On June 18, 2014, the Patent Office issued changes to how it calculates patent term adjustments under 35 U.S.C. § 154.  The new rules—drafted in response to the Federal Circuit’s decision in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014)—are now subject to public comment for the next sixty days.

As we discussed in our January 28, 2014 post, a patent term adjustment is required under 35 U.S.C. § 154, subject to certain exceptions, if an application is pending before the Patent Office for longer than three years.  One of those exceptions is time elapsed during continued examination, which is exempt from the three-year calculation under §154(b)(1)(B)(i).

In Lee, the Federal Circuit ruled that the Patent Office was correct to exclude from the three-year calculation any time resulting from continued examination, but explained that the Patent Office cannot exclude any time after the patentee receives a notice of allowance.  In other words, the time from allowance to issuance—often times several months—is no longer excludable under §154(b)(1)(B)(i).

In response, on June 18, 2014, the Patent Office issued its proposed changes to the rules of practice pertaining to patent term adjustments.  In the Patent Office’s proposed changes, “the time consumed by continued examination of the application under 35 U.S.C. §132(b) is the number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 U.S.C. §132(b) was filed and ending on the date of mailing of a notice of allowance under 35 U.S.C. § 151, unless prosecution in the application is reopened.”  79 Fed. Reg. 34681.

The proposed new rule also “provides that the submission of a request for continued examination after a notice of allowance has been mailed will constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application and thus result in a reduction of any period of patent term adjustment.”  79 Fed. Reg. 34681

Despite requesting comments on the proposed new rules for the next sixty days, the Patent Office has already started to accept requests for reconsideration of patent term adjustments filed in response to the Novartis decision.  As a result, ANDA applicants should consider this new draft language as they prepare to file their paragraph III/IV certifications.