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Unformatted text preview: use was 0.25% 18 18 Example 2
s Evidence Inventor declaration asserting that the besylate salt of amlodipine possessed good solubility, stability, non hygroscopicity and processability which were “unpredictable both individually and collectively” and was superior to prior art amlodipine maleate salt 19 19 Example 2
s Conclusion It would have been obvious to one of ordinary skill in the art at the time the invention was made to choose from a finite number of predictable pharmaceutically acceptable salt options of amlodipine with a reasonable expectation of success of producing a functional amlodipine formulation 20 20 Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 82 USPQ2d 1321 (Fed. Cir. 2007)
s Court’s Analysis Suggestion, teaching or motivation does not have be explicit and “may be found in any number of sources, including common knowledge, the prior art as a whole or the nature of the problem itself”, citing Dystar Textilfarben GMBH v. C.H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006) Formulations must be tested by routine procedures to verify expected properties 21 21 Example 3
s Claim 54[2(5ethyl2pyridyl)ethoxy]benzyl 2,4thiazolidinedione (a thiazolidinedione (TZD) with the ethyl group at the 5position pyridyl ring) 22 22 Example 3
s Prior Art Patent disclosing an effective anti diabetic compound, “Compound 42” (out of 60), which differs from the claimed compound in two ways methyl in plac...
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