TEVA PHARMACEUTICALS USA, INC V. SANDOZ INC.
- Oct 12 2018 |
- Category: CAFC Updates
Teva appeals the of the District Court’s decision invalidating as obvious all asserted claims of patents directed to COPAXONE, a product marketed for treatment of patients with relapsing forms of multiple sclerosis. Sandoz and others submitted ANDAs to the FDA for approval to engage in the manufacture and sale of generic versions of COPAXONE. The CAFC finds no error in the district court’s claim construction which held that the “sufficiency” terms, “reduced frequency of relapse” terms and “effectiveness” were non-limiting, and finds no clear error in the conclusion that a POSITA would be motivated to combine the 40mg GA dose, which had proven efficacy, with a 3x/week frequency, which was desirable because the prior art indicated that less frequent administration increased patient adherence while maintaining efficacy. Thus, the CAFC affirms.