AstraZeneca v. Dr Reddy's : Overly Aggressive Litigation has Its Limits

The ′424 patent contains 22 claims. Representative claims of the' 424 patent appear below: 1. An omeprazole magnesium salt having a degree of crystallinity which is higher than 70% as determined by x-ray powder diffraction. II. A process for the manufacture of magnesium omeprazole according to claim 1 comprising in consecutive steps (a) treating omeprazole or salt thereof with magnesium alcoholate in a solution, (b) separating inorganic salts from the reaction mixture, (c) crystallizing magnesium omeprazole by the addition of water, and (d) isolating the obtained crystalline magnesium omeprazole. 20. In a process for the manufacture of a crystalline magnesium salt comprising, (a) treating omeprazole or a salt thereof with magnesium alcoholate in a solution, (b) crystallizing magnesium omeprazole and (c) isolating the obtained crystalline magnesium omeprazole, wherein the improved process comprises separating inorganic salts from the reaction mixture prior to the crystallization step by the addition of water. 21. A method for inhibiting gastric acid secretion in mammals and man comprising administering to a host in need thereof a therapeutically effective dose of magnesium omeprazole according to any of claims 1 to 4, 6–8 and 10. 22. A method for the treatment of gastric acid related diseases in mammals and man comprising administering to a host in need thereof a therapeutically effective dose of magnesium omeprazole according to any of claims 1 to 4, 6–8 and 10.

The ′960 patent contains 22 claims. Representative claims of the ′960 patent appear below: 1. A stable oral formulation comprising: A core containing a magnesium salt of omeprazole said salt having more than 70% crystallinity as determined by x-ray powder diffraction; a subcoating layer; and an enteric coating layer, whereby the thickness of the enteric coating layer does not effect the release of omeprazole into solution at the pH predominantly present in the small intestine. 10. A process for the manufacture of a formulation of a pharmaceutical composition for the oral administration of magnesium omeprazole comprising the steps of: (a) forming a core material containing magnesium omeprazole salt said salt having at least 70% crystallinity as determined by x-ray powder diffraction; (b) applying in the presence of water at least one subcoating layer onto the core; (c) further applying in the pittance of water at least one enteric coating layer onto the subcoated core; and drying the prepared formulation. 17. A method for inhibiting gastric acid secretion in mammals and man by administering to a host in need thereof a therapeutically effective dose of an enteric coated formulation according to any of claims 1 to 9. 18. A method for the treatment of gastric acid related diseases in mammals and man by administering to a host in need thereof a therapeutically effective dose of an enteric coated formulation according to any of claims 1 to 9. 22. An improved oral pharmaceutical composition containing a core of omeprazole salt with a subcoating and an enteric coating wherein the improvement comprises magnesium omeprazole salt having more than 70% crystallinity as determined by x-ray powder diffraction.