By Jason Rantanen
Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013) Download 12-1428.Opinion.5-16-2013.1
Panel: Newman (dissenting), Bryson (author), O'Malley
Although decided under the "old" version of 35 U.S.C. 102, Dey v. Sunovion has broad ramifications for both current and future patents. At issue was whether a clinical study – conducted by the accused infringer in this case – constituted an invalidating "public use." All three judges agreed that the district court erred in granting summary judgment that the study was a public use. Judge Newman would have gone further and granted summary judgment that the study was not a public use.
A Classic Issue With a Twist: In the 1990s and 2000s, Dey and Sunovion both developed pharmaceutical products containing the compound formoterol for treating pulmonary disease. Both filed for and obtained patents and both conducted clinical trials.
In a twist on a classic issue, Sunovion – the accused infringer – asserted that its clinical trials were an invalidating public use against Dey's patents because they involved the accused formulation and took place well before Dey's 102(b) critical date. During Sunovion's clinical trials, participants were given treatments to take home and self-administer twice daily. Participants were also given some information about the study (but not the specific formulation) and signed a consent form stating that the medications must only be taken by the person for whom it was intended and that they would have to keep usage logs and return unused medications. Test administrators signed a confidentiality agreement. The district court granted summary judgment in Sunovion's favor and Dey appealed.
The Law of Public Use: On appeal, the Federal Circuit applied the public use framework articulated in Invitrogen v. Biocrest: "To decide whether a prior use constitutes an invalidating 'public use,' we ask 'whether the purported use: (1) was accessible to the public; or (2) was commercially exploited.'" Slip Op. at 6, quoting 424 F.3d 1374, 1380 (Fed. Cir. 2005). Here, the case turned on the "accessible to the public" form of public use, a fuzzy determination guided by the policies underlying the pubic use bar and a multi-factor analysis including "the nature of the activity that occurred in public; the public access to and knowledge of the public use; [and] whether there was any confidentiality obligation imposed on persons who observed the use." Id., quoting Bernhardt v. Collezione Europa USA, 386 F.3d 1371, 1379 (Fed. Cir. 2004). The court held that this approach applies equally to alleged third party public uses.
Against this backdrop, the CAFC reversed the district court's grant of summary judgment of invalidity. First, the majority viewed the issue of whether the use of Batch 3501A by study participants was "indisputably open and free" as opposed to "sufficiently controlled and restricted" as a factual determination. "The fact that a tiny fraction of the thousands of vials were lost without penalizing the responsible test subject(s), or that the practicalities of the study required self-administration at home rather than physician administration in a closed facility, does not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted, rather than unfettered and public." Id. at 9. Similarly, the issue of the confidentiality obligations imposed in the study was open to dispute. "Because a finder of fact could conclude that the study was conducted with a
reasonable expectation of confidentiality as to the nature of the formulations being tested, summary judgment on the public use issue was inappropriate." Id. at 11.
Public Use or Public Knowledge?: One of the main tensions in determining whether there has been an invalidating public use has long been the question of whether it is the use of the invention in public that matters or whether knowledge of the invention by the public is necessary. In my classes, I use the classic case of Egbert v. Lippman to start the discussion: is it a public use because Samuel gave the corset springs to Frances without restriction or is it a public use because Frances wore the corset springs under her clothes in public? Here, the court adopted the former view: what mattered in Egbert was the giving of the corset springs without restriction to the public (Frances), not the wearing of the springs in a concealed manner in public.
In adopting this view, the majority rejected the approach of New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1299 (Fed. Cir.2002), which quoted another classic case, City of Elizabeth v. American Nicholson" for the proposition that "the core issue is not public knowledge of the invention, but the public use of it":
The language quoted from New Railhead derives from the seminal “experimental use” case, City of Elizabeth v. American Nicholson Pavement Co., 97 U.S. 126, 136 (1877), and it makes good sense in that setting: During experimentation, the public might have knowledge of an invention (because they see it), but may not be using the invention within the meaning of the statute (because the inventor is experimenting).4 As for Egbert, although the invalidating use in that case was not visible to the general public, the case turned on the lack of control the inventor maintained over his invention.
4 In New Railhead, the invalidating public use took place at a public commercial job site, with the knowledge of the patentee inventor. 298 F.3d at 1293, 1298. “Commercial exploitation is a clear indication of public use,” even absent separate consideration of public accessibility,
Invitrogen, 424 F.3d at 1380, and “secret commercialization” by a third party is not public use, even if it might have resulted in forfeiture were the third party the one filing the patent application, W.L. Gore, 721 F.2d at 1550.
Slip Op. at 14-15.
Consequences for Arguing the Issue of Public Use: One major consequence of this opinion is that is makes the argument against clinical trials being public uses much easier and simpler. Rather than attempt to deal with the complexity of arguing that a clinical trial falls into the experimental use exception to public use (a challenging task, given Federal Circuit precedent over the last decade), Dey provides an excellent grounding for the argument that many clinical trials are not public uses at all.