GPhA Makes Spreadsheet Case For Patent Settlements After Legal Loss
IMS report finds that 33 drugs launched prior to patent expiry as a result of patent settlements reduced drug costs by $25.5 billion from 2005 to 2012. But the selection of which settlements to calculate the savings from reveals the fundamental difference in perspectives between industry and FTC that remain in the wake of the Supreme Court ruling.
You may also be interested in...
Solicitor General notes that FDA is considering changing its regulations in an amicus brief in Mutual Pharmaceutical v. Bartlett; government says design defect claims against generic manufacturers are preempted by federal law in the case at hand but may be brought in other situations.
Justice Ginsburg wrote two decisions in pharmaceutical related-cases over the past decade, joined the majority in opinions on the scope of patents, and dissented in decisions giving protection to generic manufacturers and speech of pharmaceutical companies. Her death could impact the outcome of cases challenging the Affordable Care Act.
Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.