is here!

https://lnkd.in/dbAwekUb

We will be joined by patent office examiners from, inter alia, the UK, Ireland, the Netherlands, France and Hungary, and the current agenda will include:
1       Update from various patent office examiners on national law developments;
2       Darren Smyth from EIP on Merck Serono's appeal in the UK Courts on Article 3d;
3       Denis Schertenleib from Schertenleib Avocats on some recent decisions from the French Courts;
4       Lawrence Cullen (Deputy Director, UIKIPO until June 2024) on the AG opinion in CJEU cases C119/22 and C149/22;
5       The state of play at the EU on changes to the SPC regulations, and
6      A question and answer session to mop up the rest!
We hope you can join.
The event is free to attend - with the caveat that if we are oversubscribed, we'll likely have to limit to 2 people per organisation.

SPC blog moves to Linkedin!

2024-06-20T10:35:00.001+01:00

We've moved the blog contents to LinkedIn here. Please do check us out on the new platform!

2020-10-07T14:22:00.001+01:00

MSD’s ezetimibe-simvastatin SCP revoked by the Paris Court of Appeal

Thanks to Jean-Baptiste Thiénot & Alexandre Ghanty of CMS Francis Lefebvre Avocats for the recent update from France - reproduced below.

In a case involving Merck Sharp and Dohme (MSD) and TEVA, Paris Court of Appeal issued an interesting decision on 25 September 2020 regarding both articles 3(a) and 3(c) of Regulation EU No.469/2009, widely in line with the ruling adopted by the CJEU in Actavis v. Sanofi (CJEU, C-443/12, 12 Dec. 2013).

Background

MSD obtained two SPCs on the basis of the same patent (EP 0 720 599) entitled “hydroxy-substituted azetidinone compounds effective as hypocholesterolemic agents”.

A first SPC had been granted to MSD on 4 February 2005 on the basis of EP 599 for a drug whose API was ezetimibe (EZETROL®).
A second SPC had been granted nearly 2 years later, on 21 December 2006, on the basis of the same patent but this time for a combination product ezetimibe + simvastatin (INEGY®).

The dispute

TEVA launched a revocation action against the second SPC, arguing – among other things - that the combination product at stake was a mere variation of the invention protected by the patent, and not a distinct “product” from ezetimibe alone, in breach of both articles 3(a) and 3(c).

TEVA’s claims have been dismissed by Paris First instance Court on 25 October 2018. In parallel, a few months later (on 08 February 2019), MSD obtained preliminary injunctions against other generic companies on the basis of this ezetimibe + simvastatin SPC.

This decision has been reversed. Indeed, on appeal, TEVA obtained from the Court of Appeal the revocation of the ezetimibe + simvastatin SPC in a decision dated 25 September 2020.

Regarding article 3(a), although the patent at stake specifically mentions the combination ezetimibe-simvastatin, the court considered that such combination cannot be deemed as “protected by a basic patent” within the meaning of the Regulation. In other words, the Court considers that patent EP 599 contains only one invention and that the combination with simvastatin cannot be regarded as another invention. Indeed, it emphasizes that the specification uses the singular when designating the invention, presents the combination as “another aspect of the invention”, and makes no distinction in therapeutic effect between the mono and the combination therapies. Besides, it is noted that the skilled person, who was deemed aware of the possibility of combining two anticholesterolemic drugs having different mechanisms of action and who was familiar with simvastatin, would not consider the ezetimibe-simvastatin combination to constitute an innovative product (towards ezetimibe alone).

Regarding article 3(c), the court recalled, in application of Actavis v. Sanofi, that where the holder of a patent has already obtained a SPC for an active ingredient entitling him to oppose the use of that active ingredient, either alone or in combination with other active ingredients, such article must be interpreted as precluding that patent holder from obtaining a second SPC relating to that combination.

To the extent that the ezetimibe-simvastatin combination is not deemed to constitute an innovative product, the Court considered that the first SPC granted for the use of ezetimibe should allow, in itself, MSD to oppose to the marketing of a drug containing ezetimibe in combination with simvastatin.

This decision was predictable since the Court of Appeal used the same reasoning a few months ago (14 February 2020, cases No. 19/03820 (Sandoz) and No. 19/06114 (Mylan) as reported by the SPC blog here) to revoke the preliminary injunctions granted to MSD on the basis of this ezetimibe + simvastatin SPC.

What next?

The battle is not over: an appeal before the Cour de cassation is pending in the above-mentioned preliminary injunction cases and the same is expected in the Teva v. MSD case.

Although the means are quite different here than in the Santen case (CJEU, C-673/18, 9 July 2020), the trend seems to be the same, leading to a stricter approach in the analysis of the conditions of SPCs where the basic patent has already given rise to a first SPC. As it has been observed in Abraxis Bioscience, “the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product” (CJEU, C-443/17, 21 March 2019, §37).

Korean IPTAB Issues Leading Decision on Patent Term Extension (PTE) - Enforceable Scope Related to Medicinal Use

2020-07-21T08:14:00.000+01:00

Thanks to Sang Young LEE and Kevin Kyumin LEE of Kim & Chang for some news from Korea - reproduced below. There is no published decision available yet, and we will post it once it appears.

"In contrast to some foreign jurisdictions where the patent scope during PTE covers all types of use, Article 95 of the Korean Patent Act stipulates that PTE patent scope should be restricted to the specific use of the approved originator product. It was generally considered that the use of medical inventions should refer to the target disease of the approved products but there has been no judicial precedent supporting how Article 95 should be interpreted on this issue.

This changed on July 1, 2020 when the Korean Intellectual Property Trial and Appeal Board (IPTAB) rendered a historic decision regarding the type of "use" that is considered within the enforceable patent scope during the PTE of a pharmaceutical compound patent. Galvus® (API: vildagliptin), a type 2 anti-diabetic drug of Novartis, has five different types of dosage regimens (or efficacy and effect under the Korean translation). Utilizing the fact that Novartis filed a PTE application based on only one approved efficacy and effect, three Korean generic companies filed scope confirmation actions claiming that their products did not fall within the patent scope because they had carved out the efficacy and effect first filed by Novartis as the basis for the PTE. They argued that the patent scope during the PTE should be limited to the first approved efficacy and effect only, and that the later approved four efficacies and effects were not covered.

An expanded five-member panel of the IPTAB held that the use (and therapeutic effect) that is within the patent scope of the compound PTE is not limited to the first efficacy and effect, and that the generic's products were within the scope of the patent during PTE ruling in favor of Novartis.

The IPTAB's detailed reasoning was as follows:

l If the scope of a patent during PTE is restricted to specific items of an approved product underlying the PTE (first approved effect and efficacy in this case), it becomes easy for generic companies to circumvent the patent during PTE when it relied on most of the approval data of the original products in gaining approval of its product. This violates the purpose of the PTE system which is to compensate the non-practicing period of the patentees.

l The Supreme Court held in a previous case ("Vesicare® case") that the patent right during the PTE should not be limited to the specific items as approved. The Vesicare® case involved the issue of whether patent scope during the PTE for a compound patent is limited to specific salt forms of the approved product. The Supreme Court held that the patent scope during the PTE should be determined based on the active ingredient, therapeutic effect, and use of an approved product underlying the PTE and not limited to the specific items as approved.

l Compound patents during PTE should be more broadly protected than dosage regimen patents considering the different technical significances (meaning that a dosage regimen as approved as efficacy and effect should not limit the scope of compound patents).

l The efficacy and effect in a marketing approval is governed by regulatory laws and is dependent on various factors including the type of disease and approval schedule, etc. Thus, it is unreasonable to confine the scope of a patent based on efficacy and effect, which has a different legislative focus from patent law.

The IPTAB decision can still be appealed to the Patent Court so is not yet the final say on this issue. However, we believe this is a significant first step in improving understanding in the patent system of how the use of a medical invention should be defined during PTE, and has the potential to affect many originator pharmaceutical companies that rely on PTE to protect their products. The IPTAB rejected the generic's efforts to unjustly narrow the PTE scope, and thereby laid the groundwork for originators to protect their legitimate interests from generic challenges as well as preserve the originator drug price after generic entry."

Santen ends Neurim-style SPCs

2020-07-10T13:46:00.000+01:00

The wording of Article 3d of the SPC Regulation requires that the SPC application must rely on “the first authorisation to place the product on the market as a medicinal product”. This always suggested that a marketing authorisation granted for a new indication of a previously approved active ingredient could not be relied upon as the basis of an SPC for the patent directed to the new medical use.

However, based on a purposive construction of the Regulation, the CJEU decision in Neurim in 2012 opened the door to just that possibility.

Unusually, the CJEU has now reversed its own Neurim decision in the Santen decision C-673/18 issued on 9 July 2020. A later MA to a new indication cannot be used as the “first MA” supporting an SPC on a new medical use of the same active ingredient. The Santen decision states:

“Article 3(d) of [the SPC Regulation] must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application.”

Neurim was always the problem child, out of step with earlier CJEU decisions, and national patent offices struggled to know how broadly to apply it. In Santen, the CJEU expressly now disapproves of the Neurim logic (see paragraph 53 of the decision).

In reaching its decision the CJEU (sitting in Grand Chamber with 13 judges) first concluded that the definition of an active ingredient under Article 1b of the SPC regulation does not import any use-limitation:

"the fact that an active ingredient, or a combination of active ingredients, is used for the purposes of a new therapeutic application does not confer on it the status of a distinct product where the same active ingredient, or the same combination of active ingredients, has been used for the purposes of a different, already known, therapeutic application".

As a result, Article 3d of the regulation must then refer to the first MA for any use of that active ingredient as a medicinal product:

"In addition, in the light of the strict definition of the term ‘product’ within the meaning of Article 1(b) of Regulation No 469/2009, .. the analysis of the wording of Article 3(d) of that regulation presupposes that the first MA for the product as a medicinal product for the purpose of that provision means the first MA for a medicinal product incorporating the active ingredient or the combination of active ingredients at issue (see, to that effect, judgment of 21 March 2019, Abraxis Bioscience, C‑443/17, EU:C:2019:238, paragraph 34), irrespective of the therapeutic application of that active ingredient, or of that combination of active ingredients, in respect of which that MA was obtained."

So, the Neurim logic appears to be dead.

Crucially, any products protected only by SPCs based on second or further medical use patents, and relying on a second, or later, MA for that active, may now be vulnerable to immediate generic competition.

Hold the Front Page: Royalty involved in SPC decision!

2020-05-26T21:01:00.000+01:00

The CMS patent litigation team in London have provided a review of the Royalty Pharma decision (C650/17). Many thanks to Gareth Morgan, Natalie Coan and Hannah Rigby for their thoughts.

On 30 April 2020, the CJEU ruled on the interpretation of Article 3(a) of the SPC Regulation in an action between the Royalty Pharma Collection Trust and the German Patent and Trademark Office (C-650/17) (“Royalty”).

In its ruling, the CJEU in Royalty held that a product developed after the filing date of a patent following an independent inventive step but falling under the functional definition of said patent was not considered ‘protected’ under Article 3(a) of the SPC Regulation. The case brings greater clarity after an uncertain line of case law following Medeva (C-322/10) in relation to what is ‘specified in the wording of the claim’. The CJEU in the Royalty ruling confirmed the test endorsed by the CJEU in Gilead (C-121/17) by following the two pronged test but most notably added clarification by confirming that the term “core inventive advance” was not relevant to the interpretation of Article 3(a). Until now the CJEU had failed to offer a clear test for applying Article 3(a) but this decision has the effect of finally placing the interpretation of Article 3(a) on more stable ground.

Article 3(a) of the SPC Regulation requires that a product be protected by a basic patent in force before an SPC may be granted in respect of it. Medeva introduced the concept of ‘specified in the wording of the claim’, although it was unclear what that really meant. A further layer of confusion appeared in the CJEU’s decision in Actavis (C-443/12) which stated that the product had to constitute “the core inventive advance of that patent”. That case related to Article 3(c) but the CJEU referred to the same test in Actavis (C-577/13) which related to Article 3(a). It was then unclear when exactly the core inventive advancement of the patent should be taken into consideration and whether it had replaced the Medeva test.

Arnold J sought some clarity on this point in his referral to the CJEU in Gilead. In his referral, Arnold J suggested that ‘protected by the patent’ should mean that the product must ‘embody the core inventive advance’ of the patent, replacing ‘specified in the wording of the claim’. The CJEU did not explicitly reject this proposal but confirmed that each active ingredient should (1) necessarily fall under the invention covered by the patent; and (2) be specifically identifiable in light of the information disclosed by that patent. Arnold J took this to mean that the patent’s technical contribution was relevant to the assessment. The UK Court of Appeal subsequently overturned Arnold J’s interpretation, replacing this with a simpler test of whether all components of the “product” were necessarily required by the language of the claim.

The confusion caused by pre-Gilead case law has however remained, leading to a number of referrals, including that of the German Federal Court in Royalty.

Royalty Pharma had applied for an SPC protecting sitagliptin on the basis of its patent claiming use of dipeptidylpeptidase IV inhibitors to lower blood glucose levels. Sitagliptin was developed after the filing date of the relevant patent. It is however a dipeptidylpeptidase IV inhibitor and was therefore covered by the functional definition in the patent’s claims.

The German Federal Court requested guidance as to whether a product is protected under Article 3(a) where:

1. The product is not expressly referred to in the patent’s claims;

2. The product is not considered the specific embodiment of the patent;

3. The product was developed after the filing date of the patent; and

4. The product was covered by a functional definition in the patent’s claims.

The CJEU held that Article 3(a):

“is to be interpreted as meaning that a product is protected by a basic patent in force within the meaning of this provision if it corresponds to a general functional definition used in one of the claims of the basic patent and necessarily relates to the invention protected by this patent, but without being individualized as a specific embodiment from the teaching of the patent, provided that it can be specifically identified, in light of all the information disclosed by said patent, by a person skilled in the art, on the basis of their general knowledge in the field, considered on the filing or priority date of the basic patent and the state of the art on that same date.”

This ruling follows the ruling in Gilead.

The CJEU’s clarification seems to have confirmed that the test for Article 3(a), in effect, equates to a question whether there has been an enabling disclosure of the product. The CJEU held that:

“Article 3(a) must be interpreted as meaning that a product is not protected by a basic patent in force within the meaning of that provision where, although that falling under the functional definition given in the claims of this patent, it was developed after the filing date of the application for the basic patent, at the end of an autonomous inventive step.”

The CJEU has therefore confirmed that the patentee of the basic patent must demonstrate that the skilled person could produce the product which is the subject of the SPC using only the common general knowledge and prior art, with no inventive activity.

The Royalty ruling confirms, and clarifies, the Gilead decision. It represents another nail in the ‘core inventive advance test’ coffin with respect of Article 3(a), and further demarcates the appropriate test for Article 3(a). Notwithstanding the clarity offered on Article 3(a) new questions arise in respect of the compatibility of this ruling with the earlier Actavis case law on Articles 3(a) and 3(c), and also the extent to which any later independent inventive activity creates a new “product” for the purposes of SPC eligibility.

Paris Court of Appeal overturns preliminary injunctions against Mylan and Sandoz/ MSD's ezetimibe/simvastatine SPCs

2020-03-31T14:36:00.000+01:00

Many thanks to Denis Schertenleib, from Schertenleib Avocats (an old friend of the blog) for the following report on events before the Paris Court of Appeal, in relation to Merck's ezetimibe/simvastatine SPC, in which he was involved:

On 14 February 2020, the Paris Court of Appeal overturned a series of preliminary injunctions against Mylan and Sandoz based on Merck's ezetimibe/simvastatine SPC. These decisions are of specific interest as they are the first to follow a series of injunctions and substantial awards of provisional damages granted against several generics by the High Court of Paris from 2018 to 2019. Commentators following such injunctions and awards of provisional damages had argued that this constituted a landmark change of practice at the High Court in pharmaceutical cases. However, these decisions had not been subject to appellate review. On appeal the court held that, in addition to the relevant SPC being invalid, the measures ordered were disproportionate. The Court of Appeal held that Merck’s SPC suffered from serious grounds of invalidity, thus overturning the previous High Court decision that found this SPC valid and infringed. The Court of Appeal further held that the various product recalls and provisional damages ordered were disproportionate and thus should not have been granted even if the SPC was valid.

A translation of the Mylan decision is attached here and the Sandoz decision here.

The AG's opinion in Santen

2020-01-28T15:44:00.000+00:00

Thanks to Nick Fischer at Marks & Clerk law for being first to alert the blog to the AG Opinion in Santen (C-673/18) which was handed down last week.

The official English translation isn’t available yet, but it looks like the AG favours a strict literal meaning of Article 3(d) (i.e. going against Neurim).

Nick comments (and the blog agrees based on Google translate!) that there is also a suggestion that, if the CJEU does want to follow Neurim, it should allow SPCs for new therapeutic indications or for uses of the same active which have a pharmaceutical, immunological or metabolic action of their own.

The Opinion is available here.

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

2019-09-12T09:04:00.000+01:00

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!

2019-07-10T14:13:00.002+01:00

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

2019-06-14T07:18:00.000+01:00

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)

2019-06-12T16:07:00.001+01:00

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!

2019-06-11T08:38:00.001+01:00

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

2019-03-21T16:05:00.000+00:00

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

2019-02-12T08:52:00.000+00:00

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

2019-02-06T19:38:00.000+00:00

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

2019-02-06T16:20:00.002+00:00

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?

2019-02-04T17:01:00.000+00:00

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

2019-01-30T16:05:00.001+00:00

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!

Call for comments for C-673/18 (Santen v INPI)

2018-12-18T14:15:00.000+00:00

The UK IPO is seeking comments on CJEU case C-673/18 by 2 January 2019 with a view to lodging observations with the CJEU. The case was previously reported on the SPC Blog here. If you would like to comment on this case, please email policy@ipo.gov.uk referencing the case number in the subject heading.

As a refresher, the questions referred to the CJEU in this case is as follows:

“1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.:

- be limited to the case of a human application following a veterinary application,
- or concern an indication in a new therapeutic field, in the sense of a new medical specialty, compared to the previous MA, or a drug in which the active principle exerts an action different from that which it exerts in the drug that was the subject of the first MA;
- or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention;

or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?

2 - Does the notion of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, therefore, limit itself to the new medical use corresponding to the therapeutic indication of said MA?”

C-443/17 - Abraxis - AG's opinion out

2018-12-13T11:59:00.000+00:00

The Advocate General of the CJEU has provided his opinion in C-443/17 (Abraxis Bioscience) today (here).

As a refresher, the questions referred to the CJEU by Mr Justice Arnold were:

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?"

The Advocate General has advised the Court to rule 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 precludes the grant of such a certificate where the marketing authorisation relied upon in support of the application for a supplementary protection certificate under Article 3(b) of that regulation is not the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product. This is so even in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon is the first to cover the formulation protected by the basic patent relied upon in support of the application for a supplementary protection certificate under Article 3(a) of that regulation.

Germany - District Court lifts several ex-parte preliminary injunctions granted for Merck Sharpe & Dohme Corp.

2018-11-18T10:15:00.000+00:00

Recently, the District Court in Düsseldorf lifted several ex-parte preliminary injunctions granted for Merck Sharpe & Dohme Corp. (MSD) against various generic companies. The District Court’s decision in German language can be found (HERE) as well as the English translation thereof (HERE). Phillip Rektorschek (Taylor Wessing) and Derk Vos (Maiwald), who acted i.a. for Hexal AG and 1A Pharma, have provided the following summary on the case:

"Earlier this year MSD, based on SPC DE 12 2004 000 026.1, applied for preliminary injunctions against eight generic companies in order to prevent market entry of generic versions of MSD’s cholersterol-lowering combination product Inegy®. Inegy® is a fixed dose combination of the actives ingredients ezetimibe and simvastatin. While, the present SPC in question, DE 12 2004 000 026.1 is directed to a product covering ezetimibe or pharmaceutically acceptable salts thereof in combination with simvastatin, MSD had also held an earlier SPC in Germany on the very same basic patent EP 1 720 599 B1, which covered the mono-product of ezetimibe (tradename EZETROL®), which expired in April 2018.

In May 2018 the District Court in Düsseldorf granted MSD ex-parte preliminary injunctions against the generic companies.

Seven of these generic companies appealed against the preliminary injunction granted by the District Court. It was argued that the SPC-in-suit is invalid and was granted contrary to the requirements of Art. 3 a), 3 c) and 3 d) SPC-Regulation.

With the decision of 1 October, 2018, these seven injunctions have now been lifted. According to the District Court’s assessment, the validity of SPC DE 12 2004 000 026.1 is not sufficiently secured and the SPC is expected to be invalidated.

In the District Court’s opinion, the requirements of Art. 3 a) SPC-Regulation were fulfilled for the combination product in question, since the combination of ezetimibe and simvastatin was mentioned in the claims as well as in the specification of the basic patent. Further, the skilled person would have known from the prior art that simvastatin would also be a suitable drug for reduction of cholesterol. Based on the fact that ezetimibe and simvastatin would act via a different mechanisms of action, the skilled person would expect achieving an additive effect with the administration of the two active ingredients.

However, the District Court concluded that the requirements of Art. 3 c) SPC-Regulations were not fulfilled for the product-in-suit.

Contrary to MSD’s submission, ezetimibe would be the sole subject matter of the invention protected in the basic patent in an SPC specific meaning. The combination of ezetimibe and simvastatin would not be the core of the technical teaching of the basic patent and should therefore not be awarded a separate SPC.

The Court made clear that according to their interpretation of the CJEU’s case law, an SPC should be granted for compensating for the duration of the authorization procedure but not for the effort/cost associated with the authorization procedure. Moreover, the extension of protection should only be granted once for a product which may be understood as an active ingredient or combination of active ingredients in the narrower meaning. This approach may lead to situations wherein a combination of active ingredients is in fact considered to be protected in the meaning of Art. 3 a) SPC-Regulaiton, but in view of Art. 3 c) SPC-Regulation there should only be awarded an SPC if a product represents the core inventive advance of the basic patent at its priority date.

This requirement was considered not to be fulfilled in the present case since the combination of ezetimibe and simvastatin is not the core inventive advance of the basic patent, but only ezetimibe. According to the District Court, the technical contribution for which the SPC should be rewarded must represent the actual technical teaching of the basic patent. In particular for combination preparations, the combination must address a specific problem in the treatment, prevention or diagnosis of a disease, for which the technical solution must be different from the solution provided by the mono product.In the District Court’s opinion not only a synergism of the two actives would qualify for such a different effect but also a reduction of side effects or the like, under the condition that this effect is different from the one observed for the mono-product. However, for the difference relied upon, there must be disclosure in the basic patent at the priority date. Referring to the recent decision C-121/17 – Teva, the District Court stated that it is not sufficient that such differences or effects were only revealed during the authorization procedure. In such a case the aim of the Regulation, namely to compensate for the duration of the authorization procedure would not be fulfilled.

The District Court further stated that also the other effects relied upon by the Claimant were not disclosed in the basic patent and have been classified as “surprising” by the Claimant itself. It is therefore apparent, that the effect relied upon by the Claimant are based on additional insight gained only during the authorization procedure, but are not disclosed in the basic patent.

Moreover, in the Court’s view the fact that the majority of the relevant clinical studies for the marketing authorization of the combination product were already conducted for the authorization of the mono-product aggrevates the situation. Only marginal additional data on the effectiveness were provided with the marketing authorization for the combination product, which, however, did not provide any additional gain in knowledge in view of the data contained in the earlier authorization of the mono-product Ezetrol®.
According to the District Court, the mere fact that the combination is provided as a “fixed dose” cannot chance the situation, since it was known to the skilled person at the priority date that patient compliance is improved by fixed dose preparations. In addition, there is no indication that the provision of the fixed dose preparation was associated with any difficulties for the skilled person.

Summarizing, the District Court found that the SPC was granted contravening the requirements of Art. 3 c) SPC-Regulation and thus the validity of the SPC is not secured and therefore the preliminary injunctions had to be revoked."

MSD has filed an appeal against the first instance decision.

Many thanks to Derk Vos and Philip Rektorschek!

An analysis of the CJEU’s ruling in Teva (C-121/2017) and a proposal for its implementation

2018-11-02T10:43:00.000+00:00

Dr. Roberto Romandini of the Max Planck Institute for Innovation and Competition in Munich has published a MPI- Research Paper on Art. 3(a) Reg. 469/2009 that includes an analysis of CJEU’s ruling in Teva (C-121/2017) and a proposal for its implementation. The abstract is reproduced below, the paper is available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3270898
Comments and critique are welcome and may be sent to roberto.romandini@ip.mpg.de.

Abstract: On 25 July 2018 the Grand Chamber of the CJEU delivered the eagerly awaited decision on Art. 3(a) Reg. 469/2009 following the referral by Justice Arnold in Teva (C-121/2017). In answering the question what it means to be protected by the basic patent under Art. 3(a) Reg. 469/2009, the CJEU formulated a two-pronged requirement. In order to be eligible for a supplementary protection certificate (SPC) the product (i) must necessarily fall under the invention covered by the basic patent and (ii) be specifically identifiable in that patent. This further formula in the case law following Medeva (C-322/10) is open to a number of interpretations, the most restrictive of which is that the CJEU has adopted a core-inventive-advance test with the first prong and required an individual disclosure of the product with the second prong. This article proposes a purposive implementation of the decision which takes into account the policy goals underlying the CJEU case law. These goals are to prevent multiple SPCs for the same product in conjunction with a number of other active ingredients (“evergreening”), unless such combinations represent a “totally separate innovation” (C-443/12), and to prevent the grant of a certificate for monotherapy products that were developed by a third unrelated entity after the priority date of the basic patent. In order to achieve the first goal, an inventive-advance test is necessary, but also sufficient. In order to ensure the second goal, requiring a disclosure of the product in an individualized form is in some cases sufficient, but not necessary where the patentee has, after the priority date of the basic patent, developed the product and obtained the MA submitted in support of the application for a certificate. In view of the persistent lack of clarity of the case law, the article concludes with some thoughts on the role of the CJEU, the task of the lawmakers and the implication of the Unified Patent Court Agreement (UPCA) for the operation of the SPC system.

C-527/17 ruling is out: No SPCs for CE-marked devices

2018-10-27T09:03:00.000+01:00

The CJEU handed down its ruling on C-527/17 (Boston Scientific)- available here. It decided:

Article 2 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 must be interpreted as meaning that a prior authorisation procedure, under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, for a device incorporating as an integral part a substance, within the meaning of Article 1(4) of that directive as amended, cannot be treated in the same way, for the purposes of applying that regulation, as a marketing authorisation procedure for that substance under Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, even if that substance was the subject of the assessment provided for in the first and second paragraphs of section 7.4 of Annex I to Directive 93/42, as amended by Directive 2007/47.

In essence, the CJEU has ruled that a CE-mark approval for a medical device comprising an active ingredient as an integral part cannot be considered as an approval in accordance with the Medicinal Products Directive, even if the ingredient was assessed using the consultation process.

Many thanks to Oswin Ridderbusch and Alexa von Uexkuell (Vossius & Partner) for spotting the ruling!

France - Court of Appeal of Paris refers questions to the CJEU

2018-10-18T08:55:00.000+01:00

Thomas Bouvet and Laura Romestant (Jones Day) kindly report below on a recent decision (here, in French only) of the Court of Appeal of Paris to refer questions to the CJEU:

On 9 October 2018, the Court of Appeal of Paris issued a decision which refers two questions to the CJEU intended to clarify the terms “different application” and “falling within the scope of protection conferred by the basic patent” as addressed in the CJEU Neurim decision.

Background
Santen is the holder of:

European patent № 1 809 237, entitled “Ophthalmic oil-in-water type emulsion with stable positive zeta potential”, filed on 10 October 2005 and granted on 31 December 2008;

a central marketing authorization № EU/1/15/990 valid in the entire European Union, granted on 19 March 2015 and notified on 23 March 2015, for the medicinal product with the proprietary name Ikervis, whose active ingredient is ciclosporin in the formulation, covered by EP 1 809 237, indicated for the treatment of severe keratitis in adult patients with dry eye disease, for which ciclosporin has not been approved before.

By a decision dated 6 October 2017, the Director General of the INPI dismissed the application to grant an SPC for ciclosporin eye drop emulsion, filed by Santen on 3 June 2015.

The Director of the INPI considered that the marketing authorization, on which the application is based, would not be the first authorization to place the product on the market as a medicinal product:

it considered that the sole active ingredient of the specialty object of MA № EU/1/15/990 for “ciclosporin for use in the treatment of keratitis” is ciclosporin which should be considered as the product object of the requested SPC, within the meaning of Article 1(b);

it considered that the previous MA for ciclosporin had been granted on 23 December 1983 for the medicinal product Sandimmun;

it considered that CJEU Neurim decision C-130/11 would not apply in the circumstances of the case because:

- the application for which Ikervis is authorized is not a different application from that of Sandimmun as both relate to inflammatory diseases of the eye;
- the basic patent does not protect a new application of ciclosporin, but a new formulation containing no specific use limitation.
Santen lodged an appeal against this decision by declaration of 3 November 2017.
In its written submissions filed before the Court of Appeal of Paris, Santen requested:

as a main request, that the Court of Appeal hold the decision of the Director General of the INPI null, as it is contrary to the case law of the CJEU as set out in the Neurim judgment of 19 July 2012 as well as to the case law of the Court of appeal itself as it is set out in the Merck & Co decision of 15 February 2013;

as an auxiliary request, that the Court of Appeal refer a question for a preliminary ruling to the CJEU, in the terms set out in its written submissions before the Court.

The decision of the Court of Appeal of Paris of 9 October 2018
The decision of the Court of Appeal (here) refers two questions to the CJEU, which read in working translation as follows:

“1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.:

- be limited to the case of a human application following a veterinary application,
- or concern an indication in a new therapeutic field, in the sense of a new medical specialty, compared to the previous MA, or a drug in which the active principle exerts an action different from that which it exerts in the drug that was the subject of the first MA;
- or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention;
or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?

2 - Does the notion of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, therefore, limit itself to the new medical use corresponding to the therapeutic indication of said MA?”

The Court of Appeal found it necessary to ask two questions resulting from the Neurim decision:

- the first one is intended to clarify the meaning of the term “different application” within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11;
- the second one intended to clarify to what extent the basic patent should cover said different application, in particular whether it should be limited to the new medical use.

Thomas Bouvet and Laura Romestant represented Santen.