Orange Book Vol. 42/Supp. 7 News
Bruce Pokras
Creator and Owner of the Orange Book Companion(R) from Blazing Dawn Software.
The recently released Vol. 42/Supp. 7 of the FDA’s Orange Book contained only 36 newly listed patents. Maybe July is a slow month? Also, there were no patent delstings. The free “What’s New” for Supp. 7 is available from a link on my?Orange Book Companion home page.
As I noted in my Supp. 6 news, the month of June saw a?letter?from a bipartisan mix of US senators to USPTO director Kathi Vidal expressing concern over??so-called “patent thickets.” Since I have been following the champion patent listing saga of Amarin’s VASCEPA? (icosapaent ethyl) for a while now, I thought that?VASCEPA?might be considered by critics to involve such a “thicket.”
Hikma’s ANDA for??their 1 gram icosapent ethyl product was the first generic version of?VASCEPA?that the FDA approved. As a result, I thought it would be interesting to delve into Hikma’s patent certifications and statements for such a large collection of listed patents. The FDA’s approval letter for Hikma’s 1 gram icosapent ethyl product provided me with a lot of raw data about their Paragraph IV certifications and Section viii statements that I will discuss in a future article. I will specifically discuss the?VASCEPA?patent families and the extent to which those families were the result of the continuation filings that concerned the senators. Stay tuned!