Life science companies operate in a heavily regulated environment and the rules of the game are constantly changing. Join members of Pepper’s Health Sciences Department as they discuss the latest in deals in the life sciences...more
Life science companies operate in a heavily regulated environment and the rules of the game are constantly changing. Join members of Pepper’s Health Sciences Department as they discuss the latest in deals in the life sciences...more
This week the Supreme Court of the United States (“Supreme Court”), in a 7-2 decision, held that inter partes review (“IPR”) proceedings conducted by the Patent Trial and Appeal Board (PTAB) do not violate Article III or...more
On March 21, 2018, the Patent Trial and Appeal Board (“PTAB”) instituted the first AIA derivation proceeding to determine whether patent claims to a window frame component should be canceled because they were derived from...more
Every year, the National Institutes of Health (NIH) spends billions of federal dollars on research and development of new drugs and therapies for treating and preventing serious illnesses....more
3/27/2018
/ Failure to Report ,
Federal Funding ,
Gilead Sciences ,
Inventions ,
Life Sciences ,
National Institute of Health (NIH) ,
Patent Ownership ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
R&D ,
Reporting Requirements ,
Research and Development ,
Scientific Research
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
The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity.
Originally published in the Intellectual Property and Life Sciences sections of...more