Recently, the United States Patent and Trademark Office proposed changes to the rules of practice pertaining to the patent term adjustment provisions in view of the decision by the United States Court of Appeals for the Federal Circuit in Novartis AG v. Lee.
Novartis filed law suits that challenged the determinations by the USPTO of how much time to add to the patent term under 35 U.S.C. § 154(b) with respect to 18 different patents. The district court dismissed 15 of the claims as untimely asserted, and the Federal Circuit affirmed that ruling. With respect to the substantive ruling on the other three patents (U.S. Patent Nos. 7,807,155; 7,968,518; and 7,973,031), the Federal Circuit in a panel decision by Judge Taranto (joined by Judges Newman and Dyk) concluded that the USPTO was partly correct and partly incorrect in its interpretation of 35 U.S.C. § 154(b)(1)(B). As a result, the Federal Circuit determined that Novartis was entitled to most, but not all, of the patent term adjustment it seeks.
Those wishing to submit comments should do so in writing on or before August 18, 2014. Comments should preferably be sent via email to AC96.comments@ uspto.gov. Comments also may be submitted by postal mail addressed 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.
The Novartis Challenge
The Novartis challenge related to the USPTO interpretation of 35 U.S.C. § 154(b)(1)(B)(i) as it applies to continued examinations requested by Novartis. The Federal Circuit ruled that time delay caused by the filing of a Request for Continued Examination (RCE) should be deducted from otherwise available patent term adjustment. Judge Taranto explained:
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 appli- cants 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.
The Federal Circuit, however, decided 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.
As a result of the Federal Circuit’s ruling in Novartis, the USPTO is proposing changes to the rules of practice to 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. The Office also is proposing changes to the rules of practice to 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.
A version of this article was earlier published by the PLI Patent Practice Center.