USPTO Proposes Rules Changes in View of Novartis v. Lee

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO SealLast month, the U.S. Patent and Trademark Office published a notice of proposed rulemaking in the Federal Register (79 Fed. Reg. 34681) discussing changes to the rules of practice to implement the Federal Circuit's decision in Novartis AG v. Lee.  In Novartis, the Federal Circuit agreed with the USPTO that "no [patent term] adjustment time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application's filing" (i.e., the filing of an RCE tolls the B Delay clock even if the RCE was filed more than three years after the application was filed).  However, the Federal Circuit agreed with Novartis "that the 'time consumed by continued examination' should be limited to the time before allowance, as long as no later examination actually occurs."

In view of the Novartis decision, the Office notes that the rules changes "provide that the time consumed by continued examination does not include the time after a notice of allowance, unless the Office actually resumes examination of the application after allowance."  In addition, the notice states that the rules changes "provide 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."  With respect to the first change, the Office explains that the change "simply implements the Federal Circuit's ruling on the provisions of 35 U.S.C. 154(b)(1)(B)(i) in Novartis," and therefore the change "is simply a procedural and/or interpretive rule" that does not require prior notice and opportunity for public comment.  Although the Office acknowledges that the same does not hold true for second proposed change, the notice indicates that "[t]he Office . . . is publishing all of these proposed changes (rather than only the proposed change to 37 CFR 1.704) for comment as it seeks the benefit of the public's views on the Office's proposed implementation of the Federal Circuit's interpretation of the provisions of 35 U.S.C. 154(b)(1)(B)(i) in Novartis."

As with its implementation of certain provisions of the AIA Technical Corrections Act, where the modification of the Office's program for calculating PTA lagged behind the issuance of patents impacted by the changes to the rules (see "USPTO Issues Final Rule to Implement PTA Provisions of AIA Technical Corrections Act and Provide Optional Procedure for Requesting PTA Recalculation"), the Office notes that its modification of the PTA program has not yet been completed.  The notice does not indicate whether an optional procedure and special form will be needed to address the lag in this case as well.

Regarding the designation of another "failure . . . to engage in reasonable efforts to conclude processing or examination of an application," the Office explains that rules change is being proposed "to ensure that an applicant does not obtain multiple periods of patent term adjustment under 35 U.S.C. 154(b)(1)(B) for the time after a notice of allowance under 35 U.S.C. 151 as a consequence of delaying issuance of the application by filing request for continued examination under 35 U.S.C. 132(b) after a notice of allowance under 35 U.S.C. 151."

Comments regarding the proposed rules changes can be submitted by e-mail to:; by regular mail to:  Mail Stop Comments -- Patents, Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313–1450, marked to the attention of Kery Fries, Senior Legal Advisor, Office of Patent Legal Administration, Office of the Deputy Commissioner for Patent Examination Policy; or via the Federal eRulemaking Portal. See the Federal eRulemaking Portal Web site.  The deadline for submitting comments is August 18, 2014.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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