1. Andrew B. Freistein Wenderoth, Lind & Ponack, L.L.P. Learning the ABC’s of Patent Term Adjustment 1 © AIPLA 2015

2. 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 2 © AIPLA 2015 Every Day Counts!

3. 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 © AIPLA 2015 3

4. 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 © AIPLA 2015 4 Effective Dates

5. 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 © AIPLA 2015 5

6. A-delay accrues in four types of USPTO delays (the 14+4+4+4 Rule) (14) 1 st 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 1 st OA may be a Restriction Requirement A-Delay © AIPLA 2015 6

7. (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 rule 37 CFR 1.703(a): days of adjustment A-Delay © AIPLA 2015 7

8. 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 © AIPLA 2015 8

9. 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 © AIPLA 2015 9

10. 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 © AIPLA 2015 10

11. 371 commencement date: May 24, 2007 3-year date: May 24, 2010 + 1 = May 25, 2010 RCE filed February 28, 2011 Notice of Allowance mailed April 25, 2014 Patent Issued: July 15, 2014 B-delay is 360 days Example of B-Delay Calculation When an RCE was Filed © AIPLA 2015 11

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13. 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 © AIPLA 2015 13

14. PTA shall not exceed the actual number of days of delay (n o 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 © AIPLA 2015 14

15. 35 U.S.C. §154(b)(2)(C) and 37 CFR 1.704 PTA 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 1 st 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 © AIPLA 2015 15

16. 37 CFR 1.704(c) provides 14 types of delay: 1. Suspension of action 2. Deferral of issuance of a patent 3. Abandonment or late issue fee payment 4. Failure to petition to withdraw abandonment or petition to revive 5. Conversion from provisional to non-provisional application 6. Submission of a preliminary amendment or other paper less than 1 month before an OA 7. Submission of a reply having an omission Types of Applicant Delay © AIPLA 2015 16

17. 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 months 12. Submission of an RCE after a NOA 13. Failure to provide an application in condition for examination within 8 months of filing 14. Further prosecution via a continuation application Mohsenzadeh v. Lee, 790 F.3d 1377 (Fed. Cir. 2015) Types of Applicant Delay © AIPLA 2015 17

18. Final Rules issued Jan. 9, 2015 define “other paper” that will reduce PTA after allowance as: 1. Amendment under 37 CFR 1.312 2. Paper containing a claim of priority or request to correct claim of priority 3. Request for corrected filing receipt 4. Certified copy of a priority document 5. Drawing 6. Letter related to biologic deposits 7. Request to correct or change inventorship 8. IDS without 37 CFR 1.704(d) statement “Other Paper” After Allowance Reducing PTA © AIPLA 2015 18

19. 1. Fee Transmittal 2. Power of Attorney 3. Power to Inspect 4. Change of Address 5. 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 © AIPLA 2015 19

20. 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 Request 12. Request for Refund 13. Inventor’s Oath/Declaration “Other Papers” that do not reduce PTA © AIPLA 2015 20

21. 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) © AIPLA 2015 21

22. 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 3 rd 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 © AIPLA 2015 22

23. 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 © AIPLA 2015 23

24. Obtain PTA calculation from PAIR Consider whether a supplemental response was expressly requested by the Examiner USPTO software does not recognize an express request by the Examiner Consider whether any IDS has the 1.704(d) statement USPTO software does not recognize an IDS having a 1.704(d) statement For national stage applications, consider whether the correct 371 commencement date was used Basic PTA Calculation Review © AIPLA 2015 24

25. Andrew B. Freistein Wenderoth, Lind & Ponack, L.L.P. 1030 15 th Street, N.W., Suite 400 East Washington, DC 20005 (202) 721-8216 afreistein@wenderoth.com QUESTIONS? © AIPLA 2015 25