Arguments Made in the Prosecution of Corresponding European Patent Useful in Interpreting U.S. Claims
In Re Omeprazole Patent Litigation, [2007-1476, -1477, -1478](June 10, 2008) [LOURIE, Bryson, And Gajarsa] NON-PRECEDENTIAL The Federal Circuit affirmed a finding noninfringement of U.S. Patents 4,786,505 (“the ’505 patent”) and 4,853,230 (“the ’230 patent”).
SIGNIFICANCE: Arguments made in the prosecution of corresponding European Patent were used to determine whether a composition met a claim limitation.
BRIEF: Omeprazole is the active ingredient in Prilosec®, a widely prescribed drug used to treat ulcers. However, Omeprazole is susceptible to degradation and suffers from other formulation problems, including sensitivity to heat, organic solvents, moisture, and light an the ‘505 and ‘230 patents relate to preparations of Omeprazole to overcome these difficulties. Astrazeneca sued for patent infringement under Hatch-Waxman and at a consolidated trial, the district court held that Astrazeneca failed to prove by a preponderance of the evidence that Mylan/Esteve’s products contained an alkaline reacting compound (ARC) as required by the claims. Astrazeneca asserted that the talc used in defendants products contained carbonates, and ARC, but the district court held that Astrazeneca failed to prove the presence of carbonates in defendant’s products. The Federal Circuit rejected Astrazeneca’s argument that the district court failed to apply a preponderance of evidence standard on the issue if infringement by requiring conclusive proof of an ARC. The Federal Circuit also noted statements in the specifications of the patents, as well as arguments in the corresponding European patent application, showed that defendant’s talc was not an ARC.
SIGNIFICANCE: Arguments made in the prosecution of corresponding European Patent were used to determine whether a composition met a claim limitation.
BRIEF: Omeprazole is the active ingredient in Prilosec®, a widely prescribed drug used to treat ulcers. However, Omeprazole is susceptible to degradation and suffers from other formulation problems, including sensitivity to heat, organic solvents, moisture, and light an the ‘505 and ‘230 patents relate to preparations of Omeprazole to overcome these difficulties. Astrazeneca sued for patent infringement under Hatch-Waxman and at a consolidated trial, the district court held that Astrazeneca failed to prove by a preponderance of the evidence that Mylan/Esteve’s products contained an alkaline reacting compound (ARC) as required by the claims. Astrazeneca asserted that the talc used in defendants products contained carbonates, and ARC, but the district court held that Astrazeneca failed to prove the presence of carbonates in defendant’s products. The Federal Circuit rejected Astrazeneca’s argument that the district court failed to apply a preponderance of evidence standard on the issue if infringement by requiring conclusive proof of an ARC. The Federal Circuit also noted statements in the specifications of the patents, as well as arguments in the corresponding European patent application, showed that defendant’s talc was not an ARC.
posted by Bryan @ 5:22 PM
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