author: ROSENBAUM, Circuit Judge:

text:
    Randall Kevin JONES, Plaintiff-Appellee, v. Officer S. FRANSEN, in his individual capacity, Offifcer Towler, in his individual capacity, Officer Ross, in his individual capacity, K-9 Draco, in his individual capacity, Chief A.A. Ayers, and Gwinnett County, Defendants-Appellants.
    No. 16-10715
    United States Court of Appeals, Eleventh Circuit.
    (May 19, 2017)

      Randall Kevin Jones, Pro Se.
    Tuwanda Rush Williams, Duane Dennis Pritchett, Gwinnett County Law Department, Lawrenceville, GA, for Defendants-Appellants.
    Before WILLIAM PRYOR and ROSENBAUM, Circuit Judges, and URSULA UNGARO, District Judge.

       The Honorable Ursula Ungaro, United States District Judge for the Southern District of Florida, sitting by designation.

   ROSENBAUM, Circuit Judge:

In history and literature, the name “Draco” has been associated with some notorious characters. Draco of ancient Greece is perhaps best known for the harsh legal code he composed, which inspired the word “draconian.” Antonios Loizides, Draco’s, Law Code, Ancient EJjs-toky Encyclopedia http://www.ancient.eu/ Dracos_Law-Code/ (last visited May 12, 2017). Draco Lucius Malfoy, of course, is Harry Potter’s perpetually maleficent rival in the Harry Potter literary series.

And to the list of infamous Dracos, add Defendant-Appellant Draco. Draco is a police canine who was involved in the apprehension of Plaintiff Randall Kevin Jones. Unfortunately, Draco inflicted some serious damage on Jones when Draco refused to release his bite. Jones sued Draco, among others, for negligence. Georgia law by its terms, however, does not provide for negligence actions directly against dogs. We therefore hold as much today and reverse the district court’s denial of Defendant-Appellants’ motion to dismiss Draco.

But while Georgia law does not allow for a negligence suit against a dog, it does permit negligence claims against a state officer who is not entitled to official immunity. Title 42, United States Code, Section 1983 likewise authorizes an action against a police officer who employs a dog in an exercise of excessive force. And Jones also sued the officers responsible for Draco’s encounter with Jones. In response, Defendant-Appellant Officers invoked official and qualified immunity and moved to dismiss. The district court summarily denied Defendant-Appellant Officers’ motion. Today we must reverse that denial and dismiss the claims. Jones has failed to allege facts establishing that the officer acted with malice, so the officers are entitled to official immunity. Nor does binding precedent allow for the conclusion that Defendant Officers’ employment of Draco in the circumstances of this case violated Jones’s clearly established rights, so the officers have qualified immunity.

I

The trouble in this case began when Jones and his girlfriend broke up. Following the split, on July 6, 2013, Jones’s ex-girlfriend called 911 to report that Jones had broken into her apartment and was carrying a television to his car, which was parked at her apartment complex.

Two of the officers who responded to the call included Defendant-Appellants Gwin-nett County Police Department Officers Brandon Towler and Richard Ross. Towler and Ross searched the apartment-complex area for Jones. Meanwhile, another officer claimed to have seen Jones carrying a bag and a television near the apartment pool.

At some point, Defendant Officers believed that Jones had fled to a “steep ravine pond area with high concert walls, boulders and vegetation.” Defendant-Appellant Officer Scott Fransen, who worked with police-canine Draco, arrived on the scene to look for Jones and issued what are known as K-9 warnings. After hearing no response, Fransen and Draco entered the ravine to find Jones. Ross and another officer provided backup.

During the search for Jones, Fransen saw Jones motionless, at the bottom of the ravine. But Fransen had already released Draco, and Draco “r[a]n loose and savagely attacked] and t[ore]” Jones’s left arm, even though Jones lay motionless during the attack. Ross, who was also present, did nothing to protect Jones from the attack.

After “a while” passed, which Jones described as “seem[ing] like a lifetime,” Fransen tried to pull Draco from Jones’s arm, but Draco refused to yield. Finally, however, Fransen was able to separate Draco from Jones. But unfortunately, the damage was done. This incident permanently disfigured and limited the use of Jones’s arm.

II.

Jones filed suit against Fransen, Ross, Towler, Draco, Gwinnett County, and Gwinnett County Police Chief A.A. Ayers. In Count I, Jones alleged a claim against Fransen under 42 U.S.C. § 1983 for the use of excessive force, in violation of the Fourth Amendment to the United States Constitution. Count II asserted a claim under § 1983 for excessive use of force, against the other officers, based on their failure to intervene and stop the .canine attack. In Count III, Jones brought a claim for negligence against all Defendants. And finally, in Count IV, Jones set forth a § 1983 claim against Gwinnett County, charging that through its allegedly inadequate police training, it had violated his Fourth Amendment right to be free from the use of excessive force.

Defendants moved to dismiss the case for failure to state a claim, invoking qualified immunity with respect to Counts I and II. With regard to the state-law negligence claim, Defendants contended, among other arguments, that the County and Defendant Police Chief Ayers in his official capacity were entitled to sovereign immunity, and Defendant Officers and Ayers in their individual capacities were entitled to official immunity. The district court denied the motion. After setting forth the applicable law on the standard on a motion to dismiss, the court wrote, “The Plaintiff has stated a plausible claim with respect to his allegation that the canine officer subjected him to excessive force. The Defendants’ Motion to Dismiss ... is DENIED. The issues of municipal liability and qualified immunity may be revisited at the summary judgment stage.”

Defendants now appeal. Despite notice, however, Jones has not filed a brief or otherwise appeared in the appeal proceedings.

III.

Title 28, United States Code, Section 1291 limits our appellate jurisdiction to final decisions of the district courts. 28 U.S.C. § 1291. But we use a “practical rather than a technical construction” to construe § 1291’s limitations. Royalty Network, Inc. v. Harris, 756 F.3d 1351, 1355 (11th Cir. 2014) (citation and internal quotation marks omitted). As a result, under what is known as the collateral-order doctrine, § 1291 extends appellate jurisdiction over “not only judgments that terminate an action, but also a small class of collateral rulings that, although they do not end the litigation, are appropriately deemed ‘final.’ ” Id. (citation and internal quotation marks omitted). District-court decisions falling into this category must meet three requirements: they must “(1) conclusively determine the disputed question, (2) resolve an important issue completely separate from the merits of the action, and (3) be effectively unreviewable on appeal from a final judgment.” Id. (citation and internal quotation marks omitted).

Here, Defendants appeal the district court’s denial of their motion to dismiss. Generally, such an order does not qualify as a “final decision.” Parker v. Am. Traffic Sols., 835 F.3d 1363, 1367 (11th Cir. 2016). But the Supreme Court has long recognized that denial of a motion to dismiss on qualified-immunity grounds “easily meets” the demands of the collateral-order doctrine because, among other reasons, qualified immunity is an immunity not only from liability but also from suit. See Mitchell v. Forsyth, 472 U.S. 511, 526-27, 105 S.Ct. 2806, 86 L.Ed.2d 411 (1985).

For the same reason, defendants may immediately appeal an order denying state official or sovereign immunity, provided that the applicable state law defines the immunity at issue as one from suit instead of from just liability. Parker, 835 F.3d at 1367-68. Georgia law does. Griesel v. Hamlin, 963 F.2d 338, 341 (11th Cir. 1992) (per curiam) (“sovereign immunity under Georgia law is an immunity from suit”); Shekhawat v. Jones, 293 Ga. 468, 746 S.E.2d 89, 91 (2013) (“official immunity protects state employees from being sued in their personal capacities”) (emphasis added and omitted); Ga. Code Ann. § 15-21-25(a) (“A state officer or employee who commits a tort while acting within the scope of his or her official duties or employment is not subject to lawsuit or liability therefor.”) (emphasis added).

So we have jurisdiction to review the district court’s denial of qualified immunity, sovereign immunity, and official immunity. But that leaves the question of whether we may review the district court’s decision to deny the County’s motion to dismiss as it pertains to Jones’s § 1983 municipal-liability claim. Decisions denying dismissal of such claims generally are not immediately appealable in their own right, as they do not constitute “final decisions” within the meaning of the collateral-order doctrine. Swint v. Chambers Cty. Comm’n, 514 U.S. 35, 43, 115 S.Ct. 1203, 131 L.Ed.2d 60 (1995).

We therefore consider whether we may review the claim under the pendent-appellate-jurisdiction doctrine. That doctrine allows us to “address [otherwise] nonappealable orders if they are inextricably intertwined with an appealable decision or if review of the former decision [is] necessary to ensure meaningful review of the latter.” Hudson v. Hall, 231 F.3d 1289, 1294 (11th Cir. 2000) (citation and internal quotation marks omitted) (alteration adopted). We have explained that “[m]at-ters may be sufficiently intertwined when they implicate[] the same facts and the same law.” Smith v. LePage, 834 F.3d 1285, 1292 (11th Cir. 2016) (citation and internal quotation marks omitted) (alteration adopted).

Here, Gwinnett County makes no argument that the issue raised in the municipal-liability claim under § 1983 is inextricably intertwined with the claims of qualified, sovereign, or official immunity. Nor does it seem to us that the issue is inextricably intertwined. While the claims presented stem from a single incident, the municipal-liability claim raises the wholly separate issue of whether Gwinnett County had a policy, custom, or practice of deliberate indifference and inadequate training of its officers regarding the use of police dogs. This is not an issue that must be determined—or even considered—in resolving the immunity claims. Under these circumstances, we do not find the requirements of the pendent-appellate-jurisdiction doctrine to be satisfied. See Swint, 514 U.S. at 51, 115 S.Ct. 1203. For this reason, we do not entertain Gwinnett County’s appeal as it relates to Count IV, the § 1983 municipal-liability claim.

Our review of the district court’s denial of the various types of immunity invoked in this case is de novo. Carollo v. Boria, 833 F.3d 1322, 1328 (11th Cir. 2016) (qualified immunity); Johnson v. Conner, 720 F.3d 1311, 1313 (11th Cir. 2013) (sovereign immunity); Bailey v. Wheeler, 843 F.3d 473, 480 (11th Cir. 2016) (official immunity). In conducting our review, we accept as true all well-pled factual allegations, and we view the facts in the light most favorable to the plaintiff. Id. (citation and quotation marks omitted).

IV.

A. The § 1983 Claims

We begin our discussion by considering Jones’s § 1983 claims against Defendant Officers in their individual capacities. Defendants assert that the district court erred when it denied them qualified immunity under the facts of the complaint as pled in this case. We agree.

The qualified-immunity defense reflects an effort to balance “the need to hold public officials accountable when they exercise power irresponsibly and the need to shield officials from harassment, distraetion, and liability when they perform their duties reasonably.” Pearson v. Callahan, 555 U.S. 223, 231, 129 S.Ct. 808, 172 L.Ed.2d 565 (2009). The doctrine resolves this balance by protecting government officials engaged in discretionary functions and sued in their individual capacities unless they violate “clearly established federal statutory or constitutional rights of which a reasonable person would have known.” Keating v. City of Miami, 598 F.3d 753, 762 (11th Cir. 2010) (quotation marks and brackets omitted).

As a result, qualified immunity shields from liability “all but the plainly incompetent or one who is knowingly violating the federal law.” Lee v. Ferraro, 284 F.3d 1188, 1194 (11th Cir. 2002). But the doctrine’s protections do not extend to one who “knew or reasonably should have known that the action he took within his sphere of official responsibility would violate the constitutional rights of the [plaintiff].” Harlow v. Fitzgerald, 457 U.S. 800, 815, 102 S.Ct. 2727, 73 L.Ed.2d 396 (1982) (internal quotation marks and alteration omitted).

To invoke qualified immunity, a public official must first demonstrate that he was acting within the scope of his or her discretionary authority. Maddox v. Stephens, 727 F.3d 1109, 1120 (11th Cir. 2013). As we have explained the term “discretionary authority,” it “inelude[s] all actions of a governmental official that (1) were undertaken pursuant to the performance of his duties, and (2) were within the scope of his authority.” Jordan v. Doe, 38 F.3d 1559, 1566 (11th Cir. 1994) (internal quotation marks omitted). Here, it is clear that Defendant Officers satisfied this requirement, as they engaged in all of the challenged actions while on duty as police officers conducting investigative and seizure functions.

Because Defendant Officers have established that they were acting within the scope of their discretionary authority, the burden shifts to Jones to demonstrate that qualified immunity is inappropriate. See id. To do that, Jones must show that, when viewed in the light most favorable to him, the facts demonstrate that Defendant Officers violated Jones’s constitutional right and that that right was “clearly established ... in light of the specific context of the case, not as a broad general proposition^]” at the time of Defendant officers’ actions. Saucier v. Katz, 533 U.S. 194, 201, 121 S.Ct. 2151, 150 L.Ed.2d 272 (2001), overruled in part on other grounds by Pearson, 555 U.S. 223, 129 S.Ct. 808. We may decide these issues in either order, but, to survive a qualified-immunity defense, Jones must satisfy both showings. Maddox, 727 F.3d at 1120-21 (citation omitted).

Here, we address the “clearly established” inquiry first. Because we conclude that Jones’s right was not clearly established in the specific context of the facts in this case, we do not reach the question of whether Defendants violated Jones’s constitutional rights.

When we consider whether the law clearly established the relevant conduct as a constitutional violation at the time that Defendant Officers engaged in the challenged acts, we look for “fair warning” to officers that the conduct at issue violated a constitutional right. Coffin v. Brandan, 642 F.3d 999, 1013 (11th Cir. 2011) (citations and quotation marks omitted). “Fair warning” comes in the form of binding caselaw from the Supreme Court, the Eleventh Circuit, or the highest court of the state (Georgia, here) that “make[s] it obvious to all reasonable government actors, in the defendant’s place, that what he is doing violates a federal law.” Priester v. City of Riviera Beach, 208 F.3d 919, 926 (11th Cir. 2000) (citation omitted).

A plaintiff may demonstrate in any one of three ways that a defendant had “fair warning” that the right he violated was clearly established. Loftus v. Clark-Moore, 690 F.3d 1200, 1204 (11th Cir. 2012) (citation and internal quotation marks omitted). First, a plaintiff may point to binding precedent that is materially similar. Id. This method requires us to consider “whether the factual scenario that the official faced is fairly distinguishable. from the circumstances facing a government official in a previous case.” Id. (citation and internal quotation marks omitted).

Second, a plaintiff may invoke a “broader, clearly established principle” that he asserts “should control the novel facts [of the] situation.” Id. at 1204-05 (citation and internal quotation marks omitted). Because “fair warning” is the driving force behind a determination that a right has been clearly established, when a plaintiff proceeds in this way, he must show that caselaw demonstrated the principle with “obvious clarity ... so that every objectively reasonable government official facing the circumstances would know that the official’s conduct did violate federal law when the official acted.” Id. at 1205 (citation and internal quotation marks omitted). The violation of a right may also fall into this category when “[t]he reasoning, though not the holding of prior cases ... send[s] the same message to reasonable officers in novel factual situations.” Mercado v. City of Orlando, 407 F.3d 1152, 1159 (11th Cir. 2005) (citation and internal quotation marks omitted).

Finally, a right is “clearly established” when the defendant’s conduct “lies so obviously at the very core of what the [Fourth Amendment] prohibits that the unlawfulness of the conduct was readily apparent to the official, notwithstanding the lack of ease law.” Loftus, 690 F.3d at 1205 (citation and internal quotation marks omitted). Similarly, we recognize the obvious-clarity exception where conduct is “so bad that case law is not needed to establish that the conduct cannot be lawful.” Vinyard v. Wilson, 311 F.3d 1340, 1350 (11th Cir. 2002). We have described this category as “narrow.” Priester, 208 F.3d at 926-27.

Here, while we have relevant excessive-force precedent in this Circuit, no binding case involves a factual scenario that is similar enough to the one here so as to have put the officers on notice that what they did violated a clearly established right.

In his complaint, Jones asserts that Defendant Officers violated his Fourth Amendment right to be free from the use of excessive force. We evaluate excessive-force claims under the Fourth Amendment’s “objective reasonableness” standard. Crenshaw v. Lister, 556 F.3d 1283, 1290 (11th Cir. 2009) (per curiam) (citation omitted). This standard directs us to ask “whether the officer’s conduct is objectively reasonable in light of the facts confronting the officer.” Id. (quoting Vinyard v. Wilson, 311 F.3d 1340, 1347 (11th Cir. 2002)) (internal quotation marks omitted). When we engage in our analysis, we must do so “from the perspective of a reasonable officer on the scene, rather than with the 20/20 vision of hindsight,” id. (quoting Graham v. Connor, 490 U.S. 386, 396, 109 S.Ct. 1865, 104 L.Ed.2d 443 (1989)) (internal quotation marks omitted), and we keep in mind that “the right to make an arrest or investigatory stop necessarily carries with it the right to use some degree of physical coercion or threat thereof to effect it.” Graham, 490 U.S. at 396, 109 S.Ct. 1865 (citation omitted).

The standard requires us to carefully balance “the nature and quality of the intrusion on the individual’s Fourth Amendment interests against the countervailing government interests at stake.” Crenshaw, 556 F.3d at 1290 (quoting Graham, 490 U.S. at 396, 109 S.Ct. 1865) (internal quotation marks omitted). Factors we account for include (1) the severity of the crime; (2) whether the individual “poses an immediate threat to the safety of the officers or others”; (3) whether the individual actively resists or tries to evade arrest by flight, id. (quoting Graham, 490 U.S. at 396, 109 S.Ct. 1865); (4) the need for force to be applied; (5) the amount of force applied in light of the nature of the need; (6) the severity of the injury; and (7) whether officers applied force “in good faith or [rather did so] maliciously and sadistically,” id. (quoting Hadley v. Gutierrez, 526 F.3d 1324, 1329 (11th Cir. 2008)).

And where, as in this case, police-canine bites are the form that the alleged use of excessive force takes, we have some further guidance in our binding precedent: Priester, 208 F.3d 919, and Crenshaw, 556 F.3d 1283. Priester and Crenshaw fall near opposite ends of our dog-bite excessive-force spectrum. They show how we have applied the Graham and Hadley factors to determine whether a Fourth Amendment violation occurred in the context of police-dog-bite cases.

In Priester, the crime at issue was one of the more minor ones; Priester was suspected of having stolen roughly $20’s worth of snacks from a golf shop. Priester, 208 F.3d at 927. Nor did anything suggest that Priester was armed or that he otherwise posed an immediate threat to the officers or anyone else. Id. And though Priester originally fled the officers, once they discovered him, he immediately submitted to them. Id. Yet the officer who controlled the police dog, nonetheless ordered his dog to attack and bite Priester for at least two minutes and threatened to kill Priester when Priester tried to resist the attack. Id. As a result of the attack, Priester suffered fourteen puncture wounds to his legs. Id. at 924. We easily concluded that the officer and his officer colleague who failed to intervene violated Priester’s Fourth Amendment right to be free from the use of excessive force. Id. at 927-28.

In Crenshaw, on the other hand, we found that the canine-controlling officer and his colleague who did not intervene did not violate Crenshaw’s Fourth Amendment right to be free from the use of excessive force, when the officer unleashed his police dog on Crenshaw. Crenshaw, 556 F.3d at 1293-94. Considering the various evaluative factors, we noted that the crime at issue was far more serious than that involved in Priester, Crenshaw was believed to have committed at least one, and possibly two, armed robberies. Id. at 1292. Crenshaw also violently fled police, crashing'his car into a marked police vehicle before running into very dense woods and hiding in brush. Id. As a result, officers reasonably thought Crenshaw posed an immediate threat to at least themselves. See id. And because it was dark and officers had lost track of Crenshaw before Crenshaw yelled out, “I am over here,” we found it reasonable for the officers to be concerned about a possible ambush and to continue to consider themselves at immediate risk from Crenshaw when they released the dog. See id. at 1291-93. The attack resulted in multiple puncture wounds to Crenshaw’s legs, including one that required six stitches to close. Id. at 1287.

The facts in Jones’s case land somewhere between ' those involved in Priester and those in Crenshaw. The alleged crime arguably was more serious than Priester’s yet less so than Cren-shaw’s. Jones purportedly stole a television from his former girlfriend’s residence. And while domestic-related crimes certainly have the potential to be extremely serious and dangerous, nothing about this particular incident indicated that it fell into that category. At the time Jones’s ex-girlfriend reported the theft, Jones was already out of the apartment, and his ex-girlfriend gave no indication that he had been violent or armed.

On the other hand, when Jones fled police, unlike Priester, he did not ultimately overtly surrender himself. Instead, he led police into physically challenging terrain with brush and boulders, similar to the place where Crenshaw fled, and he did not respond in any way to Fransen’s K-9 warnings. Like the Crenshaw officers, a reasonable officer in one of Defendants’ places could have been concerned, at the time Draco was released, about entering the heavy brush to apprehend Jones and being met by a potential ambush.

So Jones’s case is not directly on all fours with either Priester or Crenshaw. As a result, neither case alone could have provided Defendant Officers with the type of “fair notice” necessary to breach qualified immunity. And considering the cases together helps no more since Priester and Crenshaw reached opposite conclusions concerning whether an excessive-force violation occurred.

We therefore turn to the second method for proving that the right in this case was clearly established at the time of the violation. As we have noted, Jones filed no appellate brief. In the district court, though, Jones appears to have attempted to rely on this second way to demonstrate a clearly established right. He invoked the general principle that “[t]he Fourth Amendment’s freedom from unreasonable searches and seizures encompasses the plain right to be free from the use of excessive force in the course of an arrest.” (citations and internal quotation marks omitted).

But the Supreme Court has repeatedly instructed us that “‘clearly established law' should not be defined ‘at a high level of generality’ ” and must instead be “ ‘particularized’ to the facts of the case.” White v. Pauly, — U.S.-, 137 S.Ct. 548, 552, 196 L.Ed.2d 463 (2017) (citation omitted). The fact that the Fourth Amendment pro-teets against the use of excessive force during an arrest does not provide an officer with any guidance as to what constitutes an excessive use of force. So this general principle is not the type of “broader, clearly established principle [that] should control the novel facts [of the] situation” here. Loftus, 690 F.3d at 1204-05 (citation and internal quotation marks omitted).

Finally, Jones did not argue—and particularly in light of Priester and Crenshaw, we cannot find—that Defendants’ actions in this ease “lie[ ] so obviously at the very core of what the [Fourth Amendment] prohibits that the unlawfulness of the conduct was readily apparent to the official, notwithstanding the lack of case law.” Loftus, 690 F.3d at 1205 (citation and internal quotation marks omitted).

For these reasons, we must conclude that Jones’s constitutional right was not clearly established when Defendant Officers engaged in the challenged behavior. As a result, Defendant Officers are entitled to qualified immunity, and the district court’s ruling to the contrary must be reversed.

B. The Negligence Claim

1. Sovereign Immunity

As we have mentioned, Jones brought a negligence claim against Gwinnett County and Sheriff Ayers in his official capacity, and Defendants sought dismissal of this claim on the basis of sovereign immunity. The County and Sheriff Ayers appeal the district court’s denial of their motion to dismiss on the basis of sovereign immunity-

The Georgia constitution endows “the state and all of its departments and agencies” with sovereign immunity. Ga. Const, art. I § 2, ¶ IX; Gilbert v. Richardson, 264 Ga. 744, 452 S.E.2d 476, 478 (1994). Georgia’s sovereign-immunity reservation also extends to counties. Gilbert, 452 S.E.2d at 479; see also, O.C.G.A. § 36-1-4 (“A county is not liable to suit for any cause of action unless made so by statute.”).

Nevertheless, under Georgia law, a statute may expressly waive sovereign immunity and set forth the parameters of any such waiver. Grech v. Clayton Cty., 335 F.3d 1326, 1341 (11th Cir. 2003) (citing Ga. Const, art. I, § 2, ¶ 9(e)). But the party seeking to impose liability bears the burden of proof in establishing waiver. Effingham Cty. v. Rhodes, 307 Ga.App. 504, 705 S.E.2d 856, 858-59 (2010).

In the district court, Jones did not assert a waiver in response to the County’s and Sheriff Ayers’s invocation of sovereign immunity. And we have already noted that he failed to file an appellate brief. Under these circumstances, Jones has not met his burden to establish a waiver of sovereign immunity with respect to the County and to Sheriff Ayers in his official capacity. For this reason, the district court’s denial of the motion to dismiss the claims against the County and Ayers in his official capacity must be reversed.

2. Official Immunity

Chief Ayers, Defendant Officers and Draco also assert that the negligence claim filed against them in their individual capacities should have been dismissed. We agree.

a. The Claims Against Defendants Fransen, Towler, Ross, and Ayers

The Georgia constitution bestows official immunity on county government officers acting in a discretionary function and sued in their individual capacity unless they “act with actual malice or with actual intent to cause injury in the performance of their official functions.” Ga. Const. art. I, § 2, ¶ 9(d); Phillips v. Hanse, 281 Ga. 133, 637 S.E.2d 11, 12 (2006); see also O.C.G.A. § 36-33-4 (“Members of the council and other officers of a municipal corporation shall be personally liable to one who sustains special damages as the result of any official act of such officers if done oppressively, maliciously, corruptly, or without authority of law.”). “Actual malice” requires a “deliberate intention to do wrong.” West v. Davis, 767 F.3d 1063, 1073 (11th Cir. 2014) (quoting Adams v. Hazelwood, 271 Ga. 414, 520 S.E.2d 896, 898 (1999) (citations omitted)).

Here, Jones’s complaint sets forth no facts suggesting that the officers acted maliciously or with an actual intent to cause harm. Indeed, beyond naming Chief Ayers in his individual capacity as a defendant, the complaint makes no allegations whatsoever against him in that capacity. As for the other Defendant Officers, the law did not put them on notice of the wrongfulness of releasing Draco, and no other facts alleged suggest that any of the officers harbored actual ill intentions against Jones. Nor is the officers’ intent to release Draco and apprehend Jones, in and of itself, sufficient under the circumstances of this case to establish a “deliberate intention to do wrong.” As a result, the officers are entitled to official immunity for the negligence claims against them in their individual capacities, and Count III should have been dismissed. The district court’s ruling to the contrary must be reversed.

b. The Claim Against Draco

Jones did not limit himself to charging negligence against only Defendants Fran-sen, Towler, Ross, and Ayers. Instead, Jones also alleged in his complaint that “Officer K-9 Draco of the Gwinnett County Police Department” was liable for negligence in his individual capacity. We are not persuaded.

Georgia has codified the tort of negligence. And under the express terms of Georgia law, only a person may be held liable for breaching a legal duty:

‘When the law requires a person to perform an act for the benefit of another or to refrain from doing an act which may injure another, although no cause of action is given in express terms, the injured party may recover for the breach of such legal duty if he suffers damages thereby.”

O.C.G.A. § 51-1-6 (emphasis added); see also O.C.G.A. § 51-2-7 (“A person who owns or keeps a vicious or dangerous animal of any kind and who, by careless management or by allowing the animal to go at liberty, causes injury to another person ... may be liable in damages.... ”) (emphasis added).

Not surprisingly, O.C.G.A. § 50-21-22(4), which we use to determine the meaning of words used in Georgia’s tort statutes, does not define the word “person” to include dogs. See id. Rather, it limits the definition of “person” to “a natural person, corporation, firm, partnership, association, or other such entity.” O.C.G.A. § 50-21-22(4). A dog does not qualify as any of these things. Cf. Miles v. City Council of Augusta, 710 F.2d 1542, 1544 n.5 (11th Cir. 1983) (declining to hear a claim that a cat’s right to free speech was infringed because a cat “cannot be considered a ‘person’ ”).

But even if any ambiguity existed over whether a police dog may be sued in tort for acts committed while serving as a police dog, the notion of a tort lawsuit directly against a dog in these circumstances would create an abundance of practical problems as well: even setting aside the issues of service on a dog and a dog’s retention of legal representation, and even assuming that Draco can qualify as a “[s]tate officer or employee” under Georgia law, how could we reasonably apply Georgia’s concept of official immunity? How would we determine whether the dog was acting in a discretionary or ministerial capacity when it bit the plaintiff? If it were acting in a discretionary capacity, how would we discern whether it had a “deliberate intention to do wrong”? And if it were acting in a ministerial capacity and were somehow liable, could the individually liable dog be expected as a practical matter to pay damages? And if so, how? These kinds of issues, all of which flirt with holding a dog civilly liable in its own right—not as the instrument or responsibility of another—are simply not suited for resolution in our adversarial process. For all of these reasons, we must conclude that Draco in his individual capacity may not be sued for negligence under Georgia law, and the district court’s denial of the motion to dismiss Draco must be reversed.

V.

In summary, we conclude that Defendant Officers Fransen, Towler, and Ross are entitled to qualified immunity because binding precedent does not clearly establish that their actions in allowing Draco to apprehend Jones violated Jones’s Fourth Amendment rights. So we REVERSE the order of the district court and REMAND with instructions to dismiss Counts I and II of Jones’s complaint. We also hold that a dog may not be sued individually for negligence since a dog is not a “person.” And because we conclude that the County and Chief Ayers in his official capacity have sovereign immunity, and Defendants Fransen, Towler, Ross, and Ayers are entitled to official immunity for the claims against them in their individual capacities, we REVERSE and REMAND with instructions that the district court dismiss Count III. We decline to address the propriety of the district court’s denial of dismissal on Count IV in the interlocutory posture of the case.

REVERSED and REMANDED.

      . See J.K. Rowling, Harry Potter and the Sorcerer's Stone (1997); J.K. Rowling, Harry Potter and the Chamber of Secrets (1998); J.K. Rowling, Harry Potter and the Prisoner of Azkaban (1999); J.K. Rowling, Harry Potter and the Goblet of Fire (2000); J.K. Rowling, Harry Potter and the Order of the Phoenix (2003); J.K. Rowling, Harry Potter and the Half-Blood Prince (2005); J.K. Rowling, Harry Potter and the Deathly Hallows (2007).

      . We take the facts asserted here from the complaint and construe them in the light most favorable to the plaintiff. Ray v. Spirit Airlines, Inc., 836 F.3d 1340, 1347 (11th Cir. 2016).

      . Other officers were also sued, but they were not served.

      . Similarly, in Edwards v. Shanley, 666 F.3d 1289 (11th Cir. 2012), another case involving a dog bite, we concluded that Priester gave the officer fair warning that his actions violated the plaintiff's Fourth Amendment right to be free from the use of excessive force. In that case, the subject was pulled over on suspicion of having a suspended driver’s license. He fled his car, and officers used a police canine to find him. When the suspect saw the officers approaching, he surrendered. The police dog began biting him, and the suspect pled, “I'm not resisting” and begged the officers to call off the dog. Instead, the officers stood over the suspect and the police dog as the dog continued to bite the suspect for five to seven minutes. Finally, the officers cuffed the suspect and called off the dog. We explained that all “the same factors [from Priester] weighted] against the need for extraordinary force” in Edwards, yet the officer in Edwards employed "greater force than did the officers arresting Priester.” Id. at 1298.

      . Though the complaint asserts that Draco bit Jones for "a while,” which Jones described as "seem[ing] like a lifetime,” nothing in the complaint suggests that the officers gratuitously prolonged the attack under the circumstances. Rather, the complaint notes the steep ravine walls, boulders, and vegetation that the officers had to navigate to reach Jones after Draco had caught up with him. In the absence of any indication that the officers had the ability to shorten the length of the bite period, we cannot conclude that the officers employed Draco sadistically or gratuitously prolonged the attack.

      . We have jurisdiction to review this issue under the pendent-appellate-jurisdiction doctrine because the question of whether a dog may be sued at all for negligence is inextricably intertwined with the question of whether, if so, a dog may be entitled to official immunity. If we did not dispose of the claim against Draco on the ground that Georgia law does not authorize a negligence action against a dog, we would have to determine whether Draco could claim official immunity and, if so, how. In this section, we explain the problems with that scenario.

      . O.C.G.A. § 4-8-21(b) provides that "[n]o dog shall be classified as a dangerous dog or vicious dog [for purposes of O.C.G.A. § 51-2-7] for actions that occur while the dog is being used by a law enforcement ... officer to carry out the law enforcement ... officer’s official duties.” See also Eshleman v. Key, 297 Ga. 364, 774 S.E.2d 96, 99 (2015) (assuming for purposes of argument that a police canine may qualify as a “vicious or dangerous animal” under O.C.G.A. § 51-2-7, while acknowledging that § 4-8-21(b) precludes that conclusion).

      . Though O.C.G.A. § 50-21-22(7) defines "[s]tate officer or employee" to include "law enforcement officers,” the remainder of the definition suggests that the term "law enforcement officers” refers to "persons,” since the word "person” or "persons” is used three other times in the definition, and the definition does not appear to contemplate the inclusion of animals.

      . Similarly, the Seventh Circuit rejected the notion that a dog could be sued under 42 U.S.C. § 1983. In reaching this conclusion, the Seventh Circuit identified numerous dilemmas that would arise if the rule were otherwise:
      Was [the dog] served with process? Did he retain as his lawyer [the same attorney] who purports to represent all ... defendants? Was [the dog] offered the right of self-representation under 28 U.S.C. § 1654? What relief does [the plaintiff] seek from a dog—[the dog’s] awards, perhaps? Could [the dog] claim qualified immunity? If a reasonable person in the defendant’s position would not have understood that what he was doing violated the Constitution, damages are unavailable. Must we then ask whether a reasonable dog in [the defendant dog’s] position should have understood that he was violating [the plaintiff's] constitutional rights?

        Dye v. Wargo, 253 F.3d 296, 299 (7th Cir. 2001) (citation omitted).
      Draco suggests that Jones also seeks to recover against him under § 1983. We do not read the complaint the same way. But to the extent that the complaint could be understood to sue Draco under § 1983, that cause of action would also necessarily fail. In addition to the problems that the Seventh Circuit identified, the terms of § 1983 do not appear to contemplate such an action, either. Section 1983 creates a cause of action against "[e]very person who, under color of any statute, ordinance, regulation, custom, or usage, of any State ... subjects, or causes to be subjected, any citizen of the United States or other person ... to the deprivation of any rights, privileges, or immunities secured by the Constitution and laws....” 42 U.S.C. § 1983 (emphasis added). The Dictionary Act, 1 U.S.C. § 1, which we use to "determin[e] the meaning of any Act of Congress, unless the context indicates otherwise,” does not expressly include dogs in its definition of "person.” See id. Instead, it defines the term "person” to "include corporations, companies, associations, firms, partnerships, societies, and joint stock companies, as well as individuals.” Id. A dog does not obviously fall into any of these categories. And while the word "individual” can be ambiguous, the dictionary’s primary definitions for it refer solely to a human being: "la. A single human considered apart from a society or community.... b. A human regarded as a distinctive or unique personality.” Individual, The American Heritage Dictionary of the English Language (5th ed. 2011) (emphasis added). But see id. at definition 2 ("A single organism as distinguished from a species, community, or group.”). Nor does anything in the context of § 1983 suggest that Congress intended to authorize lawsuits directly against dogs. And, as we have noted above, outside the context of § 1983, we have also previously found that an animal does not qualify as a "person.” Miles, 710 F.2d at 1544 n.5.


source: Caselaw Access Project

author: LOURIE, Circuit Judge.

license: Public Domain

text:
    MYLAN INSTITUTIONAL LLC, Apicore US LLC, Plaintiffs-Appellees v. AUROBINDO PHARMA LTD., Aurobindo Pharma USA Inc., Auromedics Pharma LLC, Defendants-Appellants
    2017-1645
    United States Court of Appeals, Federal Circuit.
    Decided: May 19, 2017

      Nicole W. Stafford, Wilson, Sonsini, Goodrich & Rosati, PC, Austin, TX, argued for plaintiffs-appellees. Plaintiff-appellee Mylan Institutional LLC also represented by David S. Steuer, Palo Alto, CA; Sami Sedghani, San Francisco, CA.
    Joanna Garelick Goldstein, Sharma & DeYoung LLP, New York, NY, for Api-core US LLC. Also represented by Allen Gardner, Gillam, Smith & Gardner, Tyler, TX.
    Sailesh K. Patel, Schiff Hardin LLP, Chicago, IL, argued for defendants-appellants. Also represented by Cindy Ahn; George Chih-Lun Yu, San Francisco, CA.
    Before LOURIE, MOORE, and REYNA, Circuit Judges.
   LOURIE, Circuit Judge.

Aurobindo Pharma Ltd., Aurobindo Pharma USA Inc., and Auromedics Phar-ma LLC (together, “Aurobindo”) appeal from a decision of the United States District Court for the Eastern District of Texas granting Mylan Institutional LLC’s (“Mylan Inst.”) and Apicore US LLC’s (“Apicore”) (together, “Mylan”) motion for a preliminary injunction precluding Auro-bindo from making, using, selling, offering to sell, and importing the accused isosulfan blue (“ISB”) product that allegedly infringes three of Apicore’s patents—U.S. Patent 7,622,992 (“the ’992 patent”), U.S. Patent 8,969,616 (“the ’616 patent”), and U.S. Patent 9,353,050 (“the ’050 patent”). See Mylan Institutional LLC v. Aurobindo Pharma Ltd., No. 2:16-cv-00491, 2017 WL 497593 (E.D. Tex. Feb. 7, 2017) (“Order Adopting R & R”). Because the district court did not err in its grant of the preliminary injunction under the ’050 patent, although it did err in granting the injunction under the ’992 and ’616 patents, we affirm.

Background

Apicore owns, and Mylan Inst, is the exclusive licensee of, the ’992, ’616, and ’050 patents, which relate to ISB, a triarylmethane dye used to map lymph nodes. The ’992 and ’616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting iso-leuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. See, e.g., ’992 patent col. 7 11. 21-44. The ’992 patent further requires 2.0-3.0 equivalents of silver oxide. See id. col. 9 1. 65. Claim 1 of the ’616 patent is representative of the process patents and reads as follows:

A process of preparing N-[4-[[4-(diethyl-amino)phenyl] (2,5-disulfophenyl)methy-lene]-2,5-cyclohexadien-l-ylidene]-N-ethylethanaminium, sodium salt comprising combining a suspension of isoleu-eo acid of the formula
in a polar solvent with silver oxide, recovering isosulfan blue acid, and treating the isosulfan blue acid with a sodium solutipn.

’616 patent col. 9 11. 38-64 (emphasis added). Claim 1 of the ’992 patent adds the limitation that 2.0-3.0 equivalents of silver oxide are employed in the process, but otherwise resembles the claim shown above. See ’992 patent col. 9 11. 41-67.

The ’050 patent (which the parties refer to as “the purity patent”) is directed to an ISB compound having a purity greater than 99-0%, as measured by high performance liquid chromatography (“HPLC”). See ’050 patent col. 9 11. 54-58. Claim 1 is illustrative and reads as follows:

A compound N-[4-[[4-(diethylamino)phe-nyl] (2,5-disulfophenyl)methylene]-2,5-cyclohexadien-l-ylidene]-N-ethylethan-aminium, sodium salt having a purity of at least 99.0% by HPLC.

Id. col. 911. 55-58 (emphasis added).

Around 1981, Hirsch Industries (“Hirsch”) developed a 1% injectable solution of ISB, which it commercialized under the trade name Lymphazurin®. Covidien Ltd. (“Covidien”),. the successor-in-interest to Hirsch, held the original new drug application (“NDA”) and was the sole supplier of Lymphazurin® for 30 years. From its inception, Lymphazurin®’s production had been plagued by difficulties in synthesizing and purifying ISB. Hirsch’s original clinical trials described the mixture as containing 94.5% ISB as determined by HPLC, with the remaining 5.5% consisting of “closely related isomers” produced during synthesis. Mylan Institutional LLC v. Aurobindo Pharma Ltd., No. 2:16-cv-00491, 2016 WL 7587325, at *2 (E.D. Tex. Nov. 21, 2016) (“Report and Recommendation”) (internal quotation marks omitted).

For 26 years following the Food and Drug Administration’s (“FDA”) approval of ISB, Sigma-Aldrich Corp. (“Sigma”) supplied Hirsch and its successors with ISB that was manufactured by Allied Chemical Corp. (“Allied”). Allied’s manufacturing process was unknown, but analysis of its ISB indicated the presence of lead, which suggested the use of a lead compound in synthesis. Sigma developed an isolation process to remove the unwanted lead, but the ultimate purity of the ISB it sold was unknown. In 2000, Allied stopped supplying Sigma with ISB and, while Sigma was looking for a new supplier, Covidien was forced to notify its customers that it was “completely out of’ Lymphazurin® until it could find a new supplier for ISB. Id. at *2 (internal quotation marks omitted). By 2008, Sigma had a new supplier, Innovassynth, which synthesized ISB using ammonium dichromate, resulting in residual chromium impurities. Sigma reported numerous problems with the purity of Innovassynth’s product and eventually developed its own manufacturing process for ISB sometime around 2010.

Apicore was founded in 2003 and began developing an improved process for synthesizing ISB. In 2004, Apicore partnered with Synerx Pharma LLC (“Synerx”), My-lan Inst.’s predecessor, to develop and market a generic version of Lymphazu-rin®. In 2007, Apicore filed a patent application that ultimately led to the process and ’050 patents. Based on the claimed process, Synerx (acquired by Mylan Inst, in 2012) filed an abbreviated new drug application (“ANDA”) seeking FDA approval to market a generic Lymphazurin®; the FDA approved the ANDA in 2010. By 2011, ISB sales were a significant portion of Apicore’s revenue and in 2012, Covidien withdrew Lymphazurin® from the market for “reasons other than safety or effectiveness.” Id. at *3 (internal quotation marks omitted). Mylan Inst, became the sole supplier of the 1% ISB drug product until 2016, when Aurobindo entered the market.

Aurobindo sought FDA approval for a generic Lymphazurin®, informing the FDA that it had studied a “number of patents” describing ISB manufacture and selected, inter alia, Apicore’s ’992 patent, and that it “considered the process described [therein] for the initial sample preparation and further, the optimization of the process.” Id. (internal quotation marks omitted). Aurobindo acknowledged to the FDA that it was looking for a reagent “other than silver oxide.” Id. (internal quotation marks omitted). It eventually selected manganese dioxide, and its process resulted in ISB with a 5-10% impurity which could not be removed by recrystallization. Instead, it used preparatory HPLC to achieve an ISB purity of greater than 99.5%. Mylan sued Aurobindo for infringement and sought a preliminary injunction, which the district court granted.

First, the district court evaluated the likelihood of success on the merits and found that Aurobindo likely infringed the process patents under the doctrine of equivalents. Id. at *10-12. The court found that the difference in oxidation strength between silver oxide and manganese dioxide is “irrelevant” under both the “function-way-result” (“FWR”) and “insubstantial differences” tests for equivalence, as applied to the “face of the claims,” because the claims do not specify a requirement of oxidation strength. Id. at *11. Further, the court explained that, even if oxidation strength were relevant, it “finds manganese dioxide to be a mild oxidant equivalent to silver oxide in the context of the [process patents].” Id. The court credited Dr. Sessler’s (Mylan’s expert) testimony in light of record evidence that the silver oxide and manganese dioxide processes produce crude ISB in similar yields. The court explained that if manganese dioxide were a substantially stronger oxidizing agent than silver oxide, a skilled artisan “would expect different results.” Id. at *12.

The district court found that Aurobindo did not raise a substantial question of validity of the ’050 patent based on its arguments that the process patent is invalid: (1) under § 112 because the “by HPLC” limitation renders the claims indefinite; (2) under § 103 because the claims would have been obvious over various combinations of art; and (3) under § 102 because the claims are anticipated by Sigma’s manufacture and sale of ISB.

On the issue of indefiniteness, the district court credited Sessler’s testimony and found that “by HPLC” was a common and well-understood way of designating or determining purity, as seen in “numerous sources,” including other patents and the scientific literature. Id. at *8-9. Thus, the court concluded that Aurobindo had not raised a substantial question of validity of the ’050 patent under § 112. Id.

The district court also rejected Aurobin-do’s obviousness argument, finding that Aurobindo did not raise a substantial question regarding motivation to combine the references or a reasonable expectation of success. See id. at *22. The court noted that “a purified compound is not always prima facie obvious over the [prior art] mixture” if the process to arrive at the purified compound is itself of patentable weight. Id. at *18 (citing Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1301 (Fed. Cir. 2007)) (internal quotation marks omitted). The court concluded that Apicore’s process leading to the purified compound claimed in the ’050 patent constituted “an invention of patentable weight itself’ and thus the purity claims would not necessarily have been prima facie obvious over the prior art mixture of (less pure) ISB and “closely related isomer[ ]” by-products. Id. at *18, *19 (internal quotation marks omitted).

The district court credited Mylan’s evidence of secondary considerations—specifically, long-felt but unmet need, commercial success, copying/praise of others, and unexpected results. Id. at *20-22. The court pointed to the failure of Allied, Sigma, Innovassynth, and others in the art to “reliably” produce “high-purity” ISB for 30 years. Id. at *20. And the court emphasized that Aurobindo “admitted to the FDA” that it had copied the ’992 patent. Id. at *21. Thus, the court concluded that Aurobindo had not raised a substantial question that the ’050 patent is invalid as obvious. Id.

The district court also concluded that Aurobindo had not raised a substantial question that the ’050 patent claims were anticipated under § 102(b) and § 102(g)(2) by Sigma’s manufacture and sale of ISB. See id. at *13. Aurobindo argued that Sigma had made and sold ISB having a purity of greater than 99.0% six years before the ’050 patent priority date. See id. Auro-bindo supported its position by citing a Sigma Certificate of Analysis, which indicated that a compound named “Patent Violet Blue,” with a certain product number and Lot number, possessed a purity that was 100% by HPLC. Id. The court rejected Aurobindo’s argument, finding that: (1) it is not clear that, at the time of the Certificate, Sigma’s use of the term “Patent Violet Blue” referred to ISB because other Sigma documents indicate that “Patent Violet Blue” referred to several blue dye compounds with different structures; and (2) the record established that the Certificate is inaccurate because it “contradicts numerous other Sigma[ ] documents” that report a different purity for samples from the same Lot. Id. at *14. Thus, the court concluded that Aurobindo had not raised a substantial question that the ’050 patent is invalid as anticipated. Id.

Second, the district court found that Apicore would be irreparably harmed without a preliminary injunction and identified four “hallmark examples” of irreparable harm that are demonstrated by the record: lost sales; lost R & D; price erosion; and that Apicore must now directly compete with an infringer. Id. at *23; Order Adopting R & R, 2017 WL 497593, at *1.

The district court found a “causal nexus” between Aurobindo’s infringement and Apicore’s harm in that Aurobindo’s product “would not be on the market if [it] had not obtained [FDA] approval for a product that will likely be found to be covered by the patents.” Order Adopting R & R, 2017 WL 497593, at *1. The court noted that “[w]ithout infringing the ’992, ’616, and ’050 patents, Aurobindo would not be able to make the [ISB] product described in its ANDA” because Aurobindo’s ANDA application touted greater than 99.0% purity for ISB. Report and Recommendation, 2016 WL 7587325, at *24.

Third, the district court found that the balance of equities weighed in favor of granting the injunction. Id. The court emphasized that Apicore “stands to lose its entire [ISB] business, ... which it relies on to fund ongoing research and development,” and that Aurobindo was aware of Apicore’s patented process and copied it. Id. Thus, the court found that the balance of equities favored Apicore. Id. (citing Windsurfing Int’l Inc. v. AMF, Inc., 782 F.2d 995, 1003 (Fed. Cir. 1986) (“One who elects to build a business on a product found [likely] to infringe cannot be heard to complain if an injunction against continuing infringement destroys the business so elected.”)).

Finally, the district court found that the public interest factor also favored granting the preliminary injunction. The court observed that Apicore satisfied its end of the patent bargain by disclosing its method for preparing ISB and that it would likely not have done so if it had known that a competitor would use that method to destroy its ISB business before it “could make it to trial.” Id. The court emphasized that the public interest in obtaining lower-priced pharmaceutical compounds cannot justify “entirely eliminating the exclusionary rights covered by pharmaceutical patents.” Id. (internal quotation marks omitted).

Aurobindo appeals the district court’s grant of a preliminary injunction. We have jurisdiction pursuant to 28 U.S.C. § 1292(a)(1) and (c)(1).

Discussion

The grant or denial of a preliminary injunction is within the sound discretion of a district court, and we will not reverse its judgment absent an abuse of that discretion. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001). Accordingly, we will only overturn a decision granting a preliminary injunction on appeal if “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.” Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1374 (Fed. Cir. 2006) (quoting Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361, 1364 (Fed. Cir. 1997)). We review the district court’s conclusions of law de novo. Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd., 357 F.3d 1319,1325 (Fed. Cir. 2004).

“A plaintiff seeking a preliminary injunction must establish that he is likely to succeed on the merits, that he is likely to suffer irreparable harm in the absence of preliminary relief, that the balance of equities tips in his favor, and that an injunction is in the public interest.” Winter v. Nat. Res. Def. Council, Inc., 555 U.S. 7, 20, 129 S.Ct. 365, 172 L.Ed.2d 249 (2008).

On appeal, Aurobindo disputes the court’s findings that Aurobindo “more likely than not” infringes the process patents under the doctrine of equivalents, Report and Recommendation, 2016 WL 7587325, at *12; Aurobindo did not raise a substantial question as to validity of the ’050 patent; and there was irreparable harm to Apicore. We discuss each issue in turn.

I. Process Patents

We first consider whether the district court erred in finding that Mylan is likely to succeed on the merits because Aurobindo “more likely than not” infringes the process patents under the doctrine of equivalents. Report and Recommendation, 2016 WL 7587325, at *12. To establish a likelihood of success on the merits, a pat-entee must show that it will likely prove infringement of the asserted claims and that its infringement claim will likely withstand the alleged infringer’s challenges to patent validity and enforceability. Sciele Pharma, Inc. v. Lupin Ltd., 684 F.3d 1253, 1259 (Fed. Cir. 2012) (citing Amazon.com, 239 F.3d at 1350). A preliminary injunction should not issue if the accused infringer “raises a substantial question concerning either infringement or validity.” Amazon.com, 239 F.3d at 1350.

Aurobindo argues that it had raised a substantial question of infringement of the process patents under the doctrine of equivalents because manganese dioxide oxidizes isoleuco acid in a different way than silver oxide in that manganese dioxide is a strong oxidizing agent, whereas silver oxide is a weak oxidizing agent. Additionally, Aurobindo continues, manganese dioxide oxidation requires the use of an acid and the patents specifically report the use of silver oxide as not requiring an acid.

Mylan responds that the district court correctly found a likelihood of success on the merits of infringement under the doctrine of equivalents because the court properly found that manganese dioxide and silver oxide are equivalent in the context of the process patents. Specifically, the court credited Sessler’s testimony in light of record evidence that the silver oxide and manganese dioxide processes produce crude ISB in similar yields. The court explained that if manganese dioxide was a substantially stronger oxidizing agent than silver oxide, a skilled artisan “would expect different results.” Report and Recommendation, 2016 WL 7587325, at *12. That finding, Mylan argues, was not clearly erroneous.

As set forth below, we conclude that the district court’s analysis of equivalence in this case was flawed, no doubt because of the sparse and confusing case law concerning equivalents, particularly the paucity of chemical equivalence case law, and the difficulty of applying the legal concepts to the facts. We will attempt to provide more clarity on these subjects.

This appeal is unusual in a first sense in that it arises from the grant of a preliminary injunction based on the doctrine of equivalents. There are few such reported decisions, but see, e.g., Pfizer, Inc. v. Teva Pharm., USA, Inc., 429 F.3d 1364, 1378 (Fed. Cir. 2005), owing to the fact that equivalents cases are “highly factual inquiries] [that] rarely come[] clear on a premature record.” Jeneric/Pentron, Inc. v. Dillon Co., Inc., 205 F.3d 1377, 1384 (Fed. Cir. 2000). Moreover, the law on the doctrine of equivalents as applied to chemical materials is not clear, and its misapplication can lead to unsound results. This appears to be such a case.

In Graver Tank, the Supreme Court set out two frameworks for evaluating equivalence—the familiar FWR test (viz., whether the accused product performs “substantially the same function in substantially the same way to obtain the same result”) and the insubstantial differences test (whether the accused product or process is substantially different from what is patented). Graver Tank & Mfg. Co. v. Linde Air Prod. Co., 339 U.S. 605, 608, 609, 70 S.Ct. 854, 94 L.Ed. 1097 (1950). The Supreme Court’s most recent visit with this branch of the law was in Warner-Jenkinson, which dealt with whether a process of purification performed at a pH of 5 was equivalent to one performed at a pH of 6-9. Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 39, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). The Court noted that equivalence,is not a “prisoner of formula,” id. at 39, 117 S.Ct. 1040, but also observed that non-mechanical cases may not be well-suited to consideration under the FWR test, see id. at 39-40, 117 S.Ct. 1040 (“There seems to be substantial agreement that, while the [FWR] test may be suitable for analyzing mechanical devices, it often provides a poor framework for analyzing other products or processes.”).

The Supreme Court was surely correct in stating that non-mechanical cases may not be well-suited to consideration under the FWR test. That seems to be particularly true in the chemical arts. Although in Graver Tank, the Supreme Court recognized the use of FWR generally in chemical cases, 339 U.S. at 608, 70 S.Ct. 854 (“Today the doctrine [of equivalents] is applied to mechanical or chemical equivalents in compositions or devices.”), the Court later acknowledged in Wamer-Jen-kinson that the suitability of the two tests may vary, depending on the circumstances of the case, 520 U.S. at 40, 117 S.Ct. 1040 (“Different linguistic frameworks may be more suitable to different cases, depending on their particular facts.”). Thus, the Court seemingly blessed two equivalents tests, leaving to the lower courts in future cases the choice of which to apply.

The district court here applied the FWR test in evaluating the equivalence issue. We will therefore review its decision first in that light. In doing so, we conclude that the district court’s analysis of the process claims under FWR was flawed by being unduly truncated and hence incomplete.

Especially when evaluating an equivalents dispute dealing with chemical compositions having many components, chemical compounds with many substituents (which are usually claimed as separate limitations), and those having a medical or biological use, it is often not clear what the “function” or “way” is for each claim limitation. How a particular component’ of a composition, or substituent of a compound, functions in a human or animal body, or in what way, may not be known or even knowable (although, as technology evolves, that may change). And precedent requires that, for infringement under the doctrine of equivalents, each limitation must satisfy an equivalence test. See Warner-Jenkinson, 520 U.S. at 40, 117 S.Ct. 1040.

The “result” of using a claimed compound may be more easily evaluated, as the structure and uses of one compound may be directly compared with those of another. But, as indicated above, that is not how infringement under FWR is determined. It must be determined on a limitation-by-limitation basis. See id. Similarly, in the case of a chemical process claim, as in this case, the “result” of a process pro-during a chemical compound may be clear —why else would a claim for infringement of a process claim be brought if the claimed result is not obtained? But the “function” and “way” of a particular limitation of a chemical process claim may remain vague and often overlap. In some cases, “way” and “function” may be synonymous.

Aurobindo argued before the district court that the “function” prong of the FWR test was not met because of the difference in oxidation strength between silver oxide and manganese dioxide. But the court did not seem to address that argument, which in actuality related to the “way” component of the FWR test. The court stated that “[c]onverting the isoleuco acid to isosulfan blue acid is the function of the silver oxide,” and then dismissed Aurobindo’s oxidation strength argument as “irrelevant” to the FWR and “insubstantial difference” tests. Report and Recommendation, 2016 WL 7587325, at *11 (emphasis added). Nevertheless, the court made a finding that silver oxide and manganese dioxide are “equivalent” in the context of the process patents, without considering the “way” prong of the FWR test. Id. In fact, the court appeared to consider the relative oxidation strengths of silver oxide and manganese dioxide as a consideration for claim construction, rather than its equivalents analysis. Id. at *10-12 (stating that the relative oxidation strengths are “irrelevant” for both the FWR and insubstantial differences tests and that Au-robindo had not argued for a “narrow[er]” claim construction that would read an oxidation strength limitation into the claims, but noting that a “more fully-developed factual record and claim construction proceeding could change things” (em-phases added)).

Thus, either the district court did not address the “way” prong of the FWR analysis—having considered the relative oxidation strengths to be an issue for claim construction, and rejecting Aurobin-do’s arguments about oxidation strength because it had not argued for a narrow claim construction—or it performed a “way” analysis without considering critical factors under that prong, namely, the relative oxidation strengths of silver oxide and manganese dioxide, as well as the use of an acid in the accused process. Either characterization constitutes error in the court’s equivalents analysis.

The district court correctly evaluated the “function” aspect of the FWR test— deciding, in effect, that the function of the silver oxide was to oxidize the precursor isoleuco compound to ISB acid. But that is not considering the “way” the oxidation works. Manganese dioxide and silver oxide may have the same jfunction, but the question is whether they operate in the same way. Critical facts that might be considered in an equivalents analysis include the relative oxidation strengths of the two oxidizing agents, as argued by Aurobindo, and the fact that manganese dioxide requires the use of an acid for oxidation, but silver dioxide does not, and results in a different yield. All of this in fact may at trial indicate a different “way.” Thus, there is room for sufficient doubt as to whether silver oxide and manganese dioxide oxidize isoleuco acid in the same way so as to satisfy the “way” prong of the FWR test.

Accordingly, the district court erred in its equivalents analysis under FWR and we reverse its determination. When the case goes back to the district court for a full trial on the merits, the court may wish to consider whether the substantiality of the differences test may be more applicable in this case. Even if evaluating the “function” and “way” prongs is feasible, the FWR test may be less appropriate for evaluating equivalence in chemical compounds if it cannot capture substantial differences between a claimed and accused compound.

For example, consider the well-known compounds aspirin and ibuprofen, which chemists would not usually consider to be structural equivalents under the insubstantial differences test. Chemical compounds are characterized by their structures, and these two compounds differ substantially in structure (see appendix). However, the two compounds would seem to be substantial equivalents under the FWR test. They each provide analgesia and anti-inflammatory activity (“function”) by inhibiting prostaglandin synthesis (“way”) in order to alleviate pain, reduce fevers, and lessen inflammation (“result”). See, e.g., Hilton Davis Chem. Co. v. Warner-Jenkinson Co., 62 F.3d 1512, 1546 (Fed. Cir. 1995) (Lourie, J., dissenting). Thus, a compound may appear to be equivalent under the FWR test, but not under the substantiality of the differences test. Hence, the substantial differences test may be more suitable than FWR for determining equivalence in the chemical arts. Warner-Jenkinson, 520 U.S. at 40, 117 S.Ct. 1040 (“Different linguistic frameworks may be more suitable to different cases, depending on their particular facts.”).

In this case, the district court conducted an incomplete FWR analysis while essentially bypassing the substantial differences test, in a situation where the latter test might seemingly be more appropriate. The claims in the process patents r-ecite a method for preparing a specifically named compound by combining another specifically depicted compound with a third specific compound, viz., silver oxide. Each of these compounds is expressly named, and an infringement analysis must not take lightly the specific recitation of these materials. The district court found that the accused process using manganese dioxide was equivalent to the claimed process using silver oxide. But the court failed to consider whether the key reagent in the process, manganese dioxide, was substantially different from the claimed reagent, silver oxide, and hence whether the substitution for, and omission of, silver oxide left the accused infringer outside of the bounds of the claims.

Manganese dioxide and silver oxide are substantially different in many respects. For example, manganese and silver are in different groups of the Periodic Table. In oxide form, manganese has an oxidation state of +4, while silver is +1. Those differences may well be relevant to equivalence at trial. Thus, the choice of test under the doctrine of equivalents may matter in this case.

When the case returns to the district court for a full trial on the merits, the court should, in addition to providing further analysis regarding fulfillment of the FWR test, if it determines that it should still utilize that test, also consider whether an evaluation of equivalence under the substantial differences test may be better suited to the particular facts of this case.

In sum, we conclude that the court’s equivalents analysis was deficient in its FWR analysis. Because, on the record, there remains a substantial question concerning infringement, we conclude that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion. Thus, we modify the court’s grant of the preliminary injunction to premise it only on its evaluation of the ’050 patent, as will be discussed infra.

II. ’050 Patent

We next consider whether the district court erred in finding that Aurobindo did not raise a substantial question as to validity of the ’050 patent. Id. at *14, *23. Aurobindo does not appeal the court’s finding that it “more likely than not” infringes the ’050 patent. Id. at *12. Thus, the pre-limfyary injunction premised on the ’050 patent will stand unless Aurobindo raised a substantial question concerning the validity of the patent, or unless the court erroneously found irreparable harm. We find that the court did not err in either respect.

Aurobindo argues that the claims of the ’050 patent are anticipated by Sigma’s ISB product because a Sigma Certificate of Analysis shows that Sigma made and sold ISB with a purity of 100% six years before the relevant date of the ’050 patent. Furthermore, Aurobindo argues that the ’050 patent would have been obvious over Lymphazurin® itself because the pri- or art taught the use of HPLC and other conventional purification techniques for purifying ISB. Finally, Aurobindo argues that the ’050 patent is invalid because the limitation “having a purity of at least 99.0% by HPLC” is indefinite. Aurobindo contends that different HPLC parameters will produce different results in a purity analysis and thus, because the claims do not specify HPLC parameters, they are indefinite.

Mylan responds that the district court’s findings regarding a lack of a substantial question of validity due to anticipation, obviousness, and indefiniteness were not clearly erroneous.

We agree with Mylan. Aurobindo points to no legal error in the district court’s analysis of the record evidence; rather, it argues only that the court erred in “misreading the factual content of the prior art.” Appellant’s Br. 43. However, what the prior art teaches is a question of fact that we review with deference, especially at the preliminary injunction stage. Amazon.com, 239 F.3d at 1358. We do not “reweigh evidence on appeal.” In re NTP, Inc., 654 F.3d 1279, 1292 (Fed. Cir. 2011).

The district court rejected Aurqbindo’s argument that the ’050 patent claims are anticipated by Sigma’s manufacture and sale of ISB because it found that the Sigma Certificate of Analysis related to a compound named “Patent Violet Blue” and it was not clear that, at the time of the issuance of the Certificate, Sigma used that term to refer to ISB. Additionally, the Certificate contradicts other Sigma documents that report different purity levels for samples from the same Lot. Report and Recommendation, 2016 WL 7587325, at *14. We discern no clear error in those findings.

The district court also rejected Au-robindo’s obviousness argument, finding that Aurobindo did not raise a substantial question regarding motivation to combine the references or a reasonable expectation of success. See id. at *22. The court found that Apicore’s 'process leading to the claimed ISB product with a purity of greater than 99.0% constituted “an invention of patentable weight itself’ and thus that the ’050 patent claims would not necessarily have been prima facie obvious over the prior art mixture of (less pure) ISB and “closely related isomer[]” byproducts. Id. at *18, *19 (internal quotation marks omitted).

Finally, the district court rejected Auro-bindo’s argument that the ’050 patent claims are invalid as indefinite. The court found that the phrase “by HPLC” was a “common and well understood way of designating purity in publications and patents that are relied upon by the scientific and technical community.” Id. at *8 (quoting Sessler’s testimony). The court found that “numerous sources” support that determination, including patents filed before the relevant date of the ’050 patent.

We see no error in the district court’s analysis. We have previously acknowledged that “a purified compound is not always prima facie obvious over the [prior art] mixture” if the process to arrive at the purified compound is itself of patentable weight. Aventis, 499 F.3d at 1301. Moreover, if the prior art teaches a mixture containing a compound but does not enable its purification, then the purified form of the compound may not have been obvious over the prior art mixture. See, e.g., Spectrum Pharm., Inc. v. Sandoz Inc., 802 F.3d 1326, 1335-36 (Fed. Cir. 2015) (concluding that a purified compound would have been obvious over the prior art mixture where, inter alia, “the whole spectrum of prior art available before the invention was made would have enabled one of skill in the art to make and use the claimed substantially pure ... compound” (emphasis added)). The court expressly relied on the Aventis proposition in making its determination. Report and Recommendation, 2016 WL 7587325, at *17-18 (quoting Aventis, 499 F.3d at 1301). We see no error in its analysis. It is clear from the record here that, although ISB was known in the prior art, the path to arrive at ISB with a purity of greater than 99.0% was not known before the relevant date of the ’050 patent.

Furthermore, the district court credited Mylan’s evidence of secondary considerations—specifically, long-felt but unmet need, commercial success, copying/praise of others, and unexpected results. Id. at. *20-22. The court relied on record evidence showing the failure of Allied, Sigma, Innovassynth, and others in the art to “reliably” produce “high-purity” ISB for 30 years, id. at *20, and that Aurobindo “admitted to the FDA” that it had copied the ’992 patent, id. at *21. There is no clear error in the court’s findings. In fact, the record demonstrates that, prior to the ’050 patent’s relevant date, a reliable source of high-purity ISB was so scarce that, at one point, Covidien was forced to notify its customers that it was “completely out of’ Lymphazurin® until it could find a new supplier for ISB. Id. at *2 (internal quotation marks omitted).

Finally, there is no error in the court’s determination that the ’050 patent is likely not invalid as indefinite. The court’s finding was supported by substantial record evidence, including the scientific literature and other patents reporting purity using the same “by HPLC” designation without providing specific HPLC parameters. Id. at *8. The court found that even Dr. Brown’s testimony (Aurobindo’s expert) admitted that “purity by HPLC” is typically used in FDA submissions for describing purity levels. Id. at *9. Thus, the court determined that a skilled artisan “would readily understand” the phrase and would be able to “elucidate HPLC conditions” for determining ISB purity. Id. We see no error in that finding.

Thus, we see no error in the court’s legal analysis or its factual findings pertaining to validity of the ’050 patent, particularly at the preliminary injunction stage of the litigation.

III. Irreparable Harm

Finally, we consider whether the district court erred in finding a likelihood that Apicore will sustain “substantial and immediate irreparable injury” without preliminary relief. Id. at *22 (citing Apple, Inc. v. Samsung Elects. Co., 678 F.3d 1314, 1325 (Fed. Cir. 2012)) (internal quotation marks omitted).

Aurobindo argues that the district court erred in finding a causal nexus between Apicore’s alleged harm and the patented features of the process and ’050 patents. Aurobindo contends that the patented features are the use of silver oxide to oxidize isoleuco acid, and that the ISB employed in the finished drug product is at least 99.0% pure by HPLC. However, Aurobin-do argues, there is no evidence that the consumer demand for Mylan’s product arises from the fact that the ISB it contained was synthesized using silver oxide or that the ISB is at least 99.0% pure; in fact, argues Aurobindo, that information is not available anywhere on Mylan’s marketing materials for its ISB drug product. Rather, Aurobindo continues, the record shows that there was no consumer demand for the patented product because Lympha-zurin® was commercially successful until Mylan Inst.’s product drove it out of the market due to pricing—not due to the difference in the manufacturing process or purity of the ISB it contains.

Mylan responds that Aurobindo’s causal nexus argument is flawed because it improperly focuses on a subset of the relevant customers (physicians) and ignores all others (active pharmaceutical ingredient (“API”) suppliers, pharma companies, hospitals, the FDA, etc.). Mylan maintains that Apicore’s harm is directly caused by Aurobindo’s infringement because ample evidence shows Sigma’s difficulty in finding an acceptable ISB supplier and that, by admittedly copying Apicore’s patented process, Aurobindo gained a competitive advantage.

We agree with Mylan that the district court’s determinations were not clearly erroneous. On the record evidence, the court found that: (1) due to Aurobindo’s infringement, Apicore has, and will continue to, suffer from lost sales, lost research and development, price erosion, and having to directly compete with an infringer, id. at *23; (2) there was a causal nexus between Aurobindo’s infringement and Apicore’s harm because Aurobindo’s product “would not be on the market if [it] had not obtained [FDA] approval for a product that will likely be found to be covered by the patents,” Order Adopting R & R, 2017 WL 497593, at *1; and (3) “[without infringing the [process and purity] patents, Aurobin-do would not be able to make the [ISB] product described in its ANDA,” Report and Recommendation, 2016 WL 7587325, at *24.

Those findings do not constitute clear error. Aurobindo argues that the court could not rely on the FDA’s approval of Aurobindo’s ANDA application to automatically find a causal nexus between Api-core’s harm and Aurobindo’s infringement. But that is not what the court found or how the court used that evidence. The record evidence shows Aurobindo’s admitted copying of Apicore’s ’992 patent, id. at *4, Aurobindo’s ANDA promising an ISB purity of greater than 99.0%, id. at *24, and the failure of all others in the art to obtain an ISB purity of greater than 94.5% until the invention of the ’050 patent, id. at *20. Thus, the district court reasonably found that, “[w]ithout infringing the [process and ’050] patents, Aurobindo would not be able to make the [ISB] product described in its ANDA.” Id. at *24. In making that determination, the court did not rely on regulatory approval to automatically confer a causal nexus, as Auro-bindo argues. Rather, it made a reasoned factual determination, supported by substantial record evidence. We see no legal error in the court’s analysis and no clear error in its factual findings.

Aurobindo does not challenge the district court’s findings that the balance of equity and public interest factors weigh in favor of granting the preliminary injunction. Thus, because we find no error in the court’s determination that Aurobindo has not raised a substantial question of validity of the ’050 patent and that Apicore will be irreparably harmed without preliminary relief, we affirm the district court’s grant of the preliminary injunction premised on the ’050 patent.

Conclusion

We have considered the parties’ remaining arguments, but find them to be unpersuasive. For the reasons set forth above, we modify the court’s grant of a preliminary injunction by premising it only on the ’050 patent.

AFFIRMED

Costs

No costs.

Appendix

      . Because the '992, '616, and '050 patents have the same written description, when referring to the written description of any of the patents, we will cite only the '992 patent for simplicity.

      . Because the district court adopted the magistrate judge's report and recommendation, see Order Adopting R & R, 2017 WL 497593, at *1, we shall refer to both the district court judge's and magistrate judge's findings and conclusions as those of the district court.

      . The court only analyzed "irreparable harm” as to Apicore, a fact that neither party challenges on appeal.

      . We note that the district court recognized that the FWR test "may inform whether insubstantial differences exist between a claim element and an accused element.” Report and Recommendation, 2016 WL 7587325, at *11. Under that analysis, the district court concluded that "the oxidation strength of manganese dioxide is irrelevant under the insubstantial difference test,” dismissing any consideration of oxidation strength on claim construction grounds, as will be discussed further below. Id. Thus, the district court did not evaluate whether silver oxide and manganese dioxide are insubstantially different.

      . In this case, the parties did not dispute the "result” prong before the magistrate judge, but did do so before the district court judge, who did not address those arguments. Thus, the court never made a finding on the "result” prong. However, we need not decide whether that constituted reversible error because we modify the preliminary injunction for other reasons set forth herein below.

      . We note that the court seemed to make a finding as to the "function” prong, without stating it as such. It acknowledged that Auro-bindo only disputed the "function” of the oxidizing agents, but then stated that "[cjon-verting the isoleuco acid to isosulfan blue acid is the function of the silver oxide,” while rejecting Aurobindo's arguments on claim construction grounds. Id. at *11 (emphasis added). We will treat that part of the court's analysis as its finding under the "function” prong of the FWR test.

      . Ordinarily a failure by the district court to properly apply the doctrine of equivalents would warrant a remand. However, because the injunction will stand under the '050 patent, as will be discussed infra, we see no need to expend judicial resources and litigation expenses on a remand. Thus, we will modify the district court’s decision by affirming the grant of a preliminary injunction premised only on the '050 patent.


author: HUGHES, Circuit Judge.

text:
    Regina E. LEE, Petitioner v. MERIT SYSTEMS PROTECTION BOARD, Respondent
    2017-1232
    United States Court of Appeals, Federal Circuit.
    Decided: May 25, 2017
    Regina E. Lee, DeSoto, TX, pro se.
    Katherine Michelle Smith, Office of the General Counsel, Merit Systems Protection Board, Washington, DC, for respondent. Also represented by Bryan G. Poli-suk.
    Before O’MALLEY, HUGHES, and STOLL, Circuit Judges.
   HUGHES, Circuit Judge.

Regina Lee appeals a final decision of the Merit Systems Protection Board dismissing her appeal for lack of jurisdiction. Because Ms. Lee was not subject to an adverse action appealable to the Board, we affirm.

I

On March 16, 2008, Ms. Lee began an appointment under the Federal Career Intern Program (FCIP) with U.S. Citizenship and Immigration Services, Department of Homeland Security. Prior to her appointment in the FCIP, Ms. Lee had completed almost six years of federal service under a series of term appointments. On March 5, 2010, the agency notified Ms. Lee that her FCIP appointment would expire on March 15, 2010, and that upon completion of the appointment, the agency would not convert it into a competitive service appointment. Consequently, when Ms. Lee completed her FCIP term, she was terminated from federal service.

Ms. Lee appealed her termination to the Board. The Administrative Judge dismissed Ms. Lee’s case for lack of jurisdiction, and the Board affirmed. Ms. Lee appeals. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(9).

II

We review the Board’s decision to determine if it is: “(1) arbitrary, capricious, an abuse of discretion, otherwise not in accordance with law; (2) obtained without procedures required by law, rule, or regulation having been followed; or (3) unsupported by substantial evidence.” 5 U.S.C. § 7703(c). The Board’s determination that it lacks jurisdiction is a question of law that we review de novo. Bennett v. Merit Sys. Prot Bd., 635 F.3d 1215, 1218 (Fed. Cir. 2011).

The Board’s jurisdiction “is limited to those matters over which it has been given jurisdiction by law, rule, or regulation.” Id. Ms. Lee alleges that the Board has jurisdiction over her appeal pursuant to 5 U.S.C. § 4303 and 5 C.F.R. § 1201.3(a)(1). Ms. Lee bears the burden of proving the Board’s jurisdiction over her appeal by a preponderance of the evidence. Id.

We have previously held that the Board lacks jurisdiction over appeals from certain FCIP interns who are not converted to competitive service after the expiration of their appointment term. Rocha v. Merit Sys. Prot. Bd., 688 F.3d 1307, 1311 (Fed. Cir. 2012). An agency’s decision not to convert an FCIP intern to competitive service is not an “adverse action” appeal-able to the Board, see 5 C.F.R. § 1201.3(a)(1), because the implementing regulations clearly explain that interns have no right to further federal employment after their appointments expire:

(6) Conversion to Competitive Service. Except as provided in paragraph (o)(6)(ii) of this section, service as a career intern confers no rights to further Federal employment in either the competitive or excepted service upon expiration of the internship period.
(i) Competitive civil status may be granted to career interns who successfully complete their internships and meet all qualification, suitability, and performance requirements....
(ii) An employee who held a career or career-conditional appointment in an agency immediately before entering the FCIP in the same agency, and who fails to complete the FCIP for reasons unrelated to misconduct or suitability, shall be placed in a career or career-conditional position in the current agency....
(7) Terminations. As a condition of employment, the appointment of a career intern expires at the end of the 2-year internship period, plus any extension .... If an employee is not converted to a career or career-conditional appointment, the career intern appointment terminates, unless the employee is specifically eligible for placement under paragraph (o)(6)(ii) of this section.

5 C.F.R. § 213.3202(o) (2006).

Ms. Lee does not focus on this regulation, but argues that the Board erred by ignoring Executive Order No. 13,162, which created the FCIP. 65 Fed. Reg. 43,211 (July 6, 2000). The order is very similar to the promulgated regulation, with one notable difference. The order states, “[ejxcept as provided in subsections (4) and (5) of this section, service as a Career Intern confers no rights to further Federal employment in either the competitive or excepted service upon expiration of the internship period.” Id. According to subsection 4, “[cjompetitive civil service status may be granted to a Career Intern who satisfactorily completes the internship and meets all other requirements prescribed by the OPM.” Id. Because this is listed as an exception, Ms. Lee argues that her successful completion of the internship conferred upon her rights to further federal employment.

We disagree. We find the executive order and the regulation are consistent. The order states that competitive civil status may be granted to a successful intern, not that it shall be granted. The “exception” embodied by subsection (4) gave Ms. Lee the right to be considered for conversion, not the automatic right to be converted to competitive civil service status.

Further, the executive order explicitly states that the order “does not create any right or benefit, substantive or procedural, enforceable in law or equity, by a party against the United States, its agencies, its officers or employees, or any other person.” Id. at 43,212. Therefore, to the extent that § 213.3202(o)(6) prevents the Board from exercising jurisdiction over Ms. Lee’s case, the executive order cannot cure that deficiency.

Ms. Lee’s successful completion of her internship and satisfaction of OPM’s other requirements did not guarantee her the right to further federal employment when her internship expired. Therefore, the Board properly determined that it did not have jurisdiction over Ms. Lee’s appeal because she did not suffer an adverse action.

AFFIRMED

No costs.

      . The FCIP was an intern program created by Executive Order No. 13,162 to "attract exceptional men and women to the Federal workforce who have diverse professional experiences, academic training, and competencies, and to prepare them for careers in analyzing and implementing public programs.” 65 Fed. Reg. 43,211 (July 6, 2000). It was terminated on March 1, 2011 and replaced with the Pathways Program.

      . The Board has concluded that an FCIP intern can only establish an adverse action by proving: "(1) Immediately prior to his FCIP appointment, he held a career or career-conditional appointment in the same agency; (2) his failure to complete the internship successfully was for reasons unrelated to misconduct or suitability; and (3) he is an ‘employee’ within the meaning of 5 U.S.C. § 7511.” Scull v. Dep't of Homeland Sec., 113 M.S.P.R. 287, 295 (2010), aff'd, 515 Fed.Appx. 885 (Fed. Cir. 2013).