Federal Circuit Grants Patent Term Adjustment After Allowance If - PDF document

Federal Circuit Grants Patent Term Adjustment After Allowance If Patent Issued From Continued Examination On January 15, 2014, the U.S. Court of Appeals for the Federal Circuit decided Novartis AG v. Lee (No. 2013-1160, 1179) and Exelixis v. Lee (2013-1175, 1198), holding that for purposes of calculating Patent Term Adjustment (PTA), the time excluded from Patent Office B delay for filing a request for continued examination (RCE) more than three years after filing ends at allowance. Accordingly, any patent that issued from such a continued examination application within the last seven months can still file an Application for PTA to request that the time from allowance to issue be included in Patent Office B delay. 1 As of January 15, 2014, this included any patent issuing from a continued examination application on or after June 15, 2013. Of course, the date of issue for qualifying patents moves forward one day for every day after January 15, 2014. Background 35 U.S.C. § 154 guarantees patent term extension to a patentee for certain delays caused by the U. S. Patent and Trademark Office (USPTO) during prosecution of an original patent application. Among these is an extension if the USPTO fails to issue an original patent within three years of filing. 37 C.F.R. § 1.702(b) provides that the Patent Office will issue an original patent within three years of the actual filing date of the application 2 and if the Office fails to do so, the term of the patent will be adjusted by the additional time it takes the patent to issue, but the adjustment will not include "(1) Any time consumed by continued examination of the application under 35 U.S.C. § 132(b)." The USPTO has interpreted the "time consumed by continued examination of the application under 35 U.S.C. § 132(b)" as all time from the date an RCE is filed until the patent issues. In Novartis , the patentee argued that the delay under 37 C.F.R. § 1.702(b), should include the time consumed by continued examination application, and at any rate, the "time consumed by continued examination of the application under 35 U.S.C. § 132(b)" should not include the time from Notice of Allowance to issue. That is, the patentee argued that the time consumed by continued examination should be included in the USPTO 1 See AIA Technical Corrections Act, § 1(h)(3)(A) and Revisions to Patent Term Adjustment . Fed. Reg. Vol. 78, No. 62: 19416-19421, at page 1941837. C.F.R. § 1.705(b) as amended now states: “Any request for reconsideration of the patent term adjustment indicated on the patent must be by way of an application for patent term adjustment filed no later than two months from the date the patent was granted. This two month time period may be extended under the provisions of § 1.136(a).” 2 For a National Stage PCT application, the filing date is the "date of commencement of the national stage under [section] 371." 35 U.S.C. § 154(b)(1)(A)(i)(II). Under 35 U.S.C. § 371, the date of commencement of the national stage is the date the PCT application was filed in the United States, if all the requirements under section 371 are met at the time of filing, or 30 months from the priority date, if all the requirements under section 371 are not met at the time of filing.

delay, and, even if not included, at least the time from issuance of a Notice of Allowance to issue of the patent should be included in the USPTO delay. The Federal Circuit's Decision The Federal Circuit agreed with the USPTO's interpretation of the statute that the PTA for failing to issue a patent within three years of filing should not include the time consumed by continued examination; however, the Federal Circuit also agreed with Novartis that the time consumed by continued examination does not include the time from issuance of a Notice of Allowance to issue. Novartis , at pg. 15. The Federal Circuit stated that PTA "should be calculated by determining the length of time between application and patent issuance, then subtracting any continued examination time and determining the extent to which the result exceeds three years." Id . at 14. However, the Federal Circuit also found that the "continued examination time" does not include time from issuance of a Notice of Allowance to Issue, as all cases, even those not involving continued examination would be entitled to this time. Id . at 15- 16. Application for PTA must be filed now The parties in Novartis have 45 days from the decision to request rehearing en banc (Fed. R. App. Proc. 41(b)) and 90 days from the decision to file a writ of certiorari to the United States Supreme Court (Rules of S. Ct. 13), so at least until the time period for filing a writ of certiorari expires, there are three possible ways to calculate the delay under 37 C.F.R. § 1.702(b) vis-à-vis an RCE filed more than three years after the filing date of the original application. These are: (1) the delay does not include any time after an RCE is filed up until the issue of the patent (the PTO's position should it request rehearing); (2) the delay includes all of the time after an RCE is filed (the plaintiff's position should it request rehearing); or (3) the delay does not include the time from filing an RCE up until the Notice of Allowance issues, but does include the time from issuance of the Notice of Allowance to issue of the patent (the Federal Circuit's decision). Thus, the PTA could be (1) what the USPTO has thus far calculated, (2) an additional number of days calculated from the date an RCE was filed until issue, or (3) an additional number of days calculated from the date the Notice of Allowance issued until the patent issued, respectively. However, for patents issuing on or after January 14, 2013, all applications for PTA must be filed within seven months of the issue date (two months from the grant of the patent plus an additional 5 months with payment of extension of time fees). Therefore, unless the USPTO provides for some grace period or remedial action, as it did with the decision in Wyeth v. Kappos regarding the overlapping delay provisions of 35 U.S.C. § 154(b)(2)(A), patentees should immediately check all patents that are within seven months from issue and that issue from here on out on to determine whether additional PTO delay can be obtained by filing an application for PTA. 3 3 At this time it is not known whether the USPTO will provide for some grace period or remedial action, as it did with the decision in Wyeth v. Kappos regarding the overlapping delay provisions of 35 U.S.C. § 154(b)(2)(A). See Interim Procedure for Patentees to Request a Recalculation of the Patent Term

By: Susan J. Mack and Azy S. Kokabi adjustment to Comply With the Federal Circuit Decision in Wyeth v. Kappos Regarding the Overlapping Delay Provision of 35 U.S.C. 154(b)(2)(A), F.R. 5043 (February 1, 2010).