Patent Term Adjustment Variables under § 154 Jeffrey P. Kushan Washington, D.C.

BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C.

Patent Term Adjustment Variables under § 154Jeffrey P. KushanWashington, D.C.

AIPLA Spring MeetingCoronado, California

Basis for Accumulating PTA “Credit”35 U.S.C. § 154(b)(1)(A)

(A) ... if the issue of an original patent is delayed due to the failure of the [PTO] to―

i. provide at least one of the notifications under section 132 ... or a notice of allowance ... not later than 14 months after [the filing date] ...

ii. respond to a reply under section 132, or to an appeal ... within 4 months ...

iii. act on an application within 4 months after a decision by the Board ... or

iv. issue a patent within 4 months [of the issue fee]

... the term of the patent shall be extended 1 day for each day [of PTO delay] ...

Basis for Accumulating PTA “Credit”35 U.S.C. § 154(b)(1)(B) & (C)

(B) ... if the issue of an original patent is delayed due to the failure of the [PTO] to issue a patent within 3 years of the actual filing date ... , not including―

i. [time after the filing of an RCE];

ii. [time for an interference or secrecy order]; or

iii. any delay ... requested by the applicant ... ,

the term of the patent shall be extended 1 day for each day after the end of the 3-year period until the patent is issued.

(C) [Day-for-day extension for interferences, secrecy orders, and successful appeals]

Losing Accumulated PTA Credit35 U.S.C. § 154(b)(2)

(A) …To the extent that periods of delay [under (1)(A), (B), and (C)] overlap, the period of any adjustment ... shall not exceed the actual number of days the issuance of the patent was delayed

(C)(i) The period of adjustment ... shall 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.

...

(iii) The Director shall prescribe regulations establishing the circumstances that constitute a failure of an applicant to engage in reasonable efforts ... .

PTO Interpretation of Overlap between Prosecution Delay PTA and 3-Year PTA

If an application is entitled to an adjustment [for 3-year PTA], the entire period during which the application was pending before the Office ..., and not just the period beginning three years after the actual filing date of the application, is the period of delay under 35 U.S.C. 154(b)(1)(B) in determining whether periods of delay overlap ... .69 Fed. Reg. 21704, 21706 (April 22, 2004) (discussing revision of 37 C.F.R. § 1.703(f)).

PTA Examples

Filing Date

FAOM Response

4 Months After §132

Response

Final Rejectio

n

“3 Year” Date

Response

PatentIssues

“Overlap”

37 C.F.R. § 1.704

(b) ... an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination ... for any periods of time in excess of three months ... to reply to any notice or action by the Office ...

(c) Circumstances that constitute a failure ... to engage in reasonable efforts ... also include ...

(1) [Suspension at applicant’s request] ...

(6) Submission of a ... preliminary paper less than one month before the mailing of an Office action ...

(7) Submission of a reply having an omission ...

(8) Submission of a supplemental reply or other paper, other than ...[when] expressly requested by the examiner, after a reply has been filed ...

Cultivating PTA

• Patent Term Adjustment under 35 U.S.C. § 154 can significantly extend the life of a patent

• Prompt responses to all actions or requirements will minimize loss of PTA due to applicant delay, but ...

• As average pendency increases, the “3 year pendency guarantee” is driving more final PTA determinations

• PTA can be maximized by responding on the “PTA due date” whenever possible

– Respond 3 months from the mailing date of a PTO communication, even if a 1- or 2-month extension of time is needed (e.g., restriction requirement; Quayle action)

Any Supplemental Submission Will Generate Applicant Delay

• A supplemental amendment, IDS, or any other paper that does not fall within an exemption will be charged as delay after a first response by the applicant

• A first paper that is not a response to an outstanding action or requirement will not lead to delay for a later timely response

– Example: FAOM 5/01; IDS 7/01; reply 7/15

– Result: No applicant delay

• Delay runs from the date the initial response was filed, not from the original “PTA due date”

– Example: FAOM 5/01; reply 7/01; IDS 7/15

– Result: Applicant delay from 7/01 to 7/15

Safe Harbors

• An IDS submitting only new references from a foreign search report within 30 days of receipt

– Requires a separate “PTA certification” (§ 1.704(d))

– IDS must be filed within 30 days of receipt by any person with duty of disclosure under Rule 56(c)

• Provision of documents during an interview, if attached to the examiner’s interview summary

• Submission of an appeal brief after a notice of appeal

– PTO does not view appeal brief as a response to any Office requirement, so time from the notice of appeal to the filing of an appeal brief is not delay

PTO Inaction Can Be Held Against the Applicant

• A written status inquiry after a response is filed will be considered a supplemental submission

– Get information from PAIR or by telephone

– Document status in an examiner interview summary, if appropriate

• A notice of appeal, even if filed only to maintain pendency after a complete after-final response, will be treated as a supplemental submission

– An interview summary stating that the examiner requested applicant to file the notice will be helpful

Bank Error In Your Favor

• An erroneous PTO requirement (e.g., an incorrect/improper notice of non-compliant amendment) can lead to PTO delay

• If the PTO imposes a requirement that it later withdraws, PTO delay runs from 4 months following the original complete response until it takes action on the merits

• A request for reconsideration or petition of the erroneous requirement establishes the record, but …you’ve got to be right!

– If the questioned requirement is upheld, prosecution delay will be charged to the applicant

– Record must be clear that PTO vacated the erroneous action or requirement

Preserve Rights under Wyeth v. Doll

• D.C. District court decision rejected PTO’s formula for calculating overlap of “prosecution delay PTA” and “3-year pendency PTA”– On appeal at Federal Circuit

• 3-year pendency PTA is determined when the issue date is established– Request reconsideration (petition) within 2 months of issue date

– PTO is now promptly dismissing “Wyeth” petitions

• Patentee may file civil complaint in D.D.C. within 180 days of patent issue date– Statutory deadline - not 6 months!

• Government is seeking stays in all cases until the appeal in Wyeth is decided