Angiomax Patents: Should Contract Manufacturing Count As Commercial Sale?
This article was originally published in The Pink Sheet Daily
Executive Summary
PhRMA and US government say 'no' and hope to get Federal Circuit to agree when it rehears decision that invalided The Medicines Co.'s patents under the on-sale bar doctrine.
You may also be interested in...
Supreme Court And Patents: What’s Not Happening
High court denies petition by Mylan to limit patent litigation venue and petition by Merck KGAA to address whether “on sale” bar to obtaining patent applies to non-public sales; Zarxio case to go to conference Friday.
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.