AstraZeneca Loses at the Federal Circuit on Omeprazole

US Court of Appeals for Fed CircOn December 19, 2013, Hanmi Pharmaceuticals received good news in the form of a decision by the U.S. Court of Appeals for the Federal Circuit (CAFC). Invoking 35 U.S.C. §271(e)(2), AstraZeneca had alleged that a drug Hanmi proposed to market falls within claims of U.S. Patent Nos. 5,714,504 and 5,877,192. After the district court construed the claim terms “alkaline salt” in the ’504 patent and “pharmaceutically acceptable salt” in the ’192 patent, the parties consented to the entry of a final judgment of non-infringement based on the constructions. This case is of particular interest to the industry because omeprazole is the active ingredient in the popular over-the-counter heartburn medication know as Prilosec.

Creating a salt out of omeprazole can enhance stability during storage and transportation, a useful property in pharmaceutical compounds.  AstraZeneca discovered that certain salts of an omeprazole enantiomer have improved pharmacokinetic and metabolic properties which will give an improved therapeutic profile such as a lower degree of interindividual variation. During prosecution, AstraZeneca conducted experiments that led it to conclude that one of the two enantiomers gave particularly good results. The preferred enantiomer became known as “esomeprazole.”

Teva v. AstraZeneca – Does an Inventor Need to Understand How a Prior Invention Works in Order to Have that Prior Invention Defeat Another’s Patent?

Written by Gerald M. Murphy, Jr., Partner at Birch Stewart Kolasch & Birch, LLP 

On December 1, in Teva Pharmaceutical Ind. Ltd. v. AstraZeneca Pharmaceuticals LP, the Federal Circuit explained when a secret invention can be considered “made” (or conceived and reduced to practice) so that it can be used as prior art against a patent.  Briefly, the CAFC held that an invention can be considered “made” if the inventive entity “did not do so by accident and it knew what it had made.”  It is not necessary for the prior inventor to “know everything about how or why its invention worked.”