update

Synthon says EPO appeal board has revoked Copaxone API patent

By Gareth Macdonald contact

- Last updated on GMT

iStock/vchal
iStock/vchal
Synthon BV says a Teva patent covering the active ingredient in Copaxone has been revoked by the European Patent Office’s technical board of appeal.

The Dutch drug firm made the claim today, stating “the Technical Board of Appeal (TBA) of the European Patent Office revoked the last of Teva's three glatiramer so-called HBr patents which claimed an allegedly improved process for the synthesis of glatiramer acetate​.”

The patent is question is EP 2 361 924​ which covers "process for preparation of mixtures of trifluoroacetyl glatiramer acetate using purified hydrobromic acid.​"

Synthon has been in a legal battle​ with Teva over intellectual property relating to the synthesis of the active pharmaceutical ingredient (API), glatiramer acetate, for the blockbuster multiple sclerosis drug Copaxone for several years.

A Synthon spokeswoman told us via email that the TBA decision “was communicated verbally​” adding that “minutes will be published in a fortnight and the written communication will be posted in 3-6 months​.”

The EPO confirmed the decision, telling us "European patent EP 2 361 924 was revoked by the technical board of appeal 3.3.04 at the end of a hearing held on 12 September 2017​."

Teva statement

A Teva spokesman told us: "Teva is disappointed with the decision from the European Patent Office appeal board regarding the ‘924 patent and continues to believe in the validity of the remaining patents in its Copaxone franchise​."   

He added: "Teva will continue to challenge the regulatory approval of follow-on glatiramer acetate. 

"In Europe, Copaxone 40mg, three-times-a-week, is covered under a separate patent with a natural expiry in 2030 as well as other intellectual property rights. Copaxone 40mg  is currently the most prescribed therapy for relapsing MS in the EU and worldwide.  To date only one follow-on version of 20mg glatiramer acetate is approved in Europe and no follow on 40mg glatiramer acetate has been approved in the E​U."

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