On behalf of a plaintiff for a blockbuster heart failure fixed-dose combination medication, CRA was retained to assess the commercial success of the product and the nexus between the success and the patents-in-suit. CRA consultants assessed the product’s sales, sales growth, and profitability in a competitive environment that included numerous alternative treatments. Consideration of clinical research, clinical guidelines, and marketing literature supported a conclusion of commercial success attributable to the patents-in-suit. Finally, CRA consultants also considered whether earlier plaintiff patents deterred and “blocked” competitor research into the product in the context of typical drug development timelines.
At the nexus of commercial success and non-obviousness
Dr. Gregory K. Bell recently testified in three successful challenges to abbreviated new drug applications (ANDA) on behalf of pharmaceutical manufacturers...