Pivotal Therapeutics Inc., Woodbridge, Ontario, Canada has received a Notice of Allowance for its U.S. Patent Application for Serial Number 13/584,428 entitled “Omega 3 Fatty Acid for use as a Prescription Medical Food and Omega 3 Fatty Acid Diagnostic Assay for the Dietary Management of Cardiovascular patients with Cardiovascular Disease (CVD) who are Deficient in Blood EPA and DHA Levels.”  The patent extends to a kit for the dietary management of cardiovascular patients with VASCAZEN and an omega-3 fatty acid diagnostic assay.
 
The specialty pharmaceutical company specializes in omega-3 therapies for cardiovascular disease and overall health. The United Stated Patent and Trademark Office (USPTO) notice constitutes allowance of the patent and impending issuance. The issued patent would have a term that expires no earlier than in 2032.
 
The present invention provides a kit for the dietary management of cardiovascular patients with cardiovascular disease who are deficient in blood Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) levels. This kit includes a diagnostic assay for determining blood levels of EPA, DHA and Docosapentaenoic acid (DPA) and a pharmaceutical grade prescription medical food omega-3 fatty acid formulation containing about 90% or more omega-3 fatty acids by weight including a combination of EPA, DPA and DHA in a weight ratio of EPA:DHA of 5.7:1 to 6.3:1. The sum of the EPA, DHA and DPA are about 82% by weight of the total formulation and about 92% of the total omega-3 fatty acid content of the composition. EPA + DHA are about 80% of the total formulation and about 89% of the total omega-3 fatty acid content of the composition.
 
“This is a key patent in our portfolio that surrounds our unique omega-3 formulation,” said Dr. George Jackowski, Pivotal’s founder and chief scientific officer. “In fact, in this allowed patent, we were able to obtain separate independent claims to our unique omega-3 formulation that is the basis of a series of products being commercialized by Pivotal.”
 
This application is part of Pivotal’s expanding patent portfolio that protects its formulation. The company has a total of four issued and allowed patents and seven patent applications currently in prosecution in the U.S. The company is pursuing patent applications related to VASCAZEN’s formulation, composition, combinations with existing obesity and cardiovascular drugs and an omega-3 fatty acid diagnostic assay in the U.S. and in multiple jurisdictions outside the United States.