Supreme Court Struggles Over What Constitutes A ‘Fact’ In Copaxone Case
This article was originally published in The Pink Sheet Daily
Executive Summary
Justice Breyer seems to side with Teva’s position that Federal Circuit should have deferred to district court’s finding on meaning of patent term central to Copaxone’s manufacturing process, but other justices appear skeptical.
You may also be interested in...
Teva’s Copaxone Patent Win Delivers Bigger Blow To Sandoz Than Mylan
Sandoz, which has first to file on the generic, may have the most to lose after federal judge finds that Mylan and Sandoz ANDAs for generic Copaxone infringe all the claims in Teva’s patents, the latest of which expires in September 2015. FDA now has more time to review the ANDAs without pressure.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.