FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Teva Thwarts UK Patent Challenge Against AZ’s Symbicor

Sept. 10, 2014

Teva is clear to market its version of AstraZeneca’s chronic obstructive pulmonary disorder drug Symbicort in the United Kingdom, after the High Court there struck down an AZ indication patent on grounds of obviousness.

The EP ’877 patent covered the single inhaler maintenance and reliever therapy (SMART) indication for Symbicort (budesonide/formoterol fumarate dehydrate), Teva said. Without the patent’s protection, Teva can market its own formoterol/budesonide fixed combination product, DuoResp Spiromax, in the UK.

Teva’s therapy makes use of the formulation once covered by AZ’s patent, along with the Israeli company’s own Spiromax device technology.

AZ had sought to amend the patent during the challenge but the judge rejected those efforts, Teva said.

Teva touted the victory as the latest in its marketing efforts in Europe, having already invalidated two other AZ indication patents on Symbicort through the European Union and in Norwegian court. The Orange Book lists AZ as the only pharmaceutical company currently authorized to market budesonide/formoterol fumarate dehydrate in the U.S.

AZ said it was disappointed with the ruling and plans to ask permission to appeal. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.