United States Court of Appeals
for the Federal Circuit
__________________________
PREGIS CORPORATION,
Plaintiff-Cross Appellant,
v.
DAVID J. KAPPOS, UNDERSECRETARY OF
COMMERCE FOR INTELLECTUAL PROPERTY
and DIRECTOR, UNITED STATES PATENT and
TRADEMARK OFFICE,
Defendants-Appellees,
AND
FREE-FLOW PACKAGING INTERNATIONAL, INC.,
Defendant-Appellant.
__________________________
2010-1492, -1532
__________________________
Appeals from the United States District Court for the
Eastern District of Virginia in Case No. 09-CV-0467,
Judge Gerald Bruce Lee.
___________________________
Decided: December 6, 2012
___________________________
JAMES E. DABNEY, Fried Frank Harris Shriver, of New
York, New York, argued for plaintiff-cross appellant.
With him on the brief were STEPHEN S. RABINOWITZ and
HENRY C. LEBOWITZ; JOHN F. DUFFY, of Washington, DC.
PREGIS CORP v. KAPPOS 2
SCOTT R. MCINTOSH, Attorney, Appellate Staff, Civil
Division, United States Department of Justice, of Wash-
ington, DC, argued for defendants-appellees. With him on
the brief were TONY WEST, Assistant Attorney General,
and NEIL H. MACBRIDE, United States Attorney. Of
counsel on the brief were RAYMOND T. CHEN, Solicitor, and
SCOTT WEIDENFELLER, Associate Solicitor, United States
Patent and Trademark Office, of Alexandra, Virginia.
ROBERT FRANCIS ALTHERR, JR., Banner & Witcoff,
LTD., of Washington, DC, argued for defendant-appellant.
With him on the brief were JOSEPH M. POTENZA, BRADLEY
C. WRIGHT, CHRISTOPHER B. ROTH and NINA L. MEDLOCK.
__________________________
Before PROST, CLEVENGER, and REYNA, Circuit Judges.
REYNA, Circuit Judge.
Free-Flow Packaging International, Inc. (“Free-Flow”)
appeals the denial of its motions for judgment as a matter
of law after a jury verdict of noninfringement and invalid-
ity of certain claims of U.S. Patent Nos. 7,325,377
(“Fuss ’377”), 7,526,904 (“Fuss ’904”), and 7,536,837
(“Perkins ’837”). Pregis Corporation (“Pregis”) cross-
appeals the dismissal of its claim seeking judicial review
under the Administrative Procedure Act of the decision of
the United States Patent and Trademark Office (“PTO”)
to issue Fuss ’377, Fuss ’904, Perkins ’837, and U.S.
Patent No. 7,361,397 (“Perkins ’397”) (collectively, the
“Free-Flow Patents”). Because we conclude the district
court correctly denied Free-Flow’s motions for judgment
as a matter of law regarding obviousness, and correctly
dismissed Pregis’ claim for judicial review under the
Administrative Procedure Act, this court affirms.
3 PREGIS CORP v. KAPPOS
I. BACKGROUND
Free-Flow and Pregis are competitors in the air-filled
packaging cushion industry. Air-filled cushions are used
to fill space in shipping boxes carrying lightweight items
that do not take up all the available space in a box.
Demand for lightweight packaging rose rapidly beginning
in about 1999 due to the growth of internet retail sales.
“Air-pillow” packaging emerged as a preferred alternative
to polystyrene foam, “peanuts,” or crumpled paper as
filling material. Free-Flow and Pregis both manufacture
pre-configured plastic film and machines that inflate and
seal the film to produce air-pillow packaging.
Free-Flow holds three patents relating to air-filled
packaging technology for which infringement and validity
are at issue on appeal: the Fuss ’377, Fuss ’904, and
Perkins ’837 patents. These patents claim priority to
applications filed in late 1999 and early 2000. Fuss ’377,
issued February 5, 2008, claims an apparatus for making
air-filled packing cushions from a preconfigured plastic
film material. The apparatus comprises a feed mecha-
nism for drawing the edge of the film along a path, an
elongated guide member adapted to be inserted into a
channel in the preconfigured film material to inject air
into the film, and a sealing mechanism to close the air-
filled film chambers. The sealing mechanism comprises a
pair of blocks disposed on opposite sides of the film and a
pair of belts that carry the film past the blocks, “wherein
at least one of the blocks has a source of heat” used to seal
the film. Fuss ’377 col. 8, ll. 1–29. Fuss ’904, issued
May 5, 2009, is a continuation of the Fuss ’377 patent and
claims a system for making air-filled cushions. The
system comprises a preconfigured film with cushion
chambers and a longitudinally extending channel near
the edge of the film, and an apparatus for inflating and
sealing the preconfigured film. Fuss ’904 col. 7, l. 56 –
PREGIS CORP v. KAPPOS 4
col. 8, l. 1. Like Fuss ’377, the asserted claims of
Fuss ’904 require that the filling and sealing apparatus
has a block that “has a source of heat.” Id. at col. 8, ll. 18–
19.
The Perkins ’837 patent, issued May 26, 2009, claims
a system comprising a preconfigured film and a machine
for inflating the film to produce air-filled cushions. The
asserted claims of the Perkins ’837 patent all require a
plastic film to be drawn “through inflation, sealing and
slitting mechanisms in a planar path.” Perkins ’837
col. 14, l. 6 – col. 16, l. 33. The claimed system is illus-
trated in Figure 16 of the Perkins ’837 patent:
Perkins ’837, Fig. 16
At the time Free-Flow’s claimed inventions were
made, machines for producing air pillow packaging al-
ready were on the market. Free-Flow claims to have
improved on prior art machines by increasing the ease of
loading film, and by creating a more reliable seal to
produce uniformly-inflated air cushions. Free-Flow
markets its own air cushion machines, including the EZ I
and EZ II machines, and corresponding preconfigured
film. The EZ machine was first introduced in the United
States in February 2001. Sales of EZ film grew to more
than $8.4 million in the third full year following launch,
5 PREGIS CORP v. KAPPOS
which represented a 136% increase over the three year
period.
II. PROCEDURAL HISTORY
This action began on April 29, 2009, when Pregis filed
suit in the United States District Court for the Eastern
District of Virginia seeking a declaratory judgment of
noninfringement and invalidity of the Fuss ’377 patent.
Pregis also took the unusual step of suing the PTO, its
then-acting Director John J. Doll, and Free-Flow under
the Administrative Procedure Act (“APA”), 5 U.S.C.
§§ 701–706, to prevent the issuance of two then-pending
Free-Flow patent applications. Those two applications
issued as the Fuss ’904 and Perkins ’837 patents.
Pregis then amended its complaint to allege that the
issuance of the patents by the PTO was arbitrary, capri-
cious, an abuse of discretion or otherwise not in accor-
dance with law. Pregis alleged that the PTO failed to
discharge its statutory duty to determine whether the
claims of the patents were nonobvious over the prior art
as required by 35 U.S.C. § 103(a), and that the PTO’s
stated reasons for issuing the patents were insufficient to
support the conclusion that the allowed claims were
nonobvious. Pregis sought judgment to hold unlawful and
set aside the actions of the PTO in issuing the Per-
kins ’837 and Fuss ’904 patents. Pregis also amended its
complaint to include claims for declaratory judgment of
noninfringement and invalidity of the Fuss ’904 and
Perkins ’837 patents. Free-Flow filed counterclaims for
infringement of the Fuss ’377, Fuss ’904, and Perkins ’837
patents, and further alleged infringement of the Per-
kins ’397 patent. In response, Pregis added the Per-
kins ’397 patent to its APA claims.
The district court dismissed Pregis’ APA claims for
lack of subject matter jurisdiction on August 14, 2009. In
PREGIS CORP v. KAPPOS 6
a bench ruling, the court held “the Patent Act and its own
scheme clearly expresses Congress’ intent to preclude
putative third party infringers from seeking judicial
review” under the APA of PTO decisions to issue patents.
J.A. 3775.
A jury trial was held on February 1–25, 2010 on the
issues of infringement and obviousness. The jury re-
turned a verdict finding all asserted claims of Fuss ’377
(claims 1, 3, and 4), Fuss ’904 (claims 4, 6, 7, and 10), and
Perkins ’837 (claims 1–3 and 5–14) invalid as obvious, but
found the asserted claims of Perkins ’397 not invalid. The
jury found none of the asserted claims of the Fuss ’337,
Perkins ’837, or Perkins ’397 patents infringed, and found
only claim 10 of Fuss ’904 infringed. The jury found no
willful infringement and awarded zero damages to Free-
Flow. The district court denied Free-Flow’s post-trial
motions for judgment as a matter of law as to infringe-
ment, willful infringement, validity, and damages. Pregis
Corp. v. Doll, No. 1:09-cv-467, slip op. at 3 (E.D. Va. Aug.
10, 2010).
Free-Flow appeals the denial of its motions for judg-
ment as a matter of law as to validity and infringement of
the Fuss ’904, Fuss ’377 and Perkins ’837 patents. On
appeal, Free-Flow does not contest the district court’s
denial of judgment as a matter of law as to infringement
of the Perkins ’397 patent. Pregis cross-appeals the
dismissal of its APA claims, the district court’s grant of
summary judgment in favor of Free-Flow on Pregis’
additional invalidity defenses, and additional rulings by
the district court including the jury instructions and
burden of proof applied to the invalidity defenses. This
court has jurisdiction over the appeal and cross-appeal
under 28 U.S.C. § 1295(a)(1).
7 PREGIS CORP v. KAPPOS
III. STANDARD OF REVIEW
This court reviews the grant or denial of a motion for
judgment as a matter of law under regional circuit law, in
this case the United States Court of Appeals for the
Fourth Circuit. Revolution Eyewear, Inc. v. Aspex Eye-
wear, Inc., 563 F.3d 1358, 1370 (Fed. Cir. 2009). The
Fourth Circuit reviews a district court’s denial of judg-
ment as a matter of law de novo. In re Wildewood Litiga-
tion, 52 F.3d 499, 502 (4th Cir. 1995). The reviewing
court determines “whether a jury, viewing the evidence in
the light most favorable to [the prevailing party], could
have properly reached the conclusion reached by the
jury.” Id. Entry of judgment as a matter of law is not
appropriate when “there is substantial evidence in the
record upon which the jury could find for [the prevailing
party].” Id.
Federal Circuit law applies to “issues of substantive
patent law and certain procedural issues pertaining to
patent law.” Research Corp. Techs., Inc. v. Microsoft
Corp., 536 F.3d 1247, 1255 (Fed. Cir. 2008); see also
Midwest Indus. Inc. v. Karavan Trailers, Inc., 175 F.3d
1356, 1359 (Fed. Cir. 1999) (en banc in relevant part). “A
determination of infringement is a question of fact that is
reviewed for substantial evidence when tried to a jury.”
ACCO Brands, Inc. v. ABA Locks Mfr. Co., 501 F.3d 1307,
1311 (Fed. Cir. 2007).
Obviousness under 35 U.S.C. § 103 is a question of
law based on underlying facts. Graham v. John Deere Co.
of Kansas City, 383 U.S. 1, 17 (1966); Med. Instrumenta-
tion & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205,
1220 (Fed. Cir. 2003). What a reference teaches and
whether a person of ordinary skill in the art would have
been motivated to combine the teachings of separate
references are questions of fact. In re Gartside, 203 F.3d
PREGIS CORP v. KAPPOS 8
1305, 1316 (Fed. Cir. 2000); Para-Ordnance Mfg. v. SGS
Imps. Int’l, 73 F.3d 1085 (Fed. Cir. 1995). This court
reviews a jury’s conclusions on obviousness de novo, “and
the underlying findings of fact, whether explicit or im-
plicit in the verdict, for substantial evidence.” LNP Eng’g
Plastics, Inc. v. Miller Waste Mills, Inc., 275 F.3d 1347,
1353 (Fed. Cir. 2001).
This court reviews de novo the district court’s dis-
missal of Pregis’ APA claims against the PTO for lack of
subject matter jurisdiction. Cf. ABB Inc. v. Cooper Indus.,
LLC, 635 F.3d 1345, 1348 (Fed. Cir. 2011).
IV. THE ASSERTED CLAIMS OF THE FUSS ’377,
FUSS ’904, AND PERKINS ’837 PATENTS ARE INVALID
FOR OBVIOUSNESS
An obviousness analysis is based on underlying fac-
tual inquiries including: (1) the scope and content of the
prior art, (2) the differences between the claimed inven-
tion and the prior art, (3) the level of ordinary skill in the
art, and (4) objective indicia of nonobviousness. Graham,
383 U.S. at 17–18; Eli Lilly & Co. v. Teva Pharm. USA,
Inc., 619 F.3d 1329, 1336 (Fed. Cir. 2010). “The ultimate
judgment of obviousness is a legal determination.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007). When a
jury has found a claim to be obvious, this court presumes
the jury resolved all factual disputes in favor of the ver-
dict. Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337,
1343 (Fed. Cir. 2008).
Free-Flow does not dispute that the prior art cited at
trial, with some modifications, teaches every element of
the asserted claims of the Fuss ’377, Fuss ’904, and Per-
kins ’837 patents. Rather, Free-Flow asserts there was
no evidence of a reason to combine the prior art references
in the manner required to arrive at Free-Flow’s asserted
claims. Free-Flow also argues that the prior art taught
9 PREGIS CORP v. KAPPOS
away from such combination. This court finds there is
substantial evidence to support the factual underpinnings
of the jury verdict finding claims 1, 3 and 4 of Fuss ’377,
claims 4, 6, 7, and 10 of Fuss ’904, and claims 1–3 and 5–
14 of Perkins ’837 invalid for obviousness. We affirm the
district court’s denial of Free-Flow’s motion for judgment
as a matter of law on validity of these claims.
The primary invalidating reference presented by
Pregis is expired U.S. Patent No. 3,868,285 to Troy (“Troy
’285”), which issued in 1975. Troy ’285 discloses a ma-
chine for making bubble-wrap type cushion material from
prefabricated flat film stock. Troy ’285 col. 1, ll. 43–47.
The Troy ’285 machine includes multiple “sealing bands”
so that, rather than making a single seal along one edge
of the air-filled film, multiple seals are made parallel to
the longitudinal edges of the film. This forms smaller
sealed chambers to create a “bubble wrap” effect. Troy
’285 teaches that its apparatus can be used to “produce a
variety of cushionings, each having cells of different shape
and volume than the others.” Troy ’285 col. 12, l. 63 – col.
13, l. 1.
Pregis’ technical expert, Dr. Maslen, presented de-
tailed claim charts and testimony explaining how the
Troy ’285 patent discloses every element of the asserted
claims of Fuss ’377. Dr. Maslen testified that a person of
ordinary skill in the art would need only remove or dis-
able the multiple sealing bands in order to adapt the
machine to make larger air pillows rather than bubble
wrap.
Dr. Maslen testified that expired U.S. Patent No.
3,660,189 to Troy (“Troy ’189”), issued in 1972, and U.S.
Patent No. 4,017,351 to Larson (“Larson”) each disclose
preconfigured plastic films like those required by the
system claims of the Fuss ’904 and Perkins ’837 patents.
PREGIS CORP v. KAPPOS 10
Although bubble-wrap packaging is the preferred em-
bodiment disclosed in Troy ’189, the patent also teaches
that its preconfigured films “can be fabricated directly
into inflatables of various types with many uses,” includ-
ing “[d]isposable cushions or pads for tightly packaging
merchandise.” Troy ’189 col. 19, ll. 63–70.
Dr. Maslen explained that the Troy ’189 film or the
Larson film could be fed through the Troy ’285 machine
by one of ordinary skill in the art, making only technically
trivial modifications to the machine. Dr. Maslen testified
that the combination of the Troy ’189 film or Larson film
and the Troy ’285 machine, with such modifications,
meets all the limitations of the asserted claims of Perkins
’837 and Fuss ’904. Free-Flow contends Dr. Maslen’s
testimony was inadequate because he declined to testify
as to the legal conclusion that the combination of the prior
art teachings he presented rendered the asserted claims
“obvious.” The ultimate legal conclusion of obviousness,
however, was appropriately left to the district court and
to this court on review of the verdict. See Avia Grp. Int’l,
Inc. v. L.A. Gear Cal., Inc., 853 F.2d 1557, 1564 (Fed. Cir.
1988) (expert testimony on the ultimate “legal conclusion
of obviousness is neither necessary nor controlling”).
Free-Flow’s next argument is that the prior art taught
away from using the Troy ’285 machine in the manner
suggested by Dr. Maslen. Larson states that the ma-
chines taught by Troy ’189 and Troy ’285 were “complex
and expensive.” Larson col. 1, ll. 41–47. Larson also
states that the Troy system’s method of “sealing across
the full width of the inflated chambers causes wrinkles
which tend to leak air through the sealed areas.” Id. Dr.
Maslen testified that “if you left [the multiple sealers of
Troy ’285] in, you would perhaps suffer from some wrin-
kling.” Nonetheless, he opined that by adapting the
machine to make air pillow packaging with only a single
11 PREGIS CORP v. KAPPOS
seal, the problems of wrinkling and leaky seals would be
alleviated.
The record contains substantial evidence to support
the jury’s implicit finding that the prior art did not teach
away. Given the modest modifications required to use the
Troy ’285 machine to make air pillow packaging, the jury
reasonably could find that those skilled in the art would
have been motivated to simplify the Troy ’285 machine in
precisely the way suggested by Dr. Maslen. We are also
not persuaded by Free-Flow’s argument that removing
the mechanism used to create the bubble wrap contra-
venes the basic teaching of Troy. The mere fact that Troy
’285 teaches creation of bubble-wrap as a preferred em-
bodiment does not constitute “teaching away” from other
reasonable uses of the Troy ’285 machine. See In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004).
At trial, Free-Flow presented evidence of copying and
commercial success as objective indicia of nonobviousness.
As to copying, Pregis representatives conceded that the
company’s predecessor, Pactiv, analyzed Free-Flow’s EZ I
machine and “replicated certain unpatented components
of it.” J.A. 418. Free-Flow’s technical expert, Dr.
Kazerooni, testified to a litany of features on the accused
Pregis AirSpeed 5000 that are “substantially identical” to
features of the EZ I machine, but did not show that those
features were claimed in the patents in suit. The jury
also heard evidence from which it could conclude that the
EZ I machine did not embody the Free-Flow Patents at
all. Similarly, the jury heard conflicting evidence regard-
ing the nexus between the commercial success of Free-
Flow’s EZ I and EZ II machines and the claimed features
of the Free-Flow Patents. Pregis’ expert testified, for
example, that factors such as ease of use of the system
electronics, cost of supplied film, customer service, and
speed of maintenance—none of which were shown to be
PREGIS CORP v. KAPPOS 12
related to the claimed elements of the Free-Flow Pat-
ents—determine commercial success in the air-pillow
packaging industry.
The lack of nexus between the claimed subject matter
and the commercial success or purportedly copied features
of the EZ I machine renders Free-Flow’s proffered objec-
tive evidence uninformative to the obviousness determi-
nation. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
1311–12 (Fed. Cir. 2006) (“Evidence of commercial suc-
cess, or other secondary considerations, is only significant
if there is a nexus between the claimed invention and the
commercial success.”) Having considered the conflicting
evidence, the jury concluded that the asserted claims of
Fuss ’377, Fuss ’904, and Perkins ’837 are invalid for
obviousness. This court holds that the jury’s underlying
factual findings related to obviousness were supported by
substantial evidence, and we affirm the legal conclusion
that the asserted claims are invalid as obvious.
Because we hold that the asserted claims of the Fuss
’377, Fuss ’904 and Perkins ’837 patents are invalid, this
court need not reach, and declines to address, Pregis’
remaining defenses and Free-Flow’s appeal of the denial
of its motion for judgment as a matter of law of infringe-
ment.
V. ADMINISTRATIVE PROCEDURE ACT CLAIMS
The APA provides that “[a] person suffering legal
wrong because of agency action, or adversely affected or
aggrieved by agency action within the meaning of a
relevant statute, is entitled to judicial review thereof.”
5 U.S.C. § 702. A PTO decision to issue a patent is an
“agency action” under the APA. See Dickinson v. Zurko,
527 U.S. 150, 154 (1999). The APA sets forth several
limitations on the grant of judicial review set out in § 702.
Relevant here, the APA applies “except to the extent that -
13 PREGIS CORP v. KAPPOS
(1) statutes preclude judicial review . . . .” 5 U.S.C.
§ 701(a)(1) (emphasis added). Additionally, the APA
authorizes judicial review of final agency actions only if
“there is no other adequate remedy in a court.” 5 U.S.C.
§ 704.
The question here is whether a competitor, who has
been sued as an infringer, is entitled under the APA to
judicial review of the PTO’s decision to grant the patents
in suit. Pregis asserts a right to challenge two distinct
aspects of a PTO “decision to issue” a patent: 1) the PTO’s
stated reasons for allowing the claims during examination
under 35 U.S.C. § 131, and 2) the issuance of the patent
itself. Pregis argues the need to permit competitors to
challenge the PTO’s stated reasons for allowance is illus-
trated by the prosecution history of the Perkins ’397
patent. The PTO allowed the claims of Perkins ’397 based
on arguments made by Free-Flow’s patent attorney to
distinguish a prior art reference. During the litigation of
this case, Free-Flow conceded that its attorney’s argu-
ments during prosecution were based on a misunder-
standing of the prior art and were incorrect. Thus, at
trial, Free-Flow argued Perkins ’397 was patentable over
the prior art on a different basis. Pregis argues it should
be permitted to bring an APA claim challenging the PTO’s
reasons for allowance in addition to an invalidity de-
fense—which is subject to a corresponding presumption of
validity—in litigation against the patentee. Pointing to
§ 702 of the APA, Pregis asserts it was “adversely affected
or aggrieved” by the PTO’s action because the Free-Flow
Patents “purported to impose a direct regulation and
restriction on Pregis’ business by excluding Pregis from
making use of subject matter that was in the public
domain . . . , and by exposing Pregis to claims for alleged
infringement by its direct competitor, [Free-Flow].”
Cross-Appellant Br. 55.
PREGIS CORP v. KAPPOS 14
The district court dismissed Pregis’ APA claims and
held that the Patent Act’s comprehensive scheme pre-
cludes putative third party infringers from seeking judi-
cial review of PTO decisions to issue patents. J.A. 3775–
76. The district court based its holding on Syntex (U.S.A.)
Inc. v. United States Patent & Trademark Office, 882 F.2d
1570 (Fed. Cir. 1989), in which this court affirmed dis-
missal of a suit against the PTO by a third party reex-
amination requester.
Indeed, this court has twice previously stated that a
potential infringer cannot sue the PTO under the APA to
attack the validity of an issued patent. In Syntex, we
framed the jurisdictional issue as whether the patent
statute impliedly grants a third party requester a right to
review of the PTO’s final decision in reexamination. Id. at
1572. This court determined in Syntex that the Patent
Act’s “clear, comprehensive statutory scheme” indicates
that Congress intended to limit appeals from reexamina-
tion to the mechanisms specifically provided for by stat-
ute. Id. at 1573. The creation of a right in a third party
to challenge a result favorable to a patent owner after ex
parte prosecution cannot be inferred. Id. at 1575. We
explicitly pointed out that “a potential infringer may not
sue the PTO seeking retraction of a patent issued to
another by reason of its improper allowance by the PTO.”
Id. at 1576.
In Animal Legal Defense Fund v. Quigg, 932 F.2d 920
(Fed. Cir. 1991) (“ALDF”), this court held that plaintiffs,
various individual farmers and organizations whose goal
is the protection of animals, lacked standing to sue under
the APA to enjoin the PTO from issuing patents on multi-
cellular living organisms because the plaintiffs failed to
show injury traceable to the PTO’s actions, and because
plaintiffs were outside the zone of interests addressed by
the Patent Act. This court held that the zone of interests
15 PREGIS CORP v. KAPPOS
of the patent laws does not extend to “any member of the
public who perceives they will be harmed by an issued
patent.” Id. at 938. In so holding, we specifically declined
to “open[] the door to collateral attack on the validity of
issued patents” by permitting competitors to sue the PTO
to challenge a patent’s validity. Id. As we held, “[t]he
structure of the Patent Act indicates that Congress in-
tended only the remedies provided therein to ensure that
the statutory objectives would be realized.” Id.
Both Syntex and ALDF addressed challenges to PTO
determinations in a factual context different from that of
this case, but the reasoning expressed by the court in
those cases applies here. We affirm the district court’s
dismissal of Pregis’ APA claims and hold that a third
party cannot sue the PTO under the APA to challenge a
PTO decision to issue a patent. The comprehensive
legislative scheme of the Patent Act “preclude[s] judicial
review” of the reasoning of PTO decisions to issue patents
after examination under 35 U.S.C. § 131, and competitors
have an “adequate remedy in a court” for the issuance of
invalid patents. 5 U.S.C. §§ 701(a)(1), 704.
A. The Patent Act Precludes Review Under the APA
To determine whether a particular statute precludes
judicial review, we look to its express language, the
structure of the statutory scheme, its legislative history
and purpose, and the nature of the administrative action
involved. Block v. Cmty. Nutrition Inst., 467 U.S. 340,
345 (1984). There is a “strong presumption” that Con-
gress did not intend to prohibit all judicial review of a
type of agency action. Bowen v. Mich. Acad. of Family
Physicians, 476 U.S. 667, 672 (1986); Dunlop v.
Bachowski, 421 U.S. 560, 567 (1975).
A statute need not explicitly state that judicial review
is unavailable for preclusion to be found. See Bowen, 476
PREGIS CORP v. KAPPOS 16
U.S. at 671 (“To preclude judicial review under [the APA]
a statute, if not specific in withholding such review, must
upon its face give clear and convincing evidence of an
intent to withhold it.”) (quoting H.R. Rep. No. 1980, 79th
Cong., 2d Sess. 41 (1946)). For example, “when a statute
provides a detailed mechanism for judicial consideration
of particular issues at the behest of particular persons,
judicial review of those issues at the behest of other
persons may be found to be impliedly precluded.” Block,
467 U.S. at 349. As such, judicial review may be pre-
cluded when Congressional intent to do so is “fairly dis-
cernible in the statutory scheme.” Id. at 351 (quoting
Assoc. of Data Processing Serv. Orgs., Inc. v. Camp, 397
U.S. 150, 157 (1970)).
The Patent Act expressly provides an intricate scheme
for administrative and judicial review of PTO patentabil-
ity determinations that evinces a clear Congressional
intent to preclude actions under the APA seeking review
of the PTO’s reasons for deciding to issue a patent. First,
the Patent Act establishes specific procedures allowing a
patent applicant to appeal PTO rejections of patent
claims. 35 U.S.C. §§ 134, 141, 145. Second, the statute
permits third parties to challenge issued patents through
carefully-circumscribed reexamination proceedings. 35
U.S.C. §§ 301–307, 311–318 (2006).1 Third, putative
1 Congress extensively revised this scheme with
the passage of new post-grant review and inter partes
review procedures as part of the Leahy-Smith America
Invents Act (“AIA”). Leahy-Smith America Invents Act,
Pub. L. No. 112-29, sec. 6, 125 Stat. 284 (2011) (to be
codified at Chapters 30-32 of Title 35). Because at all
times relevant to this appeal the provisions of the AIA
governing post-grant review had not yet taken effect, this
opinion discusses the Patent Act as it existed prior to the
AIA. Nevertheless, the fact that Congress has prescribed
detailed new procedures for administrative and judicial
17 PREGIS CORP v. KAPPOS
infringers with a sufficiently immediate controversy may
challenge the validity of issued patents through a declara-
tory judgment action, or can raise invalidity as a defense
to an infringement suit. 28 U.S.C. § 2201(a); 35 U.S.C.
§ 282; MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118,
127 (2007).
The Patent Act thus presents several mechanisms by
which third parties may challenge the PTO’s decision to
issue a patent, unlike cases in which preclusion of a suit
under the APA would leave an agency action entirely free
from judicial review. Cf. Bowen, 476 U.S. at 678 (holding
“it is implausible to think [Congress] intended that there
be no forum to adjudicate statutory and constitutional
challenges to regulations promulgated by the Secretary”
for the method by which Medicare Part B payments are
calculated) (emphasis original). Having considered and
addressed the need for review of PTO patentability de-
terminations, Congress enacted specific procedures allow-
ing third parties to attack the validity of issued claims. It
is apparent that Congress decided not to provide for third
parties to obtain review of the reasons for allowance of
claims.
The carefully balanced framework of the Patent Act
specifies a well-defined process for how, when, where, and
by whom PTO patentability determinations may be
challenged. Only a patent applicant may challenge an
examiner’s decision to reject claims in original examina-
tion under 35 U.S.C. § 131. The applicant must first
bring an administrative appeal to the Board of Patent
Appeals and Interferences (the “Board”). 35 U.S.C.
§ 134(a). The applicant may then appeal the Board’s
review of issued patents reinforces the conclusion that
Congress intended to preclude other avenues of judicial
review.
PREGIS CORP v. KAPPOS 18
decision in this court under 35 U.S.C. § 141, or may file
suit against the PTO in the United States District Court
for the District of Columbia under 35 U.S.C. § 145.2 A
third party, by contrast, cannot challenge an examiner’s
decision after original examination, but only may obtain
judicial review of PTO decisions confirming patentability
by first participating in inter partes reexamination.3 35
U.S.C. §§ 134(c), 141.
The Patent Act thus reflects Congressional intent as
to which parties should be permitted to challenge the
examiner’s patentability determination made during
original examination. That the Patent Act dictates the
courts in which a disappointed applicant may appeal a
patentability determination also shows Congress intended
to preclude challenges to such PTO actions under the
APA. Every district court of the United States has juris-
diction over an APA claim, while the patent applicant is
restricted to review in a single district court or to a direct
appeal to the Federal Circuit. 35 U.S.C. §§ 141, 145.
Moreover, Congress has protected the interests of com-
petitors and the public through the mechanisms explicitly
provided to them in the Patent Act to challenge the valid-
ity of issued patents. Preclusion of APA suits challenging
the PTO’s reasons for issuing a patent therefore does not
“threaten realization of the fundamental objectives of the
statute” to promote innovation by incentivizing inventors
without unduly limiting competition. Block, 467 U.S. at
352.
2 We note that under the current version of § 145,
actions are to be brought in the Eastern District of Vir-
ginia, but Congress has retained a statutory scheme that
dictates the court in which such actions must be brought.
3 Similarly, under the AIA, a third party may resort
to either post-grant review or inter partes review after
issuance. See AIA secs. 7(b), (c).
19 PREGIS CORP v. KAPPOS
We conclude that a Congressional intent to preclude
judicial review of the PTO’s reasons for issuing patents is
“fairly discernible” from the statutory scheme of the
Patent Act. Block, 467 U.S. at 351. Allowing competitors
to collaterally attack issued patents through suits under
the APA would destroy the Patent Act’s careful frame-
work for judicial review at the behest of particular per-
sons through particular procedures.
B. Adequate Remedies are Available
The APA authorizes judicial review only where the
agency action is “made reviewable by statute” or where
there is a “final agency action for which there is no other
adequate remedy in a court.” 5 U.S.C. § 704. As we have
held, the PTO’s decision to issue a patent during original
examination is not “made reviewable by statute.” Thus,
the review Pregis seeks under the APA is barred by § 704
unless “there is no other adequate remedy” available in
court.
The Patent Act provides three different adequate
remedies in court for competitors harmed by the PTO’s
erroneous issuance of a patent. The Patent Act allows
any third party to request an inter partes reexamination
by raising a substantial new question of patentability. 35
U.S.C. §§ 301, 311. A participant in inter partes reexami-
nation may obtain judicial review of a PTO decision to
allow claims after reexamination by appealing to the
Board and then, if necessary, to this court. 35 U.S.C.
§ 315(b). Additionally, a putative infringer can raise
invalidity as a defense to a patent suit or can proactively
bring a declaratory judgment action against the patent
owner to have the patent declared invalid. 35 U.S.C.
§ 282. Each of these avenues provides review, in an
Article III court, of the validity of patents issued by the
PTO.
PREGIS CORP v. KAPPOS 20
In litigation against the patentee, the putative in-
fringer can attack the patent on a wide variety of sub-
stantive grounds (e.g., failure to comply with the
conditions for patentability set forth in Part II of Title 35,
or with the written description, enablement, definiteness
and other requirements of § 112). 35 U.S.C. § 282(b).
These are generally the same criteria on which the PTO
reviews patentability, and thus present the same issues
that would be raised in a direct challenge to the PTO’s
reasons for issuing the patent. If successful, the relief
granted—invalidation of patent claims—fully relieves the
harm caused by the PTO having erroneously issued the
patent.
Pregis argues that because not all PTO mistakes are
recognized as defenses under § 282, a declaratory judg-
ment action or the defenses in an infringement suit are
not an adequate judicial remedy. See Aristocrat Techs.
Australia Pty Ltd. v. Int’l Game Tech., 543 F.3d 657, 662-
63 (Fed. Cir. 2008) (improper revival of abandoned appli-
cation is not a cognizable defense to infringement claim).
Yet, the specific list of defenses available under § 282
reflects the deliberate judgment of Congress that not
every error during prosecution should provide a defense to
a claim of patent infringement.
Similarly, Pregis argues that the presumption of va-
lidity of an issued patent, which can be overcome only by
“clear and convincing evidence,” renders patent litigation
an inadequate alternative to review under the APA.
Pregis asserts that a civil action under 5 U.S.C. § 702
would not give such weight to the PTO decision being
challenged. 5 U.S.C. § 706. Regardless, a suit under the
APA would impermissibly alter the burden of proof, set by
Congress and confirmed by the Supreme Court, for invali-
dating a patent. See 35 U.S.C. § 282; Microsoft Corp. v.
i4i Ltd. P’ship, 131 S. Ct. 2238, 2246 (2011) (holding
21 PREGIS CORP v. KAPPOS
Congress chose the “clear and convincing” standard of
proof by stating in § 282 that a patent is “presumed
valid”).
Furthermore, a judicial remedy is adequate for pur-
poses of 5 U.S.C. § 704 even if it does not “provide relief
identical to relief under the APA, so long as it offers relief
of the ‘same genre.’” Garcia v. Vilsack, 563 F.3d 519, 523
(D.C. Cir. 2009). A private lawsuit against a third party,
such as litigation of patent validity in an action against
the patentee, need not be “as effective as an APA lawsuit
against the regulating agency.” Id. at 525. The alternate
remedy in court need only be “adequate” for it to supplant
a suit under the APA. Id.; 5 U.S.C. § 704. In sum, the
fact that the defenses available under 35 U.S.C. § 282, or
in a challenge to a patent through inter partes reexamina-
tion, are not identical to an APA suit does not render the
carefully-considered judicial remedies provided by the
Patent Act “inadequate.”4
VI. CONCLUSION
For the reasons above, this court affirms the judg-
ment of the district court.
AFFIRMED
COSTS
Each party shall bear its own costs.
4 Because we hold that third parties are not enti-
tled to judicial review under the APA of PTO decisions to
issue patents, we need not address the additional stand-
ing issues raised by Free-Flow on appeal.