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Eversheds Sutherland (International) LLP | European Union | 12 Aug 2020

Intellectual property in clinical trials

Clinical trial results may qualify for protection as IP rights and, as such, for commercialisation in the European Union. In order for clinical trial…

Grau & Angulo | European Union, Spain | 1 Jun 2020

Appeal court confirms revocation of Spanish SPC for Truvada

The Barcelona Court of Appeal recently issued a judgment confirming the invalidity of Gilead's supplementary protection certificate (SPC) for the…

Freshfields Bruckhaus Deringer | European Union, United Kingdom | 21 Apr 2020

EU’s proposed post-Brexit trade agreement: three key IP takeaways for life sciences

On 18 March 2020, the European Commission published its draft text of the Agreement on the New Partnership with the United Kingdom, detailing the…

Bristows | European Union | 5 Apr 2020

Functional claims approved in principle as basis for SPCs

On Thursday 30 April the CJEU handed down its decision in the SPC referral Royalty Pharma (C-650/17) (here[1]); its latest in a decade-long attempt…

Vidal-Quadras & Ramon | Spain | 7 Feb 2020

The (unsuccessful) challenge of the competence of the civil/commercial courts to decide on the validity of a Supplementary Protection Certificate

The Commercial Court No. 5 of Barcelona has recently needed to uphold that the civil/commercial courts are competent to decide on actions for…

Garrigues | European Union | 22 Jul 2019

'Manufacturing Waiver': una medida para incentivar a los fabricantes de medicamentos genéricos y biosimilares establecidos en la UE

El 1 de julio de 2019 entró en vigor el Reglamento 2019/933, del Parlamento Europeo y del Consejo que establece ciertas excepciones para que los…

Novagraaf | European Union, France | 9 Jul 2019

New manufacturing waiver to Supplementary Protection Certificates adopted by the European Parliament and the Council of the European Union

Regulation (EU) 2019/933 on Supplementary Protection Certificates (SPCs) entered into force on 1 July 2019. It amended Regulation (EC) No 469/2009 on…

CMS Cameron McKenna Nabarro Olswang LLP | European Union, United Kingdom | 13 Jun 2019

SPC Manufacturing Waiver to come into effect 1 July 2019

Generics companies will soon be able to manufacture SPC-protected drugs for export outside the EU under new manufacturing waiver provisions. In the…

Bird & Bird LLP | Belgium, European Union | 10 May 2019

Manufacturing and stockpiling waiver set to limit rights of holders of SPCs for medicines

On 17 April 2019, the European Parliament approved, by a large majority, an amendment of the Regulation on Supplementary Protection Certificates…

ZBM Patents & Trademarks | European Union | 24 Apr 2019

SPC manufacturing waiver adopted by the European Parliament

On April 17, the European Parliament approved the amendment of the Regulation 469/2009 on Supplementary Protection Certificates (SPCs) to include a…
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