Gilead Sciences, Inc. v. Lee, No. 14-1159 (Fed. Cir. 2015)
Annotate this CaseBefore 1994, 35 U.S.C. 154 provided that a patent’s term ran from the date of issue. That term still begins on the date of issuance, but generally ends 20 years after the application was filed. Patent Term Adjustments (PTAs) address delays in the examination process. Category A applies when the PTO does not issue section 132 notification or provide section 151 notice of allowance within 14 months. Category B applies if the PTO fails to issue a patent three years after the actual filing date; category C covers delays due to interference, secrecy order, or successful appeal. Gilead filed the 374 application covering the compound cobicistat on February 22, 2008. The Examiner, finding more than one patentably distinct invention, issued a “restriction requirement” on November 18, 2009, dividing Gilead’s claims into four groups and directing it to select a subset. Gilead responded on February 18, 2010, selecting one for examination. Gilead filed a supplemental information disclosure statement on April 16, 2010, disclosing co-pending applications. The PTO issued notice of allowance on July 29, 2011; the patent issued on April 3, 2012. The PTO issued 245 days of “A Delay” and 406 days of “B Delay,” reduced by 35 days of overlapping and 57 days of applicant-induced delay (between Gilead’s initial reply and its supplemental IDS). The PTO rejected an argument that the supplemental IDS did not cause actual delay. The Federal Circuit affirmed summary judgment upholding the calculation.
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