Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-24-02212/USCOURTS-ca13-24-02212-0/pdf.json

Nature of Suit Code: 835
Nature of Suit: other
Cause of Action: 

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NOTE: This disposition is nonprecedential.

United States Court of Appeals 

for the Federal Circuit ______________________ 

NOVARTIS PHARMACEUTICALS CORPORATION,

Plaintiff-Appellant

v.

MSN PHARMACEUTICALS, INC., MSN 

LABORATORIES PRIVATE LTD., MSN LIFE 

SCIENCES PRIVATE LTD.,

Defendants-Appellees

GERBERA THERAPEUTICS INC., NANJING 

NORATECH PHARMACEUTICAL CO., LIMITED,

Defendants

______________________ 

2024-2211, 2024-2212

______________________ 

Appeals from the United States District Court for the 

District of Delaware in Nos. 1:20-md-02930-RGA, 1:22-cv01395-RGA, Judge Richard G. Andrews.

______________________ 

Decided: December 4, 2024

______________________ 

DEANNE MAYNARD, Morrison & Foerster LLP, Washington, DC, argued for plaintiff-appellant. Also represented by SETH W. LLOYD; JOEL F. WACKS, San Francisco, 

CA; REBECCA EMILY WEIRES, Los Angeles, CA; 

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2

CHRISTOPHER EARL LOH, JARED LEVI STRINGHAM, Venable 

LLP, New York, NY. 

 WILLIAM A. RAKOCZY, Rakoczy Molino Mazzochi Siwik 

LLP, Chicago, IL, argued for defendants-appellees. Also 

represented by KEVIN E. WARNER; RONALD M. DAIGNAULT,

RICHARD JUANG, Daignault Iyer LLP, Vienna, VA; RICHARD 

CHARLES WEINBLATT, Stamoulis & Weinblatt LLC, Wilmington, DE. 

 ______________________ 

Before LOURIE, PROST, and REYNA, Circuit Judges. 

LOURIE, Circuit Judge. 

Novartis Pharmaceuticals Corporation (“Novartis”) appeals from the district court’s denial of its motion for a preliminary injunction. Novartis seeks to enjoin MSN

Pharmaceuticals, Inc., MSN Laboratories Private Ltd., and 

MSN Life Sciences Private Ltd. (collectively, “MSN”) from 

launching its generic version of Entresto®, which Novartis 

alleges would infringe U.S. Patent 11,096,918 (“the ’918 patent”). In re Entresto (Sacubitril/Valsartan) Pat. Litig., 

No. 20-md-2930, 2024 WL 3756787 (D. Del. Aug. 12, 2024)

(“Preliminary Injunction Order”). For the following reasons, we affirm. 

BACKGROUND

I 

In 2015, the U.S. Food and Drug Administration 

(“FDA”) approved Novartis’s New Drug Application 

(“NDA”) for Entresto, a combination therapy of valsartan 

and sacubitril. Entresto is indicated “to reduce the risk of 

cardiovascular death and hospitalization for heart failure 

in adult patients with chronic heart failure, and for the 

treatment of symptomatic heart failure with systemic left 

ventricular systolic dysfunction in pediatric patients aged 

one year and older.” Id. at *1 (quoting J.A. 51 ¶ 113). In 

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2023 alone, sales of Entresto in the United States totaled 

more than $3 billion.

The ’918 patent, which is owned by Novartis and expires on November 8, 2026, is directed to an amorphous 

solid form of trisodium valsartan sacubitril, or “TVS.” The 

patent contains two claims, which recite: 

1. An amorphous solid form of a compound comprising anionic [valsartan], anionic [sacubitril], and sodium cations in a 1:1:3 molar ratio.

2. A pharmaceutical composition comprising the 

amorphous solid form according to claim 1 and at 

least one pharmaceutically acceptable excipient.

’918 patent, col. 32 ll. 42–49.

Important here, the ’918 patent is not listed in the Orange Book for Entresto. Indeed, Novartis concedes that the 

’918 patent does not claim the drug product present in Entresto. See Oral Arg. at 2:48–52, available at https://oral

arguments.cafc.uscourts.gov/default.aspx?fl=24-2211_111

32024.mp3 (“[W]e have not listed [the ’918 patent] in the 

Orange Book; we don’t claim that we practice this patent.”). 

Because the ’918 patent is not Orange Book-listed, the filing of Novartis’s complaint did not trigger a statutory stay 

barring the FDA from approving any Abbreviated New 

Drug Applications (“ANDAs”) filed by drugmakers seeking 

to manufacture and sell generic versions of Entresto. 

II

In 2019, MSN, among others, submitted its ANDA for

Entresto. Novartis responded, in part, by filing a complaint under 35 U.S.C. § 271(e)(2), alleging that each manufacturer’s generic product would infringe the ’918 patent

because it contains amorphous TVS. J.A. 22–65. The case 

proceeded to discovery. 

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A. Claim Construction

At claim construction, the parties disputed the meaning of only a single claim term: “an amorphous solid form 

of a compound.” In re Entresto (Sacubitril/Valsartan) Pat. 

Litig., No. 20-md-2930, 2024 WL 2804788, at *2 (D. Del. 

May 31, 2024) (“Claim Construction Order”). Novartis argued that the term did not require any construction, while 

MSN argued that the term means “a substantially pure 

amorphous solid form of a compound.” Id. That is, the parties disputed the amount of amorphous TVS in the compound relative to the amount of any other non-amorphous 

TVS component (e.g., crystalline TVS) required by the 

claim. Id.; see also id. at *2 n.6.

The court determined that Novartis’s position, that any

presence of amorphous TVS in a solid form would fall

within the scope of the claims, “conflict[ed] with the prosecution history,” which established that amorphous and 

crystalline TVS exhibit different properties and are readily 

distinguishable. Id. at *3. In the court’s view, a compound 

that contained only a small amount of amorphous TVS

would not “embody” the “certain distinctive properties” of 

amorphous TVS, but instead those “properties associated 

with a crystalline solid.” See id. at *4. It therefore concluded that “amorphous TVS” is mutually exclusive from 

“crystalline TVS.” Id. at *3.

But the court likewise took issue with MSN’s position 

that the claimed amorphous compound must be “substantially pure.” MSN had relied on language in the specification that the solid form of TVS “can be in the crystalline, 

partially crystalline, [or] amorphous . . . form,” see ’918 patent, col. 17 ll. 43–45, to argue that, just as amorphous TVS 

is mutually exclusive of crystalline TVS, it must be mutually exclusive of “partially crystalline” TVS, which the parties agreed “is a mixture of crystalline and amorphous 

forms.” Claim Construction Order, at *3. The court disagreed with MSN’s construction, noting that there was no 

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intrinsic evidence that suggested each category to be mutually exclusive. Id. The court also cited the parties’ 

agreed understanding of “partially crystalline,” which suggested “potential overlap along the spectrum of amorphous, 

partially crystalline, and crystalline forms.” Id.

Although the court rejected MSN’s proposal, it agreed 

that “construction of the disputed term must distinguish 

between the amorphous and crystalline forms.” Id. It 

therefore construed “an amorphous solid form of a compound” to mean:

a solid form of a compound in which the amorphous 

form of the compound predominates. An amorphous solid form is mutually exclusive from a crystalline solid form, but not necessarily mutually 

exclusive from a partially crystalline form.

Id. at *2 (emphasis added). In doing so, the court “concede[d] the difficulty of pinpointing an appropriate limitation when the intrinsic record provides virtually no useful 

guidance.” Id. at *4; see id. (rejecting MSN’s “substantially 

pure” construction because “[a] determination that a construction of the terms should include line-drawing . . . is an 

insufficient reason to adopt a specific demarcation that is 

unsupported by the intrinsic record”). But given the court’s 

understanding that the claimed amorphous TVS must be 

distinct from and exhibit different properties from crystalline TVS, it determined that “it follows that an amorphous 

solid form of a compound must be predominantly amorphous.” Id.

B. Preliminary Injunction

On July 24, 2024, the FDA granted final approval of

MSN’s ANDA, clearing the way for an at-risk launch of 

MSN’s valsartan-sacubitril product, which MSN claims includes crystalline TVS, or “Form-S.” Preliminary Injunction Order, at *1–2. Novartis responded by moving the 

district court to preliminarily enjoin MSN from launching 

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its product “for the short time needed to [reach] final judgment” in this litigation. Novartis Br. 1; see also

J.A. 2467–91.1

In its motion, Novartis argued that it was likely to succeed in establishing that MSN’s generic product contains 

the claimed amorphous TVS, and therefore infringes claim 

1 of the ’918 patent. See Preliminary Injunction Order, at 

*2. Novartis argued that testing by its expert, Dr. Matzger, 

showed that, contrary to MSN’s characterization of its 

product as crystalline TVS, the product is actually a physical mixture of crystalline valsartan and crystalline sacubitril, with regions of amorphous TVS formed during the 

manufacturing process. Id. That is, in Novartis’s view, 

Form-S is not crystalline TVS at all, but merely a physical 

mixture of separate crystalline components. Novartis argued that Dr. Matzger found that the Raman spectra for 

various regions of MSN’s final product matched the reference spectra for each of crystalline valsartan, crystalline 

sacubitril, and amorphous TVS. Id.; see also Novartis’s Br. 

16–17. Accordingly, in Novartis’s view, “the amorphous 

TVS compound [in MSN’s product] therefore necessarily 

predominates over the (non-existent) crystalline TVS compound,” and thus infringes. Preliminary Injunction Order, 

at *2; see also J.A. 2476.

MSN countered that Novartis is not likely to succeed in 

establishing that MSN’s product contains any amorphous 

TVS. Preliminary Injunction Order, at *2. It first challenged Novartis’s expert testing on the basis that Dr. 

Matzger “made no attempt to distinguish the amorphous 

material he supposedly found [in MSN’s product] from 

Form-S,” i.e., crystalline TVS. J.A. 6374. Had that comparison been made, MSN argued, it would have been “clear 

that the peaks [Dr.] Matzger found [for the allegedly 

1 This case is currently scheduled to go to trial on 

December 9, 2024.

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amorphous TVS in MSN’s product] align closely with the 

Form-S reference.” J.A. 6376. MSN also argued that Novartis could not establish that Form-S is a physical mixture 

of separate crystalline components, as opposed to crystalline TVS. In support, MSN pointed to the testing data it 

had submitted to the FDA with its ANDA, which it argued 

demonstrates that Form-S is a crystalline compound. Preliminary Injunction Order, at *3; see J.A. 6379–81.

Considering the evidence and testimony of both parties, the district court concluded that Novartis had not met 

its burden of showing that it is likely to succeed in proving 

that MSN’s ANDA product contains amorphous TVS. Preliminary Injunction Order, at *2. It noted that, even if Novartis was correct that Form-S is a physical mixture of 

crystalline valsartan and crystalline sacubitril, it had not 

adequately established that the amorphous regions of 

MSN’s product identified by Dr. Matzger are actually 

amorphous TVS. Id. It further found that, with respect to 

whether Form-S is crystalline TVS or a physical mixture of 

crystalline valsartan and crystalline sacubitril, that “[i]n 

the face of supporting test data and what appear to be valid 

criticisms of said test data from both sides, I am unable to 

find that the record favors finding Form-S to be one of a 

physical mixture or a crystalline complex.” Id. at *3. Because Novartis bore the burden of proof on that issue, the 

court determined that it had not established that Form-S 

is a physical mixture and not crystalline TVS. 

The district court also concluded that Novartis had 

failed to establish that it would suffer irreparable harm absent an injunction. Id. at *3–4. It was unmoved by Novartis’s arguments that its damages could not be remedied 

through monetary damages, and it found it inappropriate 

to attribute any loss in Entresto’s market momentum to 

MSN when that loss would be the result of actions taken 

not only by MSN, but also by other generic drugmakers

launching a competing product. Id. at *3. 

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Though its findings on likelihood of success and irreparable harm alone called for the denial of Novartis’s request for injunctive relief, the court nevertheless addressed 

the balance of equities and public interest in the preliminary injunction inquiry and found that neither favored enjoining MSN’s launch. Id. at *4. It therefore denied 

Novartis’s motion for a preliminary injunction.

Novartis timely appealed. We have jurisdiction under 

28 U.S.C. § 1292(c)(1). 

DISCUSSION

“A preliminary injunction is an extraordinary remedy 

never awarded as of right.” Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 24 (2008). To establish a right to a 

preliminary injunction, a party “must make a clear showing that ‘[it] is likely to succeed on the merits, that [it] is 

likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in [its] favor, 

and that an injunction is in the public interest.” Starbucks 

Corp. v. McKinney, 602 U.S. 339, 346 (2024) (quoting Winter, 555 U.S. at 20).

We review a district court’s denial of a preliminary injunction for abuse of discretion, and its underlying factual 

findings for clear error. Takeda Pharms. U.S.A., Inc. v. 

Mylan Pharms. Inc., 967 F.3d 1339, 1345 (Fed. Cir. 2020). 

“To the extent a decision to grant [or deny] a preliminary 

injunction rests on questions of law, including claim construction, our review is de novo.” Tate Access Floors, Inc. 

v. Interface Architectural Res., Inc., 279 F.3d 1357, 1364 

(Fed. Cir. 2002) (citations omitted). In other words, “[a]n 

abuse of discretion in granting or denying a preliminary 

injunction may be found ‘by showing that the court made a 

clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly 

erroneous factual findings.’” Abbott Lab’ys v. Andrx 

Pharms., Inc., 452 F.3d 1331, 1335 (Fed. Cir. 2006)

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(quoting Novo Nordisk of N. Am., Inc. v. Genentech, Inc., 

77 F.3d 1364, 1367 (Fed. Cir. 1996)).

On appeal, Novartis contends that “the only fault that 

the district court found with [Dr. Matzger’s] testing was 

that he should have compared his Raman spectra to the 

reference spectra for MSN’s isolated API [i.e., active pharmaceutical ingredient].” See Oral Arg. at 8:51–9:00; see 

also Novartis Br. 32–35. That conclusion, Novartis argues,

was infected by clear error because “comparing Raman 

mapping of MSN’s final products to a reference spectrum 

from MSN’s isolated API would just beg the question of 

whether MSN’s isolated API itself contains amorphous 

TVS.” Novartis Br. 33. Novartis argues that the comparison “demand[ed]” by the district court would not resolve 

the relevant inquiry: whether MSN’s final product contains 

amorphous TVS. Id. at 32. We disagree. 

As an initial matter, we do observe that the district 

court stated that “MSN notes that Dr. Matzger did not compare the spectra he obtained from MSN’s API to Form-S 

reference spectra,” and that “MSN asserts that, when the 

comparison is made between MSN’s API spectra and the 

Form-S reference spectra, the peaks in MSN’s API spectra 

that Dr. Matzger points to as proving the presence of amorphous TVS more closely match the peaks in MSN’s Form-S 

reference spectra than those in amorphous reference spectra.” Preliminary Injunction Order, at *2. That is, the 

court did, as Novartis asserts, appear to characterize 

MSN’s argument as a failure of Novartis to compare the 

spectra from MSN’s API—not MSN’s final product—with a 

Form-S reference spectrum. We generally agree with Novartis’s contention that that comparison would not be dispositive of the ultimate infringement inquiry, which 

requires a showing that MSN’s final product contains 

amorphous TVS. See Oral Arg. at 9:05–17 (counsel for Novartis arguing that “[t]hat comparison would be beside the 

point because our view is that it’s not the API that has the 

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amorphous [TVS], it’s the finished products that we accuse 

and that is created in the tableting process.” (cleaned up)).

However, a closer review of the record establishes that 

MSN did not argue to the district court that Novartis had 

failed to compare the spectra obtained from MSN’s API 

with a Form-S reference spectrum. Instead, its argument 

was that Novartis had failed to compare the spectra Dr. 

Matzger obtained from MSN’s final product with a Form-S 

reference spectrum. See J.A. 6374 (noting that, although 

Dr. Matzger compared the MSN final product spectra to an 

amorphous TVS reference spectrum, he “made no attempt 

to distinguish the amorphous material he supposedly 

found from Form-S. That is, [Dr.] Matzger had no reference spectra for Form-S to conclude what he found matches 

amorphous TVS or crystalline Form-S” (citation omitted)); 

J.A. 6945 ¶ 137 (MSN’s expert report explaining that “Dr. 

Matzger did not find Form-S [in MSN’s final product] because he did not look for Form-S.”); J.A. 9168 (MSN counsel 

arguing that the “fundamental problem” with Novartis’s 

testing is that it was “taking reference spectra for sacubitril and valsartan and amorphous [TVS], but . . . not running th[ose] data to see if there’s even a match with the 

Form-S reference spectra”). Put otherwise, MSN’s argument was that Novartis had not shown that MSN’s final 

product contained amorphous TVS because it did not consider the possibility that the regions in the Raman spectra 

that Dr. Matzger identified as amorphous TVS could have 

been a closer match to crystalline TVS. That argument, 

regardless how it was characterized by the district court,

properly goes to the relevant infringement inquiry.

With that understanding in mind, we see no clear error 

in the district court’s analysis and consideration of the evidence. MSN rebutted Novartis’s argument by putting 

forth evidence to show that the supposed amorphous TVS 

regions identified by Dr. Matzger in the final product were 

actually indicative of crystalline TVS. It did so through its 

own expert, Dr. Steed, who compared the spectra Dr. 

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Matzger obtained from the final product to a Form-S reference spectrum, finding them to “align closely.” See MSN 

Br. 23–24 (citing J.A. 6945–49); J.A. 6949 (Dr. Steed report 

stating that “a more reasonable conclusion is that the regions that Dr. Matzger believes to be amorphous . . . are 

actually crystalline Form-S. At the very least, this casts 

significant doubt on Dr. Matzger’s testing and suggests 

that additional testing . . . should have been conducted to 

determine whether crystalline or amorphous materials 

were present in MSN’s ANDA product.”). Considering this 

competing evidence, as well as the fact that Novartis bore 

the burden of proof, the district court found that Novartis 

did not persuasively show that it was likely to succeed “in 

proving that MSN’s ANDA products contain amorphous 

TVS.” That finding was not clearly erroneous. 

Furthermore, we see no clear error in the district 

court’s determination that Novartis failed to establish that 

Form-S is not crystalline TVS. Each party provided ample 

evidence to support its position in this regard. Namely, 

MSN submitted the various testing data it had submitted 

to the FDA with its ANDA establishing that Form-S is crystalline TVS. See Preliminary Injunction Order, at *3; see 

also Par Pharm., Inc. v. Eagle Pharms., Inc., 44 F.4th 1379, 

1383 (Fed. Cir. 2022) (“Because drug manufactures are 

bound by strict statutory provisions to sell only those products that comport with the ANDA, if the ANDA defines a 

proposed generic drug in a manner that directly addresses 

the issue of infringement, it controls the infringement inquiry.” (cleaned up)). Novartis challenged the reliability of 

those data, arguing that they do not actually establish that 

Form-S is crystalline TVS as opposed to a physical mixture. 

Again faced with compelling evidence from both parties, it 

was not clearly erroneous for the district court to determine 

that Novartis, the party bearing the burden of proof, did 

not establish a likelihood of success on the issue.

At bottom, Novartis’s arguments on appeal ask us to 

reconsider and reweigh this highly factual evidence anew. 

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We decline to do so. Mylan Institutional LLC v. Aurobindo 

Pharma Ltd., 857 F.3d 858, 870 (Fed. Cir. 2017) (“We do 

not reweigh evidence on appeal.” (internal quotation marks 

and citation omitted)). A preliminary injunction “should 

not issue” if the would-be-enjoined party “raises a substantial question concerning either infringement or validity.” 

Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 

1343, 1350–51 (Fed. Cir. 2001). By presenting competent 

and thorough competing expert testimony and evidence, 

MSN has done just that. It is not our role to second guess, 

particularly at this juncture, the factual findings of the district court where those findings do not leave us with “the 

definite and firm conviction that a mistake has been committed.” Univ. of S. Fla. Bd. of Trustees v. United States, 

92 F.4th 1072, 1079 (Fed. Cir. 2024) (internal quotation 

marks and citations omitted). Indeed, “[w]here there are 

two permissible views of the evidence, the fact-finder’s 

choice between them cannot be clearly erroneous.” Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1328 

(Fed. Cir. 2020) (quoting Anderson v. City of Bessemer City, 

470 U.S. 564, 574 (1985)). 

We therefore hold that the district court did not clearly 

err in finding that Novartis did not meet its burden to show 

that it was likely to succeed on the issue of infringement. 

Given that conclusion, we need not reach the other elements required to establish entitlement to a preliminary 

injunction, namely, irreparable harm, the balance of equities, and the public interest. See Amazon.com, 239 F.3d at 

1350 (“Our case law and logic both require that a movant 

cannot be granted a preliminary injunction unless it establishes both of the first two factors, i.e., likelihood of success 

on the merits and irreparable harm.”). The district court 

did not abuse its discretion in denying injunctive relief.

Before closing, we note that our holding today would be 

the same even if Novartis is correct that the district court’s 

claim construction, requiring amorphous TVS to “predominate,” is erroneous as a matter of law. Indeed, we admit 

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concern with the district court’s construction, particularly 

in light of its acknowledgement that there is “virtually no 

useful guidance” in the intrinsic record supporting its conclusion that the claims require any particular amount of 

amorphous TVS to be present. Claim Construction Order, 

at *4. But because we have affirmed the district court’s 

conclusion that Novartis failed to establish that the accused product contains any amorphous TVS, any error in 

the claim construction, at this stage, is harmless. 

CONCLUSION

We have considered Novartis’s remaining arguments 

and find them unpersuasive. For the foregoing reasons, 

the district court’s denial of a preliminary injunction is affirmed. 

AFFIRMED

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