Novartis vs. Lee: No Patent Term Adjustment During Continued Examination

In Novartis vs. Lee, the Federal Circuit sided with the USPTO, in part, when it held that an applicant is not entitled to patent term adjustment for any time accrued during continued examination, even if the RCE was filed more than three years after the application date. Notably, the court held that:

The better reading of the language is that the patent term adjustment time should be calculated by determining the length of the time between application and patent issuance, then subtracting any continued examination time (and other time identified in (i), (ii), and (iii) of (b)(1)(B)) and determining the extent to which the result exceeds three years. Such a reading ensures that applicants recover for any “delay[s] due to the failure of the [PTO],” without allowing the applicant to recover for “any time consumed by continued examination,” as the statute requires. Id. § 154(b)(1)(B)(i).

This ruling finally puts to rest the open question as to whether RCE cutoff of the accrual B-delay should only apply if the RCE is filed prior to the three-year mark.


What is the take away?  In a nutshell, if possible, avoid filing an RCE during prosecution.   In addition to being placed on the “slow-pile” where prosecution may be delayed for more than a year, filing an RCE may cost you patent term adjustment.  An RCE may be avoided by implementing certain housekeeping habits during prosecutions, such as (1) planning ahead and introducing claim amendments prior to issuance of a final Office Action, (2) conducting Examiner interviews early in prosecution to get the application in condition for allowance, etc.  For example, consider conducting an Examiner interview after issuance of the first Office Action if it is apparent that the Examiner does not understand the invention.  More times than not, a brief telephonic interview will move the application closer to allowance than a well-crafted 20-page response.

An alternative to an RCE is the USPTO’s After-Final Consideration Program 2.0.  Under this Pilot Program 2.0, each applicant must request that the after final response should be considered, which may be done using form PTO/SB/434.

The form requires that the applicant agree to an interview if the Examiner decides it is necessary. The only other requirement is that at least one independent claim needs to be amended and not in a manner that broadens the scope of the claim. There are no additional fees.  The USPTO recently extended this pilot program to September 30, 2014.  You can find more information here:

Next steps?  Review your patent portfolio to see if any patents issued within the past 180 days (where an RCE was used during prosecution) are eligible for a recalculation.  The PTA can be corrected via a request for reconsideration under 37 C.F.R. 1.705(d) within two months after issuance (if you need sample, let me know).  For patents issued more than two months, litigation appears to be the only option.

By Keisha Hylton-Rodic, Ph.D., J.D.

Dr. Hylton-Rodic is an Of Counsel in the firm.    She specializes in assisting pharmaceutical and chemical companies with protecting their inventions in the U.S. and globally; and assessing risk when making key business decisions such as developing/launching products, licensing technology; and acquiring technology and other companies.  

The opinions expressed are those of the author and do not necessarily reflect the views of the firm or its clients, or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.