United States Court of Appeals 

for the Federal Circuit ______________________ 

EXELA PHARMA SCIENCES, LLC, EXELA 

PHARMSCI, INC., EXELA HOLDINGS, INC.,

Plaintiffs-Appellants

v.

MICHELLE K. LEE, Deputy Director,

U.S. Patent and Trademark Office, 

Defendant-Appellee

CADENCE PHARMACEUTICALS, INC., 

SCR PHARMATOP,

Intervenors

______________________ 

2013-1206

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 12-CV-0469, Judge 

Liam O'Grady.

______________________ 

Decided: March 26, 2015

______________________ 

MATTHEW JAMES DOWD, Wiley Rein, LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by CLAIRE JOY EVANS; CLARENCE EDWARD POLK, JR., 

Exela Pharma Sciences, LLC, Ashburn, VA; ANTHONY H.

SON, Andrews Kurth, LLP, Washington, DC. 
2 EXELA PHARMA SCIENCES, LLC v. LEE

DENNIS C. BARGHAAN, JR., Office of the United States 

Attorney for the Eastern District of Virginia, Alexandria, 

VA, argued for defendant-appellee. Also represented by

DANA J. BOENTE; NATHAN KELLEY, Office of the Solicitor, 

United States Patent and Trademark Office, Alexandria, 

VA. 

 

RICHARD P. BRESS, Latham & Watkins LLP, Washington, DC, argued for intervenors. Intervenor Cadence 

Pharmaceuticals, Inc., also represented by GABRIEL BELL, 

Washington, DC; STEPHEN P. SWINTON, San Diego, CA; 

MARC NATHAN ZUBICK, KENNETH G. SCHULER, Chicago, IL. 

Intervenor SCR Pharmatop represented by CHARLES A.

WEISS, Holland & Knight, LLP, New York, NY.

______________________ 

Before NEWMAN and DYK, Circuit Judges.∗

Concurring opinion filed by Circuit Judge NEWMAN

Concurring opinion filed by Circuit Judge DYK

PER CURIAM.

This appeal presents the question of whether a third 

party has the right to challenge, by way of the Administrative Procedure Act (APA), a ruling of the Patent and 

Trademark Office reviving a patent application that had 

become abandoned by failure to meet a filing schedule

established by the Patent Cooperation Treaty and its 

implementing statute. The challengers are Exela Pharma 

Sciences, LLC; Exela Pharmsci, Inc.; and Exela Holdings, 

Inc. (collectively “Exela”). Exela petitioned the PTO to 

“reconsider and withdraw” its revival of the national stage 

∗

 Randall R. Rader, who retired from the position of 

Circuit Judge on June 30, 2014, did not participate in this 

decision.

 
EXELA PHARMA SCIENCES, LLC v. LEE 3

application and to cancel the issued patent. The patent is 

United States Patent No. 6,992,218 (“the ’218 patent”), 

assigned to SCR Pharmatop.

The PTO declined to consider Exela’s petition, stating 

that no law or regulation authorizes non-party challenge 

to a PTO ruling to accept a tardy filing. Exela then 

brought suit under the APA in the United States District 

Court for the Eastern District of Virginia, arguing that 

the PTO’s action was ultra vires and that Exela’s petition

should have been considered and favorably decided. The 

PTO moved to dismiss Exela’s complaint on several 

grounds. 

The district court initially held that Exela was entitled to challenge the PTO’s decision under the APA, but 

on reconsideration and in view of new Fourth Circuit 

precedent, the district court dismissed Exela’s complaint 

for failing to meet the statute of limitations for claims 

filed against the United States, including APA claims.1

We affirm the dismissal, on the ground that PTO revival rulings are not subject to third party collateral 

challenge, thereby precluding review regardless of whether Exela’s claims were time-barred.

BACKGROUND

Patentee SCR Pharmatop filed its initial patent application in France on June 6, 2000 and, in conformity with 

the Patent Cooperation Treaty (PCT), filed an international patent application identifying the United States, 

among others, as a designated state on June 6, 2001. The 

1 Exela Pharma Sciences, LLC v. Kappos, No. 1:12-

cv-469, 2012 WL 3638552 (E.D. Va. Aug. 22, 2012); Exela 

Pharma Sciences, LLC v. Kappos, No. 1:12-cv-469, 2012 

WL 6697068 (E.D. Va. Dec. 21, 2012) (Reconsideration 

Decision).

 
4 EXELA PHARMA SCIENCES, LLC v. LEE

PCT implementing statute, 35 U.S.C. §351 et seq., requires the applicant to fulfill certain United States documentary and fee requirements within 30 months after the 

filing of the foreign priority application, here by December 

6, 2002. See 35 U.S.C. §371(c), (d); PCT art. 22. SCR 

Pharmatop did not file the required materials by December 6, 2002, and consequently the United States application was deemed abandoned. On January 2, 2003 SCR 

Pharmatop filed a petition to revive the application, 

stating that the delay was “unintentional,” using the form 

provided by the PTO for revival requests. The PTO 

granted the petition on April 25, 2003. The application 

was duly examined, and the ’218 patent issued on January 31, 2006.

In August 2011 SCR Pharmatop and exclusive sublicensee Cadence Pharmaceuticals, Inc. (collectively 

“Pharmatop”) sued Exela in the United States District 

Court for the District of Delaware for infringement of the 

’218 patent. The suit was brought under the HatchWaxman Act, 35 U.S.C. §271(e)(2), in response to Exela’s 

notice and filing of an Abbreviated New Drug Application 

and Paragraph IV Certification relating to Pharmatop’s 

injectable acetaminophen-based drug Ofirmev. 

On November 30, 2011 Exela filed the subject petition 

in the PTO, under the APA and 37 C.F.R. §§1.181, 1.182, 

and 1.183, challenging the PTO’s revival of the patent 

application that led to the ’218 patent. Exela argued that 

“unintentional” delay was not an available ground for 

revival of a U.S. patent application claiming priority

under the PCT-implementing statute as then in effect. 

Exela pointed out that 35 U.S.C. §371(d) limited the

revival of such national stage applications to those in 

which the non-compliance was “unavoidable”: 

The requirements with respect to the national fee 

. . ., the translation . . ., and the oath or declaration . . . shall be complied with by the date of the 
EXELA PHARMA SCIENCES, LLC v. LEE 5

commencement of the national stage or by such 

later time as may be fixed by the Director. . . . 

Failure to comply with these requirements shall 

be regarded as abandonment of the application by 

the parties thereof, unless it be shown to the satisfaction of the Director that such failure to comply 

was unavoidable. . . . 2

35 U.S.C. §371(d) (2002). Exela argued that the PTO 

erred in applying its general revival regulation, 37 C.F.R. 

§1.137, which provides: 

Revival of abandoned application, terminated 

reexamination proceeding, or lapsed patent.

(a) Unavoidable. If the delay in reply by applicant 

or patent owner was unavoidable, a petition 

may be filed pursuant to this paragraph to revive an abandoned application, a reexamination proceeding . . . , or a lapsed patent. A 

grantable petition pursuant to this paragraph 

must be accompanied by: . . . 

(b) Unintentional. If the delay in reply by applicant or patent owner was unintentional, a petition may be filed pursuant to this paragraph to 

revive an abandoned application, a reexamination proceeding . . . , or a lapsed patent. A 

grantable petition pursuant to this paragraph 

must be accompanied by: . . . 

37 C.F.R. §1.137 (2000). Exela asserted that a PTO 

regulation cannot override a statute, and therefore, the 

PTO lacked discretion to grant SCR Pharmatop’s revival 

petition for “unintentional” delay.

2 The statute was amended, effective December 18, 

2013, removing the clause stating the “unavoidable” 

standard.

 
6 EXELA PHARMA SCIENCES, LLC v. LEE

The PTO declined to consider Exela’s petition, stating

that no statute or regulation authorizes third party 

challenge to a PTO ruling concerning revival of a patent 

application. See PTO letter to Exela’s counsel, February 

17, 2012 (returning petition fee). 

Following the PTO’s rejection of its petition, Exela

filed this district court action under the APA, asking the 

court to compel the PTO to vacate its revival decision. 

The PTO moved to dismiss Exela’s complaint under 

Federal Rules 12(b)(1) and (6) on several grounds, including that Exela lacks standing to challenge the PTO’s 

revival ruling, that Exela’s APA action is time-barred, 

and that a PTO revival ruling is not subject to judicial 

review at the request of a third party challenger. 

The district court initially denied the PTO’s motion to 

dismiss on all grounds, but while its decision was pending, the Fourth Circuit issued its decision in Hire Order, 

Ltd. v. Marianos, 698 F.3d 136, 170 (4th Cir. 2012), 

holding that for facial challenges to a federal regulation, 

the six-year limitations period of 28 U.S.C. §2401(a) starts 

to accrue when the regulation is adopted. The district 

court, on reconsideration, observed that the regulation 

here at issue, 37 C.F.R. §1.137, was adopted in 1982, and 

that Exela presented a facial challenge to the regulation, 

for it sought a declaration “regarding which standard to 

apply across the board.” Reconsideration Dec. at 4–6. 

Applying Hire Order, the district court held Exela’s action 

time-barred by the six-year period of limitations.

This appeal followed.

DISCUSSION

Exela argues that its complaint was improperly dismissed and that it is entitled to proceed, citing the APA’s 

purpose of providing remedy to any “person suffering 

legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a 
EXELA PHARMA SCIENCES, LLC v. LEE 7

relevant statute.” 5 U.S.C. §702. Exela stresses that the 

dominating consideration in APA actions is the “strong 

presumption that Congress intends judicial review of 

administrative action,” Bowen v. Michigan Academy of 

Family Physicians, 476 U.S. 667, 670 (1986). Exela states 

that the PTO’s action in reviving the Pharmatop application was contrary to the PCT statute, and that unless 

judicial review is available, an ultra vires PTO action will 

escape correction, thereby enabling enforcement of a 

patent that should not have issued.

The PTO responds that there is no authority for third 

parties to collaterally challenge the correctness of PTO 

revival rulings. Thus the PTO contends that the merits 

should be decided in its favor, even if dismissal is not

appropriate on limitations grounds.

Exela argues that although such third party action is 

not explicitly authorized by statute or regulation, it is 

available under the APA. Exela cites the Court’s statement in Block v. Community Nutrition Institute that 

“where substantial doubt about the congressional intent 

exists, the general presumption favoring judicial review of 

administrative action is controlling.” 467 U.S. 340, 350–51 

(1984).

We conclude that Congress did not intend to permit 

judicial review for challenges such as the one brought 

here. Whether the APA confers such a cause of action 

upon third parties raises a substantial question of patent 

law, and is reviewable by this court applying Federal 

Circuit law. See Helfgott & Karas, P.C. v. Dickinson, 209 

F.3d 1328, 1334 (Fed. Cir. 2000) (holding “[T]he question 

of whether the Commissioner has violated the APA in 

applying the PCT rules and regulations, as well as its own 

regulations, raises a substantial question under the 

patent laws. . . .”).

The question on this appeal is not whether a patent 

applicant may challenge a PTO revival ruling as to its 
8 EXELA PHARMA SCIENCES, LLC v. LEE

application; that question was resolved in the affirmative 

by this court’s decision in Morganroth v. Quigg, 885 F.2d 

843 (Fed. Cir. 1989). The issue here is whether a third 

party may collaterally challenge and obtain judicial 

review of a PTO revival ruling concerning an unrelated 

patent application. The Patent Act’s “intricate scheme for 

administrative and judicial review of PTO patentability 

determinations,” and “the Patent Act’s careful framework 

for judicial review at the behest of particular persons 

through particular procedures” demonstrate that third 

party challenge of PTO revival rulings under the APA is 

not legislatively intended. Pregis Corp. v. Kappos, 700 

F.3d 1348, 1357 (Fed. Cir. 2012) (“[A] third party cannot 

sue the PTO under the APA to challenge a PTO decision 

to issue a patent.”).

We conclude that PTO revival actions are not subject 

to third party challenge under the APA. On this ground, 

the dismissal of the Exela complaint is affirmed.

AFFIRMED
United States Court of Appeals 

for the Federal Circuit ______________________ 

EXELA PHARMA SCIENCES, LLC, EXELA 

PHARMSCI, INC., EXELA HOLDINGS, INC.,

Plaintiffs-Appellants

v.

MICHELLE K. LEE, Deputy Director,

U.S. Patent and Trademark Office, 

Defendant-Appellee

CADENCE PHARMACEUTICALS, INC.,

SCR PHARMATOP,

Intervenors

______________________ 

2013-1206

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 12-CV-0469, Judge 

Liam O'Grady.

______________________ 

NEWMAN, Circuit Judge, concurring. 

I join the court’s decision, for neither the Patent Act 

nor the Administrative Procedure Act provides a cause of 

action in which third persons may challenge the revival 

by the PTO of an application that was deemed abandoned 

for failure to meet a filing date.
2 EXELA PHARMA SCIENCES, LLC v. LEE

I write separately to address the concerns raised in 

Judge Dyk’s concurring opinion, in which he criticizes the 

court’s ruling in Aristocrat Technologies Australia Pty 

Ltd. v. International Game Technology, 543 F.3d 657 (Fed. 

Cir. 2008). With all respect to my colleague, I do not 

share the view that Aristocrat was wrongly decided.

In Aristocrat the defendant in an infringement suit 

argued that the PTO erroneously revived Aristocrat’s 

Patent Cooperation Treaty application (which was one 

day late), and sought invalidity on that ground. This 

court stated that the PTO’s revival of an application “is 

neither a fact or act made a defense by title 35 nor a 

ground specified in part II of title 35 as a condition for 

patentability.” 543 F.3d at 663. The court explained:

If any prosecution irregularity or procedural 

lapse, however minor, became grist for a later assertion of invalidity, accused infringers would inundate the courts with arguments relating to 

every minor transgression they could comb from 

the file wrapper. This deluge would only detract 

from the important legal issues to be resolved – 

primarily, infringement and validity.

Id. 

The Patent Act is explicit as to the grounds for challenges to issued patents; these grounds do not include 

challenge to PTO discretionary actions in revival of 

deemed-abandoned applications. A PTO decision to 

excuse a tardy filing is not a statutory ground of invalidity or defense to infringement under 35 U.S.C. §282, nor is 

it a ground on which third persons can initiate and participate in post-issuance disputes, see Chapter 30 (prior art 

citations and requests for reexamination), Chapter 31 

(inter partes review), and Chapter 32 (post-grant review). 

Rather, it is an irregularity in prosecution that “becomes 

irrelevant after the patent has issued.” Magnivision, Inc. 

v. Bonneau Co., 115 F.3d 956, 960 (Fed. Cir. 1997); see 
EXELA PHARMA SCIENCES, LLC v. LEE 3

also Norian Corp. v. Stryker Corp., 363 F.3d 1321, 1324 

(Fed. Cir. 2004) (“[T]he presumption of validity is not

subject to being diluted by ‘procedural lapses’ during 

prosecution.”). The patent statutes are specific as to 

legislative intent, and do not extend to “prosecution 

irregularities and procedural lapses.” Aristocrat, 543 F.3d 

at 663. The Supreme Court in Block v. Community Nutrition Institute, 467 U.S. 340 (1984), discussed the principles of challenge to administrative actions, and 

summarized:

Whether and to what extent a particular statute 

precludes judicial review is determined not only 

from its express language, but also from the structure of the statutory scheme, its objectives, its legislative history, and the nature of the 

administrative action involved.

467 U.S. at 345. The recently enacted America Invents 

Act (AIA), which provides new mechanisms for third party 

attacks on issued patents, did not change the principle 

that internal PTO procedures are not subject to third 

party collateral attack.

The Court stated in Block: “In a complex scheme of 

this type, the omission of such a provision is sufficient 

reason to believe that Congress intended to foreclose [the 

action].” 467 U.S. at 346. The statute concerning filing 

schedules under the Patent Cooperation Treaty was 

recently amended to remove the requirement that delay 

be unavoidable, see 35 U.S.C. §371(d) (2013), demonstrating legislative knowledge of the issue decided in Aristocrat. However, Congress made no new amendments to 

the scope of infringement defenses available in the district courts. Aristocrat warrants stability, not judicial 

taint as “problematic.”

Judge Dyk correctly points out that there are areas in 

which “a non-listed defense has been recognized by 

courts,” conc. op. at 4, citing cases in which antitrust 
4 EXELA PHARMA SCIENCES, LLC v. LEE

violation, patent misuse, and shop right have been recognized as defenses to patent infringement. With all respect, my colleague errs in stating that such major 

substantive issues, each of which is a traditional defense, 

“cannot be so easily distinguished” from an excuse for a 

missed filing date. Conc. Op. at 5. If judges cannot easily 

distinguish the significance of antitrust violation from a 

missed date, we must try harder. 
United States Court of Appeals 

for the Federal Circuit ______________________ 

EXELA PHARMA SCIENCES, LLC, EXELA 

PHARMSCI, INC., EXELA HOLDINGS, INC.,

Plaintiffs-Appellants

v.

MICHELLE K. LEE, Deputy Director,

U.S. Patent and Trademark Office, 

Defendant-Appellee

CADENCE PHARMACEUTICALS, INC.,

SCR PHARMATOP

Intervenors

______________________ 

2013-1206

______________________ 

Appeal from the United States District Court for the 

Eastern District of Virginia in No. 12-CV-0469, Judge 

Liam O'Grady.

______________________ 

DYK, Circuit Judge, concurring.

I join the majority opinion holding that the structure 

of the Patent Act bars third party Administrative Procedure Act (“APA”) challenges to patent validity based on an 

improper revival of an abandoned patent application. 
2 EXELA PHARMA SCIENCES, LLC v. LEE

In my view, the Patent Act is structured to channel 

third party challenges to patent validity to either of two 

routes: as defenses to infringement actions or as challenges brought at the PTO utilizing statutorily authorized 

proceedings such as inter partes review, post-grant review, or inter partes reexamination. This statutory 

scheme is inconsistent with APA review by third parties

in the district court. See Pregis Corp. v. Kappos, 700 F.3d 

1348, 1357 (Fed. Cir. 2012) (“[A] third party cannot sue 

the PTO under the APA to challenge a PTO decision to 

issue a patent.”).

The heart of Exela’s argument to the contrary is that 

it is entitled to proceed under the APA because there is a 

“strong presumption that Congress intends judicial review of administrative action,” Bowen v. Michigan Academy of Family Physicians, 476 U.S. 667, 670 (1986), and 

because, since our precedent in Aristocrat Technologies 

Australia Pty Ltd. v. International Game Technology, 543 

F.3d 657 (Fed. Cir. 2008), barred review of improper 

revival as a defense in infringement actions, the only 

available route to review is under the APA.

 In Aristocrat, this court held that a defendant in an 

infringement action could not assert improper revival of 

an abandoned patent application as a defense in that 

action. See 543 F.3d at 660–61. We need not decide here 

whether Aristocrat was correctly decided. Whether it was 

or not, the Patent Act is inconsistent with third party 

APA review. However, I write separately to explain why I 

think our decision in Aristocrat was problematic.

The panel in Aristocrat held that improper revival 

could not be raised as a defense to an infringement action 

because improper revival was not literally among the 

catalog of defenses listed in 35 U.S.C. § 282. See id. at 

663–64. The panel noted that we have held that a “provision of the Patent Act not falling within the literal scope 
EXELA PHARMA SCIENCES, LLC v. LEE 3

of section 282 may nevertheless provide a defense of 

noninfringement or invalidity.” Id. at 664 (relying on

Quantum Corp. v. Rodime, PLC, 65 F.3d 1577, 1584 (Fed. 

Cir. 1995) (holding that a patentee who improperly enlarged the scope of its claims during reexamination, 

violating 35 U.S.C. § 305, was subject to a defense of 

invalidity)). But the panel distinguished Quantum on the 

ground that the concern in Quantum that “failure to 

impose invalidity for violation of the statute would encourage noncompliance” was not present where there is

“no legitimate incentive for an applicant to intentionally 

abandon its application, much less to attempt to persuade 

the PTO to improperly revive it.” Id.

There are four aspects of the Aristocrat opinion that 

in my view warrant its reconsideration. 

First, Aristocrat did not discuss the presumption of 

judicial review of agency action. See Sackett v. Envtl. Prot. 

Agency, 132 S. Ct. 1367, 1373 (2012); Bowen, 476 U.S. at

670; Block v. Cmty. Nutrition Inst., 467 U.S. 340, 348–49

(1984); see also 5 U.S.C. § 702 (conferring a general cause 

of action upon persons “adversely affected or aggrieved by 

agency action within the meaning of a relevant statute”). 

As we hold today, there is no APA review for improper 

revivals and no alternative mechanism for review, so an 

invalidity defense would be the only route available for 

judicial review.

Second, contrary to the suggestion in Aristocrat and 

by my colleague in her concurrence, this is not a case 

involving a minor procedural error in the PTO process. 

See Magnivision, Inc. v. Bonneau Co., 115 F.3d 956, 960

(Fed. Cir. 1997) (holding that “[p]rocedural lapses during 

examination [such as in that case, an examiner’s not 

recording a phone call] . . . do not provide grounds of 

invalidity”). Here, Congress thought the issue of timely 

filing to be sufficiently important that it provided that a 
4 EXELA PHARMA SCIENCES, LLC v. LEE

patent would be treated as abandoned for noncompliance, 

and it allowed the PTO to reinstate the patent only when 

specific criteria were satisfied. See 35 U.S.C. § 371(d)

(2002).

Third, in Morganroth v. Quigg, 885 F.2d 843, 846

(Fed. Cir. 1989), we held that review of the PTO’s refusal 

to revive a patent application was available under the 

APA. That case is not cited in Aristocrat, and it is indeed 

difficult to understand why a third party facing liability 

for infringement of the patent cannot seek judicial review 

of a revival decision if the patent applicant can do so, even 

though the patent applicant and accused infringer must 

pursue different avenues for review (a defense for the 

accused infringer and review under the APA for the 

patent applicant). 

Fourth, Aristocrat failed to recognize that Quantum

was hardly the only example of situations in which a nonlisted defense has been recognized by courts. Obviousness-type double patenting, for example, is a wellestablished defense that is not specified in the statute. 

See, e.g., Gilead Scis., Inc. v. Natco Pharma Ltd., 753 F.3d 

1208, 1212 (Fed. Cir. 2014). Patent “misuse” is also a 

defense. See, e.g., Brulotte v. Thys Co., 379 U.S. 29 (1964) 

(holding that charging royalties beyond life of the patent 

impermissibly enlarges monopoly of the patent); Princo 

Corp. v. Int’l Trade Comm’n, 616 F.3d 1318, 1326–29

(Fed. Cir. 2010) (describing patent misuse and calling it 

“mainly a judicially created defense”). The “shop rights” 

doctrine is also a “judicially created defense to patent 

infringement” that “applies when an employer is sued for 

patent infringement by an employee who created the 

patented invention with the employer’s resources while 

under its employment, even though the employer otherwise has no legal rights to the resultant invention.” 

Beriont v. GTE Labs, Inc., 535 F. App’x 919, 923 (Fed. Cir. 
EXELA PHARMA SCIENCES, LLC v. LEE 5

2013). These other cases cannot be so easily distinguished 

from the situation in Aristocrat itself.

 In the future, en banc action to reconsider Aristocrat

may be appropriate.