By Gregory Curfman
An ongoing patent battle over omega-3 fatty acids, colloquially known as as fish oils, may have broad implications for the marketing of generic drugs.
Icosapent ethyl (Vascepa®) is an omega-3 fatty acid preparation used to treat high triglycerides. It was explicitly designed to be different from most other omega-3 fatty acid preparations — instead of containing a mixture two fatty acids (docosahexaenoic acid and eicosapentaenoic acid), it is a purified preparation of just the latter, and it is a much higher dose than what is typically used.
On the basis of the ANCHOR and MARINE clinical trials, in 2012 the Food and Drug Administration (FDA) approved Vascepa for the treatment of persons with severe hypertriglyceridemia.
In 2015, Hikma Pharmaceuticals, a generic drug company, filed an abbreviated new drug application (ANDA) for its generic formulation of icosapent ethyl.
The manufacturer of branded Vascepa, Amarin Corporation, promptly filed a patent infringement lawsuit citing six method of use patents (the ‘728, ‘715, ‘677, ‘652, ‘560, ‘929 patents) on Vascepa that the company believed were infringed by Hikma’s ANDA.