Supreme Court Is Dubious About Gene Patents; May Require Something Be Added To Nature
This article was originally published in The Pink Sheet Daily
Executive Summary
Justices appeared to favor the government’s position that synthesized genetic material like cDNA can be patentable but not isolated DNA; innovators may have to add a feature to their invention to make it distinct from nature.
You may also be interested in...
Gene Patents: Supreme Court Could Be Swayed By Impact On Research
The outcome of ACLU’s suit challenging Myriad Genetics’ BRCA cancer genes is crucial for the biotech industry as it could prevent companies from getting patents on therapeutics that utilize DNA and other isolated molecules.
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.