Yeda Research And Development v. Mylan Pharmaceuticals INC.

  • Oct 12 2018
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  • Category: CAFC Updates

Yeda challenges the PTAB’s final written decisions finding the claims of U.S. Patent Nos. 8,232,250, 8,399,413, and 8,969,302 (relating to COPAXONE, a treatment for relapsing-remitting multiple sclerosis) unpatentable as obvious in three inter partes review (IPR) proceedings.  After finding that Yeda’s due process rights were not violated because Yeda received proper notice of and an opportunity to respond to the “Khan 2009” reference (which does not qualify as statutory prior art), the CAFC concludes that substantial evidence supports the Board’s reliance on the clinical data and its conclusion that a POSITA would be motivated to combine the prior art’s 40mg every other day dose with a less frequent dosing regimen, such as 3x/week, and would have had a reasonable expectation of success in therapeutic effectiveness and patient compliance. Accordingly, the CAFC affirms the Board’s decisions.

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