Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-16-01085/USCOURTS-ca13-16-01085-0/pdf.json

Parties Involved:
Akorn, Inc.
Appellee
Allergan, Inc.
Appellant
Apotex Corp.
Appellee
Apotex, Inc.
Appellee
Duke University
Not party
Hi-Tech Pharmacal Co., Inc.
Appellee
Sandoz, Inc.
Appellee

Document Text:

NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________ 

ALLERGAN, INC.,

Plaintiff-Appellant

DUKE UNIVERSITY,

Plaintiff

v.

SANDOZ, INC., AKORN, INC., HI-TECH 

PHARMACAL CO., INC., APOTEX, INC., APOTEX

CORP.,

Defendants-Appellees

______________________ 

2016-1085, 2016-1160

______________________ 

Appeals from the United States District Court for the 

Middle District of North Carolina in Nos. 1:14-cv-01028-

CCE-LPA, 1:14-cv-01034-CCE-LPA, Judge Catherine C. 

Eagles.

______________________ 

Decided: March 17, 2017

______________________ 

 CRAIG E. COUNTRYMAN, Fish & Richardson P.C., San 

Diego, CA, argued for plaintiff-appellant. Also represented by JONATHAN ELLIOT SINGER; ELIZABETH M. FLANAGAN, 

Case: 16-1085 Document: 92-2 Page: 1 Filed: 03/17/2017
2 ALLERGAN, INC. v. SANDOZ, INC. 

Wilmington, DE; DEANNA JEAN REICHEL, Minneapolis, 

MN.

 JOHN J. MOLENDA, Steptoe & Johnson, LLP, New 

York, NY, argued for all defendants-appellees. Defendant-appellee Sandoz, Inc. also represented by THOMAS J.

FILARSKI, Chicago, IL; GRETCHEN P. MILLER, Washington, 

DC. 

SAILESH K. PATEL, Schiff Hardin LLP, Chicago, IL, for 

defendants-appellees Akorn, Inc., Hi-Tech Pharmacal Co., 

Inc. Also represented by JOEL M. WALLACE. 

DEANNE M. MAZZOCHI, Rakoczy Molino Mazzochi 

Siwik LLP, Chicago, IL, for defendants-appellees Apotex, 

Inc., Apotex Corp. Also represented by JOSEPH T. JAROS,

WILLIAM A. RAKOCZY, LUKE TIMOTHY SHANNON. 

______________________ 

Before REYNA, WALLACH, and CHEN, Circuit Judges.

WALLACH, Circuit Judge. 

Appellant Allergan, Inc. (“Allergan”) appeals the final 

decision of the U.S. District Court for the Middle District 

of North Carolina (“District Court”) dismissing its patent 

infringement case against Sandoz, Inc. et al. (“Sandoz”) 

with prejudice based on collateral estoppel and declaring 

several claims of Allergan’s patent invalid as obvious. We 

affirm-in-part and reverse-in-part. 

BACKGROUND

This case comes to our court with a lengthy procedural history involving both parties and six related patents: 

U.S. Patent Nos. 7,388,029 (“the ’029 patent”), 7,351,404 

(“the ’404 patent”), 8,263,054 (“the ’054 patent”), 

8,038,988 (“the ’988 patent”), 8,101,161 (“the ’161 paCase: 16-1085 Document: 92-2 Page: 2 Filed: 03/17/2017
ALLERGAN, INC. v. SANDOZ, INC. 3

tent”), and 8,926,953 (“the ’953 patent”).1 All of the 

patents generally recite a topical solution to treat hair 

loss or reduction with the compound bimatoprost, a 

molecular substance that can affect cell growth and 

functionality. See ’029 patent, Abstract; ’404 patent, 

Abstract; ’054 patent, Abstract; ’988 patent, Abstract; ’161 

patent, Abstract; ’953 patent, Abstract. Allergan sued 

Sandoz for infringement of, inter alia, the ’029 patent and 

the ’404 patent, and Sandoz countersued, arguing that the 

patents were invalid for various reasons. See Allergan, 

Inc. v. Apotex, Inc. (Allergan I), Nos. 1:10-cv-681, 1:11-cv298, 1:11-cv-650, 2013 WL 286251, at *1 (M.D.N.C. Jan. 

24, 2013); J.A. 2988, 3998 (complaints against Apotex and 

Sandoz). The District Court found in favor of Allergan. 

Allergan I, 2013 WL 286251, at *13. Sandoz appealed, 

and we reversed the District Court’s invalidity findings 

based on obviousness for the ’404 and ’029 patents and 

vacated the District Court’s injunction. See Allergan, Inc. 

v. Apotex, Inc. (Allergan II), 754 F.3d 952, 970 & n.13

(Fed. Cir. 2014). 

While Allergan I was pending, Allergan filed a second 

suit alleging that Sandoz infringed the ’054 patent, the 

’988 patent, and the ’161 patent. See J.A. 223, 236. The 

case was stayed pending the appeal and resolution of 

 

1 The ’029, ’054, ’988, ’161, and ’953 patents are 

continuations of the ’404 patent. A continuation patent 

application is “an application filed subsequently to another application, while the prior application is pending, 

disclosing all or a substantial part of the subject matter of 

the prior application and containing claims to subjectmatter common to both applications, both applications 

being filed by the same inventor or his legal representative.” U.S. Water Servs., Inc. v. Novozymes A/S, 843 F.3d 

1345, 1348 n.1 (Fed. Cir. 2016) (internal quotation marks 

and citation omitted). 

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4 ALLERGAN, INC. v. SANDOZ, INC. 

Allergan I. J.A. 3919−20. Following Allergan II, Apotex, 

Inc. (“Apotex”), the primary named defendant in the 

second suit, filed a motion for judgment on the pleadings

pursuant to Federal Rule of Civil Procedure 12(c), which 

the District Court granted. Allergan, Inc. v. Apotex, Inc. 

(Allergan III), Nos. 1:12-cv-247, 1:13-cv-16 (M.D.N.C. Jan. 

14, 2015) (J.A. 2984−86). Allergan then moved to voluntarily dismiss its claims against the other defendants

pursuant to Federal Rule of Civil Procedure 41(a)(2), 

which the District Court granted. J.A. 2987. 

During the pendency of the two suits, Allergan’s application for the ’953 patent was pending before an examiner at the U.S. Patent and Trademark Office (“USPTO”). 

While the application for the ’953 patent was pending and 

after the ’404 patent had been invalidated as obvious by 

this court in Allergan II, Allergan submitted ex parte 

declarations to the Examiner related to two prior art 

references used to invalidate the ’404 patent. J.A. 

1965−66; see J.A. 1967–76 (ex parte declarations). The 

testimony was intended to show that one of the inventors 

of both the ’404 patent and the then-pending application 

for the ’953 patent, Dr. Amanda VanDenburgh, was an 

author of the prior art references, such that the references 

were no longer prior art under 35 U.S.C. § 102(a) (2012).2 

 

2 Section 102(a) states, in relevant part: “A person 

shall be entitled to a patent unless―the claimed invention 

was patented, described in a printed publication, or in 

public use, on sale, or otherwise available to the public 

before the effective filing date of the claimed invention.” 

35 U.S.C. § 102(a)(1). This has been interpreted by our 

predecessor court to mean that “one’s own work is not 

prior art under § 102(a) even though it has been disclosed 

to the public in a manner or form which otherwise would 

fall under § 102(a).” In re Katz, 687 F.2d 450, 454 (CCPA 

1982). Congress amended § 102(a) when it passed the 

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ALLERGAN, INC. v. SANDOZ, INC. 5

J.A. 1965−76. The USPTO issued the ’953 patent and 

Allergan filed two complaints asserting claims 1–26 of the

’953 patent against Sandoz. J.A. 363−80 (First Amended 

Complaint against Apotex), 1500−52 (First Amended 

Complaint against remaining defendants).3 These complaints form the basis for this appeal. However, Allergan 

was given leave to file second amended complaints, which 

reduced the disputed claims to claims 8, 23, and 26 of the 

’953 patent (“the Asserted Claims”). See J.A. 944−56

(Second Amended Complaint against Apotex), 1875−98 

(Second Amended Complaint against remaining defendants).

Sandoz filed a motion to dismiss the subject suit pursuant to Federal Rule of Civil Procedure 12(b)(6) for 

failure to state a claim upon which relief could be granted 

based on collateral estoppel, J.A. 957–62, 1918–21, which 

the District Court granted, Allergan, Inc. v. Sandoz, Inc.

(Allergan IV), Nos. 1:14-cv-1028, 1:14-cv-1034 (M.D.N.C. 

Aug. 31, 2015) (J.A. 1–13). The District Court stated that 

“[t]he ’953 patent at issue in this case 

claims . . . substantially the same subject matter as[] 

invalid ’404 patent claim 14 and the relevant claims of the 

 

Leahy-Smith America Invents Act (“AIA”). Pub. L. No. 

112-29, § 3(b)(1), 125 Stat. 284, 285 (2011). Because the 

application that led to the ’953 patent contained claims 

having an effective filing date on or after March 16, 2013 

(the effective date of the statutory changes enacted in 

2011), the AIA’s § 102(a) would apply to a substantive 

review of the ’953 patent. See id. § 3(n)(1), 125 Stat. at 

293. This court has not determined whether the Katz

standard applies to reviews of prior art under the AIA’s 

§ 102, nor does either party ask us to do so here. See 

generally Appellant’s Br.; Appellee’s Br. 3 The original complaints did not assert the ’953 patent. See J.A. 300−62, 3650−732.

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6 ALLERGAN, INC. v. SANDOZ, INC. 

’054, ’161, and ’988 patents.” J.A. 5. The District Court 

did not consider the ex parte testimony that Allergan 

submitted to the Examiner during the ’953 patent prosecution. See J.A. 1−13. The District Court entered judgment for Sandoz, holding that “[t]he ’953 patent is hereby 

declared and adjudged invalid as obvious . . . .” J.A. 9.4 

Allergan appealed. We have jurisdiction pursuant to 

28 U.S.C. § 1295(a)(1) (2012). 

DISCUSSION

I. Choice of Law and Standard of Review 

Because the criteria of collateral estoppel are not 

unique to patent issues, “[w]e apply the law of the regional circuit to the general procedural question of whether 

issue preclusion applies,” here, the Fourth Circuit. 

Soverain Software LLC v. Victoria’s Secret Direct Brand 

Mgmt., LLC, 778 F.3d 1311, 1314 (Fed. Cir. 2015) (citation omitted). The Fourth Circuit reviews de novo the 

application of collateral estoppel. See Tuttle v. Arlington 

Cty. Sch. Bd., 195 F.3d 698, 703 (4th Cir. 1999). “However, for any aspects that may have special or unique application to patent cases, Federal Circuit precedent is 

applicable.” Aspex Eyewear, Inc. v. Zenni Optical Inc., 713 

F.3d 1377, 1380 (Fed. Cir. 2013). For example, “the 

question whether a particular claim in a patent case is 

the same as or separate from another claim has special 

application to patent cases, and we therefore apply our 

own law to that issue.” Id. (internal quotation marks and 

citation omitted).

 

4 Separate amended final judgments were issued 

for all appellees except Sandoz, Inc. declaring that only 

the Asserted Claims of the ’953 patent were invalid as 

obvious. J.A. 7, 12−13 (Final Judgments); see J.A. 195 

(describing the initial judgment), 204−05 (describing 

amended judgments). 

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ALLERGAN, INC. v. SANDOZ, INC. 7

II. The District Court Properly Dismissed the Case Based 

on Collateral Estoppel

A. Legal Standards 

The doctrine of “[c]ollateral estoppel forecloses the relitigation of issues of fact or law that are identical to 

issues which have been actually determined and necessarily decided in prior litigation in which the party 

against whom issue preclusion is asserted had a full and 

fair opportunity to litigate.” Sedlack v. Braswell Servs. 

Grp., Inc., 134 F.3d 219, 224 (4th Cir. 1998) (internal 

quotations marks, brackets, and citation omitted). In the 

Fourth Circuit, collateral estoppel bars subsequent litigation of an issue of law or fact when: (1) “the issue sought 

to be precluded is identical to one previously litigated”; 

(2) “the issue was actually determined in the prior proceeding”; (3) “the issue’s determination was a critical and 

necessary part of the decision in the prior proceeding”; 

(4) “the prior judgment is final and valid”; and (5) “the 

party against whom collateral estoppel is asserted had a 

full and fair opportunity to litigate the issue in the previous forum.” Collins v. Pond Creek Mining Co., 468 F.3d 

213, 217−18 (4th Cir. 2006) (internal quotation marks and 

citation omitted). 

Allergan alleges that collateral estoppel should not 

apply in this case because elements (1), (2), and (5) are 

not met. Appellant’s Br. 14. We review these elements in 

turn.

1. Identity of the Issues

“Complete identity of claims is not required to satisfy 

the identity-of-issues requirement for claim preclusion.” 

Soverain Software, 778 F.3d at 1319 (citations omitted). 

“If the differences between the unadjudicated patent 

claims and adjudicated patent claims do not materially 

alter the question of invalidity, collateral estoppel applies.” Ohio Willow Wood Co. v. Alps S., LLC, 735 F.3d 

Case: 16-1085 Document: 92-2 Page: 7 Filed: 03/17/2017
8 ALLERGAN, INC. v. SANDOZ, INC. 

1333, 1342 (Fed. Cir. 2013) (citation omitted). For example, in Ohio Willow Wood, this court found that issue 

preclusion applied where a different claim in another 

patent had previously been invalidated because “the[] 

patents use[d] slightly different language to describe 

substantially the same invention.” Id. 

Allergan argues that the Asserted Claims of the ’953 

patent present new issues that were not decided in Allergan I, Allergan II, or Allergan III because “prior cases 

addressed whether it would have been obvious to use 

bimatoprost to increase eyelash growth, not eyelash 

darkness” as recited in the Asserted Claims. Appellant’s 

Br. 15, see id. at 15−22. In addition, Allergan argues that 

the prior art references do not teach increasing eyelash 

darkness, id. at 17−19, and that the District Court in 

Allergan IV improperly looked to the specification of the 

’953 patent, rather than only the Asserted Claims, in 

reaching its conclusion that collateral estoppel applied, id.

at 19−20. 

The District Court held that the issues related to the 

Asserted Claims were identical to those addressed in all 

prior litigations against invalidated claims of the ’404, 

’054, ’161, and ’988 patents because “[t]he ’953 patent is 

not limited to darkness,” citing its “repeated[] references 

[to] ‘enhancing the growth’ of eyelashes by increasing 

length, thickness[,] and darkness.” J.A. 4. These enhancements, it found, were also at issue in Allergan I, 

Allergan II, and Allergan III. J.A. 4−5. It also found that 

the ’404 patent trial determined issues of eyelash darkness, as found in the District Court’s claim construction of 

the term “a method for stimulating hair growth” to mean 

“a method of converting vellus intermediate hair to 

growth as terminal hair,” where the patent defined vellus 

hairs as “fine” and “thin” and defined terminal hairs as 

“coarse” and “pigmented.” J.A. 4−5 (internal quotation 

marks omitted). 

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ALLERGAN, INC. v. SANDOZ, INC. 9

We agree with the District Court that the Asserted 

Claims are substantially similar to the invalidated claims 

of the ’404, ’054, ’161, and ’988 patents, and that any 

differences between the claims do not materially alter the 

question of invalidity. With respect to the darkness 

limitation claimed in the Asserted Claims of the ’953 

patent, that limitation was also disputed in all three prior 

litigations as one of many attributes flowing from the use 

of the claimed bimatoprost solution. During the ’404 

patent’s claim construction, Allergan offered, and the 

District Court accepted, J.A. 3073, a construction for “a 

method for stimulating hair growth” to include “a method 

of converting vellus or intermediate hair to growth as 

terminal hair,” which would “increas[e] the . . . thickness 

of hair,” J.A. 3072. The ’404 patent’s specification defined 

vellus hairs as “fine” and “thin” and terminal hairs as 

“coarse” and “pigmented.” J.A. 4−5. The ’404 patent’s

specification recites the change from “coarse, pigmented, 

long hairs” to “fine, thin, non-pigmented short hairs,” the 

type of hair loss that the patented invention seeks to 

remedy. ’404 patent col. 1 ll. 36−39. Thus, the parties’ 

original claim construction dispute included darkness. 

The previously litigated patents include several additional statements that demonstrate that increasing 

eyelash darkness was one attribute of their inventions. 

For example, the ’404 patent’s specification describes 

“increased pigmentation of the lashes” as an example of 

more robust hair growth, id. col. 7 l. 51, and describes 

lashes treated with the solution as “longer, thicker[,] and 

fuller,” id. col. 7 ll. 1−6. Indeed, the ’404 patent claims a 

method that enhances hair growth and increases “one or 

more” of the following traits: “luster, sheen, brilliance, 

gloss, glow, shine or patina.” Id. col. 16 ll. 13−15 (claim 

9). The ’054 patent, estopped in Allergan III, goes even 

further, making increased eyelash darkness a requirement of claim 1. See ’054 patent col. 14 ll. 3−6 (“A method 

of increasing eyelash growth in a human including length, 

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10 ALLERGAN, INC. v. SANDOZ, INC. 

thickness and darkness of the eyelashes, the method 

comprising administering bimatoprost to an eyelid margin of the human.” (emphasis added)). 

Both the current litigation and prior litigation concern

eyelash darkness as well as broader qualities associated 

with hair growth. The patent claims “use slightly different language to describe substantially the same invention” and, thus, satisfy the identity of issues requirement 

for finding collateral estoppel. Ohio Willow Wood, 735 

F.3d at 1342.5 

2. The Issue Was Actually Determined in 

the Prior Litigation

The requirement that an issue have been actually decided is generally satisfied if the issue “was actually 

litigated and decided in an earlier proceeding.” Combs v. 

Richardson, 838 F.2d 112, 114 (4th Cir. 1988); Restatement (Second) of Judgments § 27(d) (1982) (an issue is 

actually litigated if it “is properly raised, by the pleadings 

 

5 Allergan argues in the alternative that the identity−of−issues requirement is not met because “[n]either 

[prior art] references . . . disclose a method of using a 

bimatoprost composition to increase eyelash darkness, as 

required by the [A]sserted [C]laims of the ’953 patent.” 

Appellant’s Br. 17. But “any need or problem known in 

the field . . . and addressed by the patent can provide a 

reason for combining the elements in the manner 

claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418, 

420 (2007). We previously found in Allergan II that it 

would have been obvious to use a topical application of a 

bimatoprost composition to grow eyelashes. Solving the 

problem of growing eyelashes would have provided a 

motivation to combine the same prior art in the same 

manner that is claimed by the ’953 patent to achieve 

increased eyelash darkness.

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ALLERGAN, INC. v. SANDOZ, INC. 11

or otherwise, and is submitted for determination, and is 

determined”). Allergan contends that “the parties never 

briefed ‘darkness,’” and “the [D]istrict [C]ourt’s opinion 

never discussed it,” such that the issue was never actually 

determined. Appellant’s Br. 22; see id. at 19−22. 

However, we find evidence in the record sufficient to 

hold that the issue was actually determined in Allergan I 

and Allergan II. Unlike cases where we have found this 

element was not met because “[n]either party requested 

that any terms of the . . . method claims . . . be construed” 

or “move[d] for a determination of summary judgment,” 

Brain Life, LLC v. Elekta, Inc., 746 F.3d 1045, 1055 (Fed. 

Cir. 2014), the issue of darkness was discussed in the 

claim construction proceedings for the ’404 patent, see 

J.A. 3069, 3071−73. Moreover, the claims of the ’404 

patent, as construed to include the language covering 

increased pigmentation, were litigated by the parties at a 

bench trial. See Allergan I, 2013 WL 286251, at *1, *7–8. 

The trial record further demonstrates that the parties 

debated the language “converting vellus or intermediate 

hair to growth as terminal hair” which, as discussed 

above, describes a process of increasing eyelash darkness. 

Id. at *13 (internal quotation marks and brackets omitted) (reviewing Sandoz’s arguments with respect to the 

phrase); see J.A. 3247–48 (Allergan’s proposed findings of 

fact in the ’404 patent litigation stating that “Latisse®,” a 

“commercial embodiment of claim 14 of the ’404 patent,” 

“increas[es] . . . eyelash darkness”), 3248 (Allergan stating 

that the use of Latisse® results in “darker eyelash hair”), 

3253−54 (Allergan alleging infringement of its ’404 patent

for reasons marked as confidential). We find this sufficient to meet the “actually litigated” prong of the collateral estoppel test. 

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12 ALLERGAN, INC. v. SANDOZ, INC. 

3. Allergan Had a Full and Fair Opportunity to Litigate 

the Issues in the Prior Litigation

A judgment will not have a preclusive effect if a patentee can demonstrate that it did not have a full and fair 

opportunity to litigate the issue. Va. Hosp. Ass’n v. 

Baliles, 830 F.2d 1308, 1311 (4th Cir. 1987). “Determining whether a patentee has had a full and fair chance to 

litigate the validity of [the] patent . . . is . . . not a simple 

matter.” Blonder-Tongue Labs., Inc. v. Univ. of Ill. 

Found., 402 U.S. 313, 333 (1971). However, most of the 

grounds relevant to this test—e.g., incentive to litigate, 

choice of forum, or comprehension of the technical subject 

matter—are inapplicable here. See id. at 332−34. Allergan’s full and fair opportunity argument hinges on the ex 

parte testimony submitted to the Examiner during the

prosecution of the application leading to the ’953 patent. 

Allergan alleges that it did not have the opportunity 

to present certain ex parte evidence in Allergan I or 

Allergan II because this court changed the legal standard 

to prove that one’s own work is not prior art under 

§ 102(a) by adding a requirement that the inventor be 

“responsible for directing the production of the publication’s content.” Appellant’s Br. 23 (internal quotation 

marks omitted). In support of the purported change in 

law, Allergan cites our statement in Allergan II that 

“Appellees have not produced evidence that shows [Dr. 

VanDenburgh] was responsible for directing the production of either article’s content.” Id. at 24 (quoting Allergan II, 754 F.3d at 969) (emphasis added); see id. at 

22−26. 

Allergan’s arguments are not persuasive. First, Allergan offers no explanation for why such additional 

evidence could not have been submitted to the District 

Court in Allergan III. See generally id. Second, Allergan 

II did not change the applicable legal standard for showing an inventor’s work on a publication removes the 

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ALLERGAN, INC. v. SANDOZ, INC. 13

material from § 102(a) prior art. Instead, we repeated the 

applicable standard articulated in Katz and analyzed the 

evidence against that standard. See Allergan II, 754 F.3d 

at 969 (stating the relevant inquiry was whether the 

references “were solely Dr. VanDenburgh’s work and hers 

alone” (citation omitted)). In reaching our conclusion, we 

looked to authorship of the reference in question and of 

internal pre-publication reports, supervision of clinical 

trials, and involvement in the trials and resultsassessment. Id. The language Allergan cites is a descriptive part of the comprehensive, fact-based evidentiary test 

in Katz. We quoted Katz in our conclusion, holding that 

there was no evidence that Allergan’s explanation of the 

prior art references were “in any way consistent with the 

content of the articles and the nature of the publications.” 

Id. (citation omitted); see Katz, 687 F.2d at 455 (stating 

that, in addition to authorship, “[t]he content and nature 

of the printed publication” must be considered). Allergan 

had a full and fair opportunity to litigate its position, and 

all elements of the test for collateral estoppel have been 

met.

III. The District Court Erred in Invalidating the Entire 

’953 Patent 

Finally, notwithstanding collateral estoppel, Allergan 

alleges that the District Court “erroneously invalidated 

unasserted claims of the ’953 patent” in its final judgment 

with respect to Sandoz, Inc. Appellant’s Br. 26 (capitalization omitted). Because Allergan narrowed its assertion 

of infringement in its Second Amended Complaint to the 

three Asserted Claims, it contends that “[t]he [D]istrict 

[C]ourt . . . had no subject matter jurisdiction over any of 

the other claims of the ’953 patent and [had] no power to 

invalidate them.” Id. We agree.

We may consider the scope of the judgment where it 

relates to a question of subject matter jurisdiction, an 

issue we review de novo. See Metabolite Labs., Inc. v. 

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14 ALLERGAN, INC. v. SANDOZ, INC. 

Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1369 (Fed. 

Cir. 2004); Textile Prods., Inc. v. Mead Corp., 134 F.3d 

1481, 1485–86 (Fed. Cir. 1998). Article III courts have 

subject matter jurisdiction in a suit where there is an 

actual case or controversy. See MedImmune, Inc. v. 

Genentech, Inc., 549 U.S. 118, 128–29 (2007). For declaratory actions in patent infringement suits, we have clarified that where only certain claims of a patent are raised 

in a complaint and additional claims are not asserted or 

litigated, additional claims can be included in a final 

judgment only where there is a case or controversy for the 

court to adjudicate. See Carroll Touch, Inc. v. Electro 

Mech. Sys., Inc., 15 F.3d 1573, 1581 n.8 (Fed. Cir. 1993); 

see also MedImmune, 549 U.S. at 127 (stating that there 

is no bright line rule for determining whether the case or 

controversy requirement is satisfied and asking courts to 

look at whether the dispute is “definite and concrete, 

touching the legal relations of parties having adverse 

legal interests,” and is “real and substantial” (internal 

quotation marks omitted)). “[C]ourts must look at all the 

circumstances to determine whether a declaratory judgment plaintiff has shown a case or controversy between 

the parties.” Streck, Inc. v. Research & Diagnostic Sys., 

Inc., 665 F.3d 1269, 1282 (Fed. Cir. 2012) (internal quotation marks omitted). 

Allergan’s Second Amended Complaint only asserted 

three claims of the ’953 patent.6 Sandoz, Inc. has not 

 

6 Allergan’s Second Amended Complaint is the operative pleading document here. The Magistrate Judge 

entered an order granting leave to file an amended complaint, which was allowed as a matter of course for nondispositive motions and was not contested or appealed by 

Sandoz. J.A. 1870–74; see Aluminum Co. of Am. v. EPA, 

663 F.2d 499, 501 (4th Cir. 1981) (“[E]xceptions [in 28 

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ALLERGAN, INC. v. SANDOZ, INC. 15

shown a continuing case or controversy with respect to 

the withdrawn claims. As in prior cases in which we have 

found unasserted claims not invalidated, here, “the patentee narrowed the scope of its claims . . . before any 

dispositive rulings by the court,” and Sandoz, Inc.’s response “was limited to the ‘asserted claims.’” Id. at 1283, 

1284; see J.A. 1918, 1919 (Sandoz, Inc.’s Rule 12(b)(6) 

motion requesting the court dismiss “Allergan’s claims in 

its Second Amended Complaint” and “declare that the 

claims” are invalid). Moreover, Sandoz, Inc. “did not 

present evidence or argument of how the prior [patents] 

suggested the additional limitations present in” the 

unasserted claims. Sandt Tech., Ltd. v. Resco Metal & 

Plastics Corp., 264 F.3d 1344, 1356 (Fed. Cir. 2001); see 

J.A. 1978−93 (Sandoz, Inc.’s expert declaration filed with 

its motion to dismiss reviewing only the Asserted Claims 

and claims referenced therein). 

All claims are “presumed valid independently of the 

validity of the other claims.” 35 U.S.C. § 282. Considering all of the circumstances before the District Court, we 

find that “[t]here was no case or controversy with respect 

to the unasserted claims at the time of the [Rule 12(b)(6)] 

motions; therefore the [D]istrict [C]ourt did not have 

jurisdiction over the unasserted claims.” Fox Grp., Inc. v. 

Cree, Inc., 700 F.3d 1300, 1308 (Fed. Cir. 2012) (citation 

omitted). Because we find that the District Court erred in 

 

ered to be ‘dispositive.’”); 28 U.S.C. § 636(b)(1)(a)−(c) 

(omitting motion to amend complaint from list of actions 

on which a magistrate judge can only issue a recommendation or cannot otherwise rule); Fed. R. Civ. Proc. 72(a) 

(instructing magistrate judges to “issue a written order 

stating the decision” when appropriate for non-dispositive 

matters); J.A. 1918 (Sandoz, Inc.’s Rule 12(b)(6) motion to 

dismiss “Allergan’s claims in its Second Amended Complaint”).

Case: 16-1085 Document: 92-2 Page: 15 Filed: 03/17/2017
16 ALLERGAN, INC. v. SANDOZ, INC. 

invalidating the unasserted claims in the ’953 patent, we 

reverse the District Court’s order granting collateral 

estoppel and finding invalidity of Allergan’s ’953 patent 

with respect to Sandoz, Inc. for claims 1−7, 9−22, and 

24−25 of the ’953 patent. 

CONCLUSION

We have considered the parties’ remaining arguments 

and find them unpersuasive. We affirm the District 

Court’s judgments with respect to Akorn, Inc., Hi-Tech 

Pharmacal Co., Inc., Apotex Inc., Apotex Corp., and 

claims 8, 23, and 26 of the ’953 patent as applied to 

Sandoz, Inc. We reverse the District Court’s judgment for 

Sandoz, Inc. with respect to claims 1−7, 9−22, and 24−25 

of the ’953 patent. For these reasons, the final decision of 

the U.S. District Court for the Middle District of North 

Carolina is 

AFFIRMED-IN-PART, REVERSED-IN-PART

COSTS

Each party shall bear its own costs.

Case: 16-1085 Document: 92-2 Page: 16 Filed: 03/17/2017