Amicus Curiae Brief — Cellect, LLC, Petitioner v. Katherine K. Vidal, Under Secretary of Commerce for Intellectual Property and Director, United States Patent and Trademark Office

No. 23-1231

In the

Supreme Court of the United States

CELLECT, LLC,

Petitioner,

v.

KATHERINE K. VIDAL, UNDER SECRETARY OF

COMMERCE FOR INTELLECTUAL PROPERTY

AND DIRECTOR, UNITED STATES PATENT AND

TRADEMARK OFFICE,

Respondent.

On Petition for a Writ of Certiorari to the United

States Court of A ppeals for the Federal Circuit

BRIEF OF TEIGE P. SHEEHAN AS AMICUS

CURIAE IN SUPPORT OF CERTIORARI

Teige P. Sheehan

Counsel of Record

Heslin Rothenberg Farley

& Mesiti P.C.

Five Columbia Circle

Albany, New York 12203

(518) 452-5600

teige.sheehan@hrfmlaw.com

Counsel for Amicus Curiae

330523

A

(800) 274-3321 • (800) 359-6859

i

TABLE OF CONTENTS

Page

TABLE OF CITED AUTHORITIES . . . . . . . . . . . . . . . ii

I. INTERSTS OF THE AMICUS CURIAE . . . . . . . . . 1

II. SUMMARY OF ARGUMENT . . . . . . . . . . . . . . . . . . 1

III. ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

A. THE FEDERAL CIRCUIT’S CIRCULAR

REASONING YIELDS AN UNFOUNDED

CONSTRUCTION OF § 154 . . . . . . . . . . . . . . . . 7

B. § 154 REQUIRES RESOLUTION OF

AN OBVIOUSNESS-TYPE DOUBLE

PATENTING A NA LYSIS BEFORE

PATENT TERM A DJUSTMENT IS

AWARDED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

IV. CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

ii

TABLE OF CITED AUTHORITIES

Page

Cases

Bilski v. Kappos,

561 U.S. 593 (2010) . . . . . . . . . . . . . . . . . . . . . . 5, 12, 15

Chevron, U.S.A., Inc. v.

Nat. Res. Def. Council, Inc.,

467 U.S. 837 (1984) . . . . . . . . . . . . . . . . . . . . . . . . . 9, 10

In re: Cellect, LLC,

81 F.4th 1216

(Fed. Cir. 2023) . . . . . . . . . . . . 2, 3, 8, 10, 11, 14, 15, 17

King v. St. Vincent’s Hosp.,

502 U.S. 215 (1991) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

KSR Int’l Co. v. Teleflex Inc.,

550 U.S. 398 (2007) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Merck & Co. v. Hi-Tech Pharmacal Co.,

482 F.3d 1317 (Fed. Cir. 2007) . . . . . . . . . . . . . . . . . . 12

Morse v. Republican Party of Virginia,

517 U.S. 186 (1991) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Nationwide Mut. Ins. Co. v. Darden,

503 U.S. 318 (1992) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Novartis AG v. Ezra Ventures LLC,

909 F.3d 1367 (Fed. Cir. 2018) . . . . . . . . . . . . . . . . . . 11

iii

Cited Authorities

Page

Octane Fitness, LLC v.

ICON Health & Fitness, Inc.,

572 U.S. 545 (2014) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Procter & Gamble Co. v.

Teva Pharms. USA, Inc.,

566 F.3d 989 (Fed. Cir. 2009) . . . . . . . . . . . . . . . . . . . . 2

SAS Inst., Inc. v. Iancu,

584 U.S. __, 138 S. Ct. 1348 (2018) . . . . . . . . . . . 12, 17

SCA Hygiene Prod. Aktiebolag v.

First Quality Baby Prod., LLC,

580 U.S. 328 (2017) . . . . . . . . . . . . . . . . . . . . . . . . . 5, 17

Application of Vogel,

422 F.2d 438 (C.C.P.A. 1970) . . . . . . . . . . . . . . . . . . . . 4

Statutes

35 U.S.C. § 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

35 U.S.C. § 101 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

35 U.S.C. § 103 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2, 14

35 U.S.C. § 154 . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15, 17, 18

35 U.S.C. § 156 . . . . . . . . . . . . . . . . . . . . . . 3, 10, 11, 12, 17

iv

Cited Authorities

Page

Administrative Materials

Manual of Patent Examining Procedure § 2733 . . . . 7

Other Authorities

Kazhdan, Obviousness-Type Double Patenting:

Why It Exists And When It Applies, 53 Akron

L. Rev. 1017 (2019) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

1

I. INTERSTS OF THE AMICUS CURIAE1

Amicus curiae is a patent attorney who counsels

clients in intellectual property matters, including in

connection with the obtention and protection of patents

and patent rights before the U.S. Patent and Trademark

Office and federal courts. His interest in this case in

particular derives from a desire for a properly and well

functioning patent system that provides sufficient and

predictable support for rights of inventors and other

stakeholders, as provided for by law, to promote progress

of science and useful arts.

II. SUMMARY OF ARGUMENT

A patent term adjustment (PTA) award is a statutorily

mandated addition of time to the end of a patent’s term

to compensate a patentee for administratively delayed

patent issuance, thereby preventing such a delay from

depriving a patentee of the full term to which she is

entitled. Separately, if deemed to confer an unjustifiably

extended duration of patent term, a patent may be invalid

under the judicial doctrine of obviousness-type double

patenting (ODP). In resolving a perceived conflict between

postponing a patent’s expiration date by an award of PTA

1. Counsel of record for all parties received notice of

amicus curiae’s intention to file this brief at least 10 days before

the deadline for its filing. Rule 37.2. Counsel for amicus curiae

certifies that this brief was not authored in whole or in part by

counsel for any party and that, other than the law firm of Heslin

Rothenberg Farley & Mesiti P.C., which paid all costs for printing,

filing, and serving this brief, no person or entity other than amicus

curiae has made a monetary contribution to the preparation or

submission of this brief. Rule 37.6.

2

and alleged ODP-invalidity due to an unjustified extension

of patent term, Respondent came down in favor of ODP,

finding Petitioner’s patents invalid for ODP because they

had received statutorily required PTA awards consequent

to administratively delayed patent issuance. But in so

doing, Respondent misinterpreted the statutory scheme

prescribed for administering PTA, creating a conflict

between PTA and ODP where none exists, and the Court

of Appeals for the Federal Circuit (“Federal Circuit”)

applied faulty reasoning and ignored statute in upholding

Respondent’s decision. This Court is urged to grant a writ

certiorari to correct such errors.

Two faults in statutory construction central to

the Federal Circuit’s decision are responsible for the

incorrect holding. First, the court held that reference

to a terminal disclaimer in 35 U.S.C. § 154, the statute

that sets out the scheme for calculating and awarding

PTA, was “tantamount” to an expression of Congress’s

intent that a PTA award can cause invalidity for ODP.

In re: Cellect, LLC, 81 F.4th 1216, 1228 (Fed. Cir. 2023). A

terminal disclaimer is a cure for an ODP defect, truncating

a patent’s term by setting an expiration date earlier

than it would otherwise have enjoyed. Id. at 1226. If an

application’s claims are found unpatentable for ODP, 2 a

2. This can occur, for example, if its claims are deemed

obvious variants over those of an earlier-expiring, reference

patent that is excluded from being citable against it for statutory

obviousness under 35 U.S.C. § 103, such as a patentee’s own

reference patent that had not issued, and arose from application

that had not published, before the priority date to which the patent

is entitled. Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566

F.3d 989, 999 (Fed. Cir. 2009) (“[S]tatutory obviousness compares

claimed subject matter to the prior art, while non-statutory

3

patentee can request a terminal disclaimer, which cures

the ODP defect by removing such portion of term as was

deemed an unjustified extension. Id. Section 154 states

that a PTA award cannot yield an expiration date later

than one set by a terminal disclaimer (if present). § 154(b)

(2)(B) (“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.”).

The Federal Circuit concluded that, because § 154 states

that a terminal disclaimer—the cure for ODP—limits a

PTA award, a PTA award itself can confer unpatentability

for ODP in the absence of a terminal disclaimer. In re:

Cellect, LLC, 81 F.4th at 1229. This is a classic instance

of circular reasoning, an illogical basis for analysis

repeatedly dismissed by this Court and which provides no

insight at all into whether Congress intended for a PTA

award to confer ODP invalidity.

On the basis of such faulty reasoning, the Federal

Circuit agreed with Respondent and held that ODP for a

patent that received a PTA award is assessed based on its

later expiration date resulting from application of PTA,

not on when the patent would have expired had no PTA

been awarded, resulting in invalidity for ODP. Id. To reach

this conclusion, the court compared § 154 with a different

statute, 35 U.S.C. § 156, which postpones patent expiration

in compensation for a different kind of administrative

delay. In re: Cellect, LLC, 81 F.4th at 1223-24. But the

comparison between §§ 154 and 156 for this purpose is

not only of no help in revealing Congress’s intent as to an

effect of PTA on ODP, it is also unnecessary. The scheme

[obviousness-type] double patenting compares claims in an earlier

patent to claims in a later patent or application.”).

4

by which PTA is calculated according to the terms of § 154

itself requires that ODP be determined before PTA is

awarded. To interpret the statutory scheme otherwise is

to require Respondent to compensate a patentee for an

administrative delay in a patent’s issuance by attaching

to it a new defect in validity on the very day the patent

issues. This absurd result cannot accurately reflect

Congress’s intent.

Thus, the Federal Circuit drew an unfounded

conclusion as to whether Congress intended for PTA

to cause ODP based on circular reasoning and an inapt

comparison while overlooking statutory indications of

Congress’s intent to the contrary, forcing an absurd

operation of § 154 that cannot be correct. It seems

unlikely in the extreme that Congress would have used a

statutory scheme intended to compensate a patentee for

administrative delays in patent issuance by compelling3

Respondent to issue patents rendered invalid on their day

of issue by the very “compensation” dispensed according

to the statutory scheme.

The doctrine of ODP is judicial in provenance,

not statutory. 4 Courts should therefore not endorse

Respondent’s attempt to expand its application in

3. “The Director shall proceed to grant the patent after

completion of the Director’s determination of a patent term

adjustment under the procedures established under this

subsection . . . .” 35 U.S.C. § 154(b)(3)(D) (emphasis added).

4. In contrast, the prohibition of statutory double patenting

is based on the statement in 35 U.S.C. § 101 that an inventor “may

obtain a patent” (emphasis added). Application of Vogel, 422 F.2d

438, 440 (C.C.P.A. 1970).

5

contradiction of Congress’s expressed intent. See, e.g.,

SCA Hygiene Prod. Aktiebolag v. First Quality Baby

Prod., LLC, 580 U.S. 328, 335 (2017) (refusing to expand

application of a judicially created defense to patent

infringement in contradiction of statute because doing so

would “give judges a ‘legislation-overriding’ role that is

beyond the Judiciary’s power”); Bilski v. Kappos, 561 U.S.

593, 603 (2010) (rejecting a rule that would characterize all

business methods as falling within the judicial exceptions

to statutory patent eligibility, stating “[t]his Court has

not indicated that the existence of these well-established

exceptions gives the Judiciary carte blanche to impose

other limitations that are inconsistent with the text and

the statute’s purpose and design.”). These reasons, at

least, militate in favor of granting a writ of certiorari.

III. ARGUMENT

The Federal Circuit’s untenable interpretation of § 154

both deviates from this Court’s guidance for construing

statutes and extracts irrational results from the statute’s

congressionally prescribed operation. Because § 154 limits

the effect of PTA in the presence of a terminal disclaimer,

the court concluded that a PTA award must produce a

need for a terminal disclaimer, as if PTA creates the

defect (ODP) so that a terminal disclaimer could cure

it. But that is circular logic. Though the statute refers

to how to calculate PTA when a terminal disclaimer has

been applied, a terminal disclaimer is not likely to have

been applied in the absence of ODP, such as if PTA does

not create a risk of ODP. That is, the statute stating what

would be the result for PTA if a terminal disclaimer had

been applied is not the same as the statute stating that

PTA gives rise to ODP necessitating a terminal disclaimer.

6

To jump from noting a reference to a terminal disclaimer

in § 154 to the conclusion that PTA causes ODP is begging

the question. The Federal Circuit thereby presupposed a

construction of § 154 in the process trying to construe it,

an analytical process disfavored by this Court, devoid of

persuasiveness, and ultimately without a sound foundation

in reason or law.

Moreover, the conclusion that ODP validity is

ascertained after PTA is awarded frustrates the

scheme Congress set out in § 154 for how to calculate

accrual of PTA. Section 154 lists various deadlines by

which Respondent is to take certain actions during

examination of an application. § 154(b)(1)(A)-(C). For

each day by which such a deadline is exceeded, one day

of PTA accrues (offset by days of delay attributable to

the applicant). Id., § 154(b)(2)(C). When a patent is set to

issue after completion of examination, net PTA accrual

is calculated and, if it is greater than zero, the patent’s

expiration date is postponed by the net number of days

of PTA accrued. § 154(b)(3)(b)(i). Notably, one day of PTA

accrues for each day in excess of three years between an

application’s filing date and issuance of a patent and for

each day in excess of four months it takes Respondent

to issue a patent after an applicant pays the issue fee.5

§ 154(b)(1). Both of these bases of potential PTA span

administrative processing that occurs after allowance of

an application. § 154(b)(1)(A)(iv), (b)(1)(B). A PTA award

therefore cannot be conclusively determined until patent

issuance and, accordingly, § 154 provides for notifying a

patentee of a PTA award when a patent is granted. § 154(b)

5. § 154(b)(2)(A) provides that, if two types of delay overlap,

only one day for each day of overlap accrues as PTA.

7

(3)(B)(i).6 The order of operations prescribed by § 154

therefore contemplates examination of an application and

determining that claims are free from defects (including,

for example, for ODP), followed by patent issuance and

awarding PTA.

Thus, if Congress’s scheme for calculating and

awarding PTA as laid out in § 154 is followed, PTA is not

awarded until after claims are deemed free of ODP, which

can hardly mean that PTA was to have been considered

when ODP was assessed during examination. On the

contrary, according to § 154, the expiration date as

postponed by an award of PTA simply cannot be taken into

consideration when ODP is assessed, because it cannot be

known until a patent’s issue date is established following

administrative action that occurs after completion of

examination. It would be extremely irrational if, by this

sequence of events, Congress intended for Respondent

to find claims valid right up until patent issuance, only to

poison the patent with a new, ODP defect in the form of

PTA awarded on the very day the patent is granted.

A.

THE FEDERAL CIRCUIT’S CIRCULAR

REASONING YIELDS AN UNFOUNDED

CONSTRUCTION OF § 154

Section 154 does not state that a PTA award would

render a patent invalid for ODP if the award would cause

the patent to expire after another, reference patent over

6. In turn, Respondent currently provides a first, “preliminary

[PTA] calculation” in an issue notification mailed after payment of

the issue fee, but the “official” notification of PTA does not occur

until it is printed on the patent when issued thereafter. Manual

of Patent Examining Procedure § 2733.

8

which it claims an obvious variant. Thus, on its face,

§ 154 does not require the result urged by Respondent.

Nevertheless, the Federal Circuit was troubled by the

provision of § 154 that states “[n]o 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.” § 154(b)(2)(B); In re:

Cellect, LLC, 81 F.4th at 1228 (“§ 154(b)(2)(B)’s provision

regarding terminal disclaimers . . . remains critical in

our analysis of the statute.”). The court concluded that

§ 154’s explicitly delimiting a PTA award according to the

terms of a terminal disclaimer was equivalent to requiring

that a PTA award can cause ODP invalidity: “Given the

interconnection of ODP and terminal disclaimers as ‘two

sides of the same coin,’ . . . the statutory recognition of the

binding power of terminal disclaimers in § 154(b)(2)(B)

is tantamount to a statutory acknowledgement that ODP

concerns can arise when PTA results in a later-expiring

claim that is patentably indistinct.” In re: Cellect, LLC,

81 F.4th at 1228. But the basis for this interpretation is

contrary to this Court’s precedent regarding rules for

statutory construction and does not withstand scrutiny.

This Court consistently rejects use of circular

reasoning in interpreting statutes. See, e.g., Nationwide

Mut. Ins. Co. v. Darden, 503 U.S. 318, 327 (1992)

(rejecting a statutory interpretation “infected with

circularity” because it “begs the question”); King v. St.

Vincent’s Hosp., 502 U.S. 215, 222 (1991) (rejecting a

proposed construction because it “rests on quite circular

reasoning”); Morse v. Republican Party of Virginia, 517

U.S. 186, 233 n.43 (1991) (rejecting construction because

it was “circular to rely” on the conclusion underlying it).

The Federal Circuit’s interpretation of § 154 is infected

9

with circularity because it relies on a conclusion that the

statutory delimitation of PTA that results if a terminal

disclaimer had been applied to cure it of an ODP defect is

equivalent to a PTA award itself giving rise to the defect.

But the effect of a cure is not equivalent to a defect giving

need of it, and such an interpretation should be rejected.

Similarly incorrect reasoning was rejected in Chevron,

U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837

(1984). There, whether a permitting program required

by statute would apply to a given source of pollution

depended on what the statute meant when referring to

a pollution “source.” The respondent argued that the

interpretation of the term given by the Court of Appeals

was correct because to interpret it otherwise allowed

for a permitting program that was explicitly prohibited

by the statute. Id. at 862 n.34. This Court rejected what

it called the respondent’s “classic example of circular

reasoning” that “proves nothing.” Id. Finding that the

statutory “waiver” from permitting requirements relied

on by the respondent did not pertain unless permitting of

the purported “source” was required to begin with, this

Court rejected the statutory interpretation proponed by

the respondent, stating “the statute merely deals with

the consequence of the definition of the term ‘source.’” Id.

The Federal Circuit’s interpretation of § 154 suffers

from the same infirmity, confusing statutory language

as to the consequences of a terminal disclaimer with a

definition of whether PTA could result in the need for

one. Congress’s statutorily limiting PTA if a terminal

disclaimer has been entered does not mean Congress

intended that an award of PTA means a terminal

disclaimer should have been entered, or that PTA can

10

cause ODP. Rather, reference to a terminal disclaimer

and its effect on PTA simply means what it says: if an

applicant has entered a terminal disclaimer, such as to

disclaim patent term beyond the expiration of a reference

patent over which the application’s claims are obvious

variants, administrative delay in granting a patent on

the application cannot give rise to PTA that extends

beyond the date set in the terminal disclaimer. In other

words, the statute explains the consequence on PTA of

a terminal disclaimer having been entered to overcome

ODP. It does not mean, as the Federal Circuit would have

it, PTA creates the need for the terminal disclaimer by

causing ODP invalidity. See In re: Cellect, LLC, 81 F.4th

at 1228 (“If terminal disclaimers had been filed in this

case, the provisions of § 154(b)(2)(B) would have come

into play.”). Such circular reasoning, in the words of the

Chevron Court, “proves nothing” at all as to Congress’s

intent. Chevron, U.S.A., Inc. v. Nat. Res. Def. Council,

Inc., 467 U.S. at 862 n34.

B. § 1 5 4 R E QU I R E S R E S OLU T ION OF

A N O BV I O U S N E S S -T Y P E D O U BL E

PATENTING ANALYSIS BEFORE PATENT

TERM ADJUSTMENT IS AWARDED

Because ODP functions to prevent an unjustifiably

extended duration of patent coverage, ODP invalidity is

more likely if a patent in question is considered to have

a later expiration date (e.g., more likely to be considered

to expire after, and thereby unjustifiably extend the

term of, a reference patent). To that point, the Federal

Circuit made much of a comparison between the language

of § 154 in relation to PTA and the language of § 156

in relation to another example of postponing a patent’s

11

expiration to compensate for an administrative delay,

patent term extension (“PTE”). In re: Cellect, LLC, 81

F.4th at 1223-24. The former statute mentions an effect

of a terminal disclaimer while the latter statute does not.

Id. at 1225. However, this comparison is misplaced and

was given undue, outsized import by the court. As argued

above, the mention of terminal disclaimers in § 154 is

not informative as to whether a PTA award affects ODP,

so whether or not it is referred to in a different statute

pertaining to postponed patent expiration is of no moment.

Moreover, reliance on this analysis overlooks the directly

relevant and revealing language of § 154 itself, which

establishes that PTA cannot finally be awarded until after

assessment of ODP during examination. The expiration

date yielded by a PTA award can therefore hardly be

taken into consideration when assessing ODP. Moreover,

a contrary conclusion requires perverse results contrary

to the statutory purpose of PTA and divorced from the

purported justifications for ODP.

For a patent with a PTE award, ODP is assessed

based on when the patent would have expired without

PTE having been awarded. Novartis AG v. Ezra Ventures

LLC, 909 F.3d 1367, 1375 (Fed. Cir. 2018). Because § 154

states that a terminal disclaimer limits the extent of a

PTA award while § 156 is silent as to terminal disclaimers,

the Federal Circuit concluded that Congress intended

different ODP analyses for PTA and PTE. In re: Cellect,

LLC, 81 F.4th at 1227. Unlike for PTE, the court concluded

that ODP for a patent that received an award of PTA

is assessed based on its later expiration date, after

application of PTA, not the earlier date on which it would

have expired in the absence of PTA. Id. at 1226-27 (“We

conclude that, while the expiration date used for an ODP

12

analysis where a patent has received PTE is the expiration

date before the PTE has been added, the expiration date

used for an ODP analysis where a patent has received PTA

is the expiration date after the PTA has been added.”) As

a result, the court concluded that PTA awards rendered

Petitioner’s patents invalid for PTA. Id. at 1229. But, as

argued above, the mention of terminal disclaimers in

§ 154 is of no assistance in determining whether Congress

intended for PTA to generate ODP invalidity, and silence

of § 156 as to terminal disclaimers does not change that

analysis.7

The correct approach is to derive from § 154 itself

whether Congress intended for an ODP analysis to be

based on the expiration date of a patent before or after PTA

is awarded. 8 The scheme set out in § 154 for calculating

7. Of course, an interpretation of §§ 154 and 156 that yielded

no difference between how PTA and PTE are applied despite

reference to a terminal disclaimer in the former statute but

not the latter could be criticized as “violating the canon against

interpreting any statutory provision in a manner that would render

another provision superfluous.” Bilski v. Kappos, 561 U.S. at 130.

However, because PTA and PTE are applied differently as a result

of this statutory difference, it is not rendered superfluous: unlike

for PTA, an award of PTE can yield an expiration date later

than one set by a terminal disclaimer. Merck & Co. v. Hi-Tech

Pharmacal Co., 482 F.3d 1317, 1322 (Fed. Cir. 2007).

8. Although Congress provided Respondent with authority

to establish procedures for applying PTA (§ 154(b)(3)(A)), the

absence of uncertainty as to Congress’s intent here leaves no room

for deference to Respondent. SAS Inst., Inc. v. Iancu, 584 U.S. __,

138 S. Ct. 1348, 1359 (2018) (in declining to defer to an agency’s

preferred interpretation in the absence of statutory ambiguity,

stating “[o]ur duty is to give effect to the text that 535 actual

legislators (plus one President) enacted into law.”).

13

PTA accrual includes consideration of administrative

delays of patent issuance that occur after examination

for patentability is completed, meaning PTA cannot have

been conclusively determined by the time evaluation

of patentability, including for ODP, is completed. For

example, if more than three years elapses between the

filing of a patent application and patent issuance, or more

than four months elapses between when an applicant pays

the patent issue fee and patent issuance, PTA accrues.

§ 154(b)(1)(A)(iv), (b)(1)(B). In turn, § 154 provides for

notifying a patentee of PTA when a patent issues. § 154(B)

(3)(b)(i). In other words, § 154 dictates that at least some

contributions to PTA, and possibly all in some cases, can

occur after examination for patentability is completed (i.e.,

between the close of examination and the issuance of a

patent), which in turn is completed before PTA is awarded.

Simply put, according to § 154 ODP is evaluated during

patent examination and patent examination concludes

before PTA can be finally determined. Obviousness-type

double patenting for a pending application therefore

cannot be based on the expiration date of a patent that

results from the application of PTA because such date is

not conclusively determined by the time assessment of

ODP is completed according to § 154. Obviousness-type

double patenting therefore must instead be assessed based

on when the patent would expire before accounting for an

effect of PTA.

If Congress instead intended for ODP to be assessed

based on a patent’s expiration date after application of

PTA, then the operation of § 154 would be perverse indeed.

In that case, examination of an application could come to

a close with a conclusion that it is allowable for patenting.

Until the patent’s issue date, PTA would not yet have

14

been conclusively determined. If, subsequent to the close

of examination and by the time the patent issues, a PTA

award is deemed deserved (e.g., perhaps PTA accrued, but

only after payment of the issue fee), it is applied on the

date the patent issues. Under this counterfactual where

the PTA expiration date is used for assessing ODP, only

then, for the first time, on the very day the patent issues,

would it become invalid for ODP. Deriving this intent from

Congress’s scheme set out in § 154 would be unreasonable.

There is another odd result of the Federal Circuit’s

interpretation of § 154. According to the Federal Circuit’s

decision, a patent can validly issue with a PTA award

and its corresponding expiration date publicized, only to

be rendered invalid for ODP later, when another patent

subsequently issues. By way of illustration, Petitioner’s

U.S. Patent No. 6,424,369 (“the ’369 Patent”) issued with

an award of 45 days of PTA. Over two-and-a-half years

later, another patent was issued to Petitioner, U.S. Patent

No. U.S. 6,862,036 (“the ’036 Patent”), without receiving

a PTA award. See In re: Cellect, LLC, 81 F.4th at 122021, figure and table. Both patents descended from and

claimed priority to the same prior patent application9 so

both would have had the same expiration date as each

other, not including the PTA awarded to the ’369 Patent.

Id. at 1219. However, Respondent held that issuance of

9. The ’036 and ’369 Patents therefore have the same

“effective filing date,” meaning the ’036 Patent is not relevant

in evaluating the ’369 Patent for statutory obviousness. See 35

U.S.C. § 100(i)(1), defining a patent’s “effective fling date” as

“the filing date of the earliest application for which the patent . . .

is entitled . . . to a right of priority,” and § 103, requiring that

obviousness be assessed as of “the effective filing date of the

claimed invention.”

15

the ’036 Patent, more than two-and-a-half years after

the ’369 Patent issued, suddenly rendered the ’369 Patent

invalid for ODP. The ’369 Patent’s 45 days of PTA meant

it was set to expire after the ’036 Patent did, resulting in

a supposedly unjust extension of patent term, according

to Respondent. Id. at 1226, 1229 (stating that a “crucial

purpose of ODP is to prevent an inventor from securing

a second, later-expiring patent for non-distinct claims.

This purpose applies equally to situations in which the

later patents have received grants of PTA resulting from

examination delays at the USPTO” and agreeing with

Respondent that “Cellect received an unjustified timewise

extension of its patent terms and that it does not matter

how the unjustified extensions are obtained.”).

This inflexible application of ODP10 is not only contrary

to Congress’s intent that ODP should be determined based

on a patent’s expiration date absent PTA, as expressed in

§ 154, but also serves none of the purported purposes of

ODP doctrine while delivering an inequitable result to a

patentee. Obviousness-type double patenting is supposed

to prevent a patentee from obtaining an unjustified

extension of patent term, either because the public

should be able to rely on an expiration date of a patent so

10. This Court has repeatedly rejected proposed rules

deemed too rigid or inflexible for analyzing patent-related issues.

See, e.g., Octane Fitness, LLC v. ICON Health & Fitness, Inc.,

572 U.S. 545, 553 (2014) (“The framework established by the

Federal Circuit . . . is unduly rigid . . . .”); Bilski v. Kappos, 561

U.S. at 604 (declining to endorse the Federal Circuit’s “machineor-transformation test” as “the sole test for deciding whether an

invention is a patent-eligible ‘process’”); KSR Int’l Co. v. Teleflex

Inc., 550 U.S. 398, 415 (2007) (“We begin by rejecting the rigid

approach of the Court of Appeals.”).

16

as to be able to practice its claims and obvious variants

thereof after it expires, because the applicant engaged

in gamesmanship in obtaining unjustified extension of

patent term, or some combination of both. See Kazhdan,

Obviousness-Type Double Patenting: Why It Exists And

When It Applies, 53 Akron L. Rev. 1017 (2019), at 1026,

summarizing justifications for ODP doctrine. But neither

goal is aided by a rule where, for example, a patent can

issue having a known expiration date and exist for years

without ODP invalidity, then suddenly become invalid

for ODP because another patent issues having an earlier

expiration date.

The public was made aware of the date of expiration

of the ’369 Patent, including with its PTA award conferred

as required by statute, on the day it issued. There is no

reason why the lack of PTA awarded to the ’036 Patent

when it issued over two-and-a-half years later should

suddenly have given the public the expectation that the

’369 Patent should expire 45 days sooner than had long

been expected. That is, the ’369 Patent validly issued, with

a publicized expiration date including PTA. Years later, a

different patent issued, then expired. Somehow, according

to Respondent, expiration of this other, subsequently

issued patent deprived the public of an expectation of

being able to practice supposedly obvious variants of

its claims covered by the claims of the ’369 Patent, even

though the public had known the ’369 Patent’s expiration

date all along. There was therefore no deprivation of public

expectations that justifies finding that the ’036 Patent

rendered the ’369 Patent invalid for ODP because the ’369

Patent previously issued with a PTA award.

And there is no allegation that gamesmanship on

Petitioner’s part resulted in an unjustified extension of

17

patent term. In re: Cellect, LLC, 81 F.4th at 1230. The

entire basis for the ODP allegation is that the ’369 Patent

received a PTA award and had claims that were obvious

over those of a reference patent, the ’036 Patent, which

did not receive PTA. Patent term adjustment is applied

by Respondent as required by § 154 to compensate for

administrative delays in patent issuance and Congress

imposed safeguards against manipulation of PTA by

a patent applicant. Whereas days of PTA accrue when

Respondent takes longer to accomplish various tasks than

as prescribed in § 154, days of PTA are deducted for delays

in patent issuance attributable to the applicant. § 154(b)

(2)(C). Thus, § 154 requires Respondent to confer a PTA

award, which is insulated from applicant manipulation. No

gamesmanship by Petitioner could have been involved in

the awarding of PTA to the ’369 Patent that required a

remedy of holding the ’369 Patent invalid for ODP over the

’036 Patent. And in any event, Respondent cannot pursue

a policy-based objective in contravention of Congressional

intent as expressed in statute. SAS Inst., Inc. v. Iancu,

138 S. Ct. at 1359 (“The Director may (today) think his

approach makes for better policy, but policy considerations

cannot create an ambiguity when the words on the page

are clear.”); see also SCA Hygiene Prod. Aktiebolag v.

First Quality Baby Prod., LLC, 580 U.S. at 345 (rejecting

a judicially created patent infringement defense that

supposedly solved a problem left unsolved by, and in

contradiction of, statute, because Congress provided the

statutory remedy, stating that this Court “cannot overrule

Congress’s judgment based on our own policy views.”).

Thus, Respondent and the Federal Circuit looked

in the wrong place, an inapt comparison between § 154

and § 156, to determine what expiration date Congress

18

intended to be used when evaluating a patent with a

PTA award for ODP. Properly relying instead on the

text of § 154 itself yields the correct conclusion that the

pertinent date for assessing when ODP may apply is the

date the patent would have expired without application of

PTA. Respondent’s contrary conclusion yields a rule that

compels irrational and unfair results and creates problems

where none need solving. This Court is urged to grant a

writ of certiorari to correct these significant errors.

19

IV. CONCLUSION

This Court is urged to grant a writ for certiorari

to rectify Respondent’s misapplication of Congress’s

statutorily expressed intent in applying PTA. The

wanting and strained reasoning used by the Federal

Circuit in approving Respondent’s approach is devoid of

sound analytical basis and, moreover, ignores the result

the straightforward application Congress’s text would

yield. The dissonance between Congress’s intended

compensatory purpose for PTA and PTA’s toxic effect

on patents required by the Federal Circuit’s circular

reasoning supports jettisoning it in favor of the sensible

outcome that follows naturally from the statute’s

prescribed scheme. To permit otherwise would be to allow

an expansion of a judicial exception to patent validity

in contrast to a Congressional mandate, without any

corresponding public benefit yet with significant detriment

to the patent system.

Respectfully submitted,

Teige P. Sheehan

Counsel of Record

Heslin Rothenberg Farley

& Mesiti P.C.

Five Columbia Circle

Albany, New York 12203

(518) 452-5600

teige.sheehan@hrfmlaw.com

Counsel for Amicus Curiae