537:
priority dates). If the applicant is required to file, and does file, a terminal disclaimer in the later filed patent, then the later filed patent will expire at the same time as the earlier filed patent, the extra term having been disclaimed ("terminal disclaimer"). In filing the terminal disclaimer, the later filed patent and the earlier filed patent must be, and remain, commonly owned. In the case of co-pending applications, either or both of the applications may have claims rejected for obviousness-type double patenting, and a terminal disclaimer may be required in either or both, in which case the earlier expiration date will control.
286:(5 Stat. 117, 119, 5) provided (in addition to the fourteen-year term) an extension "for the term of seven years from and after the expiration of the first term" in certain circumstances, when the inventor hasn't got "a reasonable remuneration for the time, ingenuity, and expense". In 1861 the seven-year extension was eliminated and the term changed to seventeen years (12
544:(URAA), some patents with terminal disclaimers were eligible for a term adjustment because their referenced patents received a term adjustment under the URAA. Patents whose parents received extensions were eligible to file to receive a similar extension, because the claims they depended on were still protected. This has been discussed in the
554:
that patent's term was ongoing because of a Patent Term
Extension due to FDA regulatory review delay. Under 35 U.S.C. 156(a), the term of a patent "shall be extended" after a series of provisions are satisfied. The district court found the language of the statute unambiguous and gives the court "no discretion".
514:
Patent Term
Adjustment (PTA) and Patent Term Extension (PTE) compensate a patent applicant for delays that occur during patent prosecution. Patent Term Adjustment (PTA) (see above) compensates applicants for USPTO-caused delays; Patent Term Extension (PTE) compensates a patent owner for delays caused
484:
changes the original expiration date. A reissued or reexamined patent expires on the day the original granted patent would have ordinarily expired. Example: The validity of a patent (filing: January 1, 2000; issue: January 1, 2002; end: January 1, 2020) is challenged. The USPTO issues a
Certificate
423:
Type B - USPTO estimates the normal prosecution period of an application to be 3 years, i.e. between the date of filing a non-provisional application and the issue of the patent. If the prosecution exceeds this time, then Type B delay come into place. Type B delay will calculated if no RCE (Request
419:
Type A - this delay is caused when USPTO fails to reply within the time period provided, which is 14 months from filing of a non-provisional application for the First Office action, and within 4 months of receipt of an applicant response for all subsequent actions. Failing to this condition, type A
558:
patentee in the first instance had expressly disclaimed term subsequent to 2003 to get the patent granted. However, the holding of this case does not apply to Patent Term
Adjustment granted under 35 U.S.C. 154. Such term adjustments will be subject to any terminal disclaimer that has been filed.
553:
A terminal disclaimer does not negate Patent Term
Extension that has been granted under 35 U.S.C. 156. In a pharmaceutical patent dispute, Teva argued that Wyeth's patent on zaleplon drug products (Sonata) had expired because of a terminal disclaimer. Wyeth (and its exclusive licensee King) argued
536:
a part of the term of the pending application. For example, an applicant's patent A expires on
December 24, 2000. The applicant filed another patent application two years later. Under some conditions, the second patent might expire later than the first (based upon the respective earliest claimed
557:
Thus, if the enumerated conditions are satisfied, the patentee is entitled to a term extension calculated pursuant to
Section 156. Teva's motion to dismiss was consequently denied because "a terminally disclaimed patent is eligible for extension under 156." The case is interesting because the
414:
This extension is known as a patent term adjustment (PTA). Its intention is to accommodate for delays caused by the USPTO during the prosecution of a US patent application. The total PTA is an addition to the 20-year lifespan of a US patent. The delays are broadly classified into 4 types:
515:
by the regulatory review (e.g. by FDA) before a product can be commercially marketed. PTA and PTE lengthen the term of the patent, theoretically permitting patent owners to enjoy more than 20-year patent term from the time of first non-provisional filing.
430:
Applicant delay - Applicant delay occurs when the applicant fails to respond to the office action within 3 months of mailing of an office action. Applicants delays are subtracted from the USPTO delays, when calculating the term
768:
411:(USPTO) fails to examine a patent application in time (deadlines for various steps are different), the patent term may be extended. Extensions or other delay taken by the applicant can reduce or eliminate the extension.
269:
have a shorter term than utility patents. Design patents filed on or after May 13, 2015, have a term of 15 years from issuance. Design patents filed prior to May 13, 2015, have a term of 14 years from issuance.
712:
252:
523:
A terminal disclaimer is a process by which a patent's term is shortened because it duplicates the claims of another patent which expires sooner. If any claim of a pending patent application would have been
424:
For
Continued Examination) is filed prior to completion of 3-year period. If the first RCE is filed after 3-year period then type B delay will be calculated up to the date of filing of RCE.
494:
50:
651:
733:
CHRISTOPHER M. HOLMAN. Patent Term
Adjustment: Recent Developments at the Federal Circuit and PTO. 39 Biotechnology Law Report 266 Number 4, 2020. DOI: 10.1089/blr.2020.29191.cmh
569:(Trusopt). Here too, the first company (Merck) had filed a standard form terminal disclaimer. This patent was later given an extension and became the crux of the litigation.
497:(Hatch-Waxman Act) of 1984 provides patent holders on approved patented products with an extended term of protection under the patent to compensate for the delay in obtaining
215:
240:
are paid on time, is 20 years from the filing date of the earliest U.S. or international application to which priority is claimed (excluding provisional applications).
704:
814:("No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer").
184:
439:
525:
148:
408:
133:
179:
208:
189:
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There is now a similar case wherein a company was given extension under S.156 and the generic entrant arguing against such extension between
910:
852:
578:
546:
541:
168:
55:
648:
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of
Reexamination on January 1, 2004. The reexamined patent is in force until January 1, 2020, assuming payment of all maintenance fees.
174:
894:
807:
683:
611:
596:
143:
60:
941:
691:
298:
then changed the patent term from seventeen years from the date of issue to the current twenty years from the earliest filing date.
201:
35:
769:"Reclaiming Their Time: Patent Term Adjustment (PTA) and Patent Term Extension (PTE) Post Supernus, Novartis I, and Novartis II"
511:
term extension. However, patents in force on June 8, 1995, solely because of the Hatch-Waxman term adjustment are not eligible.
467:(beyond the term of the patents) in cases where introduction of a product into a market was caused by the FDA approval process.
371:
287:
916:
743:
824:
477:
138:
921:
498:
460:
389:
295:
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in light of at least one claim of the applicant's issued patents, the USPTO may reject that claim for obviousness-type
946:
358:
248:
237:
229:
21:
453:
Type B delay = Date of issue of patent/Date of filing of first RCE - (Date of filing of application + 3 years)
450:
Type A delay = Date of issuance of office Action -(Date of receipt of applicant response + 4 months/14 months)
667:
626:
76:
637:
81:
45:
825:"Opinion - USCA – #30 in MERCK & CO., INC. v. HI-TECH PHARMACAL CO., INC. (D.N.J., 3:06-cv-00266)"
904:
782:
533:
107:
464:
345:
332:
40:
880:
876:
850:
For a detailed description of the laws and rules governing patent terms in the U.S., see the
756:
529:
260:
86:
857:
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Type C - This type of delay is calculated in the events of secrecy orders or interferences.
247:
in the United States was changed in 1995 to bring U.S. patent law into conformity with the
811:
795:
655:
283:
279:
112:
91:
926:
600:
562:
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in the U.S., since the patent term now depends on the filing date, not the issue date.
244:
935:
481:
266:
256:
158:
153:
117:
687:
615:
367:
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was decided individually for each patent, but "not exceeding fourteen years". The
898:
864:
566:
438:(and other continuing) patents issued from the same priority application (see
435:
440:
Mohsenzadeh v. Lee, 790 F. 3d 1377 - Court of Appeals, Federal Circuit 2015
456:
Total PTA =Type A+Type B + Type C - Applicant delay - overlapping delays
375:
291:
507:
ruled that patents extended under Hatch-Waxman are still eligible to
253:
Agreement on Trade-Related Aspects of Intellectual Property Rights
867:(1994). "An Empirical Study of the Twenty-Year Patent Term".
627:
2701 Patent Term (R-2); - 2700 Patent Terms and Extensions
784:
2701 Patent Term (R-2) - 2700 Patent Terms and Extensions
259:. As a side effect, it is no longer possible to maintain
495:
Drug Price Competition and Patent Term Restoration Act
434:
Notably, patent term adjustment is not available for
505:
Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc.
906:
2701 Patent Term - 2700 Patent Terms and Extensions
744:"EXPLANATION OF PATENT TERM ADJUSTMENT CALCULATION"
476:Even if the scope of a patent is narrowed, neither
359:
901:- Contents and term of patent; provisional rights
796:King Pharma v. Teva, 78 USPQ2d 1237 (D.N.J. 2006)
922:Calculating Patent Term Adjustment Post-Novartis
638:"Government Printing Office p. 126, stat. 1532"
209:
8:
216:
202:
17:
409:United States Patent and Trademark Office
134:United States Patent and Trademark Office
679:
677:
300:
589:
125:
99:
68:
27:
20:
398:Adjustments possible under current law
694:(AIPA), enacted on November 29, 1999.
7:
911:Manual of Patent Examining Procedure
853:Manual of Patent Examining Procedure
579:Supplementary protection certificate
547:Manual of Patent Examining Procedure
542:Uruguay Round Agreements Act of 1994
169:Manual of Patent Examining Procedure
294:, 248). The enactment of the 1994
278:The original patent term under the
364:Tooltip Public Law (United States)
61:Title 35 of the United States Code
14:
692:American Inventors Protection Act
36:American Inventors Protection Act
715:from the original on 2023-05-14
56:Leahy–Smith America Invents Act
1:
757:80 F.3d 1543 (Fed. Cir. 1986)
669:MPEP - 2701 Patent Term (R-2)
532:and require the applicant to
463:(FDA) can provide additional
255:(TRIPS) as negotiated in the
139:Patent Trial and Appeal Board
499:Food and Drug Administration
461:Food and Drug Administration
390:Uruguay Round Agreements Act
296:Uruguay Round Agreements Act
963:
403:USPTO processing extension
565:and Hi-tech for the drug
472:Reissue and reexamination
307:Maximum term of validity
942:United States patent law
249:World Trade Organization
230:United States patent law
190:List of patent law cases
22:United States patent law
869:AIPLA Quarterly Journal
781:USPTO web site, MPEP,
489:FDA approval extension
355:17 years from issuance
342:21 years from issuance
329:14 years from issuance
77:Article of manufacture
69:Types of patent claims
917:USPTO PTA calculation
420:delay will accounted.
82:Composition of matter
46:Invention Secrecy Act
875:(3&4): 369–424.
705:"Mohsenzadeh v. Lee"
386:20 years from filing
812:§ 154(b)(2)(B)
519:Terminal disclaimer
108:Inter partes review
947:Time in government
709:scholar.google.com
654:2014-01-10 at the
465:market exclusivity
346:Patent Act of 1836
333:Patent Act of 1790
180:Biological patents
927:PTA determination
711:. June 25, 2015.
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603:
601:§ 154(a)(2)
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530:double patenting
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501:(FDA) approval.
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238:maintenance fees
236:, provided that
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185:Software patents
51:Hatch-Waxman Act
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459:In the US, the
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310:Established by
284:1836 Patent Act
280:1790 Patent Act
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113:Markman hearing
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149:Infringement
126:Other topics
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567:dorzolamide
431:adjustment.
304:Year filed
245:patent term
28:Legislation
936:Categories
899:§ 154
834:2022-11-13
585:References
540:After the
436:divisional
144:Exhaustion
100:Procedures
370:(12
352:1861–1994
339:1836–1860
326:1790–1835
713:Archived
652:Archived
573:See also
534:disclaim
881:2127292
526:obvious
478:reissue
407:If the
360:Pub. L.
274:History
175:History
87:Machine
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719:14 May
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232:, the
228:Under
171:(MPEP)
159:Racism
154:Misuse
92:Method
563:Merck
383:1995-
372:Stat.
368:36–88
315:-1789
288:Stat.
877:SSRN
806:See
721:2023
509:URAA
493:The
480:nor
243:The
909:in
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292:246
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