The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds. Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more