The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more
7/15/2025
/ Biotechnology ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovation ,
Intellectual Property Protection ,
Life Sciences ,
Medical Research ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Regulatory Reform
Personalized medicine—tailoring treatments to individual patients based on their genetic makeup, lifestyle, and environment—is transforming healthcare. But this revolution didn’t begin in the private sector. It was sparked...more
Somatic mosaicisms are post-conception changes to cellular DNA that lead to genetic variation among cells in an organism. These changes can account for variation among individuals’ health or disease progression. Therefore, an...more
The USPTO recently released a Report to Congress (“Report”) detailing the results of its call for public comments regarding the impact of U.S. jurisprudence on patent subject matter eligibility. The Report is responsive to...more
On December 12, 2019, an outbreak of a severe pneumonia broke out of Wuhan, China. The causative agent of the outbreak was determined to be a coronavirus, an enveloped positive- and single-stranded RNA virus that infects...more
Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more
11/4/2015
/ AMP v Myriad ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratories ,
Complete Genomics ,
Diagnostic Method ,
Diagnostic Tests ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Insurance ,
Healthcare ,
Healthcare Costs ,
Healthcare Reform ,
Innovation ,
Insurance Industry ,
Intellectual Property Protection ,
Life Sciences ,
Medicaid ,
Medicare ,
Personalized Medicine ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Reimbursements ,
Research and Development ,
SCOTUS
Five industry executives argue for an overhaul of the current approval and reimbursement framework for diagnostic tests. In A Pay-For-Value, Data-Driven Approach for the Coverage of Innovative Genetic Tests a case is made for...more