Patent Office Guidance Oversteps Myriad Court Decision, Industry Argues
Executive Summary
Development of products derived from natural sources will be deterred by PTO’s factor-based approach to patent eligibility, firms contend, noting special concern about examples given in guidance document.
You may also be interested in...
Supreme Court Overturns Drug Calibration Patents, Creating Confusion In Biotech Realm
The court’s finding that Prometheus’ drug calibration test is unpatentable has left the biotech community reeling with uncertainty as to whether method of treatment claims, particularly those involving biomarkers, will be patent eligible.
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.