Supp2d381sdnyjune 12007 s courtsanalysis

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Unformatted text preview: 33 33 Example 5 s Claim A formulation comprising (a) a core comprising omeprazole plus an alkaline reacting compound (ARC); (b) an inert subcoating, which is soluble or rapidly disintegrates in water, disposed on the core region, (c) an outer layer disposed on the subcoating comprising an enteric coating 34 34 Example 5 s Prior Art References disclose drugs formulated in a core with a subcoating and enteric coating but do not disclose omeprazole References disclose omeprazole but do not disclose coatings or an alkaline reacting compound References describe subcoating techniques but do not disclose omeprazole – subcoatings should not be used with moisture­sensitive drugs 35 35 Example 5 s Evidence Omeprazole is acid labile, sensitive to heat, moisture, solvents and light Expert testimony of “multitude of possible paths and dead­ends” in formulation attempts 36 36 Example 5 s Conclusion It would not have been obvious to one of ordinary skill in the art at the time the invention was made to formulate omeprazole with an alkaline reacting compound and then sub­coat and enterically coat the combination 37 37 In re Omeprazole Patent Litigation, 490 F. Supp. 2d 381 (S.D. N.Y. June 1, 2007) s Court’s Analysis Prior art compounds that were subcoated...
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