Teva wins another Symbicort patent challenge

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Teva wins another Symbicort patent challenge

Genéricos/Novedades | Posted 12/09/2014 0 Post your comment

Teva Pharmaceutical Industries (Teva) has gained another win in its campaign to launch a generic version of AstraZeneca’s asthma and chronic obstructive pulmonary disorder (COPD) treatment Symbicort (formoterol/budesonide) in Europe.

Teva announced on 3 September 2014 that it had received a positive judgement from the UK High Court in support of Teva’s case against AstraZeneca relating to the validity of the EP 1,085,877 patent, which covered the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AstraZeneca’s fixed dose formoterol/budesonide combination product, Symbicort.

The UK Court agreed with Teva that AstraZeneca’s patent covering the SMART indication of Symbicort was obvious and rejected AstraZeneca’s proposed amendments to the patent on the basis that they added matter. This opens the market for Teva’s generic product, which was approved by the European Medicines Agency (EMA) in April 2014. The ruling should also come as good news to other generics companies pursuing this market. EMA is reviewing three other budesonide/formoterol generics [1].

Symbicort’s combination patent expired in the EU in 2012 and is due to expire in the US later in 2014, although AstraZeneca claims it has formulation patents valid until 2018 in the EU and 2023 in the US.

Teva’s DuoResp Spiromax product brings effective treatment to the patient in a device that is intuitive and easy to use, according to Rob Koremans, MD, President and CEO, Teva Global Specialty Medicines. ‘Yesterday's judgement is a big step in enabling us to make a difference to people’s lives in the UK and all across Europe.’

This is just the latest decision to go Teva’s way. Teva has previously successfully revoked patents covering the use of the fixed-dose combination in the treatment of asthma and in COPD, and their national equivalents, before the European Patent Office and the Norwegian court.

Related Article
Patent cliff winners and losers

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – April 2014 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 12]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-April-2014

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: EMA, Teva