Dey LP v. Sunovion Pharm.: No SJ that Clinical Trials Amounted to Public Use

Categories: 102
      Date: Mar  5, 2014
     Title: Dey LP v. Sunovion Pharm.: No SJ that Clinical Trials Amounted to Public Use

Category: 102

By: Samuel Dillon, Contributor

Title	Dey, L.P. v. Sunovion Pharm., Inc., No. 2012-1428 (Fed. Cir. May 20, 2013).
Issue	[Whether] Sunovion was entitled to summary judgment of invalidity because Sunovion’s own clinical trial constituted clear and convincing evidence of a third-party public use of Dey’s inventions. Dey, *at 8.**
Holding	[W]e conclude that Sunovion has not shown that it is entitled to summary judgment based on its assertion that its use of formulations meeting the limitations of Dey’s later-issued patents constituted a public use of Dey’s inventions within the meaning of section 102(b). We therefore reverse the grant of summary judgment for Sunovion. Id. at *3.

Procedural History

During the late 1990s and 2000s, Sunovion Pharmaceuticals, Inc., and the Dey plaintiffs . . . were simultaneously developing pharmaceutical products to treat lung disease. Sunovion filed a patent application, followed by an application to test its products in human subjects. It then received a patent and held clinical trials, all before ultimately releasing a commercial product. . . . Dey’s patent applications were filed after Sunovion’s, and its patents were issued after consideration of Sunovion’s patent. When Dey sued Sunovion for patent infringement, Sunovion argued, and the district court agreed, that some of Dey’s patents were invalid because a Sunovion clinical trial in which Sunovion tested its own product constituted a prior public use of Dey’s inventions within the meaning of 35 U.S.C. § 102(b). Dey, at *2.

Legal Reasoning (Bryson, O'Malley)
Legal Standard for Public Use
§ 102(b)'s public use	An applicant may not receive a patent for an invention that was “in public use . . . in this country, more than one year prior to the date of the application for patent in the United States.” 35 U.S.C. § 102(b) (2006). 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.” Dey, at *6 (citation omitted).
Third Party Use	Although prior uses are often carried out by or at the direction of the inventor-patentee, we have held that “third party prior use accessible to the public is a section 102(b) bar.” But even in the case of third-party uses, being “accessible to the public” still requires public availability; secret or confidential third-party uses do not invalidate later-filed patents. Id. at *7 (citation omitted).
Degree of Confidentiality	The degree of confidentiality necessary to avoid a finding of public use naturally depends on the circumstances. For example, if there is no confidentiality agreement in place, the skill and knowledge of those observing an invention can shed light on the degree to which it was kept confidential. Even limited disclosure to those who are skilled enough to know, understand, and “easily demonstrate the invention to others,” may mean that there was no reasonable expectation of secrecy and that the invention was therefore in public use. Id. at *7-8 (citation omitted).
Sunovion's clincial trial not unequivocally a public use
Medication was Restricted	[T]est subjects agreed that only they would take the medications, and they promised to keep accurate usage logs and return all unused medication. Similarly, test administrators could dispense drugs only to trial subjects, were held accountable for secure storage and records of drug use, and knew that unused supplies had to be returned. . . . 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. Dey, at *9 (citation omitted).
Expectation of Privacy	[T]he fact that no formal obligation of secrecy was imposed on the study subjects does not automatically transform Sunovion’s clinical trial into a public use. We have never required a formal confidentiality agreement to show non-public use; in the absence of such an agreement, we simply ask whether there were “circumstances creating a similar expectation of secrecy.” The “public use” inquiry is replete with factual considerations, such as the (disputed) extent to which study participants were informed of and able to disclose the pertinent details of the claimed prior art. 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 (citation omitted).
Clinical Trial Like Many Others	Our conclusion is bolstered by the fact that the confidentiality controls in Study 50 were far from unique. In fact, Sunovion appears to have conducted its clinical trial like many others, at least with respect to formal confidentiality obligations and restrictions on information regarding the drugs being studied. . . . Many cases concern studies in which investigators sign strict confidentiality agreements but patients do not, and courts have routinely rejected the argument that such an arrangement necessarily strips the trial of confidentiality protection or renders it accessible to the public. Id. at *11-12 (citation omitted).
District court unduly expanded reach of 102(b)
Adequacy of Confidentiality Guarantees	The district court’s decision was also premised on several misconceptions about the reach of section 102(b). First, the court found it significant that the patent holder, Dey, did not control Sunovion’s clinical studies and that study participants did not owe any obligation of confidentiality to Dey. . . . Instead, we measure the adequacy of the confidentiality guarantees by looking to the party in control of the allegedly invalidating prior use. In third-party use cases, that is the third party. . . . Because a secret third-party use is not invalidating, our task is to assess whether the third party’s use was sufficiently “public” to impose the section 102 bar. That Sunovion’s trial subjects owed no duty of confidentiality to Dey is, of course, true, but it does not bear on that question. Dey, at *13.
Use by Public Not Always a "Public Use"	[Second,] although Sunovion is correct that we do not ask for an “‘enablement-type inquiry’” under section 102(b), a court still must decide whether the “claimed features of the patents [were placed] in the public’s possession.” And here, a reasonable jury could conclude that if members of the public are not informed of, and cannot readily discern, the claimed features of the invention in the allegedly invalidating prior art, the public has not been put in possession of those features. Id. at *15 (citation omitted).
Decision to Remand
Remand to District Court is Proper	The dissent agrees that the district court erred in granting summary judgment to Sunovion but would go farther and direct the entry of judgment for Dey. Our decision is not intended to foreclose the district court from entering summary judgment for Dey if the district court determines to do so on remand. We think it appropriate, however, to leave that decision to the district court. Dey, at *16 n. 5.
Conclusion
	Accordingly, we decline to hold, on summary judgment, that Sunovion’s clinical trials of its own product represent clear and convincing evidence that Dey’s inventions were accessible to the public more than a year before Dey sought to patent them. REVERSED and REMANDED. Dey, at *16.

Newman, dissenting. Dey, Newman Op. at *1.
Remand Casts Judicial Doubt on Clinical Trials	I would reverse the district court’s judgment and hold that Sunovion’s clinical trial does not constitute an invalidating “public use” of Dey’s invention. There are no facts to be found, no debate as to how the trials were conducted. No sound reason appears for remanding for findings or trial, when the matter is readily resolved on undisputed facts. Nor is there any reason for casting judicial doubt on the standard confidentiality procedures of clinical trials, at this late date of decades of established practice. Dey, Newman Op. at *1.
No Public Use on Uncontested Facts	We know the formulation and quantity of drug distributed; the number of trial participants; the terms of the investigators and participants’ participation agreements; the information disclosed to the trial participants; and the restrictions on drug use and distribution imposed by Sunovion. Moreover, both parties agree that Batch 3501A used in Study 50 falls within Dey’s patent claims. No pertinent fact remains at issue; the only question is the legal conclusion of whether these facts constitute a “public use” within the meaning of 35 U.S.C. §102(b). . . . On the uncontested facts, Sunovion’s clinical trial was not a “public use” within the meaning of 35 U.S.C. §102(b). Id. at *5-6.

Image Attribution Statement: Multidisciplinary Association for Psychedelic Studies, “LSD-clinical-trial-bottle,” available under a Creative Commons CC0 1.0 Universal Public Domain Dedication, http://commons.wikimedia.org/wiki/File:LSD-clinical-trial-bottle.jpg, (last visited March 4, 2014) (edited).