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Federal Circuit Finds District Court Erred in Analysis of Motivation to Combine Prior Art References, Yet Affirms Ultimate Conclusion of Non-obviousness Due to the Lack of a Reasonable Expectation of Success
On May 13, 2019, Federal Circuit Judges Stoll, Plager, and Clevenger issued an opinion, authored by Judge Stoll, in Novartis Pharms. Corp. v. West-Ward Pharms. Int'l Ltd., Case No. 2018-1434. The issue on appeal was whether the United States District Court for the District of Delaware erred in holding that claims 1-3 of U.S. Patent No. 8,410,131 ('131 patent) would not have been obvious in view of the prior art. Upon concluding that the district court did not err, the panel affirmed the district court's ruling.
Novartis Pharmaceuticals Corp. and Novartis AG (collectively, Novartis) own the '131 patent, which claims methods of using the compound everolimus to treat advanced renal cell carcinoma (“RCC). Slip op. at 2. West-Ward's predecessor in interest filed an Abbreviated New Drug Application (ANDA) seeking to manufacture and sell generic versions of Novartis' Afinitor product (which contains the active ingredient everolimus), and Novartis responded by filing claims of patent infringement. Id. The parties stipulated that the ANDA infringes claims 1-3 of the '131 patent, and a bench trial proceeded on invalidity. Id. at 9. The district court ruled that West-Ward failed to prove that the patent claims are obvious, and West-Ward appealed. Id. at 2.
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