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Any Request for Continued Examination Limits Patent Term Adjustment: Federal Circuit
Practical Law Legal Update 9-554-8146 (Approx. 4 pages)
Any Request for Continued Examination Limits Patent Term Adjustment: Federal Circuit
by Practical Law Intellectual Property & Technology
| Law stated as of 17 Jan 2014 • USA (National/Federal) |
In Novartis AG v. Lee, the US Court of Appeals for the Federal Circuit held that any request for continued examination limits the length of a patent term adjustment under 35 U.S.C. § 154(b)(1)(B) for a period of time extending until the notice of allowance.
In Novartis AG v. Lee, the US Court of Appeals for the Federal Circuit partly reversed the US District Court for the District of Columbia's interpretation of patent term adjustments (PTAs) under 35 U.S.C. § 154(b)(1)(B), finding that:
- Any request for continued examination (RCE) limits a PTA's length under Subsection 154(b)(1)(B)(i).
- For PTA determinations, the period of time consumed by a RCE extends until the US Patent and Trademark Office (USPTO) issues a notice of allowance.
The Federal Circuit's holding resolves a split among district courts concerning the proper interpretation of Subsection 154(b)(1)(B). The Federal Circuit also affirmed the district court's finding that Novartis' claims challenging the PTAs for 19 patents were untimely under 35 U.S.C. § 154(b)(1)(B).
Section 154(b)(1) of the Patent Act governs the determination and measurement of PTAs and describes three broad categories of delays that will result in a patent term's extension:
- Subsection 154(b)(1)(A) or part "A" delays, which extend the patent term if the USPTO fails to carry out certain acts during examination of the patent application within prescribed timeframes.
- Subsection 154(b)(1)(B) or part "B" delays, which extend the patent term on a day-for-day basis for each day after the end of the three-year period beginning on the patent application's filing date. As relevant here, subsection 154(b)(1)(B)(i) excludes from part B-delays "any time consumed by continued examination of the application requested by the applicant."
- Subsection 154(b)(1)(C) or part "C" delays, which extend the patent term on a day-for-day basis for each day the application is either:
- involved in an interference or appeal; or
- subject to a secrecy order.
Novartis brought four suits against Michelle Lee, in her capacity as USPTO Deputy Director, claiming that the USPTO improperly determined the PTAs for 23 patents. As relevant here, Novartis challenged the USPTO's findings that:
- Any RCE limits the PTA under Subsection 154(b)(1)(B).
- For PTA determinations, the period of time consumed by a RCE extends until the patent's issuance.
After consolidating Novartis' cases, the district court:
- Dismissed Novartis' claims concerning 19 patents as untimely under Subsection 154(b)(1)(B) because they were filed more than 180 days after the USPTO denied reconsideration of its PTA determinations.
- Granted Novartis summary judgment on the PTAs for three patents, finding that the USPTO's interpretation of Subsection 154(b)(1)(B) was contrary to law.
- Adjusted the PTA for one patent to conform to the Federal Circuit's standard in Wyeth v. Kappos (591 F.3d 1364 (Fed. Cir. 2010)), which neither party challenged on appeal.
On appeal, the parties disputed the correct interpretation of Subsection 154(b)(1)(B) as it applies to RCEs. The Federal Circuit:
- Rejected Novartis' argument that RCEs filed three years after the original application-filing date do not limit the length of the PTA. The Federal Circuit agreed with the USPTO's interpretation that any RCE will limit the PTA, even RCEs filed three years after the application-filing date.
- Agreed with Novartis that the length of time consumed by a RCE, for purposes of PTA determinations, should be limited to the time before allowance, provided no further examination occurs. The Federal Circuit rejected the USPTO's interpretation that the time consumed by a RCE extends until patent issuance.
Novartis also challenged the district court's dismissal of 15 claims as untimely. Applying a de novo standard of judicial review, the Federal Circuit rejected Novartis' argument that the 180-day statute of limitations only applies to provisional PTA determinations made at the time of allowance, finding that the limitations period applies to all PTA determinations. The Federal Circuit also found that Novartis failed to show why the limitations period should have been tolled.
In connection with its opinion, the Federal Circuit also vacated and remanded for further proceedings two other appeals that involved similar issues concerning Subsection 154(b)(1)(B) (Exelixis, Inc. v. Lee, Nos. 2013-1175, 2013-1198, (Fed. Cir. Jan. 15, 2014)).