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The US Supreme Court has now heard arguments in the appeal of Teva v Sandoz from the US Court of Appeals for the Federal Circuit. This could fundamentally change how patent decisions are reviewed by the Federal Circuit and the deference given to district court rulings, says Felicia Boyd of Barnes & Thornburg.
In October the US Supreme Court heard arguments in the closely watched appeal of Teva Pharmaceutical Industries Ltd v Sandoz, Inc from the US Court of Appeals for the Federal Circuit. The issue before the Supreme Court could fundamentally change how patent decisions are reviewed by the Federal Circuit and the deference given to district court rulings.
Teva owns a patent covering a drug used to treat multiple sclerosis. The drug, Copaxone (glatiramer acetate), is reported to bring in $4 billion a year in revenue for Teva. With the last patent set to expire in 2015, several pharmaceutical companies are looking to introduce generic formulations of the drug and cut into this revenue stream, sooner rather than later.
Sandoz and Mylan (collectively Sandoz) submitted to the US Food and Drug Administration (FDA) Abbreviated New Drug Applications (ANDAs) to develop and market generic versions of Copaxone.
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patents; Federal Circuit; Teva; FDA; ANDA