Kundu v. Ragunathan

Informative decision only: persuasive authority, not binding precedent. When a junior party under a Rule 617 show-cause order has a prima facie earlier actual reduction to practice but filed about thirty-five months later and shortly after the senior party's patent issued, it must show by clear and convincing evidence (Rule 657(c)) that its total conduct was reasonable, and suppression under 35 U.S.C. 102(g)(1) is found where its work was directed to FDA ANDA approval and commercialization rather than inexorable progress toward public or USPTO disclosure. Work toward an ANDA is weak evidence of such progress because ANDA development is confidential and need not lead to public disclosure. No prior precedent directly addressed this issue in the text, which applies existing suppression case law (Lutzker, Fujikawa, Young, Shindelar) to ANDA drug-approval work. For the senior party, an unexplained delay of about thirty-five months after reduction to practice, together with filing shortly after its patent issued, creates an inference of suppression and spurring that the junior party must rebut. For a junior party or applicant, regulatory development work gets little credit, and perfecting work must be tied to the application's disclosure. The Board relied on Lutzker v. Plet, 843 F.2d 1364, Fujikawa v. Wattanasin, 93 F.3d 1559, Dow Chem. Co. v. Astro-Valcour, Inc., 267 F.3d 1334, and Price v. Symsek, 988 F.2d 1187 (Fed. Cir.), and Young v. Dworkin, 489 F.2d 1277, and Shindelar v. Holdeman, 628 F.2d 1337 (CCPA). LEGAL TEST OR STANDARD: Suppression is a pragmatic balancing of reasonable real-world delays and the enhanced value of further perfecting the invention against the social disutility of further delay in disclosure. Delay and spurring are the two guideposts. Delay does not itself prove suppression but supports an inference absent adequate explanation, and spurring is relevant but not necessary. Suppression is judged from the reasonableness of the inventor's total conduct. Slow (even fitful) but inexorable progress toward disclosure can overcome the inference. The work must not be directed only to commercialization and should be reflected in the application. The junior party must meet Rule 657(c)'s clear and convincing standard. TRIGGERING FACTS: Kundu alleged an actual reduction to practice on 29 August 1997 but filed its first application on 21 July 2000, nearly thirty-five months later, twenty-seven months after Ragunathan's filing and one day short of five months after Ragunathan's 065 patent issued on 22 February 2000. Kundu sought an interference, and the Rule 617 order to show cause issued. Its work was largely development toward an FDA ANDA, and patent-drafting evidence began late (November-December 1999, or March 2000). Declarations were assumed true at this stage. KEY QUOTE: "Thus, work toward an ANDA is weak evidence of an inexorable effort to place the invention in the possession of the public since an ANDA development program would not necessarily become public or lead to a publically used product." (Paper 51, p. 18) PRIOR PRECEDENT AFFECTED: No prior Board precedential or informative decision is directly affected. The Board followed Basmadjian v. Landry, 54 USPQ2d 1617 (BPAI 1997), on Rule 617 practice and Holmwood v. Cherpeck, 2 USPQ2d 1942 (BPAI 1986), on allowing a showing on the reason for delay. It applied Lutzker v. Plet, Fujikawa v. Wattanasin, Young v. Dworkin and Shindelar v. Holdeman. PRACTICE TIP: If you face a suppression inference in an interference, precisely identify and explain in your opening brief all patenting activity, including early drafting. Tie each development step to what the application discloses, and do not rely on FDA ANDA development to excuse delay. New evidence in a reply will be suppressed as untimely under Rule 645(b).