Teva wins another Symbicort patent challenge

Generics/News | Posted 12/09/2014 post-comment0 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.

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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.

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

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Source: EMA, Teva

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