Dey, L.P. v. Sunovion Pharm., Inc.
- Jun 11 2013 |
- Category: News
The Federal Circuit recently tackled Dey, L.P v. Sunovion Pharm., Inc., No. 2012-1428 (Fed. Cir. 2013), which presented an unusual twist regarding the ever-familiar public use bar codified in pre-AIA 35 U.S.C. § 102(b). Specifically, in defending the patent infringement suit brought by Dey, Sunovion argued that some of Dey’s patents were invalid on grounds that Sunovion’s own clinical trial constituted a prior public use of Dey’s invention within the meaning of pre-AIA 35 U.S.C. § 102(b). Sinovion at 2. This unusual case departs from the typical fact patterns involving the prior public use bar in that, rather than alleging that Dey’s clinical trial or other use of its patented invention constituted a prior public use, Sunovion instead argued that its own clinical trials constituted a prior public use of Dey’s invention. Id.
Following Eloas Techs. Inc. v. Microsoft Corp., 399 F. 3d 1325, 1334 (Fed. Cir. 2005), which delineated that “third party prior use accessible to the public is a section 102(b) bar,” the District Court proceeded to analyze Sunovion’s clinical trial in the same manner as it seemingly would have if it were Dey’s clinical trial in question; that is, to determine whether Sunovion’s clinical trial, “the purported use: ‘(1) was accessible to the public; or (2) was commercially exploited.'” Id. at 6 (quoting Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F. 3d 1374, 1380 (Fed. Cir. 2005)).
Ultimately, the Federal Circuit found that the District Court erred in granting summary judgment for Sunovion on the grounds that “Sunovion’s clinical trials of its own product represent[ed] clear and convincing evidence that Dey’s inventions were accessible to the public more than a year before Dey sought to patent them,” and remanded the case back to the District Court to determine whether Sunovion’s clinical trials were kept sufficiently confidential, i.e., whether the clinical trials constituted a public use. Sunovion at 15-16. Judge Newman, in dissent, took it one step further, arguing that “Sunovion’s clinical trial does not constitute an invalidating ‘public use’ of Dey’s invention” because confidentiality standards were upheld throughout the trials. Dey, L.P v. Sunovion Pharm., Inc., No. 2012-1428 (Fed. Cir. 2013); Dissenting Opinion of Judge Newman, 1.