Patent Term Patent Term Extension Patent Term Adjustment

Transcription

1 Patent Term Patent Term Extension Patent Term Adjustment

2 PATENT TERM

3 Patent Term (Utility & Plant) June 8, 1978 June 8,

4 Patent Term (Utility & Plant) 1 June 8, 1978 June 8, 1995 Zone 1 Issued prior to June 8, 1978 (all expired now) 17 Years from Issue Date

5 Patent Term (Utility & Plant) June 8, 1978 June 8, Zone 2 Filed prior to June 8, 1995 and Pending or Enforced on June 8, 1978 Longer of 17 Years from Issue Date & 20 Years from Earliest Filing Date (earliest parent US/PCT filing date, not foreign filing date)

6 Patent Term (Utility & Plant) June 8, 1978 June 8, Zone 3 Filed on or after June 8, Years from Earliest Filing Date (earliest parent US/PCT filing date, not foreign filing date)

7 Patent Term (Design) June 8, 1978 June 8, 1995 May 13, Zone 1, 2 or 3 Filed prior to May 13, Years from Issue Date Zone 4 Filed on or after May 13, Years from Issue Date

8 Patent Term Extension/Adjustment June 8, 1995 May 29, 2000 PTE (II) PTE (I + II) PTA + PTE (II)

9 Patent Term Extension June 8, 1995 May 29, 2000 PTE (II) PTE (I) + PTE (II) PTE (I) Former 35 U.S.C. 154 Filed on/after 6/8/1995 and prior to 5/29/2000 PTE (II) 35 U.S.C. 156 Hatch-Waxman Act, 1984

10 PATENT TERM EXTENSION (PTE)

11 Patent Term Extension (I) Former 35 U.S.C. 154 Filed on/after 6/8/1995 and prior to 5/29/2000 Patent Term Extension for Interference Delay Secrecy Orders, and Successful Appellate Review Reduced by Time within 3 years of filing date Time Applicant did not act with due diligence Up to 5 years Subject to Terminal Disclaimer

12 Patent Term Extension (Ii) 35 U.S.C. 156 Extension if a product has been subject to a regulatory review period before its commercial marketing or use. Delays in obtaining Food and Drug Administration (FDA) approval for a regulated product Up to 5 years Terminal Disclaimer does not negate the PTE (II) Limitations Only for first commercial marketing of the product One extension for a patent One patent for a single regulatory period

13 PATENT TERM ADJUSTMENT (PTA)

14 Patent Term Adjustment June 8, 1995 May 29, 2000 PTA + PTE (II) PTA 35 U.S.C. 154 Filed on or after 5/29/2000

15 Patent Term Adjustment 35 U.S.C. 154(b) Different from Patent Term Extension (PTE) Applies to original utility and plant applications filed on or after May 29, 2000

16 Patent Term Adjustment For patent issued from application filed on or after 5/29/2000 PTA = USPTO Delay Applicant Delay = A Delay + B Delay + C Delay Overlap (A/B and A/C) Applicant Delay Patent Term = Original Term (20-yr rule) + PTA (always 0) (subject to Terminal Disclaimer) + PTE (II)

17 A Delay Occurs if USPTO Does Not Provide at least one notification within 14 months from filing date Office Action Restriction Requirement Notice of Allowance Respond within 4 months for other actions Respond to a reply Respond when an appeal is taken Act on a decision by PTAB Issue a patent after issue fee paid

18 A Delay - Illustration Actual Filing Date 14 mos. 1 st OA (Rest. Req.) Non-final OA mos. Reply to Rest. Req. A Delay = Period 1 (14-mo. rule) + Period 2 (4-mo. rule)

19 B Delay Occurs if USPTO Does Not Issue a patent within 3 years after the actual filing date Not including Any time consumed by continued examination (RCE*) time from allowance to issuance would still count toward the PTO s three-year allotment (Novartis AG v. Lee) Any time consumed by interference, secrecy order, appellate review of PTAB or Federal court Any delay at the request of the applicant

20 B Delay - Illustration Actual Filing Date X (< 3) yrs 1 st RCE NOA Date Y yrs 1 Issue Date X+Y = 3 Years B Delay = Period 1

21 B Delay - Illustration Actual Filing Date 3 yrs 1 st RCE NOA Date Issue Date 1 2 B Delay = Period 1 + Period 2

22 C Delay Occurs Due To Interference Secrecy order Successful appellate review Start from date jurisdiction passes to PTAB (Reply Brief received) until a final favorable decision (New 37 C.F.R (e))

23 C Delay - Illustration Actual Filing Date NOA Appeal Brief Examiner s Answer Reply Brief Successful PTAB Reiew 1 2 C Delay: Period 2 only

24 Patent Term Adjustment Overlap occurs if A/B and A/C Delays occur on the same calendar day(s) USPTO Delay = A Delay + B Delay + C Delay Overlap (A/B and A/C)

25 Patent Term Adjustment Actual Filing Date 14-mo. Mark 3-yr Mark Issue Date B C A Total USPTO Delay B A

26 Applicant Delay Occurs if Applicant failed to engage in reasonable efforts to conclude prosecution; 37 C.F.R sets forth time in excess of 3 months to reply to any action notice suspension of action deferral of issuance abandonment or late payment of issue fees failure to timely request withdrawal of a holding of abandonment conversion of a provisional application submission of a reply having an omission submission of a supplemental reply or other paper (e.g., IDS) not expressly requested by Examiner after a reply has been filed

27 37 C.F.R (cont d) submission of a preliminary amendment requiring the mailing of a supplemental office action submission of an amendment after a decision by the PTAB submission of an amendment or other paper (other than RCE) after a notice of allowance has been mailed failure to file Appeal Brief or RCE within 3 months after Notice of Appeal submission of an RCE after Notice of Allowance failure to provide an application in condition for examination within eight months from filing

28 Patent Term Adjustment USPTO PTA Determination USPTO only needs to provide PTA determination when patent grants Request for Reconsideration of PTA Must be filed to USPTO no later than 2 months (extendable for up to 5 months) from the date the patent was granted Appeal of Final Determination Must be filed to Federal District Court of E.D. Va within 180 days of the final decision on the Request for reconsideration

29 Patent Term Adjustment PTA on Patent 2-mo. Mark PTO Final Determination 180 days Extension Up to 5 mos. Request for Reconsideration (to PTO) Appeal (to E.D. Va)

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