Oswin Ridderbusch, Author at Kluwer Patent Blog

Case Law, CJEU, European Union, Patents, Pharma, SPC

CJEU’s Advocate General expounds on the availability of SPCs where the basic patent claims a functionally defined active ingredient or a Markush formula in the joined cases Royalty Pharma (C-650/17) and Sandoz v. Searle (C-114/18)

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/September 11, 2019September 11, 2019 /1 Comment

In the field of supplementary protection certificates (SPCs) in the European Union, the majority of all CJEU referrals resolved to date have dealt with the interpretation of the – presumably simple – condition that an SPC can only be granted for an active ingredient (or a combination of active ingredients) that is “protected” by the…

European Union, Generics, Legislation, Pharma, SPC

SPC manufacturing waiver enters into force in July 2019

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/June 11, 2019June 11, 2019 /1 Comment

The legislative procedure introducing an SPC manufacturing waiver in the European Union has been completed today on 11 June 2019 with the publication of the corresponding new Regulation (EU) 2019/933 of 20 May 2019 (PDF) in the Official Journal of the EU. The manufacturing waiver provisions will enter into force on the 20th day after…

European Union, Generics, Legislation, Pharma, SPC

EU adopts SPC manufacturing waiver under protest from several member states

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/May 14, 2019May 22, 2019

After the European Parliament adopted a controversial new regulation introducing an SPC manufacturing waiver for export and stockpiling in its last plenary session on 17 April 2019, as previously reported on this blog, the corresponding legislative act has now also been adopted by the Council of the European Union in its meeting today on 14…

European Union, Generics, Legislation, Pharma, SPC

SPC manufacturing waiver adopted by European Parliament

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/April 17, 2019April 18, 2019

The European Parliament has finally adopted the legislation introducing an SPC manufacturing waiver in its last plenary session before the upcoming European elections. The corresponding legislation was endorsed today on 17 April 2019, with 572 votes in favor, 36 votes against, and 22 abstentions. The vote was preceded by a discussion in plenum yesterday late…

Case Law, CJEU, European Union, Pharma, SPC

CJEU bids farewell to SPCs for new formulations of old drugs

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/March 21, 2019March 21, 2019

The eagerly-awaited judgment of the Court of Justice of the European Union (CJEU) in the SPC referral Abraxis Bioscience (C-443/17) has been handed down today. In the case underlying this referral, the UK IPO had refused an SPC application filed by Abraxis Bioscience for the product “paclitaxel formulated as albumin-bound nanoparticles” (nab-paclitaxel; marketed as Abraxane®)…

European Union, France, Germany, Netherlands, Pharma, SPC, TRIPS, TRIPs Agreement

SPCs not available for animal feed additives

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/February 25, 2019February 25, 2019

The fundamental question which types of products are amenable to SPC protection and which types of marketing authorizations allow the filing of SPCs has aroused much controversy in Europe, and reached a climax when the CJEU in its judgment Boston Scientific (C-527/17) of 25 October 2018 denied the grant of SPCs on the basis of…

European Union, Generics, Legislation, Pharma, SPC

Legislative breakthrough: SPC manufacturing waiver to be introduced for export and stockpiling

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/February 20, 2019February 21, 2019

The introduction of an SPC manufacturing waiver in the European Union is now all but a done deal. Following the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal products (COM(2018) 317 final) issued on 28 May 2018, the European Parliament’s Committee on Legal Affairs (JURI) adopted its final…

European Union, Generics, Legislation, Pharma, SPC

SPC manufacturing waiver enters final legislative stage in the EU, with possible extension to allow stockpiling

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/February 4, 2019February 4, 2019

The introduction of an SPC “manufacturing waiver” in the European Union, aimed at boosting the competitiveness of EU-based generics and biosimilar industry, gains momentum as the current EU legislative period draws to a close. Under the EU’s legislative procedure, the European Commission’s initial proposal for a regulation amending Regulation (EC) 469/2009 on SPCs for medicinal…

Case Law, CJEU, European Union, Pharma, SPC, Switzerland

SPCs cannot be revoked on the grounds of a wrongfully granted reestablishment of rights, confirms Swiss Federal Supreme Court

Oswin Ridderbusch, Alexa von Uexküll, Brigitte Bieler (Vossius & Partner)/January 3, 2019January 3, 2019

Regardless of whether someone intends to enforce their own supplementary protection certificate (SPC) or finds themself at the receiving end of an SPC infringement action, the question which grounds of invalidity justify the revocation of an SPC may become highly relevant. This question is all the more intriguing in light of the CJEU’s corresponding case…

Case Law, CJEU, European Union, Pharma, SPC

CJEU’s Advocate General in Abraxis (C-443/17) denies SPCs for new formulations of old drugs and questions Neurim approach

Oswin Ridderbusch, Alexa von Uexküll (Vossius & Partner)/December 13, 2018December 13, 2018

A quarter-century after supplementary protection certificates (SPCs) were introduced in the European Union, there are still a number of unresolved questions as to which types of products are, in principle, eligible for SPC protection. One further important piece in this puzzle will be provided by the CJEU’s forthcoming decision in the pending referral Abraxis Bioscience…