Adjustments, Extensions, Disclaimers, and Continuations: When Do Patent Term Adjustments Make Sense?

AuthorStephanie Plamondon Bair
PositionAssociate, Goodwin Procter LLP
Pages445-511
ADJUSTMENTS, EXTENSIONS, DISCLAIMERS, AND
CONTINUATIONS: WHEN DO PATENT TERM
ADJUSTMENTS MAKE SENSE?
STEPHANIE PLAMONDON BAIR *
I. INTRODUCTION .............................................................................................. 449
II. OPPORTUNITIES FOR ADJUSTING THE PATENT TERM .................................... 451
A. The Uruguay Round Agreements Act .................................................. 451
1. Terminally Disclaimed Patents and the URAA ....................... 452
a. Generally ...................................................................... 452
b. Interaction of the Terminal Disclaimer with a URAA
Adjustment .................................................................... 453
B. Patent Term Adjustments Due to USPTO Delay ............................... 454
1. Availability of a USPTO Delay Adjustment for a Patent
Previously Adjusted Under the URAA .................................... 456
2. Availability of a USPTO Delay Adjustment for a
Terminally Disclaimed Patent ................................................ 456
a. If a Reference Patent Has Received an Adjustment
for USPTO Delay ........................................................ 457
C. The Hatch-Waxman Act ..................................................................... 458
1. Generally ................................................................................ 458
2. Hatch-Waxman Extension Provisions ..................................... 460
3. Concurrent Availability of a Hatch-Waxman Extension
and a URAA Adjustment ......................................................... 461
a. Availability of a Hatch-Waxman Extension and a
URAA Adjustment for a Patent Not Yet Expired
on June 8, 1995 ............................................................ 461
b. Availability of a Hatch-Waxman Extension and a
URAA Adjustment for a Patent in Force on
June 8, 1995, Solely Due to a Hatch-Waxman
Extension ...................................................................... 461
4. Availability of a Hatch-Waxman Extension for a
Terminally Disclaimed Patent ................................................ 462
5. Availability of a Hatch-Waxman Extension for a Patent
Adjusted for USPTO Delay ..................................................... 462
6. Availability of More than One Hatch-Waxman Extension
for a Single Product ................................................................ 462
Copyright © 2013, Stephanie Plamondon Bair.
* Associate, Goodwin Procter LLP.
446 CAPITAL UNIVERSITY LAW REVIEW [41:445
D. Continuations .................................................................................... 464
1. Availability of a URAA Adjustment for a Patent Based
on a Continuation Application ................................................ 465
2. Terminal Disclaimer of a Patent Based on a
Continuation Application ....................................................... 466
3. Availability of a Hatch-Waxman Extension for a Patent
Based on a Continuation Application ..................................... 467
4. Availability of a USPTO Delay Adjustment for a Patent
Based on a Continuation Application ..................................... 467
E. Other Specific Extensions .................................................................. 468
III. POLICY IMPLICATIONS OF PATENT TERM ADJUSTMENTS .............................. 469
A. The Uruguay Round Agreements Act ................................................ 469
1. Generally ................................................................................ 469
2. The URAA Alternative Term Calculation ............................... 471
3. The Availability of a URAA Extension for a Terminally
Disclaimed Patent ................................................................... 472
B. Patent Term Adjustment Due to USPTO Delay ................................. 475
1. Availability of a USPTO Delay Adjustment for a Patent
Previously Adjusted Under the URAA .................................... 476
a. The Rule in Light of the Impetus Behind the Patent
Term Guarantee Act ..................................................... 476
b. The Rule in Light of Policy Considerations
Underlying the URAA and the Patent Term
Guarantee Act .............................................................. 477
c. The Rule in Light of the Overarching Goals of the
Patent System ............................................................... 479
2. Availability of a USPTO Delay Adjustment for a
Terminally Disclaimed Patent ................................................ 480
a. If a Reference Patent Has Received an Adjustment
for USPTO Delay ......................................................... 481
i. Approach (i): Eliminate the Cap on
Adjustment for the Disclaimed Patent ............... 482
ii. App roach (ii): Eliminate All USPTO Delay
Adjustments for a Disclaimed Patent ................ 483
iii. Approach (iii): Adjust the Disclaimed Patent
Concurrent with the Reference Patent ............... 483
iv. Approach (iv): Adjust the Disclaimed Patent
up to, but Not Exceeding, Any Adjustments
to the Reference Patent ...................................... 485
C. The Hatch-Waxman Act ..................................................................... 485
1. Generally ................................................................................ 485
2013] PATENT TERM ADJUSTMENTS 447
2. URAA ...................................................................................... 487
a. Availability of a Hatch-Waxman Extension and
a URAA Adjustment for a Patent Not Yet Expired
on June 8, 1995 ............................................................ 487
i. The Federal Circuit’s Holding in Kessler ......... 487
ii. Policy Implications ............................................ 489
b. Availability of a Hatch-Waxman Extension and
a URAA Adjustment for a Patent in Force on
June 8, 1995, Solely Due to a Hatch-Waxman
Extension ...................................................................... 490
i. The Federal Circuit’s Holding in Kessler ......... 490
ii. Policy Implications ............................................ 491
3. Availability of a Hatch-Waxman Extension for a
Terminally Disclaimed Patent ................................................ 494
a. Merck & Co. v. Hi-Tech Pharmacal Co. and
King Pharmaceuticals, Inc. v. Teva
Pharmaceuticals USA, Inc. .......................................... 494
b. Policy Implications....................................................... 497
4. Availability of a Hatch-Waxman Extension for a Patent
Adjusted for USPTO Delay ..................................................... 498
a. 35 U.S.C. § 156(a) ....................................................... 498
b. Policy Implications....................................................... 499
5. Availability of More than One Hatch-Waxman Extension
for a Single Product ................................................................ 500
a. The USPTO’s Interpretation of the
Hatch-Waxman Act ...................................................... 500
b. Policy Implications....................................................... 501
D. Continuations .................................................................................... 502
1. Availability of a URAA Adjustment for a Patent Based
on a Continuation Application ................................................ 502
a. MPEP § 2701 ............................................................... 502
b. Policy Implications....................................................... 502
2. Terminal Disclaimer of a Patent Based on a Continuation
Application .............................................................................. 503
3. Availability of a Hatch-Waxman Extension for a Patent
Based on a Continuation Application ..................................... 504
a. Evergreening ................................................................ 505
4. Availability of a USPTO Delay Adjustment for a Patent
Based on a Continuation Application ..................................... 506
a. USPTO Delay Adjustment for a Patent Based
on a Continuation, Continuation-in-Part, or

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