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The case of Amarin Pharma, Inc. and its affiliates versus Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals PLC presents a fascinating intersection of patent law, FDA regulatory strategy, and pharmaceutical marketing. Central to this legal dispute are U.S. Patents 9,700,537 and 10,568,861, owned by Amarin, which describe methods of reducing cardiovascular risk by administering icosapent ethyl, a compound found in the drug Vascepa®. Vascepa® had initially received FDA approval for treating severe hypertriglyceridemia, a condition marked by high levels of triglycerides in the blood. However, Amarin’s continued research into the drug’s benefits led to an expanded FDA approval in 2019, allowing Vascepa® to be marketed for reducing cardiovascular risk in certain patient populations.Continue Reading Federal Circuit Provides Insight on Induced Infringement Claims in Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in Hatch-Waxman litigation. Specifically, the Federal Circuit reviewed the lower court’s obviousness analysis for dosage regimen and polymorph patent claims, as well as its interpretation of ANDA approval resetting provisions.Continue Reading Federal Circuit Upholds Rifaximin Patent Rulings, Affirms ANDA Approval Restrictions

EcoFactor, Inc. is the holder of U.S. Patent No. 8,498,753, titled “System, Method and Apparatus for Just-In-Time Conditioning Using a Thermostat,” which focuses on optimizing climate control systems, particularly HVAC systems, in residential and commercial buildings. The patented technology utilizes a thermostat that considers external weather conditions and the thermal characteristics of individual structures to dynamically adjust temperature settings, aiming to improve energy efficiency and comfort. Within Claim 1, a method is outlined for decreasing the cycling time of a climate control system, comprising steps such as accessing historical temperature data, determining thermal performance values, and calculating the optimal activation time for the system based on various inputs.Continue Reading Federal Circuit Rules on when the Patent Trial and Appeal Board is Engaging in Erroneous Claim Construction