We've moved the blog contents to LinkedIn here. Please do check us out on the new platform!
The SPC blog
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here
Thursday 20 June 2024
Wednesday 7 October 2020
MSD’s ezetimibe-simvastatin SCP revoked by the Paris Court of Appeal
Background
- 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).
Tuesday 21 July 2020
Korean IPTAB Issues Leading Decision on Patent Term Extension (PTE) - Enforceable Scope Related to Medicinal Use
"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.
Friday 10 July 2020
Santen ends Neurim-style SPCs
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.
Tuesday 26 May 2020
Hold the Front Page: Royalty involved in SPC decision!
Tuesday 31 March 2020
Paris Court of Appeal overturns preliminary injunctions against Mylan and Sandoz/ MSD's ezetimibe/simvastatine SPCs
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.
Tuesday 28 January 2020
The AG's opinion in Santen
Thursday 12 September 2019
Opinion of Advocate General out on joined referrals C-650/17 (Royalty Pharma) and C-114/18 (Sandoz v Searle)
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 UexkĆ¼ll (Vossius and Partner) for pointing this opinion out to us.
Wednesday 10 July 2019
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.