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

Tuesday, 31 March 2020

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

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.


Tuesday, 28 January 2020

The AG's opinion in Santen


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.