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, 12 February 2019

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.

Wednesday, 6 February 2019

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. 

Monday, 4 February 2019

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!

Wednesday, 30 January 2019

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!