Dey, L.P., et al. v. Sunovion Pharmaceuticals, Inc.

Docket No. 2012-1428

May 20, 2013

Brief summary: Formal confidentiality agreements are not required to prevent invalidation for public use under 35 U.S.C. 102(b) (pre-2011) as long as “there were ‘circumstances creating a similar expectation of secrecy'” (including in third-party disclosure cases).

Summary: Dey appealed DC grant of SJ to Sunovion that Dey’s patent was invalid under the public use provisions of 35 U.S.C. 102(b) (pre-2011). Dey and Sunovion were simultaneously developing formulations for treatment of lung diseases. Sunovion filed a patent application, conducted clinical trials and released a commercial product. Dey also filed patent applications, but after Sunovion, which were allowed after consideration of Sunovion’s patent. Dey sued Sunovion for infringement of its patent but Sunovion convinced the court that its clinical trials constituted a prior public use of Dey’s claimed subject matter. The FC panel disagreed, finding that Dey’s claimed formulations were not “accessible to the public” (e.g., “reasonably believed to be freely available”) under its precedent (e.g., Invitrogen (FC 2005); Tone Bros., Inc. (FC 1994); Bernhardt, LLC (FC 2004); and Allied Colloids Inc. (FC 1995); W.L. Gore (FC 1983)). The DC found that one of Sunovion’s potentially invalidating formulations was tested in an “indisputably open and free” manner because patients were allowed to take it home and failed to return some of the unused product. Dey argued, however, that the use was restricted by agreements with the patients, including confidentiality agreements with investigators (although patients were allowed to inform their doctors that they were taking the active ingredient), and the patients were given incomplete descriptions of the formulations. Regarding the fact that the patients themselves were not bound by a confidentiality agreement, the FC panel noted that formal confidentiality agreements are not required as long as “there were ‘circumstances creating a similar expectation of secrecy'” (citing Invitrogen (FC 2005), several lower court cases, and Janseen Pharm. (FC 2005)). The FC panel also disagreed with the DC with respect to whether Dey needed to be in control of the disputed clinical trials (e.g., there was no obligation of confidentiality to Dey), explaining that this concept does not apply to third party use cases (citing Eolas (FC 2005)). Thus, the FC panel agreed with Dey that SJ was inappropriate. Judge Newman’s dissent argued that the case was so clear that the panel should have granted SJ to Dey.

This entry was posted in Anticipation (35 USC 102), Public Use. Bookmark the permalink.

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