As has been in the news lately, some big time drugs in the Pharma industry are approaching the end of their patents. The revenue these companies stand to lose highlights the importance in this industry of getting every last drop of life out of patents. One way to do this is to make sure that the term of the patent is adjusted correctly by the USPTO to make up for any delays. Reading about the patent term adjustment in 35 U.S.C. § 154(b)(1), I thought the term adjustment determinations were straightforward. But when applying the USPTO rules to particular applications, I really got a sense of the subtleties and complexities that can make this doctrine tricky. I then applied it to one of Google’s most recent patents.
The ABC’s of the statute
There are three kinds of term adjustments, A, B, and C (named such because they fall in subparagraph (a), (b), and (c) respectively).
“A” adjustments are for those where the USPTO failed to promptly respond in a specific instance. These adjustments find support in the statute 35 U.S.C. § 154(b)(1)(A) and are provided with more detail in CFR 1.703(a). An adjustment is appropriate here where the PTO:
- has not given a first office action within 14 months.
- has not given a response to an office action response within 4 months of the date that your reply was filed or the appeal was taken.
- has not acted on a response within 4 months from a BPAI or Federal Circuit decision where your application includes allowable claims.
- has not issued the patent within 4 months of the issue fee being paid.
The “B” adjustments are for the total examination taking longer than 3 years. These adjustments find support in 35 U.S.C. § 154(b)(1)(B) and are provided with more detail in CFR 1.703(b). These adjustments do not include certain exceptions:
- Time that is spent on RCEs (Section 132(b)) do not count
- Time spent on an interference (Section 135(a)) proceeding.
- Time spent on an a patent being withheld if determined as detrimental to national security under Section 181
- Any time spent at the BPAI or Federal Circuit
- Any delay in the processing of the application requested by the applicant except:
- Extensions of additional time to respond to a shortened statutory period.
The “C” adjustments apply if there have been interferences, secrecy orders, and appeals. Support for this category is found in the statute 35 U.S.C. § 154(b)(1)(C), with more detail provided in CFR 1.703(c), (d), and (e).
There is one subtle difference between the “B” and “C” adjustments and the “A” adjustments in when each time starts. With the B and C adjustments, these exceptions include the day of the event (for instance, the delay begins accruing time the day your RCE is filed, the day the interference is declared, etc) while the A delays are the day after the event (for instance, if your office action hasn’t been sent within 4 months, the day after is when the clock starts ticking).
The overlap provision
Paragraphs A and B are both subject to the overlap provision of 154(b)(2):
To the extent that periods of delay attributable to grounds specified in paragraph (1) overlap, the period of any adjustment granted under this subsection shall not exceed the actual number of days the issuance of the patent was delayed.
In Wyeth v. Kappos, the Federal Circuit held that A guarantees do not always overlap when there are B guarantees. You first look to the time the USPTO delayed the issued patent past the 3-year mark, then you look backwards and if there are A guarantees in that time frame, these do not get counted twice.
Another overlap situation is if A guarantees occur during C guarantees.
If the applicant is at fault for delaying the process, the number of days of delay gets subtracted from the total patent term adjustment. 37 CFR 1.704(a). Applicants fall under this category if they exceed the shortened statutory deadlines. 704(b). Also are the following actions specifically outlined in 37 CFR 1.704(c):
- If the applicant suspends the application
- Deferral of issuance
- Abandonment of the application or late payment of the issue fee
- Failure to file a petition to withdraw the holding of abandonment or to revive an application within two months from the mailing date of a notice of abandonment
- Conversion of a provisional application to a non-provisional
- Submission of a preliminary amendment or other preliminary paper less than one month before the mailing of an Office action
- Submitting a non-compliant response, which is the time from the original response to the corrected response, no matter how long it takes for the PTO to notice the non-compliance and no matter how long the error is corrected
- Submission of a supplemental reply or other paper, other than a supplemental reply or other paper expressly requested by the examiner, after a reply has been filed
- Submission of an amendment or other paper after a decision by the Board of Patent Appeals and Interferences not including a new rejection response
- Submission of an amendment under § 1.312 or other paper after a notice of allowance has been given or mailed
- Further prosecution via a continuing application
Actual application – Google Doodles
In determining how these rules apply in the real world, I found it useful to look at Google’s 7,912,915 patent. This patent had a broad range of issues that made for an interesting analysis. The non-provisional application for this patent was filed on April 30, 2001, almost 10 years ago. This patent would expire only 10 years after the issue date if it weren’t for the patent term adjustment doctrine. In this case, Google was rewarded with 2618 days or 7+ years.
|Date||Action||USPTO delay||Applicant delay||Why the adjustment, according to Trent|
|4/30/2001||Initial Exam Team nn||0|
|5/9/2001||IFW Scan & PACR Auto Security Review||0|
|6/20/2001||Correspondence Address Change||0|
|6/21/2001||Application Dispatched from OIPE||0|
|6/28/2001||Case Docketed to Examiner in GAU||0|
|4/30/2001||Information Disclosure Statement (IDS) Filed||0|
|4/30/2001||Information Disclosure Statement (IDS) Filed||0|
|10/4/2002||Case Docketed to Examiner in GAU||0|
|11/12/2002||Case Docketed to Examiner in GAU||0|
|6/8/2004||IFW TSS Processing by Tech Center Complete||0|
|6/16/2004||Case Docketed to Examiner in GAU||0|
|7/12/2004||Case Docketed to Examiner in GAU||0|
|7/20/2004||Correspondence Address Change||0|
|8/23/2004||Mail Non-Final Rejection||785||“A” guarantee. 1.703(a)(1). Fourteen months after the filing date is June 30, 2002. From the next day, July 1st, 2002 to August 23, 2004 is 785 days.|
|11/22/2004||Workflow incoming amendment IFW||0|
|11/22/2004||Response after Non-Final Action||0|
|2/14/2005||Date Forwarded to Examiner||0|
|4/21/2005||Mail Restriction Requirement||30||“A” guarantee. 1.703(a)(2). Four months after Nov. 22, 2004 is Mar. 22, 2005. From the next day of March23 to Apr. 21 is 30 days.|
|5/2/2005||Response to Election / Restriction Filed||0|
|5/17/2005||Date Forwarded to Examiner||0|
|7/21/2005||Mail Non-Final Rejection||0|
|11/22/2005||Request for Extension of Time – Granted||0|
|11/22/2005||Response after Non-Final Action||32||1.704(b). Three months from the non-final rejection was October 21, 2005. From the next day of Oct. 22 to Nov. 22 is 32 days.|
|12/8/2005||Date Forwarded to Examiner||0|
|2/22/2006||Mail Final Rejection (PTOL – 326)||0|
|4/12/2006||Examiner Interview Summary Record (PTOL – 413)||0|
|4/24/2006||Amendment after Final Rejection||0|
|5/8/2006||Date Forwarded to Examiner||0|
|4/24/2006||Oath or Declaration Filed (Including Supplemental)||0|
|5/9/2006||Change in Power of Attorney (May Include Associate POA)||0|
|5/10/2006||Advisory Action (PTOL-303)||0|
|5/11/2006||Mail Advisory Action (PTOL – 303)||0|
|6/13/2006||Disposal for a RCE / CPA / R129||0|
|5/17/2006||Request for Continued Examination (RCE)||0|
|6/13/2006||Date Forwarded to Examiner||0|
|4/24/2006||RCE- AF Processed||0|
|6/13/2006||Date Forwarded to Examiner||0|
|8/23/2006||Mail Non-Final Rejection||0|
|11/22/2006||Response after Non-Final Action||0|
|12/1/2006||Date Forwarded to Examiner||0|
|2/7/2007||Mail Non-Final Rejection||0|
|5/8/2007||Request for Extension of Time – Granted||0|
|5/8/2007||Notice of Appeal Filed||1||1.704(b). Three months from the non-final rejection was May 8, 2007. From the next day to May 9th is 1 day.|
|7/9/2007||Appeal Brief Filed||0|
|8/1/2007||Date Forwarded to Examiner||0|
|8/1/2007||Appeal Brief Review Complete||0|
|11/13/2007||Examiner’s Answer to Appeal Brief||0|
|11/16/2007||Mail Examiner’s Answer||7||“A” guarantee. 1.703(a)(4). Four months after the appeal brief was filed (July 9, 2007) is Nov. 9. From the next day of Nov. 10 to Nov. 16, when the examiner answered is 7 days.|
|12/3/2007||Exam. Ans. Review Complete||0|
|1/14/2008||Reply Brief Filed||0|
|1/17/2008||Date Forwarded to Examiner||0|
|1/17/2008||Reply Brief Noted by Examiner||0|
|1/18/2008||Mail Reply Brief Noted by Examiner||0|
|9/29/2008||Appeal Awaiting BPAI Docketing||0|
|10/6/2008||Case Docketed to Examiner in GAU||0|
|10/23/2008||Assignment of Appeal Number||0|
|10/24/2008||Docketing Notice Mailed to Appellant||0|
|9/22/2010||BPAI Decision – Examiner Affirmed in Part||0|
|9/23/2010||Mail BPAI Decision on Appeal – Affirmed in Part||1235||“C” guarantee. § 1.703(b)(4). Notice of appeal was filed May 8, 2007. From that day to Sept. 23, 2010 is 1235 days.|
|11/16/2010||Examiner’s Amendment Communication||0|
|11/16/2010||Notice of Allowance Data Verification Completed||0|
|11/16/2010||Issue Revision Completed||0|
|11/17/2010||Mail Notice of Allowance||0|
|11/19/2010||Export to Initial Data Capture||0|
|12/10/2010||Finished Initial Data Capture||0|
|2/15/2011||Issue Fee Payment Received||0|
|2/15/2011||Issue Fee Payment Verified||0|
|2/16/2011||Application Is Considered Ready for Issue||0|
|2/16/2011||Dispatch to FDC||0|
|2/17/2011||Export to Final Data Capture||0|
|3/22/2011||Patent Issue Date Used in PTA Calculation||0|
|5/16/2006||PTA 36 Months||746||“B” guarantee. 1.703(b). Here we start 36 months after the filing date of Apr. 30, 2001, which is Apr. 30, 2004. B-time gets counted until there is a request for continued examination, in which case the clock stops ticking until the issue date. 1.703(b)(1). The day after April 30, 2004 to May 16, 2006 is 746 days. Now we adjust our B-time for overlaps below.|
The final adjustment
The above B-time (746 days) is not entirely accurate until overlap is taken into consideration. Since the beginning B-term term is already being counted as “A” delay, we start at Aug. 24, 2004 (the day after the overlap) all the way to the restriction adjustment Mar. 22, 2005 (remember PTO delay overlaps can’t be counted here either!) it is 211 days. From Apr. 21, 2005 when the overlap stops the day before the RCE was filed, May 16, 2006, which is 390 days. Thus the B-time is 601 days.
The above C-term of 1235 days also needs to be adjusted for overlap. Here, there was 7 days of A-time that overlapped with the C-term. This reduces 1235 by 7 days to equal 1228 days.
The grand total
When you add up all the A time, 822 days, the B time, 601 days, and the C time, 1228, you get 2651 days. Subtracting the 33 days of applicant delay equals 2618 days.
The adjustment is publicly available as its own tab on PAIR for any patent that qualified for PTA. I found it interesting to learn that the PTO uses a computer program to determine an issued patent’s term adjustment. While the PTO’s efforts to increase efficiency by using such a program are commendable, I see the value in having a patent attorney verify that this value is correct, considering how important your patent life can be. This whole concept of seemingly automated task and human labor makes me think back to Paul Krugman’s piece, Degrees and Dollars, in the NYTimes. In it, Krugman discusses how computers are sabotaging automated jobs, including legal research. I can see this beginning to take place right now with patent term adjustment. However, with the number of errors the PTO usually has, plus with the wide variability of patent term adjustment responses among attorneys, it is easy to see that we are not all the way to a computer-takeover yet. It will be interesting to see the increasing reliance on computers in this area.
Here’s an interesting question to wrap this PTA discussion up, if a patent is issued with more PTA time than deserved, and the attorney knows it, is she under a duty to correct the patent term adjustment? What are the consequences to such a patent? Invalidation? Or just adjustment?
Here is a very useful website for calculating the number of days between two dates: http://www.timeanddate.com/date/duration.html.