The Week That Was In Skinny Labels

• Published date: 10 August 2021
• Subject Matter: Intellectual Property, Patent
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Author: Mr Richard D. Kelly

This week saw two cases reported with possible implications for skinny labels. The first was a recommendation be Magistrate Judge Hall, District of Delaware, that Hikma Pharmaceuticals could not dodge Amarin's lawsuit claiming Hikma induced infringement of Amarin's patents on the use of its heart drug Vascepa' . The patents in suit are U.S. Patent Nos. 9,700,537 (the '537 patent), 8,642,077 (the '077 patent), and 10,568,861 (the '861 patent) under 35 U.S.C. ' 271(b). In an interesting twist, Amarin also sued Health Net, an insurance provider, for also inducing infringement of the same patents. The suit against Health Net appears to be a first where an insurance company was sued for inducing infringement of method of using a drug.

Vascepa' currently has two FDA-approved indications: (1) treatment of severe hypertriglyceridemia (the "SH indication"); and (2) cardiovascular risk reduction (the "CV indication"). Only the CV indication is protected by patents.

The '537 patent claim 1 reads:

A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:

identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,

wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after A method of reducing occurrence of a cardiovascular event in a hypercholesterolemia patient consisting of:

identifying a patient having triglycerides (TG) of at least 150 mg/DL and HDL-C of less than 40 mg/dL in a blood sample taken from the patient as a risk factor of a cardiovascular event, wherein the patient has not previously had a cardiovascular event, and administering ethyl icosapentate in combination with a 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor,

wherein said 3-hydroxyl-3-methylglutaryl coenzyme A reductase inhibitor is administered to the patient at least one of before, during and after administering the ethyl icosapentate; and

wherein the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is selected from the group consisting of pravastatin, lovastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin, and...