DNA Patents May Not Be Possible After All; Supreme Court Tosses Question Back To Lower Court
This article was originally published in The Pink Sheet Daily
The Supreme Court orders the Federal Circuit to reconsider its decision that Myriad Genetics’ isolated BRCA genes are patentable in the wake of the high court’s ruling in Mayo v. Prometheus; BIO says second review may lead to more coherent and uniform opinion.
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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.
Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.
Rutgers University professor testifies in support of bill directing the FDA to designate National Centers of Excellence in Continuous Manufacturing; other bills target generic labeling, orphan exclusivity and counterfeit devices.