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Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. Case Brief
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Case Brief Summary & Legal Analysis
tl;dr: A generic drug maker challenged a patent for the osteoporosis drug risedronate, arguing it was an obvious modification of a similar prior art compound. The court upheld the patent, finding the field of chemistry was too unpredictable for the modification to be obvious.
Legal Significance: In an unpredictable art like chemistry, structural similarity to a prior art compound is insufficient to prove obviousness without a specific reason to modify the compound and a reasonable expectation of success, reinforcing the limits of the KSR obviousness framework.
Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc. Law School Study Guide
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Case Facts & Court Holding
Key Facts & Case Background
The Procter & Gamble Company (P&G) held U.S. Patent No. 5,583,122 (‘122 patent) for the compound risedronate, the active ingredient in its osteoporosis drug, Actonel®. Teva Pharmaceuticals sought to market a generic version and challenged the ‘122 patent’s validity. Teva argued the patent was invalid for obviousness under 35 U.S.C. § 103 in light of P&G’s earlier U.S. Patent No. 4,761,406 (‘406 patent). The ‘406 patent claimed an intermittent dosing method for osteoporosis and disclosed several potential compounds, including a preferred compound known as 2-pyr EHDP. Risedronate and 2-pyr EHDP are positional isomers, meaning they contain the same atoms arranged differently on a pyridine ring. Teva contended that a person of ordinary skill in the art (POSA) would have been motivated to select 2-pyr EHDP as a lead compound and modify it to create risedronate. The district court found, and the Federal Circuit accepted, that the field of bisphosphonates was highly unpredictable at the time of invention (1985). Evidence showed that minor structural changes led to significant, unforeseeable differences in biological activity; for example, another isomer, 4-pyr EHDP, was completely inactive.
Court Holding & Legal Precedent
Issue: Would a person of ordinary skill in the art have been motivated to modify a known prior art compound (2-pyr EHDP) to create its structurally similar isomer (risedronate) with a reasonable expectation of success, thereby rendering the patent for risedronate invalid for obviousness?
No. The court affirmed the district court’s judgment, holding that Teva failed Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pa
IRAC Legal Analysis
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Legal Issue
Would a person of ordinary skill in the art have been motivated to modify a known prior art compound (2-pyr EHDP) to create its structurally similar isomer (risedronate) with a reasonable expectation of success, thereby rendering the patent for risedronate invalid for obviousness?
Conclusion
This case clarifies that in unpredictable arts, the obviousness inquiry requires more Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercit
Legal Rule
To establish a prima facie case of obviousness for a new chemical Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint oc
Legal Analysis
The court's analysis centered on the application of the obviousness standard in Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatu
Flash-to-Full Case Opinions
Flash Summary
- A chemical compound is not obvious simply because it is a
