MSD’s ezetimibe-simvastatim SCP revoked by the Paris Court of appeals 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 ..read more

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 ha ..read more

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 deci ..read more

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 de ..read more

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 Pa ..read more

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 acti ..read more

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 469/200 ..read more

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 foundhere The planned agenda (allowing for some evolution!) is: 1          Introduction and review of pending CJEU refe ..read more

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 ..read more

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 Regu ..read more