author: PROST, Chief Judge.

text:
    ELI LILLY AND COMPANY, Plaintiff-Appellee v. TEVA PARENTERAL MEDICINES, INC., APP Pharmaceuticals LLC, Pliva Hrvatska D.O.O., Teva Pharmaceuticals USA, Inc., Barr Laboratories, Inc., Defendants-Appellants
    2015-2067
    United States Court of Appeals, Federal Circuit.
    Decided: January 12, 2017

      Adam Lawrenoe Perlman, Williams & Connolly LLP, Washington, DC, argued for plaintiff-appellee. Also represented by Dov Philip Grossman, Bruce Genderson, David M. Krinsky, Allison Jones Rushing, Ellen E. Oberwetter.
    William M. Jay, Goodwin Procter LLP, Washington, DC, argued for defendants-appellants. Also represented by Daryl L. Wiesen, Elaine Blais, Emily L. Rapalino, Henry C. Dinger, Boston, MA; Brian Joseph Prew, Miohael B. Cottler, Natasha Elise Daughtrey, New York, NY.
    Christina Jordan McCullough, Perkins Coie, LLP, Seattle, WA, for amicus curiae Generic Pharmaceutical Association. Also represented by Shannon Bloodworth, Washington, DC.
    Kevin Soott Prussia, Wilmer Cutler Pickering Hale and Dorr LLP, Boston, MA, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by Sameer Ahmed; Jamie Wisz, Washington, DC.
    David S. Forman, Osha Liang LLP, Alexandria, VA, for amicus curiae Biotechnology Innovation Organization. Also represented by Hansjorg Sauer, Biotechnology Innovation Organization, Washington, DC.
    Before PROST, Chief Judge, NEWMAN and DYK, Circuit Judges.
   PROST, Chief Judge.

Eli Lilly & Co. (“Eli Lilly”) is the owner of U.S. Patent No. 7,772,209 (“ ’209 patent”). It fried this consolidated Hatch-Wax-man suit against Teva Parenteral Medicines, Inc.; APP Pharmaceuticals LLC; Pliva Hrvatska D.O.O.; Teva Pharmaceuticals USA, Inc.; and Barr Laboratories, Inc. (collectively, “Defendants”) to prevent Defendants from launching a generic version of a chemotherapy drug with accompanying product literature that would allegedly infringe methods of treatment claimed by the ’209 patent. The United States District Court for the Southern District of Indiana held two bench trials, one on infringement and one on invalidity. The district court found that no single actor performs all steps of the asserted claims because the actions of both physicians and patients are required. Nonetheless, under Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai V), 797 F.3d 1020, 1022 (Fed. Cir. 2015) (en banc) (per curiam), cert. denied, — U.S. -, 136 S.Ct. 1661, 194 L.Ed.2d 767 (2016), the court found direct infringement attributable to physicians and held Defendants liable for inducing that infringement. The court also determined that the asserted claims were not invalid for, inter alia, in-defrniteness, obviousness, or obviousness-type double patenting.

For the reasons below, we affirm.

BACKGROUND

The ’209 patent, which issued in 2010, relates to methods of administering the chemotherapy drug pemetrexed disodium (“pemetrexed”) after pretreatment with two common vitamins — folic acid and vitamin B12. Pemetrexed is an antifolate that kills cancer cells by inhibiting the function of folates, a class of nutrients necessary for cell reproduction. The purpose of the dual vitamin pretreatments is to reduce the toxicity of pemetrexed in patients. Eli Lilly markets pemetrexed under the brand name ALIMTA®, and the drug is used to treat certain types of lung cancer and mesothelioma.

Around 2008-2009, Defendants notified Eli Lilly that they had submitted Abbreviated New Drug Applications (“ANDAs”) seeking approval by the Food and Drug Administration (“FDA”) to market generic versions of ALIMTA®. After the ’209 patent issued, Defendants sent Eh Lilly additional notices regarding their ANDAs, including notices that they had filed Paragraph IV certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), declaring that the ’209 patent was invalid, unenforceable, or would not be infringed. Eli Lilly subsequently brought this consolidated action against Defendants for infringement .under 35 U.S.C. § 271(e)(2). Specifically, Eli Lilly alleged that Defendants’ generic drugs would be administered with folic acid and vitamin B12 pretreatments and, thus, result in infringement of .the ’209 patent. Defendants .raised noninfringement and invalidity defenses.

Eli Lilly asserted claims 9, 10,12,14,15, 18, 19, and 21 of the ’209 patent at trial. Importantly, all of the asserted claims require patient pretreatment by “administering” or “administration of’ folic acid. Claims 9 and 10 depend from claim 1, which recites:

1. A method of administering peme-trexed disodium to a patient in need thereof comprising administering an effective amount of folic acid and an effective amount of a methylmalonic acid lowering agent followed by administering an effective amount of pemetrexed diso-dium, wherein
the methylmalonic acid lowering agent is selected from the group consisting of vitamin B12, hydroxycobalamin, cyano-10-chlorocobalamin, aquocobalamin perchlorate, aquo-10-cobalamin perchlorate, azidocobalamin, cobalamin, cyanocobala-min, or chlorocobalamin.

’209 patent col. 10 11. 55-65 (emphasis added). The additional limitations of claims 9 and 10 restrict the dose of folic acid to particular ranges. Id. at col. 11 11. 19-22.

Asserted claim 12 is independent and recites:

12. An improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment, wherein the improvement comprises:
a) administration of between about 350 |xg and about 1000 |xg of folic acid prior to the first administration of pemetrexed disodium;
b) administration of about 500 p,g to about 1500 |xg of vitamin B12, prior to the first administration of pemetrexed disodium; and
c) administration of pemetrexed disodium.

Id. at col. 11 1. 25-col. 12 1. 4 (emphasis added). Asserted claims 14, 15, 18, 19, and 21 depend from claim 12 and further limit the dose, schedule, or route of folic acid or vitamin B12 administration. Id. at col. 1211. 7-11, col. 12 11. 16-20, col. 12 11. 24-27.

The parties agree for purposes of this appeal that no single actor performs all steps of the asserted claims; rather, the steps are divided between physicians and patients. Though physicians administer vitamin B12 and pemetrexed, patients self-administer folic acid with guidance from physicians. Eli Lilly’s theory of infringement therefore requires establishing liability for divided infringement — an area of law that this court was actively reconsidering during the pendency of this case.

In June 2013, Defendants conditionally conceded induced infringement under then-current law set forth in Akamai Technologies, Inc. v. Limelight Networks, Inc. (Akamai II), 692 F.3d 1301 (Fed. Cir. 2012) (en banc) (per curiam), rev’d, — U.S.-, 134 S.Ct. 2111, 189 L.Ed.2d 52 (2014). At the time, the Akamai II decision was the subject of a petition to the Supreme Court for a writ of certiorari. The parties’ stipulation included a provision reserving Defendants’ right to litigate infringement if the Supreme Court reversed or vacated Akamai II.

Eli Lilly and Defendants proceeded with a bench trial on invalidity, after which the district court held that the asserted claims were not invalid for, inter alia, obviousness or obviousness-type double patenting. The court had also previously rejected Defendants’ contention that the asserted claims were invalid for indefiniteness of the term “vitamin B12.” Defendants filed an appeal on invalidity, which was docketed in this court as Case No. 14-1455. While that appeal was pending, the Supreme Court reversed Akamai II, holding that liability for inducement cannot be found without direct infringement, and remanding for this court to possibly reconsider the standards for direct infringement. Limelight Networks, Inc. v. Akamai Techs., Inc. (Akamai III), — U.S.-, 134 S.Ct. 2111,189 L.Ed.2d 52 (2014). In view of that development, the parties in this case filed a joint motion to remand the matter to the district court for the limited purpose of litigating infringement. We granted the motion.

The district court held a second bench trial in May 2015 and concluded in a decision issued on August 25, 2015 that Defendants would induce infringement of the ’209 patent. As explained in further detail below, the court applied our intervening Akamai V decision, which had broadened the circumstances in which others’ acts may be attributed to a single actor to support direct-infringement liability in cases of divided infringement. See Akamai V, 797 F.3d at 1022. The court accordingly entered final judgment against Defendants, barring them from launching their generic products before the expiration of the ’209 patent.

Defendants timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(1).

Discussion

Defendants appeal the district court’s finding of induced infringement, as well as the court’s decision that the asserted claims are not invalid for indefiniteness, obviousness, or obviousness-type double patenting. We will address each of these issues in turn.

I

Pursuant to 35 U.S.C. § 271(b), “[w]hoever actively induces infringement of a patent shall be liable as an infringer.” Importantly, liability for induced in-fringement under § 271(b) “must be predicated on direct infringement.” Akamai III, 134 S.Ct. at 2117. The patentee must also show that the alleged infringer possessed the requisite intent to induce infringement, which we have held requires that the alleged infringer “knew or should have known his actions would induce actual infringements.” DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1304 (Fed. Cir. 2006) (en banc in relevant part) (internal quotation marks omitted). A patentee seeking relief under § 271(e)(2) bears the burden of proving infringement by a preponderance of the evidence. Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1366 (Fed. Cir. 2003).

“Infringement is a question of fact that, after a bench trial, we review for clear error.” Alza Corp. v. Mylan Labs, Inc., 464 F.3d 1286, 1289 (Fed. Cir. 2006). Reversal for clear error is appropriate “only when this court is left with a definite and firm conviction that the district court was in error.” Id.

The district court relied in part on Defendants’ proposed product labeling as evidence of infringement. For purposes of this case, the parties have agreed that Defendants’ product labeling would be materially the same as the ALIMTA® product labeling, which consists of two documents: the Physician Prescribing Information and the Patient Information. Both documents include instructions regarding the administration of folic acid— the step that the district court found would be performed by patients but attributable to physicians. For example, the Physician Prescribing Information provides, among other things:

“Instruct patients to initiate folic acid 400 [¡xg] to 1000 [pg] orally once daily beginning 7 days before the first dose of [pemetrexed].... ” J.A. 11256.
“Instruct patients on the need for folic acid and vitamin B12 supplementation to reduce treatment-related hematologic and gastrointestinal toxicity....” J.A. 11278.

The Patient Information includes similar information:

“To lower your chances of side effects of [pemetrexed], you must also take folic acid ... prior to and during your treatment with [pemetrexed].” J.A. 11253 (emphasis omitted).
“It is very important to take folic acid and vitamin B12 during your treatment with [pemetrexed] to lower your chances of harmful side effects. You must start taking 400-1000 micrograms of folic acid every day for at least 5 days out of the 7 days before your first dose of [peme-trexed] ....” Id. (emphasis omitted).

A

Where, as here, no single actor performs all steps of a method claim, direct infringement only occurs if “the acts of one are attributable to the other such that a single entity is responsible for the infringement.” Akamai V, 797 F.3d at 1022. The performance of method steps is attributable to a single entity in two types of circumstances: when that entity “directs or controls” others’ performance, or when the actors “form a joint enterprise.” Id. Eli Lilly did not pursue a joint enterprise theory, so the question of direct infringement before us is whether physicians direct or control their patients’ administration of folic acid.

In Akamai V, we held that directing or controlling others’ performance includes circumstances in which an actor: (1) “conditions participation in an activity or receipt of a benefit” upon others’ performance of one or more steps of a patented method, and (2) “establishes the manner or timing of that performance.” Id. at 1023 (emphases added). In addition to this two-prong test, we observed that, “[i]n the future, other factual scenarios may arise which warrant attributing others’ performance of method steps to a single actor. Going forward, principles of attribution are to be considered in the context of the particular facts presented.” Id.

Here, the district court decided that “the factual circumstances [we]re sufficiently analogous to those in Akamai [V] to support a finding of direct infringement by physicians.” Eli Lilly & Co. v. Teva Parenteral Meds., Inc. (Eli Lilly III), 126 F.Supp.3d 1037,1041 (S.D. Ind. 2015). The court observed initially that taking folic acid in the manner recited by the asserted claims is a “critical” and “necessary” step to “reducfe] ... potentially life-threatening toxicities caused by pemetrexed,” i.e., to “receive the benefit of the patented method.” Id. at 1042. Regarding the first Akamai V prong, the court found, based on the product labeling, that “taking folic acid in the manner specified is a condition of the patient’s participation in pemetrexed treatment.” Id. Regarding the second prong, the court found that physicians would “prescrib[e] an exact dose of folic acid and direct[ ] that it be ingested daily.” Id. at 1043. The court therefore held that, under Akamai V, the performance of all steps of the asserted claims would be attributable to physicians.

l

With respect to the first prong — conditioning participation in an activity or receipt of a benefit upon performance of one or more method steps — Defendants argue at the outset that the district court did not make a relevant finding because it misidentified the benefit that would be conditioned as the “benefit of the patented method, i.e., a reduction of potentially life-threatening toxicities caused by peme-trexed.” Appellants’ Opening Br. 21-22. We agree that a reduction in toxicities is not a benefit that physicians can condition (as it follows from folic acid pretreatment) and that the relevant benefit that may be conditioned on folic acid administration is pemetrexed treatment. But the court’s discussion of reducing pemetrexed toxicities in relation to its direction-or-control analysis was not erroneous. A reduction in pem-etrexed toxicities is relevant only if peme-trexed treatment is administered, and it provides a reason why physicians would condition the receipt of pemetrexed treatment on folic acid administration. The court recognized this relationship and correctly identified pemetrexed treatment as the benefit to be conditioned: “What is relevant is whether the physician sufficiently directs or controls the acts of the patients in such a manner as to condition participation in an activity or receipt of a benefit — in this case, treatment with pem-etrexed in the manner that reduces toxicities — upon the performance of a step of the patented method and establishes the manner and timing of the performance.” Eli Lilly III, 126 F.Supp.3d at 1042 (emphasis added); see also id. (“[TJaking folic acid in the manner specified is a condition of the patient’s participation in pemetrexed treatment.” (emphasis added)).

The district court’s finding that physicians “condition” pemetrexed treatment on the administration of folic acid is supported by the. record evidence. The Physician Prescribing Information, which is “directed to the physician,” J.A. 2181, explains that folic acid is a “[requirement for [p]remedication” in order “to reduce the severity of .hematologic and gastrointestinal toxicity of [pemetrexed].” J.A. 11258. Consistent with the importance of folic acid pretreatment, the product labeling repeatedly states that physicians should “[i]nstruct patients” to take folic acid and includes information about folic acid dosage ranges and schedules. J.A. 11256; see also J.A. 11255, 11278. The Patient Information also informs patients that physicians may withhold pemetrexed treatment: “You will have regular blood tests before and during your treatment with [pemetrexed]. Your doctor may adjust your dose of [pemetrexed] or delay treatment based on the results of your blood test and on your general condition.” J.A. 11253 (emphasis added).

Furthermore, Eli Lilly’s expert, Dr. Chabner, testified that it is “the physician’s responsibility to initiate the supplementation” of folic acid. J.A. 2181. He explained that the product labeling shows that taking folic acid is “an absolute requirement” before pemetrexed treatment because “it wouldn’t be safe to take the drug without the vitamin supplementation— [I]t must be done this way.” J.A. 2192; see also J.A. 2195 (“[I]t’s an absolute requirement.”), 2246 (“I think it’s that important.”). He further testified that if a physician realizes that a patient did not follow his or her instructions to take folic acid, then the “doctor will not give the pemetrexed.” J.A. 2218. Even Defendants’ expert, Dr. Schulz, acknowledged that it is “standard practice” — both his personally and physicians’ generally — that a patient “must have taken their required folic acid in order to have the pemetrexed administered.” J.A. 2329-40; see also J.A. 2304 (“I would withhold the pemetrexed therapy until [the patient] had initiated or resumed their folic acid treatment ... [s]o as to avoid the toxicities associated with peme-trexed without vitamin replacement.”). Dr. Schulz agreed that he was “not aware of any reputable institution or doctor ... who, when they think the patient hasn’t taken the required folic acid” would go ahead and administer pemetrexed. J.A. 2330-31.

The record is thus replete with evidence that physicians delineate the step of folic acid administration that patients must perform if they wish to receive pemetrexed treatment.

Defendants argue that mere guidance or instruction is insufficient to show “conditioning” under Akamai V. But the evidence regarding the critical nature of folic acid pretreatment and physicians’ practices support a finding that physicians cross the line from merely guiding or instructing patients to take folic acid to conditioning pemetrexed treatment on their administration of folic acid. If a patient does not take folic acid as instructed, a physician, in his or her discretion, need not provide pemetrexed treatment based on the patient’s failure to perform the step of folic acid administration. Defendants also complain that there is no evidence that physicians go further to “verify compliance” with their instructions or to “threaten” denial of pemetrexed treatment. Appellants’ Opening Br. 22. Conditioning, however, does not necessarily require double-checking another’s performance or making threats.

We also reject Defendants’ argument that an actor can only condition the performance of a step “by imposing a legal obligation to do so, by interposing that step as an unavoidable technological prerequisite to participation, or, as in [Aka-mai V], both.” Id. In Akamai V, we found “conditioning” based on evidence that the defendant required all of its customers to sign a standard contract delineating the steps that customers had to perform to use the defendant’s service. 797 F.3d at 1024. But we did not limit “conditioning” to legal obligations or technological prerequisites. We cautioned that “principles of attribution are to be considered in the context of the particular facts presented” and even expressly held that § 271(a) infringement “is not limited solely to principal-agent relationships, contractual arrangements, and joint enterprise.” Id. at 1023.

The product labeling, combined with the testimony discussed above, provide sufficient evidence that physicians condition pemetrexed treatment on folic acid pretreatment.

2

With respect to the second prong— establishing the manner or timing of performance — Defendants argue that the product labeling “gives patients wide berth to select the dose ..., the dosage form ..., and the timing ... of folic acid self-administration.” Appellants’ Opening Br. 23. Eli Lilly submits that expert testimony and product labeling demonstrate that “physicians prescribe or specify a dose of folic acid, specify that patients must ingest the folic acid daily during a particular span of days, and withhold pemetrexed if patients do not follow orders.” Appellee’s Br. 25. We agree with Eli Lilly.

The product labeling is again informative. For instance, the Physician Prescription Information instructs physicians not only to tell patients to take folic acid orally, but also to take “400 [¡xg] to 1000 [¡xg] [of folic acid] once daily beginning 7 days before the first dose of [pemetrexed],” accompanied with warnings about the consequences of non-compliance. J.A. 11256. That dosage range and schedule overlaps with all of the asserted claims’ dosage ranges and schedules. In addition, Dr. Chabner testified that “it’s the doctor” who “decides how much [folic acid] the patient will take and when the patient takes it.” J.A. 2197. In view of the record evidence, the court’s finding that physicians establish the manner and timing of patients’ folic acid intake is not clearly erroneous. Even if, as Defendants argue, patients are able to seek additional outside assistance regarding folic acid administration, such guidance is beyond what is required here to establish the manner or timing of performance and is therefore immaterial.

We therefore see no reversible error in the district court’s finding that physicians condition patient participation in an activity or receipt of a benefit (pemetrexed treatment) on folic acid administration and also establish the manner or timing of performance. Our holding today does not assume that patient action is attributable to a prescribing physician solely because they have a physician-patient relationship. We leave to another day what other scenarios also satisfy the “direction or control” requirement. The two-prong test that we set forth in Akamai V is applicable to the facts of this case and resolves the existence of underlying direct infringement.

B

Although we conclude that the two-prong Akamai V test is met here, this does not end our inquiry. “The mere existence of direct infringement by physicians, while necessary to find liability for induced infringement, is not sufficient for inducement.” Takeda Pharm. USA, Inc. v. WestWard Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015). To show inducement, Eli Lilly carries the burden of further proving “specific intent and action to induce infringement.” Takeda, 785 F.3d at 631. Mere “knowledge of the acts alleged to constitute infringement” is not sufficient. DSU Med., 471 F.3d at 1305.

As noted before, the district court found that the administration of folic acid before pemetrexed administration was “not merely a suggestion or recommendation, but a critical step,” Eli Lilly III, 126 F.Supp.3d at 1042. It further held that Defendants induce physicians’ infringement because physicians act “in accordance with Defendants’ proposed labeling.” Id. Accordingly, the district court concluded that Defendants would induce infringement of the ’209 patent.

Defendants submit that, even if there is direct infringement, their product labeling does not induce such infringement. They argue that Eli Lilly has not offered any evidence of what physicians do “in general,” offering instead only “speculation about how physicians may act.” Appellants’ Opening Br. 24 (second emphasis added). Furthermore, they submit that physicians “who merely follow the product label” are not induced to infringe because physicians must go beyond the labeling instructions — such as by prescribing specific doses of folic acid or requiring patients to keep “pill counts” or “pill diaries” — to infringe. Id. at 23, 26. We agree with Eli Lilly that Defendants’ arguments are unavailing.

We make two observations at the outset. First, to be clear, the intent for inducement must be with respect to the actions of the underlying direct infringer, here physicians. Second, we have not required evidence regarding the general prevalence of the induced activity. When the alleged inducement relies on a drug label’s instructions, “[t]he question is not just whether [those] instructions describ[e] the infringing mode, ... but whether the instructions teach an infringing use such that we are willing to infer from those instructions an affirmative intent to infringe the patent.” Takeda, 785 F.3d at 631 (internal quotation marks omitted). “The label must encourage, recommend, or promote infringement.” Id. For purposes of inducement, “it is irrelevant that some users may ignore the warnings in the proposed label.” AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042,1060 (Fed. Cir. 2010).

Depending on the clarity of the instructions, the decision to continue seeking FDA approval of those instructions may be sufficient evidence of specific intent to induce infringement. Id. at 1059. With respect to those instructions, we held in As-traZeneca that a label that instructed users to follow the instructions in an infringing manner was sufficient even though some users would not follow the instructions. Id. at 1059-60. This was true even though the product in question had substantial noninfringing uses. Id.

Conversely, “vague” instructions that require one to “look outside the label to understand the alleged implicit encouragement” do not, without more, induce infringement. Takeda, 785 F,3d at 632, 634. Defendants try to analogize the product labeling here to the labeling in Takeda that we held did not provide clear enough instructions for the infringing use to show inducement. Takeda, however, is distinguishable. The generic manufacturer in that case sought FDA approval for a generic drug to be used as a prophylaxis for gout flares — a use not covered by the patents that had been asserted. Id. at 628. The only link between the proposed use described on the labeling and the patented use was an instruction stating, “[i]f you have a gout flare while taking [the drug], tell your healthcare provider.” Id. at 632 (first alteration in original) (internal quotation marks omitted). The patent owner argued that physicians who are accordingly consulted might prescribe the drug for the infringing, off-label use and that the accused infringer was willfully blind to this possibility. Id. We rejected the patent owner’s reliance on such “vague label language” and “speculation about how physicians may act.” Id. The product labeling here is not so tenuously related to the use covered by the asserted claims, and Eli Lilly does not need to rely on speculation about physician behavior.

Again, the product labeling includes repeated instructions and warnings regarding the importance of and reasons for folic acid treatment, and there is testimony that the Physician Prescribing Information, as the name indicates, is directed at physicians. See J.A. 2181, 11253, 11255, 11256, 11258, 11278. The instructions are unambiguous on their face and encourage or recommend infringement.

Defendants rely heavily on evidence that physicians as a matter of practice take steps beyond the instructions in the product labeling, such as asking patients to keep pill diaries or pill counts, or confirming compliance with folic acid administration. For example, they point to Dr. Chabner’s testimony that he gives patients instructions “beyond what the instruction is in th[e] patient information.” J.A. 2235-36. But the asserted claims do not recite additional steps such as pill diaries, pill counts, and compliance measures. Where the product labeling already encourages infringement of the asserted claims, as it does here, a physician’s decision to give patients even more specific guidance is irrelevant to the question of inducement.

In sum, evidence that the product labeling that Defendants seek would inevitably lead some physicians to infringe establishes the requisite intent for inducement. The district court did not clearly err in concluding that Defendants would induce infringement of the asserted claims of the ’209 patent.

II

We turn next to the district court’s holding that the limitation “vitamin B12” was not indefinite. Pursuant to 35 U.S.C. § 112, ¶ 2, a patent specification must “conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.” The district court considered the indefiniteness of the asserted claims before the Supreme Court changed the relevant standard in Nautilus, Inc. v. Biosig Instruments, Inc., — U.S.-, 134 S.Ct. 2120, 189 L.Ed.2d 37 (2014), and held that “vitamin B12” was not indefinite. Eli Lilly & Co. v. Teva Parenteral Meds., Inc. (Eli Lilly I), No. 1:10-cv-1376-TWP-DKL, 2012 WL 2358102, at *11-12 (S.D. Ind. June 20, 2012). The district court further construed “vitamin B12” to mean “cyanocobalamin,” a particular vitamin supplement. Id. at *12.

In Nautilus, the Supreme Court rejected our “not amenable to construction or insolubly ambiguous” standard for indefiniteness and articulated, instead, that “a patent is invalid for indefiniteness if its claims, read in light of the specification delineating the patent, and the prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention.” 134 S.Ct. at 2124. Indefiniteness is a question of law that we review de novo. Teva Pharrn. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335, 1341 (Fed. Cir. 2015). We have reiterated post -Nautilus that “general principles of claim construction apply” to the question of indefiniteness. Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1377 (Fed. Cir. 2015) (internal quotation marks omitted). Accordingly, we review subsidiary factual determinations made by the district court based on extrinsic evidence for clear error. Id.; see also Teva, 789 F.3d at 1341 — 42 (reviewing subsidiary factual findings in the indefiniteness context for clear error).

The parties do not dispute that, depending on the context, “vitamin B12” can be used in the art to refer either to cyanoco-balamin specifically or, more broadly, to a class of compounds including pharmaceutical derivatives of cyanocobalamin. The parties do not dispute that the written description of the ’209 patent uses the term both ways. Defendants argue that, because “vitamin B12” is used in two different ways in the intrinsic record, “it is impossible to determine” which meaning applies to the claims “with any reasonable certainty,” as required by Nautilus. Appellants’ Opening Br. 31. Eli Lilly counters that the claims of the ’209 patent “involve administering a vitamin B12 supplement to a patient,” and in that context, “the one and only meaning” of vitamin B12 to a person of ordinary skill is cyanocobalamin. Appellee’s Br. 35.

The district court expressly “accepted]” the testimony of Eli Lilly’s expert, Dr. O’Dwyer, who concluded that a person of ordinary skill would understand “vitamin B12” to mean cyanocobalamin in the context of the patent claims. Eli Lilly I, 2012 WL 2358102, at *11. We do not defer to Dr. O’Dwyer’s “ultimate conclusion about claim meaning in the context of th[e] patent,” as that is a legal question. Teva, 789 F.3d at 1342. But the district court’s underlying determination, based on extrinsic evidence, of what a person of ordinary skill would understand “vitamin B12” to mean in different contexts is a question of fact. See id. (“Understandings that lie outside the patent documents about the meaning of terms to one of skill in the art or the science or state of the knowledge of one of skill in the art are factual issues.”). Dr. O’Dwyer testified that, although “vitamin B12” can refer to a class of compounds in other contexts, it refers specifically to cyanocobalamin when “vitamin B12” is prescribed in the medical field. See, e.g., J.A. 3571 (“ ‘Vitamin B12’ is used by medical oncologists to mean a particular vitamin supplement, and medical oncologists refer to ‘vitamin B12,’ and prescribe ‘vitamin B12,’ without further explanation or definition.”). We see no clear error in the district court’s acceptance of the understanding that “vitamin B12,” when used to refer to vitamin B12 supplementation in a medical context, refers to cyanocobalamin. In view of this understanding, and because the specification uses “vitamin B12” primarily in two ways, we do not face the problem that we did in Teva, in which the disputed term did “not have a plain meaning to one of skill in the art” that could be determined from context. 789 F.3d at 1345.

The claim language here would inform a person of ordinary skill that the term “vitamin B12,” as used in the ’209 patent claims, refers to “cyanocobalamin.” First, the claims, on their face, are directed to administering vitamin supplements, including vitamin B12, followed by chemotherapy treatment. This context informs persons of ordinary skill that “vitamin B12” is being used to refer to the supplementation form of vitamin B12, cyanocoba-lamin. Second, the structure of the claims also supports such an understanding. Claim 1 requires administering a “methyl-malonic acid lowering agent ... selected from the group consisting of,” inter alia, vitamin B12 and cyanocobalamin. ’209 patent col. 10 11. 61-65. Claim 2, which depends from claim 1, further requires that “the methylmalonic acid lowering agent is vitamin B12.” Id. at col. 10 11. 66-67. Eli Lilly asserts, and Defendants do not dispute, that if “vitamin B12” were to refer to a class of compounds, then claim 2 would be the same scope as claim 1, as claim 2 “would encompass the same methylmalonic acid lowering agents set forth in claim 1.” Appellee’s Br. 36. The doctrine of claim differentiation, however, presumes that dependent claims are “of narrower scope than the independent claims from which they depend.” AK Steel Corp, v. Sollac & Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003). Reading the claims to require “vitamin B12” to be a specific compound in the class of “methylmalonic acid lowering agents” would avoid this problem, as it would render claim 2, and all of the claims that depend from it, narrower than claim 1.

Defendants submit that, if “vitamin B12” means “cyanocobalamin,” then claim 1 recites a Markush group of “me-thylmalonic acid lowering agents” that lists the same compound twice. Although we have in some instances interpreted claim terms to avoid redundancy, “the rule is not inflexible.” Power Mosfet Techs., LLC v. Siemens AG, 378 F.3d 1396, 1409-10 (Fed. Cir. 2004); see also Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corp., 831 F.Sd 1350, 1363-64 (Fed. Cir. 2016); Manual of Patent Examining Procedure § 2173.05(h)(1) (“The mere fact that a compound may be embraced by more than one member of a Markush group recited in the claim does not necessarily render the scope of the claim unclear.”). Here, the redundancy is supported by the prosecution history, during which the examiner stated that vitamin B12 and cyanocobalamin “are the same” agents. J.A. 4239. Therefore, faced with an interpretation that would read redundancy into claim 1 and another that would violate the doctrine of claim differentiation, we hold that the claims here support the former result over the latter.

We are not persuaded by Defendants’ contention that the prosecution history fails to “provide reasonable confidence in any particular meaning of the term ‘vitamin B12.’ ” Appellants’ Opening Br. 30. In response to the examiner’s statement that “vitamin B12” and “cyanocobalamin” are synonymous, the patentee initially removed the term “cyanocobalamin” from the proposed claims. See J.A. 4825-27, 4832-33. Later during prosecution, the patentee added “cyanocobalamin” back into the claim that eventually issued as claim 1. J.A. 4836. Defendants do not point to any reason, though, that a person of ordinary skill would understand the paten-tee’s decision to ultimately include “cyano-cobalamin” in the claim language to be a departure from the understanding expressed by the examiner that “vitamin B12” and “cyanocobalamin” refer to the same compound. The prosecution history here does not detract from, and is consistent with, the other intrinsic evidence that would inform a skilled artisan regarding the scope of the claim term “vitamin B12.”

We therefore hold that a person of ordinary skill in the art would understand the scope of the claim term “vitamin B12” with reasonable certainty. Applying Nautilus in this case does not lead us to a different result from the district court’s conclusion on the question of indefiniteness.

Ill

Next, we address Defendants’ arguments that the asserted claims were obvious over several references that are not disputed to be prior art as of the critical date in June 1999. To prevail on obviousness, an alleged infringer must prove by clear and convincing evidence “that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir. 2009) (internal quotation marks omitted). Obviousness is a question of law based on underlying facts, and “[o]n appeal from a bench trial, this court reviews the district court’s conclusions of law de novo and findings of fact for clear error.” Prometheus Labs., Inc. v. Roxane Labs., Inc., 805 F.3d 1092, 1097 (Fed. Cir. 2015) (internal quotation marks omitted).

In a thorough opinion, the district court found, inter alia, that a skilled artisan would not have been motivated to: (1) use folic acid pretreatment with pemetrexed; (2) use vitamin B12 pretreatment with pemetrexed; or (3) use the claimed doses and schedules of folic acid and vitamin B12 pretreatments with -pemetrexed. The court also found that Eli Lilly had established several secondary considerations in favor of nonobviousness. On appeal, Defendants contend that all of those findings were erroneous. Eli Lilly submits that Defendants’ arguments “amount to nothing more than an effort to reargue the facts.” Appel-lee’s Br. 46.

We agree with Eli Lilly that Defendants’ arguments fail to raise reversible error with respect to at least the findings that a skilled artisan would not have been motivated to use vitamin B12 pretreatment with pemetrexed, let alone the appropriate doses and schedules of such vitamin B12 pretreatment.

A

The district court found, based upon two abstracts published in 1998 by Dr. Niyikiza (“the Niyikiza abstracts”), that a skilled artisan “would have concluded that vitamin B12 deficiency was not the problem in pemetrexed toxicity.” Eli Lilly & Co. v. Teva Parenteral Meds., Inc. (Eli Lilly II), No. 1:10-cv-01376-TWP-DWL, 2014 WL 1350129, at *10 (S.D. Ind. Mar. 31, 2014). It further found that a skilled artisan would not have used vitamin B12 supplementation to address antifolate toxicities because of “concem[ ] about ... a reduction of efficacy of the antifolate” treatment. Id. at *11.

Dr, Niyikiza was an Eli Lilly scientist at the time and is the named inventor on the ’209 patent. In 1997, he performed statistical analyses to try to determine which clinical trial patients were likely to develop toxicities from pemetrexed treatment. J.A. 1045,1071-72. He published the results in the Niyikiza abstracts and reported a correlation between increased pemetrexed toxicities and elevated homo-cysteine levels. J.A. 7948, 7950-51. Elevated homocysteine levels serve as an indicator of either a folic acid or vitamin B12 deficiency, but they do not indicate which of those two vitamins is specifically lacking. J.A. 622, 719, 7910. Levels of another marker, methylmalonic acid (“MMA”), serve more specifically as an indicator of vitamin B12 deficiency. J.A. 720. But the Niyikiza abstracts reported that “no correlation between toxicity ... and [MMA levels] was seen.” J.A. 7948.

Given the toxicity correlations that Dr. Niyikiza observed with homocysteine levels but not with MMA levels, Eli Lilly’s experts testified that the Niyikiza abstracts “present[ed] no evidence for a relationship of vitamin B12 and pemetrexed toxicity” and would not have motivated a skilled artisan to administer vitamin B12 to patients to address pemetrexed toxicity. J.A. 1466-67; see also J.A. 1475, 1942. Defendants’ expert, Dr. Ratain, confirmed that if a patient exhibits elevated homocy-steine but normal MMA levels, a skilled artisan “would conclude that that patient was folate deficient” but “not [vitamin] B12 deficient.” J.A. 622-23.

To try to overcome this missing link between vitamin B12 deficiency and peme-trexed toxicity, Defendants turn to other prior art references. They argue that, based on those references and perhaps preexisting knowledge, a person of ordinary skill would have known that folate deficiency is correlated with pemetrexed toxicity and that vitamin B12 “directly affect[s] the amount of folate available to healthy cells.” Appellants’ Opening Br. 45 (citing J.A. 2482, 7894, 7910-11, 8086). As a result, they argue, skilled artisans would have been motivated to use vitamin B12, along with folic acid, to address peme-trexed toxicities. Id. Put another way, if we assume that the prior art would have motivated skilled artisans to use folic acid pretreatment to counter pemetrexed toxicity (an issue we do not reach), Defendants submit that those skilled artisans would have also used vitamin B12 as part of the pretreatment because the biochemical pathways for vitamin B12 and folic acid are related. Defendants further submit that other prior art “expressly teaches that folic acid supplementation improves the therapeutic index of pemetrexed,” so a skilled artisan would not have been concerned about using vitamin B12 supplementation to reduce pemetrexed toxicities. Id. at 46.

But the parties’ experts agreed that nothing in the literature as of the critical date described “cancer patients being provided with vitamin B12 supplementation prior to receiving any antifolate,” with or without folic acid. J.A. 597-98; see also J.A. 1957. Defendants fail to point to evidence that, even if folic acid supplementation were known to improve effects of peme-trexed treatment, a skilled artisan would have thought the same of vitamin B12. Indeed, Eli Lilly offered expert testimony that a skilled artisan would have viewed the use of vitamin B12 with antifolates as “a problem” based on “having to increase the [antifolate] dose to get the same activity” of cancer treatment. J.A. 1453-54.

We are therefore not convinced that the district court committed clear error in concluding that Defendants failed to carry their burden of proving that it would have been obvious to a person of ordinary skill to use vitamin B12 pretreatment to reduce pemetrexed toxicities.

B

Regarding the dose and schedule of vitamin B12, the district court reiterated that “there are no prior art references where any amount of vitamin B12 pretreatment had been used with an antifolate in the treatment of cancer.” Eli Lilly II, 2014 WL 1350129, at *13 (emphasis added). The court also discounted Defendants’ citations to literature outside the field of oncology. Id. at *13-14.

Defendants argue that, “[o]nce a [skilled artisan] is motivated to use vitamin B12 pretreatment,” selecting a dose and schedule for vitamin B12 “would have been routine.” Appellants’ Opening Br. 47. Setting aside motivation to use vitamin B12 pretreatment in the first instance, Defendants only cite evidence of vitamin B12 doses and schedules that are “routine” in other medical contexts. See, e.g., J.A. 8150, 8169, 756-57. There is no evidence that, considering the context of pemetrexed treatment and associated toxicity problems, a person of ordinary skill would have applied such doses and schedules wholesale.

We therefore also see no clear error in the court’s finding that Defendants failed to carry their burden of proving that the prior art disclosed the claimed doses and schedules of vitamin B12 for purposes of pemetrexed pretreatment.

C

Defendants make two additional, overarching arguments that we also find unavailing.

First, Defendants cite PharmaStem Therapeutics, Inc. v. ViaCell, Inc., 491 F.3d 1342 (Fed. Cir. 2007), to argue that the district court erred by accepting expert testimony that was inconsistent with the express disclosures of the prior art. But PharmaStem is distinguishable. In that case, we discounted testimony regarding prior art references that “[could not] be reconciled with statements made by the inventors in the joint specification [of the asserted patents] and with the prior art references themselves.” Id. at 1361. Here, despite Defendants’ averments, we do not perceive any irreconcilable differences between the prior art disclosures on their face and the testimony regarding whether a person of ordinary skill would have been motivated to use vitamin B12 pretreatment in the claimed doses and schedules with pemetrexed treatment.

Second, Defendants argue that the district court committed legal error by requiring an express prior art disclosure of the claimed combination because KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007), rejected such a “rigid” formula in favor of a more flexible inquiry. Id. at 402-OS, 127 S.Ct. 1727. While KSR did make the obviousness inquiry more flexible, it does not advance Defendants’ position here. Defendants cite to two prior art references that would purportedly “motivate a [skilled artisan] to review literature regarding known doses and schedules for vitamin B12 supplementation.” Appellants’ Opening Br. 51. But those references merely note in passing that vitamin B12 can be related to homocysteine levels and folate biochemical pathways. See J.A. 7894, 7910. Defendants do not cite to any testimony to support their contention that those references would motivate a skilled artisan to arrive at the claimed use of vitamin B12 as a pretreatment for peme-trexed, especially in view of the evidence of gaps and concerns regarding the prior art discussed above.

The district court did not commit reversible error in finding that the prior art fails to render obvious use of vitamin B12 pretreatment with pemetrexed, or use of the doses and schedules of vitamin B12 that are recited in the asserted claims. We therefore affirm the determination of non-obviousness. We need not reach the other grounds put forth for obviousness.

IV

Finally, we address Defendants’ argument that the district court erred in holding that the asserted claims are not invalid for obviousness-type double patenting over U.S. Patent No. 5,217,974 (“’974 patent”), an earlier patent also owned by Eh Lilly.

The judicially-created “doctrine of obviousness-type double patenting is intended to ‘prevent the extension of the term of a patent ... by prohibiting the issuance of the claims in a second patent not patentably distinct from the claims of the first patent.’ ” Eli Lilly & Co. v. Teva Parenteral Meds., Inc., 689 F.3d 1368, 1376 (Fed. Cir. 2012) (alteration in original) (quoting In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985)). After determining the differences in the claims of the earlier and later patents, the court must determine if the alleged infringer has proven by clear and convincing evidence that the claims are not patentably distinct. Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 962, 968 (Fed. Cir. 2001). “A later patent claim is not patentably distinct from an earlier claim if the later claim is obvious over, or anticipated by, the earlier claim.” Id. Even where a patent is found invalid for obviousness-type double patenting, though, a patentee may file a terminal disclaimer. Boehringer Ingelheim Int’l GmbH v. Barr Labs., Inc., 592 F.3d 1340, 1347 (Fed. Cir. 2010); see also Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,1375 (Fed. Cir. 2005) (noting that there is no “prohibition on post-issuance terminal disclaimers” and that “[a] terminal disclaimer can indeed supplant a finding of invalidity for double patenting”). Obviousness-type double patenting is a question of law based on underlying facts, so “[o]n appeal from a bench trial, this court reviews the district court’s conclusions of law de novo and findings of fact for clear error.” Prometheus, 805 F.3d at 1097 (internal quotation marks omitted).

Defendants argued to the district court that the asserted claims of the ’209 patent are obvious variants of claim 20 of the ’974 patent. The court found that the asserted claims differ from claim 20 of the ’974 patent “in that the Asserted Claims limit the drug to pemetrexed and the administration to a patient, use a dose range for folic acid of 350-1000 p,g or 350-600 fxg and add[] vitamin B12, whereas claim 20 of the ’974 Patent discloses the use of a much greater amount of folic acid' — 500-30,000 ¡xg — with an antifolate ... administered to a mammal.” Eli Lilly II, 2014 WL 1350129, at *17. In particular, the ’974 patent lacks any recitation of vitamin B12 pretreatment, let alone dosage ranges or schedules of such pretreatment.

For many of the same reasons it articulated in its obviousness analysis and with additional explanation, the district court found that the use of pemetrexed, use of vitamin B12, and doses and schedules of the asserted claims were patentably distinct from claim 20 of the ’974 patent. Id. at *17-18. In relevant part, the district court held that, “as previously discussed, there would have been no reason for a [skilled artisan] to add vitamin B12 to the folic acid pretreatment.” Id. at *17. For the same reasons that we discussed with respect to nonobviousness, the- court did not err in finding that those limitations regarding vitamin B12 would not have been obvious to a person of ordinary skill.

Therefoi’e, we affirm the district court’s conclusion that the asserted claims are not invalid for obviousness-type double patenting.

Conclusion

For the foregoing reasons, we affirm the district court’s judgment.

AFFIRMED.

      . Akamai II held that "induced infringement can be found even if there is no single party who would be liable for direct infringement.” 692 F.3d at 1317-18.

      . Following remand from the Supreme Court, a panel of this court initially found that the accused infringer in Akamai was not liable for direct infringement, Akamai Techs., Inc. v. Limelight Networks, Inc. (Akamai IV), 786 F.3d 899 (Fed. Cir. 2015), as had the first panel in the case, Akamai Techs., Inc. v. Limelight Networks, Inc. (Akamai I), 629 F.3d 1311 (Fed. Cir. 2010). We later vacated Akamai TV and took the case en banc, which resulted in the Akamai V decision.

      .Section 271 was not amended by the Leahy-Smith America Invents Act ("AIA”), Pub. L. No. 112-29, 125 Stat. 284 (2011).

      , Before the district court, Eli Lilly also asserted theories of direct infringement that did not rely on showing physicians’ direction or control of patient action, arguing that: (1) as a matter of claim construction, physicians “administer” folic acid; and (2) under the doctrine of equivalents, physicians' actions are equivalent to putting folic acid into patients’ bodies. The district court did not reach those issues. Although Eli Lilly asks us to reach them in the alternative, we need not do so in light of our decision to affirm the district court under Akamai V.

      . As Eli Lilly points out, nor did we rely on legal obligations or technological prerequisites to reach our decision in Akamai V. The standard contract in that case was not significant for imposing potential civil liability but for “delineat[ing] the steps” that customers would have to perform ‘‘if [they] wish[ed] to use [defendant’s] product.” Akamai V, 797 F.3d at 1024. And we did not focus on whether a customer’s failure to perform certain steps might have made it technologically impossible for other steps to occur. Id.

        . Asserted claims 9, 12, 14, and 15 recite administering ‘‘about 350 |xg to about 1000 |xg” of folic acid. '209 patent col. 11 11. 19-20, col. 11 1. 25-col. 12 1. 4, col. 12 11. 7-11. Asserted claims 10, 18, and 19 recite administering "350 p.g to 600 |xg” of folic acid. Id. at col. 11 11. 21-23, col. 12 11. 16-20. Asserted claim 21 recites either of those folic acid dosage ranges. Id. at col. 12 11. 24-27. Asserted claim 19 further recites a schedule for folic acid administration "wherein folic acid is administered 1 to 3 weeks prior to the first administration of the pemetrexed.” Id. at col. 12 11. 18-20.

      . As Dr. Chabner testified, such additional instructions are rightfully "left to the medical judgment of [the] doctor,” depending on the circumstances. J.A. 2231.

      . Paragraph 2 of 35 U.S.C. § 112 was replaced with § 112(b) by § 4(c) of the AIA, and § 4(e) makes that change applicable "to any patent application that is filed on or after” September 16, 2012. Pub. L. No. 112-29, § 4, 125 Stat. at 296-97. Because the application resulting in the '209 patent was filed before that date, we refer to the pre-AIA version of § 112.

      .Under the prevailing standard at the time, a term was indefinite only if it was "not amenable to construction” or was "insolubly ambiguous.” Datomize, LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1347 (Fed. Cir. 2005) (internal quotation marks omitted), overruled by Nautilus, 134 S.Ct. at 2124.

      .The specification provides that "[t]he term ‘vitamin B12’ refers to vitamin B12 and its pharmaceutical derivatives,” and that “[p]ref-erably the term refers to vitamin B12, cobala-min, and chlorocobalamin.” ’209 patent col. 5 11.5-10. The district court held, and Defendants do not dispute on appeal, that this language did not signify that the patentee was redefining the term "vitamin B12.” Eli Lilly I, 2012 WL 2358102, at *10-11.

      . Indeed, Defendants’ expert, Dr. Green, agreed that "in the strict biochemical nomenclature, the term ‘vitamin B12’ is restricted to cyanocobalamin,” J.A. 3767, and that it can refer specifically to cyanocobalamin in the context of vitamin B12 injections, J.A. 3748-49.

      . C. Niyikiza et al, LY231514 (MTA): Relationship of Vitamin Metabolite Profile to Toxicity, 17 Proc. of Am. Society of Clinical Oncology 558a, Abstract 2139 (1998); C. Niyikiza et al., MTA (LY231514): Relationship of Vitamin Metabolite Profile, Drug Exposure, and Other Patient Characteristics to Toxicity, 9 Annals of Oncology 126, Abstract 609P (4th Supp. 1998).


source: Caselaw Access Project

author: CLEVENGER, Circuit Judge. NEWMAN, Circuit Judge,

license: Public Domain

text:
    Jason Carl KENNEDY, Plaintiff-Appellant v. UNITED STATES, Defendant-Appellee
    2016-1512
    United States Court of Appeals, Federal Circuit.
    Decided: January 17, 2017

      Jason CáRL Kennedy, Denver, CO, argued pro se.
    William James Grimaldi, Commercial Litigation Branch, Civil Division, United States Department of Justice, Washington, DC, argued for defendant-appellee. Also represented by Reginald T. Blades, Jr., Robert E. Kirschman, Jr., Benjamin C. Mizer.
    Before NEWMAN, CLEVENGER, and DYK, Circuit Judges.
   Opinion concurring in part, dissenting in part filed by Circuit Judge NEWMAN.

CLEVENGER, Circuit Judge.

Jason Carl Kennedy was disenrolled from the Navy Reserve Officer Training Corps (NROTC) program at George Washington University (GWU) in Washington, DC, after he failed to complete the required course at the Officer Candidate School (OCS) in Quantico, VA. Mr. Kennedy challenged his disenrollment by suit in the United States Court of Federal Claims. As Mr. Kennedy’s claim for monetary relief involved a challenge to his Navy records, the Court of Federal Claims directed the case to the Board for Correction of Naval Records (BCNR), a civilian body that exists to make necessary corrections in Naval Records. The BCNR concluded, with affirmation from the Secretary of the Navy, that Mr. Kennedy’s disenrollment must stand. Upon return from the BCNR, the Court of Federal Claims held that Mr. Kennedy’s disenrollment was lawful and that Mr. Kennedy’s claims for monetary relief thus lacked merit. Kennedy v. United States, 124 Fed.Cl. 309 (2015). Mr. Kennedy timely appealed to this court. For the reasons set forth below, we reverse.

I

Mr. Kennedy enrolled as an undergraduate at GWU in August of 2003. He applied for an NROTC scholarship (which would cover his tuition and other education related costs) in February of 2004, during the spring term of his freshman year. On March 16, 2005, in the spring term of his sophomore year, he was awarded a three year NROTC scholarship. Pursuant to the scholarship, Mr. Kennedy agreed to complete satisfactoi-ily his college education and any educational requirements imposed on him by the Navy and the Marine Corps. Among such requirements was successful completion of a six week term at the OCS in Quantico, VA, a requirement which is not waivable. The scholarship provided that if Mr. Kennedy failed to complete the educational requirements, including the military requirements, he could be disen-rolled and become liable to reimburse the United States for the educational costs expended on his behalf.

Beginning in May of 2005, Mr. Kennedy suffered emotional, physical and sexual abuse by a family member, and as a result he began to act abnormally. In November of 2005, in the fall of his junior year, he was required to go to the GWU Center Clinic for observation, after having been expelled from campus housing following a physical altercation with his roommate and an attempt to throw himself out of a dormitory room window. The GWU Hospital diagnosed Mr. Kennedy with Adjustment Disorder, and he attended six therapy sessions thereafter.

At the end of May in the spring term of his junior year in college, Mr. Kennedy went to Quantico to attend OCS. On two occasions at Quantico, Mr. Kennedy lost control of his emotions, and sought counsel from the chaplain on numerous occasions. In the third week at Quantico, his platoon commander recommended that Mr. Kennedy be disenrolled from OCS as emotionally unstable. His company commander noted that Mr. Kennedy “breaks down in tears when faced with stress or responsibility.” Kennedy, 124 Fed.Cl. at 315; J.A. 1138. Mr. Kennedy’s company and battalion commanders recommended disenrollment without opportunity to reapply, due to their concerns about Mr. Kennedy’s ability to handle himself in front of Marines and in combat. A Commanding Officer’s Board was convened on June 22, 2006, and it disenrolled Mr. Kennedy from OCS without opportunity to return.

On August 7, 2006, the commanding officer of the GWU NROTC unit informed Mr. Kennedy that a Performance Review Board (PRB) would be convened on August 17, 2016, to evaluate his suitability for continuing in the NROTC program. The commanding officer told Mr. Kennedy of his right to appear before the PRB and advised him to do so, explaining that the PRB could recommend his disenrollment from the NROTC Program, based on his disenrollment from OCS without opportunity to return.

Mr. Kennedy’s NROTC advisor, Captain Ward, sent a memorandum to the PRB, recommending Mr. Kennedy’s disenrollment from the NROTC program, but without the additional penalty of reimbursement of the sums the government had already expended for Mr. Kennedy’s education at GWU. On August 8, 2006, Captain Ward sent Mr. Kennedy an email message about the upcoming PRB, in which he commented as follows: “Although the paper work says there will be a formal board, we won’t have one due to the CO [Commanding Officer], OCS not allowing your return. Your case is open and shut— nothing disputable about it. You will see where I am recommending you not be responsible for reimbursement.” J.A. 1144.

Whether the three member PRB physically met on August 17 is unclear, but the PRB members did sign a report under that date recommending disenrollment without the additional penalty of reimbursement. The report indicated that Mr. Kennedy was “not present.” J.A. 1145. The PRB recommendation went to the commanding officer of the GWU NROTC Unit, who recommended disenrollment, but with recoupment of costs already expended by the government. That recommendation went further up the Marine Corps chain of command to the Recruiting Command- and finally to the Secretary of the Navy’s authorized representative (the Assistant Secretary of the Navy for Manpower and Reserve Affairs). All along the chain of command, the reason for the recommendation of disenrollment and recoupment of costs was the failure to complete OCS. On February 16, 2007, the Assistant Secretary approved the recommendation of disenrollment with recoupment of $50,675 of educational assistance Mr. Kennedy had received. Shortly thereafter, on March 16, 2007, the Commanding General of the Marine Corps Recruiting Command executed a letter to the GWU NROTC Unit ordering that Mr. Kennedy be disenrolled from the Unit and separated from the Marine Corps.

After graduation from GWU in May of 2007, Mr. Kennedy attended and graduated from law school and was admitted to the bar of the State of Colorado.

Thereafter, Mr. Kennedy brought suit in the United States Court of Federal Claims, as noted above. His amended complaint set forth several causes of action, in which he sought relief from the recoupment obligation that he was fulfilling, and sought compensation for the costs of his GWU education that were not paid by the government. First, the government had not paid the tuition for the first semester of his sophomore year (the semester before the award of his scholarship). Second, it had not paid for his senior year (Fall 2006 and Spring 2007), due to his disenrollment by then from OCS, thus breaching his obligation under the scholarship agreement. Mr. Kennedy stopped receiving scholarship benefit payments in August of 2006. His complaint alleged breach of contract and also violations of law and regulations in connection with his disenrollment from the NROTC program.

The United States filed a motion on December 20, 2013, to send the case to the BCNR to enable the BCNR to consider Mr. Kennedy’s complaint and requests for relief, and to correct his Navy records if necessary. Mr. Kennedy opposed the motion, but the court held that it had discretion to hear the claims in the first instance or to send the case to the BCNR, and thought it prudent to afford Mr. Kennedy the opportunity to be heard first by the BCNR. Accordingly, the court sent the case to the BCNR on January 23, 2014, ordering the BCNR to let Mr. Kennedy respond to the Navy’s disenrollment decision and to consider whether reimbursement of scholarship tuition is appropriate if disenrollment is sustained.

In due course, Mr. Kennedy filed a thirteen-count statement, accompanied by his court complaint, at the BCNR. Mr. Kennedy sought correction of his Naval record in several specific regards. His fundamental claim was that he was improperly disen-rolled from the NROTC program. To correct that asserted error, he asked that his record be corrected to delete all references to his disenrollment and to show that he could reapply to OCS. Further, he sought a corrected record showing that he was retained in the NROTC program up to his graduation day, that he was entitled to scholarship benefits for three years, and that he should be relieved of any obligation to reimburse the government for educational benefits received.

The BCNR forwarded Mr. Kennedy’s request for correction to the Naval Service Training Command for an advisory opinion. On July 7, 2014, the advisory opinion concluded that Mr. Kennedy’s disenrollment was proper and that the obligation to repay his scholarship monies was not unreasonable. On October 15, 2014, the BCNR issued its decision. The BCNR agreed with the advisory opinion in all regards but one: the BCNR concluded that Mr. Kennedy had been denied the opportunity to appear before the August 17, 2006 PRB, and that this violation of his rights warranted some relief for Mr. Kennedy, namely that he be relieved from reimbursing the government for the three semesters worth of financial aid that he had received and be repaid for the amount the government had already recouped. The BCNR thus ordered the correction of Mr. Kennedy’s Navy records to show that the $50,567.00 of benefits paid should not be recouped and that he should be repaid the sums he had already returned. The Assistant Secretary of the Navy for Manpower and Reserve Affairs reviewed and approved the BCNR decision.

Upon return to the Court of Federal Claims, the court entertained joint motions for judgment on the administrative record, and the government’s motion to dismiss the case. Mr. Kennedy’s amended complaint pitched five counts, all seeking money damages. His first three contract-based claims are for “full benefits under the NROTC Scholarship Service Agreement,” arguably entitling him to all funds that he had paid back, and to funds he did not receive for his first sophomore semester and his two senior year semesters. His fourth and fifth claims alleged that his disenrollment violated money mandating statutes, entitling him to monetary relief.

II

We exercise jurisdiction pursuant to 28 U.S.C. § 1295(a)(3). We review the legal conclusions of the Court of Federal Claims de novo. Renda Marine, Inc. v. U.S., 509 F.3d 1372, 1378 (Fed. Cir. 2007). We review its factual findings for clear error. Id.

The Court of Federal Claims found that it lacked jurisdiction to entertain Mr. Kennedy’s first three contract-based claims. Mr. Kennedy does not appeal that ruling, and we thus need not consider those claims.

For purposes of analysis under the applicable six-year statute of limitations in 28 U.S.C. § 2501, the Court of Federal Claims separated Mr. Kennedy’s claim regarding his first sophomore semester from his claim for the two semesters of his senior year. Regarding the former, the Court of Federal Claims held that claim to have accrued in March of 2005, after Mr. Kennedy executed his enlistment agreement but had not received payment for the previous semester. Because this claim predates and is unrelated to Mr. Kennedy’s later disenrollment, the Court of Federal Claims held it time-barred by the six-year statute of limitations, as Mr. Kennedy only filed his complaint on March 5, 2013. We agree that Mr. Kennedy’s claim regarding the first semester of his sophomore year is time-barred.

As to Mr. Kennedy’s fourth and fifth claims based on the alleged wrongful disenrollment, the Court of Federal Claims found these claims timely asserted, and noted that the BCNR had already provided Mr. Kennedy with relief concerning scholarship benefits for the spring 2005 semester and the 2005-2006 academic year, when it upset the recoupment order and ordered reimbursement of the sums he had already paid back. The Court of Federal Claims thus focused on Mr. Kennedy’s remaining monetary claims for his senior academic year.

To the extent Mr. Kennedy’s remaining claims depended on adjudication of the merits of the Navy’s decision to disenroll Mr. Kennedy from OCS and the NROTC program, the Court of Federal Claims correctly held that the adjudication of those merits were not justiciable, because the decision “pertained to who should be permitted to serve in the Marine Corps, [which is] solely within the province of the Navy.” Kennedy, 124 Fed.Cl. at 329. See Heisig v. United States, 719 F.2d 1153, 1156 (Fed. Cir. 1983); Sargisson v. United States, 913 F.2d 918, 922 (Fed. Cir. 1990). There remained, however, three arguments by Mr. Kennedy in support of his claim for monetary relief for his senior academic year. Because those arguments questioned whether a statute or regulation had been violated in connection with his disenrollment from NROTC, the Court of Federal Claims properly asserted jurisdiction over, and decided, those arguments.

We agree with the Court of Federal Claims that Mr. Kennedy’s fourth and fifth claims based on the alleged disenrollment are not time barred. A claim based on an alleged unlawful discharge accrues on the date of discharge. See, e.g., Hurick v. Lehman, 782 F.2d 984, 986 (Fed. Cir. 1986). Thus, Mr. Kennedy’s claims accrued on March 16, 2007, and he filed his complaint within the six-year statute of limitations.

First, Mr. Kennedy argued that the Navy failed to conduct a required medical examination before disenrolling him, thus violating statutory and regulatory rights and consequently undermining the legitimacy of his disenrollment. Second, he argued that the Navy failed to convene a PRB at the initiation of his disenrollment process, thus violating his rights and requiring his reinstatement. Third, he argued that he had been denied the right to appear before the August 17 PRB, again with the effect of undermining the legality of his disenrollment. The Court of Federal Claims concluded that each of these arguments lacked merit. As explained below, we agree on the first two issues, but not the third.

It is undisputed that Mr. Kennedy did not have a medical examination in connection with his disenrollment. The statute and regulation on which he relies to show entitlement to a medical examination, 10 U.S.C. § 2107(3) and DoDI 1215.08, sec. 6.10.1, do not apply to his case. As the Court of Federal Claims observed, the statute provides that payment of financial assistance under the NROTC program may be suspended for health-related incapacity only in accordance with promulgated regulations. The pertinent regulation specifies that such assistance may be suspended when an involuntary medical leave of absence from the program is being considered, and in such circumstances, a medical examination of the student in question is required. In short, the statute and regulation exist to provide medical examinations in the instances in which the government wishes to impose an involuntary medical leave of absence. Such is not the case here. Mr. Kennedy was not being considered for a leave of absence. Mr. Kennedy was deemed unqualified to serve as an officer in the Marine Corps and thus was disenrolled from the NROTC program.

Regarding Mr. Kennedy’s second argument, the Court of Federal Claims correctly found that the record does show that a PRB was convened, albeit without a physical meeting, and resulted in a formal recommendation up the chain of command. Indeed, Mr. Kennedy was informed of the PRB’s action and was afforded the opportunity to respond to the PRB decision. Mr. Kennedy does not challenge this holding.

Mr. Kennedy’s third argument begins with the effect of Captain Ward’s August 8 email. The Court of Federal Claims concluded that email deprived Mr. Kennedy of his opportunity to appear in person before the PRB. However, the Court of Federal Claims held that this deprivation “had no effect on [Mr. Kennedy’s] disenrollment from the NROTC.” Kennedy, 124 Fed.Cl. at 334. The court reasoned that in accordance with the pertinent regulations, Mr. Kennedy was required to complete OCS in order to qualify for an officer’s commission upon graduation. Because the failure to complete OCS undermines a candidate’s qualifications for a commission, and because the NROTC scholarship was for such a commission, the court concluded that Mr. Kennedy’s disen-rollment was inevitable. With the opportunity for successful completion of OSC barred to Mr. Kennedy, the court surmised that Mr. Kennedy’s appearance before the PRB could not have prevented his disenrollment.

The court’s analysis turns on whether the decision by the Commanding Officer’s Board at Quantico, denying Mr. Kennedy the opportunity to return, was final, i.e., not subject to reversal by a recommendation by a PRB, or the BCNR, and a decision by the Secretary of the Navy. If the authority to grant admission to OCS is finally delegated to the Commanding Officer’s Board at Quantico, then Mr. Kennedy’s disenrollment was inevitable. But if the Quantico authority over admission is not so final, Mr. Kennedy’s disenrollment was not inevitable.

The initial briefing in this appeal did not answer the question concerning authority over admission to OCS. We asked the parties for supplemental briefing on the issue, and the supplemental briefs were also inconclusive. The issue, however, was clearly resolved at oral argument.

For disenrollment cases involving either recoupment or students obligated to active service (in this case, Mr. Kennedy satisfies both conditions), “SECNAV [the Secretary of the Navy] makes the final decision.” CNETINST 1553.12G, § 315(a). Mr. Kennedy argued that this provision means that the Secretary, not the Commanding Officer’s Board at Quantico, has the final say on who may attend OCS. In other words, whatever authority has been delegated to that Board, while likely of great weight, is not final. In response to the question whether the Secretary could overrule Quantico on admissions to OCS, the government responded, “yes.” Oral Argument (Oct. 3, 2016) at 22:09-22:38.

At oral argument, Mr. Kennedy repeated his argument that the due process violation deprived him of the opportunity to make his case in person to the PRB that he be given another chance at OCS. Although the command at Quantico at the time stated that he should not have the opportunity to return, Mr. Kennedy points out that his platoon commander opined that he “needs to resolve his personal issues in a satisfactory manner and return to OCS once they are resolved.” J.A. 1137. Further, Mr. Kennedy’s company commander opined that “[h]e may be capable of returning to OCS at a later date if he could pull himself together.” J.A. 1138. At oral argument, the government conceded that, had Mr. Kennedy appeared in person before the August 17, 2006 PRB, it is possible that the PRB could have awarded him greater relief than the waiver of tuition recoupment that it did recommend. According to the government, such greater relief could have included further tuition payments, and if the PRB denied his request to return to OCS, the government agreed that Mr. Kennedy could have pursued that denial up the chain of command all the way to the Secretary. The government agreed that the Secretary is authorized and not estopped to instruct Quantico to admit a student to OCS.

Conclusion

Given the concession by the government that Mr. Kennedy’s due process rights had been violated when he was dissuaded from attending his PRB, and its concession that the error was not harmless, it is clear that the Court of Federal Claims erred in concluding that Mr. Kennedy’s disenrollment was inevitable because Quantico deemed him unfit to return. On this limited point, the Court of Federal Claims must be reversed.

At oral argument, the parties agreed that it is not possible to reconvene the PRB that met on August 17, 2016, but it is possible for the BCNR to hear the case Mr. Kennedy would have made to the PRB, and to recommend to the Secretary that Mr. Kennedy receive further relief. The proper course therefore is for this court to reverse the judgment that the violation of Mr. Kennedy’s due process rights was harmless and remand the case to the Court of Federal Claims for it promptly to direct the case again to the BCNR, with instructions that the BCNR promptly consider Mr. Kennedy’s case and recommend such further relief for him it deems appropriate.

REVERSED.

Costs

Costs to Mr. Kennedy.

NEWMAN, Circuit Judge,

concurring in part, dissenting in part.

I agree that the Court of Federal Claims correctly sustained the holding of the Board for Correction of Naval Records (BCNR) that Mr. Kennedy is not required to reimburse the government for the tuition payments made to George Washington University on his behalf while he was enrolled in the Naval Reserve Officers Training Corps (NROTC), and that the reimbursement that he has paid should be returned.

However, I do not join the court’s decision ordering the BCNR, on constitutional and harmful error grounds, to conduct further review to “possibly” recommend “further relief,” Maj. Op. at 1383. Such possible relief is undefined, and the BCNR and the courts have responded to any justicia-ble issues raised by Mr. Kennedy. Mr. Kennedy is not entitled to receive from the government the tuition he paid before and after his period of enrollment in the NROTC program.

The decision to disenroll Mr. Kennedy from the NROTC program was a necessary consequence of his failure to complete the required Officer Candidate School program at Quantico. CNETIST 1553, 12G, ¶ 501(e). Mr. Kennedy did not request reversal of the Navy’s fitness-to-serve determination, which was endorsed by three levels of commanders at Quantico and made after a hearing before the Commanding Officer’s Board. The courts lack competence to revisit that fitness-to-serve determination. See Gilligan v. Morgan, 413 U.S. 1, 10, 93 S.Ct. 2440, 37 L.Ed.2d 407 (1973) (“[I]t is difficult to conceive of an area of governmental activity in which the courts have less competence” than “decisions as to the composition, training, equipping, and control of a military force”).

The record documents instances of Mr. Kennedy’s mental instability, including expulsion from campus housing in November 2005 after an altercation with his roommate, an attempt to fling himself out of a window, and psychological counseling. J.A. 1131. At Officer Candidate School, the record documents several instances of Mr. Kennedy’s breaking into tears during training. Following reports by his platoon, company, and battalion commanders of emotional instability, Mr. Kennedy appeared before a Commanding Officer’s Board at Quantico on June 22, 2006. The record contains the handwritten notes of the Commanding Officer, including:

3) You have demonstrated you can’t remain calm. My question is, do I allow you to come back?
4) Candidate] isn’t having problems w/ OCS but w/ family
5) What is the issue?
6) Candidate] needs to work it out @ home
7) Can it be fixed?
8) Candidate] doesn’t know.
10) Ok then I’m going to Disenroll you & not allow you to reapply

J.A. 1139. The D.C. Circuit, considering a constitutional question raised by disenrollment from Officer Candidate School, stated that:

The district court properly granted summary judgment on appellant’s claim that his disenrollment from Officer Candidate School denied him due process because there is no property or liberty interest in a military promotion per se. Nor has appellant pointed to any statute or regulation limiting the Navy’s discretion to disenroll an OCS trainee.

Yamashita v. England, No. 02-5176, 2002 WL 31898182, at *1 (D.C. Cir. Dec. 23, 2002) (internal citations omitted).

Mr. Kennedy did not dispute his dismissal from Officer Candidate School, but now argues that he was denied due process in his dismissal from the NROTC program because he did not have the opportunity to appear before the Performance Review Board when it considered disenrollment. My colleagues hold that the disenrollment recommendation of the Performance Review Board, made in view of his discharge from Officer Candidate School without permission to reapply, since made without Mr. Kennedy’s presence, was harmful error warranting judicial intervention. The record shows that the disenrollment recommendation was adopted by the commanding officer of the NROTC, who made his own recommendations, which were then reviewed by the Chief of Naval Education and Training, then by the Naval Service Training Command, then by the Marine Corps Recruiting Command, then forwarded to the Assistant Secretary of the Navy for Manpower and Reserve Affairs. This court has recognized that “judicial deference to administrative decisions of fitness for duty of service members is and of right should be the norm.” Maier v. Orr, 754 F.2d 973, 984 (Fed. Cir. 1985).

The record also shows that Mr. Kennedy agreed that he was not then suited for Marine leadership. In his written response to the NROTC commanding officer’s disenrollment recommendation, Mr. Kennedy wrote:

I still want to serve my country, but I am unable due to lost mental stability, through no fault of my own, and thus my ability to serve my country.

J.A. 1154. Although Mr. Kennedy now requests that his Naval records be changed to show that he completed the full NROTC program, according to the record Mr. Kennedy did not request reinstatement in the NROTC, and the BCNR declined to change his Naval records. See Dodson v. United States, 988 F.2d 1199, 1204 (Fed. Cir. 1993) (“The military is entitled to substantial deference in the governance of its affairs.”).

Although my colleagues recognize that the decision of whether Mr. Kennedy “should be permitted to serve in the Marine Corps [is] solely within the province of the Navy,” Heisig v. United States, 719 F.2d 1153, 1156 (Fed. Cir. 1983), the court’s remand for the BCNR now to “hear the case Mr. Kennedy would have made to the PRB,” Maj. Op. at 1383, is on the premise that the Navy’s procedures that led to his disenrollment were subject to major flaw. I cannot agree. See Orloff v. Willoughby, 345 U.S. 83, 93, 73 S.Ct. 534, 97 L.Ed. 842 (“[JJudges are not given the task of running the Army.”)-

I discern no basis for further proceedings in the Court of Federal Claims and the Board for Correction of Naval Records. Thus I respectfully dissent from the court’s remand action.

      . The Secretary of the Navy has delegated NROTC training to the Chief of Naval Education and Training (CNET). CNETINST 1553, 12G, ¶ 102(c). CNET delegates authority over Marine Corps Option scholarship students to the Marine Corps Recruiting Command (MCRC). CNETINST 1553, 12G, ¶ 502(a). All NROTC students must undergo a 6-week training and evaluation period at Officer Candidate School, Marine Corps Combat Development Center, Quan-tico, Virginia. This requirement for completion of Marine Corps summer training will not be waived.
      CNETIST 1553, 12G, ¶ 502(c) (underline in original).