Patent Term Adjustment: 2015 Final Rules

Background

• Change in patent term from 17 years from issuance to 20 years from filing or national stage entry date
  • prompted creation of patent term adjustment to compensate for certain processing delays at the USPTO
• 35 U.S.C. 154(b)(1) United States Patent Act,  the term of a patent may be extended in instances when the issuance of a patent was delayed due to:

• (B) GUARANTEE OF NO MORE THAN 3-YEAR APPLICATION PENDENCY
• Failure by the USPTO to issue a patent within 3 years of the actual filing date or national stage entry of an international application (B delay), not including "any time consumed by continued examination" requested by the applicant; or

• 35 U.S.C. 154(b)(2)(C) period of adjustment may be reduced:

• "by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application"
• USPTO granted authority to "prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application".

• Novartis - January 15, 2014 Federal Circuit issued its decision regarding effect of an RCE on patent term

• Issue - whether USPTO had incorrectly interpreted Section 154(b)(1)(B) of the Patent Act regarding B delay calculations where an RCE was submitted during prosecution.

• Novartis challenged USPTO interpretation on two grounds:

• RCE was only meant to limit the B delay when filed within the first 3 years of prosecution
• the time consumed by continued examination was limited to the time between the filing of the RCE and the allowance of the application.

• CFR 1.703 (b)(1) Period of adjustment of patent term due to examination delay
  • As written, as of Novartis, no patent term adjustment award after filing date of RCE
• Federal Circuit partially upheld and partially reversed USPTO interpretations. 

• Agreed with USPTO that no adjustment of time available during the time consumed by continued examination, even when initiated more than three years after the filing date of the application
• Agreed with Novartis that examination presumptively concluded at allowance           
  • At allowance, prosecution is closed and there is normally no further examination on the merits. 
  • Unless examination resumed, the period of time between allowance and issuance would be eligible for consideration under B term delay.

• Patents in which an RCE filed may be entitled to a longer term as the period of time between allowance and issuance may be considered in calculation of a PTA award. 

• USPTO Final Patent Term Adjustment Rules
  • January 9, 2015, USPTO published final rules implementing changes to patent term adjustment (PTA).
  • Revised 37 CFR 1.703(b)(1), effective January 9, 2015:
    • (b) The period of adjustment under § 1.702(b) is the number of days, if any, in the period beginning on the day after the date that is three years after the date on which the application was filed under 35 U.S.C. 111(a) or the national stage commenced under 35 U.S.C. 371(b) or (f) in an international application and ending on the date a patent was issued, but not including the sum of the following periods:
    • (1) The number of days, if any, in the period beginning on the date on which a request for continued examination of the application under 35 U.S.C. 132(b) was filed and ending on the date of mailing of a notice of allowance under 35 U.S.C. 151

• 37 CFR § 1.704(c)(12), effective for RCE’s filed after March 10, 2015, reads as follows: 
  • (12) Submission of a request for continued examination under 35 U.S.C. 132(b) after any notice of allowance under 35 U.S.C. 151 has been mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the number of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the request for continued examination under 35 U.S.C. 132(b) was filed. 
• Consequently, the filing of an RCE after a notice of allowance can result in PTA loss between the date of the notice of allowance and the date of the RCE filing. 

• Oftentimes the most valuable portion of a U.S. patent’s term is its last few months or years.  I will review the empirical data and observations which show this to be the case. 
• The PTO’s January 9, 2015 final rule did more than simply implement the Federal Circuit’s Novartis decision.  I will explain the new rules and what can be done to avoid the loss of accrued patent term adjustment. 
• I will also discuss the PTO’s Quick Path IDS pilot program, and how it may be used to avoid PTO filing fees and the loss of accrued patent term adjustment. 
• It is important to take a close look before filing an RCE after allowance.  An RCE can be time-consuming, the PTO filing fee is much greater than it used to be, and now, under the new rules, an RCE may result in the loss of patent term adjustment.  

• In light of inspector general report…should applicants be entitled PTA
• Applications related to rapidly changing areas – should PTA rules we altered to adapt
• Telecomm & FCC, should patent terms be extended to other agencies