Recently, the Federal Circuit issued a decision in Novartis v. Lee (2013-1160, Fed. Cir., Jan. 15, 2014) which alters Patent Term Adjustment (PTA) calculations for patents where a Request for Continued Examination (RCE) was filed during prosecution.

In the Novartis decision, the Federal Circuit agreed with the USPTO that the filing of an RCE tolls the running of the three year B-delay clock regardless of whether the RCE was filed before or after the 3 year date. Thus, the Federal Circuit concluded that once an RCE is filed, no B-Delay is available for any time in continued examination. (See Novartis at page 13).

The Federal Circuit also held that, for cases where an RCE was filed during prosecution, applicants could be entitled to B-Delay for the time period between allowance and issuance. The USPTO currently excludes all time following the filing of an RCE from the B-Delay calculation. However, in the Novartis decision, the Federal Circuit held that the time from allowance to issuance does not fall under the exclusion set forth in 35 U.S.C. 154(b)(1)(B)(i). Thus, according to the Federal Circuit, the “examination” referred to in the 35 U.S.C. 154(b)(1)(B)(i) exclusion presumptively ends at allowance, unless prosecution on the merits resumes following receipt of a Notice of Allowance. (See Novartis at pages 15-16).

Because RCEs are filed in many cases, the Novartis decision could potentially impact a large number of patents. The USPTO has not yet indicated when it will change its procedure for calculating B-delay in cases where an RCE has been filed or whether the decision will be applied retroactively.

We recommend reviewing all patents that have issued recently where an RCE was filed to determine whether they may be entitled to additional PTA days in view of this decision.