Andrew B. Freistein Wenderoth, Lind & Ponack, L.L.P.

Learning the ABC’s of Patent Term Adjustment

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Humira® is the #1 selling drug in the world, earning $23.5 Million per day in the U.S.**AbbVie Second-Quarter 2015 Financial Results

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Every Day Counts!

1995: Uruguay Round Agreements Act (URAA)• 17 years from issue changed to 20 years from filing• 35 U.S.C. §154: patent term extension (PTE) created

1999: America Inventors Protection Act (AIPA)• §154 changes PTE to patent term adjustment (PTA)

2013: America Invents Act (AIA) Technical Corrections Act

2015: Final Rules Implementing Novartis v. Lee, 740 F.3d 593 (Fed. Cir. 2014)

Relevant Historical Dates

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Patent term adjustment (PTA) applies to all utility and plant patents filed on or after May 29, 2000

For patents filed on or after June 8, 1995 and before May 29, 2000, the patent term extension (PTE) provisions of the URAA apply

No PTA or PTE for any utility or plant patent filed before June 8, 1995

No PTA or PTE for any design patent

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Effective Dates

• A-delay: 35 USC §154(b)(1)(A)• B-delay: 35 USC §154(b)(1)(B)• C-delay: 35 USC §154(b)(1)(C)• Applicant delay: 35 USC§154(b)(2)(C)• 37 CFR 1.702 to 1.704

USPTO Delay Under 35 U.S.C. §154

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A-delay accrues in four types of USPTO delays (the 14+4+4+4 Rule)

(14) 1st Office Action (OA) must issue within 14 months of the filing date

National stage application: the filing date is the date of commencement of the national stage, which is the earliest of: • an express request to begin the national stage,

or• 30 months from the earliest priority date

1st OA may be a Restriction Requirement

A-Delay

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(4) USPTO must respond to Applicant’s Reply within 4 months

(4) USPTO must respond to a Board decision within 4 months

(4) USPTO must issue a patent within 4 months of payment of the issue fee

37 CFR 1.702(a): 14+4+4+4 rule37 CFR 1.703(a): days of adjustment

A-Delay

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• After 3 years of prosecution, Applicant accrues B-delay for each day until the patent issues

• 3 years is measured from:• the U.S. filing date (35 U.S.C. §111(a)), or • the commencement of the national stage (35

U.S.C. §371)• not a foreign priority date• not a U.S. provisional filing date

• 37 CFR 1.702(b) and 1.703(b)

B-Delay

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• Time consumed by an RCE• Time consumed by an interference,

derivation proceeding or secrecy order• Time consumed from review by the Board

or a federal court• Applicant Requested Delay

Exceptions to B-Delay

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Time consumed by RCE begins on the date the RCE is filed and ends on the date a Notice of Allowance is mailed• Novartis v. Lee, 740 F.3d 539 (Fed. Cir. 2014)• 37 CFR 1.703(b)(1) amended Jan. 9, 2015

If an RCE is filed after allowance, then there is Applicant delay under 1.704(c)(12)• Exception: no delay for an RCE filed with an

IDS having a statement under § 1.704(d)

Exceptions to B-delay:Time Consumed by RCE

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371 commencement date: May 24, 20073-year date: May 24, 2010 + 1 = May 25,

2010RCE filed February 28, 2011Notice of Allowance mailed April 25, 2014Patent Issued: July 15, 2014B-delay is 360 days

Example of B-Delay Calculation

When an RCE was Filed

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5/24/2007

371 Commencement

5/25/2010

3-year +

1 day

2/28/2011

RCE Filed

Notice of Allowance

4/25/2014 7/15/2014

Issuance Date

PTO’s B-delay calculation

279 days

1,512 days

Period after 3-year mark to issuance

1,152 days

Time consumed by RCE PTO’s B-delay pre-Novartis is: 279 days Actual B-delay post-Novartis is: 1,512 – 1,152 = 360 days

81 days

Extra B-delay

Post-Novartis

C-delay fills the gaps of the B-delay exceptions against delays for:• Interference or derivation proceeding• Secrecy order• Successful civil action• Successful Board appeal• To obtain PTA for a successful appeal,

all rejections of at least one claim must be reversed

C-Delay

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PTA shall not exceed the actual number of days of delay (no overlapping calendar days)• Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010)

Terminal Disclaimer filed limiting the patent term to a specific date

Applicant Delay, 35 U.S.C. §154(b)(2)(C)

Limitations on PTA

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35 U.S.C. §154(b)(2)(C) and 37 CFR 1.704PTA is reduced by the number of days Applicant

“failed to engage in reasonable efforts to conclude prosecution”

Failure to respond to any Notice or Office Action (OA) within 3 months of mail date

For any PTO Notice or OA setting a 2-month due date, the 1st month extension does not reduce PTA• E.g., response to restriction, filing appeal brief or RCE

following notice of appeal, response to missing parts, or corrected application papers, etc.

Applicant Delay

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37 CFR 1.704(c) provides 14 types of delay:§ Suspension of action§ Deferral of issuance of a patent§ Abandonment or late issue fee payment§ Failure to petition to withdraw abandonment

or petition to revive§ Conversion from provisional to non-provisional

application§ Submission of a preliminary amendment or

other paper less than 1 month before an OA§ Submission of a reply having an omission

Types of Applicant Delay

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8. Submission of a supplemental reply or “other paper”, other than one expressly requested by the Examiner

Gilead Sciences, Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015)9. Submission of an Amendment or “other paper” after a

Board decision less than 1 month before issuance of an OA or Notice of Allowance (NOA)

10. Submission of an Amendment under 37 CFR 1.312 or “other paper” after a NOA

11. Failure to file an Appeal Brief within 3 months12. Submission of an RCE after a NOA13. Failure to provide an application in condition for

examination within 8 months of filing14. Further prosecution via a continuation application

Mohsenzadeh v. Lee, 790 F.3d 1377 (Fed. Cir. 2015)

Types of Applicant Delay

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Final Rules issued Jan. 9, 2015 define “other paper” that will reduce PTA after allowance as:

1. Amendment under 37 CFR 1.3122. Paper containing a claim of priority or request

to correct claim of priority3. Request for corrected filing receipt4. Certified copy of a priority document5. Drawing6. Letter related to biologic deposits7. Request to correct or change inventorship8. IDS without 37 CFR 1.704(d) statement

“Other Paper” After Allowance Reducing PTA

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1. Fee Transmittal 2. Power of Attorney3. Power to Inspect4. Change of Address5. Change of Entity Status (micro/small/large)6. Response to the Examiner’s reasons for

allowance or a request to correct an error or omission in the Notice of Allowance

7. Letter related to government interests

“Other Papers” that do not reduce PTA

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8. Resubmission of unlocatable paper previously filed in the application

9. Request for acknowledgment of IDS provided that Applicant requested consideration of the IDS prior to issuance of a Notice of Allowance

10. Comments on the substance of an interview where an Applicant-initiated interview resulted in a Notice of Allowance

11. Status Request12. Request for Refund13. Inventor’s Oath/Declaration

“Other Papers” that do not reduce PTA

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Under 37 CFR 1.704(d), an IDS will not reduce if each item of information in the IDS: (i) was first cited in any communication from a patent office in a counterpart foreign or international application or from the USPTO, and this communication was not received by an individual designated in 37 CFR 1.56(c) more than 30 days prior to the filing of the IDS; or (ii) is a communication that was issued by a patent office in a counterpart foreign international application or by the USPTO, and this communication was not received by any individual designated in 37 CFR 1.56(c) more than 30 days prior to the filing of the IDS

IDS with Statement Under 37 CFR 1.704(d)

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A request for reconsideration of the PTA calculation must be filed within 2 months of the issuance of the patent (37 CFR 1.705)• Due date is extendable for 5 months with

payment of an extension fee• Request requires $400 processing fee• 3rd Party cannot request reconsideration of PTA

After USPTO considers request, a dissatisfied patentee may file a civil action in district court within 180 days (35 U.S.C. §154(b)(4))

Correcting the PTA Calculation

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Avoid extensions of time and, when necessary, do not wait until the next due date to file a response

File IDS within 30 days of receipt of foreign/US Office Actions and make 1.704(d) statement

Avoid submissions after Notice of Allowance that do not fall under an “other paper” exception

Maximizing PTA during prosecution

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Obtain PTA calculation from PAIRConsider whether a supplemental response was

expressly requested by the Examiner• USPTO software does not recognize an express

request by the ExaminerConsider whether any IDS has the 1.704(d)

statement• USPTO software does not recognize an IDS having a

1.704(d) statementFor national stage applications, consider whether

the correct 371 commencement date was used

Basic PTA Calculation Review

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Andrew B. FreisteinWenderoth, Lind & Ponack, L.L.P.

1030 15th Street, N.W., Suite 400 EastWashington, DC 20005

(202) 721-8216afreistein@wenderoth.com

QUESTIONS?

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