Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has won a victory in Europe in its efforts to maintain patent protection for its blockbuster multiple sclerosis treatment Copaxone. Yesterday, the opposition division of the European Patent Office (EPO) upheld, in an oral ruling, the validity of Teva’s European Patent No. 2405749 covering Copaxone 40mg/mL (glatiramer acetate) administered three times per week. Teva’s patent does not expire until 2030.
Synthon, Actavis and Mylan had challenged Teva’s patent on various grounds, chiefly that the current version of Copaxone does not represent an innovation in comparison with the longstanding version. The EPO is expected to issue a detailed written decision within a few weeks. The ruling is subject to appeal, but it is expected that any appeal will take up to two years to be heard.
In June this year, the US Federal Court of Appeals ruled that Teva's patent on its previous, 20 mg, version of Copaxone was no longer valid, opening the way for generic versions of Teva's flagship product.
The win in Europe is nevertheless important for Teva, because it has so far managed to switch 70% of patients treated with Copaxone in the US to the new, 40 mg, version.
In the past four quarters, Copaxone has generated revenue of some $4.2 billion, accounting for 21% of the company's total revenue. Teva's guidance for 2015 was for Copaxone sales of $3.5-3.7 billion, with a gross margin of 89-90%.
Separately, Teva and Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced today that the US Food and Drug Administration (FDA) had approved Bendeka (bendamustine hydrochloride) injection for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL).
“Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and healthcare providers,” said Paul Rittman, Senior Vice President and General Manager, Teva Oncology.
Published by Globes [online], Israel business news - www.globes-online.com - on December 8, 2015
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