For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more
8/27/2019
/ Administrative Procedure Act ,
Arbitrary and Capricious ,
Chevron Deference ,
Clinical Trials ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Exclusivity ,
Statutory Interpretation
FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more
This is the fourth article in our five-part series on PTE.
When applying for a patent term extension (PTE), due diligence matters. If an applicant did not act with due diligence during the testing phase or the approval...more
This is the third article in our five-part series on PTE.
Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
5/19/2017
/ Biologics ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
USPTO