Mylan/Synthon win European patent ruling on generic Copaxone Posted 09/10/2020

Mylan and their development partner Synthon have won a European Patent Office (EPO) ruling related to the multiple sclerosis treatment Copaxone (glatiramer acetate).

Glatiramer acetate is an immune modulating drug used in the treatment of multiple sclerosis (MS). It consists of the amino acids found in the antigen in the myelin sheaths of neurons that stimulates an autoimmune reaction in people with MS (effectively acting as a decoy) and is approved in the US to reduce the frequency of relapses in MS.

The originator drug is sold as Copaxone by Israeli generics giant Teva Pharmaceuticals, who has been petitioning against generic versions of the drug since at least 2010 [1]. One of the companies trying to market a generic version of Copaxone is Mylan, together with their development partner Synthon.

In 2017, the EPO revoked one of Teva’s patents on Copaxone, on the basis of a case filed by Synthon [2]. However, patent action from Teva has been ongoing, with a total of four patent litigation cases in the US, eight citizen petitions, and more than 15 challenges across Europe.

In the latest news, Mylan announced on 15 September 2020 that the Technical Board of Appeal of the EPO held that a further of Teva’s patents related to Copaxone (40 mg/mL) is invalid. The patent has since been revoked across Europe.

The ruling will allow Mylan/Synthon to immediately return to the European market with their generic version of Copaxone.

Mylan CEO Heather Bresch said: ‘The decision by the EPO marks a significant step forward for Mylan in several ongoing legal actions around Europe related to this important product, and further increases our confidence in our ability to continue to expand access to a lower-cost, high quality, therapeutically equivalent version of Copaxone to the multiple sclerosis community across even more markets in Europe and beyond’.

Mylan's product is sold under a number of brand names in European markets including Brabio, Clift, Copemyl, Copemyltri, and Glatiramyl. In the UK for example, Brabio was launched onto the market in January 2018 [3].

In the US, the first generic version of Copaxone was approved in April 2016 (Glatopa by Sandoz) [4].

Related articles
FDA approves 40 mg follow-on version of glatiramer acetate

Follow-on versions of glatiramer acetate in Russia and Europe

Follow-on glatiramer acetate gains European approval

References
1. GaBI Online - Generics and Biosimilars Initiative. Teva again files citizen petition against generic Copaxone [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Generics/News/Teva-again-files-citizen-petition-against-generic-Copaxone
2. GaBI Online - Generics and Biosimilars Initiative. Synthon prevails over Copaxone patent dispute [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Pharma-News/Synthon-prevails-over-Copaxone-patent-dispute
3. GaBI Online - Generics and Biosimilars Initiative. Mylan launches first follow-on glatiramer acetate in the UK [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/Mylan-launches-first-follow-on-glatiramer-acetate-in-the-UK
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves first follow-on version of glatiramer acetate [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Oct 9]. Available from: www.gabionline.net/Non-Biological-Complex-Drugs/News/FDA-approves-first-follow-on-version-of-glatiramer-acetate

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Source: Mylan

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