Supernus Pharmaceuticals, Inc. v. Iancu, No. 17-1357 (Fed. Cir. 2019)Annotate this Case
In April 2006, Supernus filed the “100 application” In August 2010, the USPTO issued a final rejection. In February 2011, Supernus filed a request for continued examination (RCE), 35 U.S.C. 132(b). Also in April 2006, Supernus filed an international application, claiming priority from the 100 application, which was subject to opposition. Supernus notified USPTO of the opposition. In October 2011, the European Patent Office issued European Patent EP2010189. The 100 application issued in June 2014, as the 897 patent, titled “Osmotic Drug Delivery System,” reflecting a patent term adjustment (PTA), adding 1,260 days to the patent’s 20-year term. The USPTO attributed 2,321 days to USPTO delay: 1,656 days for USPTO’s failure to meet the mandated statutory response deadlines and 665 days for failure to issue the patent within three years of the application’s filing date. The USPTO reduced the PTA by 175 days to account for overlapping delays, and by 886 days for applicant delay. Of the 886 "applicant delay" days attributed, 646 days were assessed for the period Supernus did not attempt to invoke the protections of the 30-day safe harbor established by 37 C.F.R. 1.704(d)(1). Supernus argued that “37 C.F.R. 1.704(c)(8) does not govern post-RCE submissions.” The USPTO rejected a request for reconsideration. The district court granted USPTO summary judgment. The Federal Circuit reversed. The PTA went beyond the period during which the applicant failed to undertake reasonable efforts, exceeding the limitations set by the PTA statute.