author: RAKOFF, District Judge:

text:
    IN RE ACTOS END-PAYOR ANTITRUST LITIGATION United Food and Commercial Workers Local 1776 & Participating Employers Health and Welfare Fund, individually and on behalf of all others similarly situated, 199 SEIU-National Benefit Fund, Plaintiffs-Appellants, Crosby Tugs, LLC, International Union of Operating Engineers Local 132 Health and Welfare Fund, Painters District Council No. 30 Health and Welfare Fund, Individually and on Behalf of All Others Similarly Situated, NECA-IBEW Welfare Trust Fund, individually and on behalf of all others similarly situated, City of Providence, Rhode Island individually and on behalf of all others similarly situated, Minnesota and North Dakota Bricklayers and Allied Craftworkers Health Fund, on behalf of themselves and all others similarly situated, New England Electrical Workers Benefit Fund, Individually and on behalf of all others similarly situated, Man-U Service Contract Trust Fund, on behalf of themselves and all others similarly situated, Consolidated Plaintiffs-Appellants, Plumbers & Pipefitters Local 178 Health & Welfare Trust Fund, Fraternal Order of Police, Fort Lauderdale Lodge 31, Insurance Trust Fund, A.F. of L.A.G.C. Building Trades Welfare Plan, individually and on behalf of all others similarly situated, Greater Metropolitan Hotel Employers-Employees Health and Welfare Fund, on behalf of themselves and all other similarly situated, Local 17 Hospitality Benefit Fund, on behalf of itself and all others similarly situated, Dennis Kreish, on behalf of himself and all others similarly situated, Teamsters Union Local 115 Health & Welfare Fund, on behalf of themselves and all others similarly situated, Consolidated Plaintiffs, v. Takeda America Holdings, Inc., Takeda Pharmaceuticals, U.S.A., Inc., Takeda Development Center Americas, Inc., Takeda Pharmaceuticals Company Limited, Defendants-Appellees, Ranbaxy Laboratories, Ltd., Mylan, Inc., Mylan Pharmaceuticals Inc., Actavis PLC, f/k/a Actavis, Inc., Watson Laboratories, Inc., Ranbaxy, Inc., Ranbaxy Pharmaceuticals, Inc., Teva Pharmaceuticals Industries, Ltd., Teva Pharmaceuticals USA, Inc., Defendants.
    Docket No. 15-3364
    August Term 2016
    United States Court of Appeals, Second Circuit.
    Argued: September 16, 2016
    Decided: February 8, 2017

      Steve D. Shadowen (Jayne A. Goldstein, Pomerantz LLP, Weston, FL; Kenneth A. Wexler, Wexler Wallace LLP, Chicago, IL, on the brief), Hilliard & Shadowen LLP, Austin, TX, for Plaintiffs-Appellants.
    Rohit K. Singla (Blanca F. Young, Mun-ger, Tolies & Olson LLP, San Francisco, CA; Jeffrey I. Weinberger, Adam R. Law-ton, Munger, Tolies & Olson LLP, Los Angeles, CA, on the brief), Munger, Tolies & Olson LLP, San Francisco, CA, for Defendants-Appellees.
    Thomas M. Sobol, Davis S. Nalven, Gregory T. Arnold, Kristen A. Johnson, Hagens Berman Sobol Shapiro LLP, Cambridge, MA; Linda P. Nussbaum, Bradley J. Demuth, Nussbaum Law Group, P.C., New York, NY, for amicus curiae Direct Purchasers in support of no party.
    Before: JACOBS and LIVINGSTON, Circuit Judges, and RAKOFF, District Judge.

      . Judge Jed S. Rakoff, of the United States District Court for the Southern District of New York, sitting by designation.

   RAKOFF, District Judge:

Plaintiffs allege that the defendants-ap-pellees (collectively “Takeda”) prevented competitors from timely marketing a generic version of Takeda’s diabetes drug ACTOS by falsely describing two patents to the Food and Drug Administration. Plaintiffs claim that these false patent descriptions channeled Takeda’s competitors into a' generic drug approval process that granted the first-filing applicants a 180-day exclusivity period, which in turn acted as a 180-day “bottleneck” to all later-filing applicants. Of the ten generic applicants, nine took that route. However, one generic manufacturer, Teva Pharmaceutical Industries, Ltd. and Teva Pharmaceuticals USA, Inc. (collectively “Teva”), sought approval via another regulatory mechanism, but was thwarted when the FDA announced that all generic manufacturers would be required to take the bottlenecked route. The FDA’s announcement was expressly based on Takeda’s representations that it had correctly described its patents. Thereafter, Takeda settled pending patent infringement suits with the three first-filing generic manufacturers and Teva on terms that kept them out of the market until August 2012 (though Teva, unlike the three first-filing generics, could only enter the market as an authorized distributor at that time), and with the other six later-filing generic manufacturers on terms that kept them out of the market for another 180 days after that, i.e., until at least February 2013.

Plaintiffs and the class they seek to represent are drug purchasers who allege that they were wrongfully obliged to pay monopoly prices for ACTOS from January 2011, when Takeda’s patent on the active ingredient in ACTOS expired, to at least February 2013, when the mass of generic market entry occurred.

The district court dismissed plaintiffs’ antitrust claims for failing to plausibly allege that Takeda’s false patent descriptions caused any delay in generic market entry. The district court reasoned that, inter alia, plaintiffs failed to identify a viable regulatory route for generic drug approval that would have avoided the 180-day bottleneck, and that even if they had, they failed to plausibly allege how the generic manufacturers would have avoided Takeda’s infringement lawsuits, all of which were voluntarily settled. Plaintiffs appealed.

To the extent plaintiffs’ theory posits a delay in the marketing of generic alternatives to ACTOS by all the generic applicants other than Teva, we affirm, because plaintiffs’ theory presupposes that these applicants were aware of Takeda’s allegedly false patent descriptions when they filed their applications, which is not supported by well-pleaded allegations. However, because plaintiffs’ theory as to Teva does not require any knowledge of the false patent descriptions, we reach other issues as to Teva and find that plaintiffs plausibly alleged that Takeda delayed Teva’s market entry. We therefore vacate the judgment of the district court to that limited extent.

Discussion

Although the violations of which plaintiffs ultimately complain are antitrust violations, they occur in the context of the pharmaceutical regulatory scheme governed by the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (the “Hatch-Waxman Act”), and various rules promulgated thereunder. We focus in this appeal on two complementary aspects of that regulatory scheme: an initial applicant’s duty to inform the FDA of patents covering a proposed new drug, and a subsequent applicant’s duty to assure the FDA that a proposed generic version of the drug will not infringe those patents.

More specifically, under the Hatch-Wax-man Act, an initial or “brand” manufacturer, before marketing a new drug, must obtain approval from the FDA by filing a New Drug Application (“NDA”). 21 U.S.C. § 355(b). An NDA must include, inter alia, “the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug.” Id. § 355(b)(1). The NDA must classify these patents as “drug” (or “drug substance”), “drug product,” or “method of use” patents. See 21 C.F.R. §§ 314.53(c)(1)(ii), 314.53(b) (1999) & (2002).

The FDA publishes the brand applicants’ patent submissions, including the patent descriptions, in a tome titled Approved Drug Products with Therapeutic Equivalence Evaluation, commonly known as the “Orange Book.” See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399, 132 S.Ct. 1670, 1676, 182 L.Ed.2d 678 (2012); 21 C.F.R. § 314.53(e). The FDA considers its role in publishing the Orange Book to be purely ministerial. See, e.g., aaiPharma Inc. v. Thompson, 296 F.3d 227, 237 (4th Cir. 2002). Thus, it does not review the brand applicants’ patent submissions for substantive accuracy; instead, it simply publishes them as submitted. See Caraco, 132 S.Ct. at 1677.

After a new drug has been approved, an applicant seeking to market a generic version may file an Abbreviated New Drug Application (“ANDA”). See 21 U.S.C. § 355(j)(2)(A). Among the many requirements a generic applicant must fulfill is to “assure the FDA that its proposed generic drug will not infringe the brand’s patents.” See Caraco, 132 S.Ct. at 1676. Generic applicants learn which patents they must address by consulting the Orange Book, see id. and may satisfy their obligation of assuring the FDA of non-infringement in several different ways. See 21 U.S.C. § 355(j)(2)(A)(vii)-(viii). Of relevance here, when a generic applicant wishes to market a drug in seeming competition with one or more of an existing brand manufacturer’s patents, it has two choices:

One option is to certify that each of the brand’s patents “is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted.” Id. § 3550)(2)(A)(vii)(IV). Filing such a “Paragraph IV certification” is a justiciable act of patent infringement entitling the patent holder to sue. See 35 U.S.C. § 271(e)(2)(A). To encourage these certifications despite the risk of litigation, the first generic filer that submits a Paragraph IV certification and has its ANDA approved receives a valuable 180-day window of exclusivity during which it alone is permitted to market a generic version of the drug. 21 U.S.C. § 355(j)(5)(B)(iv); see also FTC v. Adams, Inc., — U.S. -, 133 S.Ct. 2223, 2228-29, 186 L.Ed.2d 343 (2013). Before December 8, 2003, the Hatch-Waxman Act did not provide any mechanism by which this 180-day exclusivity period could be lost. See Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303, 1306-07 (D.C. Cir. 2010).

A second option is available when a brand’s patent covers a method of using a drug. In that circumstance, an applicant seeking to market a generic version of the drug for a non-patented use can submit a “Section viii statement” that “carves out” any patented uses from its proposed label. 21 U.S.C. § 355(j)(2)(A)(viii). This route “is typically used when the brand’s patent on the drug compound has expired and the brand holds patents on only some approved methods of using the drug.” See Caraco, 132 S.Ct. at 1677. Filing a Section viii statement is not a justiciable act of infringement, so applicants that take this route are not immediately vulnerable to suit. Moreover, while a successful applicant is not entitled to an exclusivity period, it is exempt from any other generic’s exclusivity period pursuant, to Paragraph IV. See Purepac Pharm. Co. v. Thompson, 354 F.3d 877, 879-80 (D.C. Cir. 2004). In other words, a successful Section viii application is not subject to the 180-day “bottleneck” delay.

In the instant case, three patents are principally at issue. In the 1980s, Takeda obtained U.S. Patent No. 4,687,777 (the “’777 patent”), which claims the invention of pioglitazone hydrochloride (commonly known simply as pioglitazone), the active ingredient in ACTOS. Plaintiffs do not allege any invalidity connected to the filing of the ’777 patent. Its relevance here is simply that its expiration date of January 17, 2011 marks the earliest point at which generic forms of ACTOS could have been marketed with appropriate label carve-outs or certifications.

The alleged misconduct involves two other patents related to ACTOS: U.S. Patent Nos. 5,965,584 (the “’584 patent”) and 6,329,404 (the “’404 patent”), both of which expired on June 19, 2016. These patents claim pharmaceutical compositions consisting of pioglitazone with a biguanide (the ’584 patent) and with an insulin secretion enhancer (the ’404 patent); and both also claim methods of using ACTOS. Takeda also has eight other patents that cover only methods of using ACTOS.

On January 15, 1999, Takeda submitted its NDA for ACTOS to the FDA, which approved the application on July 15, 1999. In connection with the ACTOS NDA, Takeda submitted the ’777 patent for listing in the Orange Book as a drug substance patent. Subsequently, however, Takeda represented to the FDA (on November 5, 1999 and January 3, 2002, respectively) that both the ’584 and ’404 patents were drug product, as well as method-of-use, patents relating to ACTOS. Plaintiffs allege that Takeda’s descriptions of the ’584 and ’404 patents as drug product patents were false, because neither one “claims” ACTOS (ie., pioglitazone) by itself; they only claim combinations of AC-TOS and other drugs, as well as methods of using ACTOS. In other words, according to plaintiffs, neither patent actually prohibits a generic marketing of pioglita-zone after January 17, 2011, but Takeda in effect falsely misrepresented that such a marketing would infringe the later-expiring patents.

On July 15, 2003, Actavis pic f/k/a Watson Laboratories, Inc. (“Actavis”),' Mylan Pharmaceuticals, Inc. (“Mylan”), and Ranbaxy Laboratories, Ltd. (“Ranbaxy”) became the first manufacturers to file ACTOS ANDAs. These first-filers all submitted Paragraph IV certifications as to the drug product claims of the ’584 and ’404 patents, and Section viii statements as to Takeda’s assorted method-of-use claims. Because they all filed their ANDAs on the same day, the FDA found that they were entitled to share the 180-day exclusivity period. Seven other generic manufacturers ultimately also filed AN-DAs. Six of these generics, like the first-filers, made Paragraph IV certifications as to the ’584 and ’404 patents.

Teva, however, took a different course. On or around July 14, 2004, Teva filed an ANDA that made only Section viii statements as to the ’584 and ’404 patents. According to plaintiffs, this was because Teva believed that Takeda had falsely described these patents as drug product patents.

The FDA tentatively approved the AN-DAs filed by Mylan and Actavis in November 2004 and December 2005, respectively. In 2006, the FDA also tentatively approved Teva’s ANDA.

On October 17, 2003, Takeda filed suit against Mylan, Ranbaxy, and Actavis, alleging that their generic ACTOS products would infringe the drug product claims of the ’584 and ’404 patents, as well as induce infringement of the method-of-use claims of those patents and Takeda’s other method-of-use patents. Takeda filed similar infringement suits against the six other generics whose later-filed ANDAs also made Paragraph IV certifications as to the ’584 and ’404 patents. In March 2010, Takeda settled its infringement suits with the first-filers under terms that allowed them to begin marketing generic ACTOS on August 17, 2012. Takeda settled its lawsuits with the six other generics under terms that allowed them to begin marketing generic ACTOS 180 days later, in February 2013.

In May 2009, Takeda also filed an infringement suit against Teva in the Southern District of New York. While the suit was pending, Sandoz, Inc. (“Sandoz”), one of the six later-filing generics that relied on Paragraph IV certifications, filed a “citizen petition” with the FDA in August 2009, arguing that a generic application for ACTOS without a Paragraph IV certification as to the ’584 and ’404 patents — i.e., Teva’s Section viii application — should not be approved. See Sandoz Citizen Pet., Dkt. No. FDA-2009-P-0411-0001 (Aug. 25, 2009). In connection with the citizen petition, Takeda, on January 22, 2010, confirmed to the FDA that its patents had been (in its view) correctly described as both drug product and method-of-use patents in its ACTOS NDA. See Takeda Comment, Dkt. No. FDA-2009-P-0411-0008 (Jan. 22, 2010). On March 15, 2010, the FDA granted the citizen petition, see FDA Resp. to Sandoz Citizen Pet., No. FDA-2009-P-0411-0010, at 11 (Mar. 15, 2010), stating that the “FDA will consider any ANDA referencing Actos that lacks appropriate [Paragraph IV] certifications to the ’584 and ’404 patents ineligible for final approval.” The FDA’s ruling was expressly based on the fact that Takeda had described these patents to the FDA as drug product patents. As was its practice, the FDA declined to make its own independent evaluation of these representations. Id. at 9-10.

After the FDA granted the Sandoz citizen petition, Teva moved to amend its answer in the Takeda infringement litigation to assert a counterclaim challenging Takeda’s patent descriptions. Before the court in the Southern District of New York could rule on that motion, however, Take-da and Teva settled under terms that allowed Teva to distribute Takeda-manufac-tured ACTOS product beginning in August 2012, and otherwise enter the market 180 days later. This was considerably later than Teva could have begun marketing the drug if its tentatively approved ANDA had not been derailed by the FDA’s decision on the citizen petition based on Takeda’s representations about the nature and scope of its ’584 and ’404 patents.

Plaintiffs timely commenced this lawsuit on December 31, 2013. On August 22, 2014, plaintiffs filed a third amended complaint (the operative complaint here) alleging, inter alia, that Takeda falsely described the ’584 and ’404 patents to the FDA as claiming the ACTOS drug product, which ultimately delayed Takeda’s competitors from selling generic ACTOS until after the expiration of the ’777 patent and thereby caused plaintiffs to pay monopoly prices after January 2011. Specifically, because no generic entry took place until August 2012, and mass generic entry did not take place until February 2013, plaintiffs claim that they were forced to pay monopoly prices for ACTOS from January 2011, when the ’777 patent covering the active ingredient in ACTOS expired, until at least February 2013.

Claims 1 and 2 — the only claims at issue on this appeal' — allege monopolization and attempted monopolization of the market for ACTOS under various state antitrust laws, to wit, state-law analogs to Section 2 of the Sherman Act, which imposes liability on “[e]very person who shall monopolize[ ] or attempt to monopolize ... any part of the trade or commerce among the several States.” See 15 U.S.C. § 2. It is not disputed that the standards governing federal antitrust claims apply to these claims so far as the issues raised on this appeal are concerned.

As noted, the district court dismissed the complaint for failing to- adequately plead causation with respect to the alleged delay. The Court of Appeals reviews a district court’s grant of a motion to dismiss de novo. Stratte-McClure v. Morgan Stanley, 776 F.3d 94, 99-100 (2d Cir. 2015). “To survive a motion to dismiss, a complaint must contain sufficient factual matter, accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662, 678, 129 S.Ct. 1937, 173 L.Ed.2d 868 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007)). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Id.

“Causation in fact is, of course, a necessary element of any claim for relief. ...” Argus Inc. v. Eastman Kodak Co., 801 F.2d 38, 41 (2d Cir. 1986). An antitrust plaintiff must show that a defendant’s anticompetitive act was a “material” and “but-for” cause of plaintiffs injury, although not necessarily the sole cause. See In re Publ’n Paper Antitrust Litig., 690 F.3d 51, 65-66 (2d Cir. 2012). Further, “a plaintiff need not exhaust all possible alternative sources of injury in fulfilling his burden of proving compensable injury.” Zenith Radio Corp. v. Hazeltine Research, Inc., 395 U.S. 100, 114 n.9, 89 S.Ct. 1562, 28 L.Ed.2d 129 (1969); see also In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 695 (2d Cir. 2009). For purposes of analyzing causation, we, like the district court, will assume that plaintiffs plausibly alleged that Takeda falsely described its patents in its submissions to the FDA.

Here, the plaintiffs offer two causal theories, one applying to the generic applicants who addressed the ’584 and ’404 patents with Paragraph IV certifications, and one applying just to Teva, which instead relied on Section viii statements. We find that plaintiffs’ former theory does not satisfy Iqbal and Twombly, but that the latter does.

For their first theory, plaintiffs argue that Takeda’s allegedly false descriptions of its ’584 and ’404 patents forced the generics to file Paragraph IV certifications, which triggered a 180-day exclusivity period for first-filers and a corresponding 180-day delay (the “bottleneck”) for all subsequent filers. Under the law and regulations in place at that time, first-filers could not disclaim or lose their statutory exclusivity period, so when Takeda settled its infringement suits against the first-filers on terms that allowed them to begin selling ACTOS in August 2012, all subsequent filers were kept out of the market for at least another 180 days. Consistent with that exclusivity requirement, Takeda thereafter settled by granting licenses to the subsequent filers allowing them to begin selling ACTOS after the statutory exclusivity period ended. Plaintiffs claim that but for the false patent descriptions, applicants would not have been forced to make Paragraph IV certifications, no bottleneck would have arisen, and one or more generics would have entered the market as early as January 2011.

Although we agree with the district court that this causal theory does not satisfy Iqbal and Twombly, we do so on a somewhat different basis than the district court relied upon. We find that this theory is implausible because it rests on a necessary premise that is not supported by well-pleaded factual allegations.

In particular, because plaintiffs claim that the generic manufacturers filed their Paragraph IV certifications as to the ’584 and ’404 patents under duress, their theory presupposes that the generic manufacturers knew that Takeda had described them as drug product patents when they filed their ANDAs. If the generic manufacturers did not know this, then the causal chain would be broken at the first link, because the generic applicants would necessarily have filed their Paragraph IV certifications for some other reason, such as a belief that the Hateh-Waxman Act required them to do so. It was thus incumbent upon plaintiffs to allege that the generic applicants were aware of the descriptions when they filed their ANDAs in 2003 and 2004. The complaint is bereft of any such allegations.

Given that generic applicants must themselves assure the FDA that they will not infringe brand patents, and given that this duty turns at least in part on how a brand describes its patents, see Caraco, 132 S.Ct. at 1677, one might expect that plaintiffs could easily allege how the generics learned of .Takeda’s patent descriptions. But it turns out that the Orange Book — the go-to source of brand patent information — had a significant flaw at the time: for patents submitted before August 2003, it could reflect only one description (ie., drug substance, drug product, or method of use) per patent. If a brand indicated that a patent claimed both a method of using a drug and the drug product itself, the Orange Book would only list it as a method-of-use patent. Indeed, there is no dispute that the Orange Book listed the ’584 and ’404 patents as only method-of-use patents. The Orange Book therefore cannot plug the gap in plaintiffs’ causal theory.

In their papers, plaintiffs suggest that the generics could plausibly have learned of the allegedly false patent descriptions through an FDA-specific information disclosure provision or by consulting a supplemental Takeda filing on the FDA’s website. Even if this had been alleged in their complaint, it would not have sufficed. For one thing, nothing in the plain terms of the disclosure provision suggests that a generic could obtain patent descriptions thereunder. See 21 C.F.R. § 314.53(e). As for the supplemental filing, while it lists the ’584 patent as both a drug product and method-of-use patent, it lists the ’404 patent only as a method-of-use patent, and so plainly was not a dependable source of patent information for generic applicants. But the more fundamental flaw is that even if these were viable methods to learn of the alleged false patent descriptions, plaintiffs needed to allege facts in support of these theories in their complaint, which — even after amending their complaint several times — they totally failed to do.

Even more abstractly, plaintiffs argue that because the generic applicants were required to address Takeda’s patents in their ANDAs, there must have been some way to learn how Takeda described them, and that it is therefore reasonable to infer that they did so. See, e.g., Chase Grp. Alliance LLC v. City of N.Y. Dep’t of Fin., 620 F.3d 146, 150 (2d Cir. 2010) (“[W]e review the grant of a Rule 12(b)(6) motion to dismiss de novo, ... drawing all reasonable inferences in the plaintiff’s favor.”). We cannot sustain plaintiffs’ antitrust claims on the basis of wishful thinking. Plaintiffs are due all reasonable inferences, but they must allege some factual basis from which to make those inferences. Here, there are simply no allegations from which we can infer that the generics were aware of the alleged false patent descriptions at the core of this ease. In the absence of such facts, plaintiffs’ theory of causation must fail.

However, plaintiffs propose a different causal mechanism for Teva, which addressed the ’584 and ’404 patents with Section viii statements rather than Paragraph IV certifications. Teva’s application received preliminary approval from the FDA in 2006, see supra note 4, and if Teva had been granted final approval, then it would not have been subject to the first-filers’ 180-day exclusivity period, and could have begun marketing generic ACTOS for non-patented uses as soon as the ’777 patent expired in January 2011. Teva’s application stalled, however, when the FDA, on the express basis of Takeda’s own patent descriptions, announced in response to a citizen petition that it would not finally approve an ACTOS ANDA that made only Section viii statements to the ’584 and ’404 patents. See FDA Resp. to Sandoz, Inc. Citizen Pet., No. FDA-2009-P-0411-0010 (Mar. 15, 2010). Plaintiffs claim that but for the false patent descriptions, the FDA would not have made this announcement, and Teva would have entered the market sooner than it did.

Unlike plaintiffs’ first theory of causation, this second theory does not depend on Teva’s knowledge of Takeda’s description of its patents as drug product patents, because the FDA’s 2010 announcement was itself expressly based on Takeda’s repeated and allegedly false patent descriptions. See id. at 9-10 (explaining that because “Takeda’s original patent declaration to FDA for the ’584 and ’404 patents stated that the patents included drug product claims and method-of-use claims,” the agency “will consider any ANDA referencing Actos that lacks appropriate certifications to the ’584 and ’404 patents ineligible for final approval”). Thus, even if Teva originally filed only a Section viii ANDA, not because it knew of Takeda’s false descriptions but, e.g., because the Orange Book failed to include such descriptions, their otherwise valid Section viii ANDA was derailed because the FDA, made aware of the product claims in the ’584 and ’404 patents, automatically credited Takeda’s allegedly false assurances of the accuracy of those claims.

This theory of causation is highly plausible. As noted, the FDA first preliminarily approved Teva’s application, then entertained a citizen petition seeking to force all applicants to make Paragraph IV certifications as to the ’584 and ’404 patents, and then publicly announced that certifications would indeed be required. In so doing, the FDA expressly stated that certifications would be required precisely because Take-da had described these patents as drug product patents. In other words, the FDA made no attempt to evaluate whether the descriptions were true, but simply accepted them at face value — thus frustrating Teva’s Section viii application. While Teva thereafter sought to challenge the truthfulness of these descriptions in its litigation with Takeda (but settled before the issue was resolved), the damage had been done. A plaintiff could hardly ask for a clearer causal connection.

Takeda nonetheless argues (and the district court seemingly agreed) that this theory is implausible because it fails to rule out a litany of alternative possible causes of Teva’s delayed market entry. Takeda claims, for example, that Teva’s market entry was also delayed because Teva voluntarily settled Takeda’s infringement suit on terms that kept it out of the market until August 2012; because Takeda had lawfully sought to delay Teva’s market entry through its own citizen petition, which was still pending when Teva eventually did enter the market; and because the FDA did not ultimately grant final approval to Teva’s ANDA until 2014. Takeda argues that since the complaint does not allege how any of these barriers would have been overcome, plaintiffs’ theory that Takeda delayed Teva’s market entry is too speculative to survive a motion to dismiss.

It is Takeda, however, that is here engaging in gross speculation. While it is possible that one or more of these factors may turn out to be barriers to plaintiffs’ causation theory at later stages of the litigation, they do not mandate dismissing the complaint now. See Zenith Radio Corp., 395 U.S. at 114 n.9, 89 S.Ct. 1562; see also DDAVP, 585 F.3d at 695. Indeed, even at summary judgment, an antitrust plaintiff may be entitled to a presumption of causation where the anticompetitive conduct “is deemed wrongful because it is believed significantly to increase the risk of a particular injury” and that injury occurred. See Publ’n Paper, 690 F.3d at 66. If plaintiffs reach the summary judgment stage and make that showing, then it would be Takeda’s burden to show that some other factors, such as the ones iden-tilled above, are the “true” cause of the delay, and therefore the “true” cause of the artificially high drug prices plaintiffs paid. Dismissal at this early stage on the basis of speculation about possible and not inherently more plausible alternative causes would be premature.

Finally, we note in passing that the parties have here raised on appeal several arguments not reached by 'the district court. Takeda argues, for example, that it in fact correctly described the ’584 and ’404 patents as drug product patents under 21 U.S.C. § 355(b). In the alternative, Takeda argues that even if it incorrectly described the patents, plaintiffs have failed to plausibly allege that Takeda did so fraudulently and in bad faith. See, e.g., Phonetele, Inc. v. AT & T Co., 664 F.2d 716, 737-38 (9th Cir. 1981) (“If a defendant can establish that, at the time the various anticompetitive acts alleged here were taken, it had a reasonable basis to conclude that its actions were necessitated by concrete factual imperatives recognized as legitimate by the regulatory authority, then its actions did not violate the antitrust laws.”). On remand, the. district court can consider such issues in the first instance.

For the foregoing reasons, the district court’s decision is affirmed in part, vacated in part, and remanded for further proceedings consistent with this decision.

      . Unless otherwise indicated, this opinion cites the here-applicable 2000 edition of Title 21 of the U.S. Code and 2003 edition of Title 21 of the Code of Federal Regulations.

      . In general, the FDA grants tentative approval when a generic’s drug meets all regulatory requirements, but final approval may be prohibited because of another manufacturer's exclusivity period. See 21 U.S.C. § 355(j)(5)(B)(iv)(II)(dd) (2003).

      . See FDA, Tentative Approvals — February 2006, http://www.fda.gov/Drugs/Development ApprovalProcess/HowDrugsareDevelopedand Approved/DrugandBiologicApprovalReports/ ANDAGenericDrugApprovals/ucm064278. htm. Teva’s tentative approval date is judicially noticeable because it is publicly available and its accuracy cannot reasonably be questioned. See Apotex Inc. v. Acorda Therapeutics, Inc., 823 F.3d 51, 60 (2d Cir. 2016).

      . See Takeda Pharm. Co. Ltd. v. Teva Pharm. Indus., Ltd., No. 09-cv-4665, 2009 WL 1467381 (S.D.N.Y. 2009). Because Teva's 2004 ACTOS ANDA did not make Paragraph IV certifications as to the '584 and '404 patents, Takeda was not eligible to immediately sue Teva for infringement. Takeda’s 2009 suit followed Teva’s application to market a generic version of a related Takeda drug (ACTOplus met). Although the complaint here also alleges a variety of misconduct connected to that drug, plaintiffs have not pursued on their appeal claims arising out of that alleged misconduct.

      ."Citizen petitions are a means by which any ‘interested person’ can request that the FDA 'issue, amend, or revoke a regulation or order,' or ‘take or refrain from taking any other form of administrative action.’ ” Michael A. Carrier & Daryl Wander, Citizen Petitions: An Empirical Study, 34 Cardozo L. Rev. 249, 260 (2012) (quoting 21 C.F.R. §§ 10.25, 10.30).

      . Federal jurisdiction in this case is provided by the Class Action Fairness Act of 2005. See 28 U.S.C. § 1332(d).

      . The FDA's approach to this difficulty at that time created a "Catch-22” in which generic applicants were required to address brand patents submitted to the FDA, but directed to consult a source that did not always reflect what the brands submitted. See FDA Resp. to Sandoz, Inc. Citizen Pet., Dkt. No. FDA-2009P-0411-0010, at 10 (Mar. 15, 2010) ("[T]he statute requires certification where the patent (or patent claim) claims a listed drug, and where the NDA holder is required to submit and has submitted that patent information to FDA. This obligation to certify attaches regardless of whether that submission is accurately reflected in the Orange Book.”). We do not doubt that this made it more difficult for generics to comply with the Hatch-Waxman Act, but that does not change the fact that the plaintiffs here cannot simply rely on the Orange Book listings at that time to show that generics had notice of the patent descriptions.

      . See Center for Drug Evaluation & Research, Approval Package for Application Number NDA 21-073/S-020, at 109, available at http:// www.accessdata.fda.gov/drugsatfda_docs/nda/ 2003/021073_S020_ACTOS% 20TAB-LETS_AP.pdf (last visited Feb. 7, 2017). Moreover, plaintiffs fail to show that this document, which is easily accessible today, was as readily available in 2003 and 2004, when the generics filed their ACTOS ANDAs.

      . Gatt Communications, Inc. v. PMC Associates, LLC, 711 F.3d 68 (2d Cir. 2013), upon which Takeda relies, is not to the contrary. There, we found that a member of a bid-rigging conspiracy lacked antitrust standing to sue the orchestrator of the scheme in part because it failed to allege that it could lawfully have won the contracts absent the conspiracy. See id. at 79. For one thing, Takeda has never challenged plaintiffs’ antitrust standing; and for another, Teva had no trouble in receiving tentative approval to market generic ACTOS notwithstanding the alleged antitrust violation, and ultimately did succeed in entering the market.

      . Takeda also argues that even if it had not described the '584 and '404 patents as drug product patents, the generics — including Teva — would have been required to submit Paragraph IV certifications anyway. The district court appeared to accept a version of Takeda's argument, holding that because the patents were listed in the Orange Book as method patents, generics would have had to make an "appropriate certification” even if Takeda had not elsewhere described the '584 and '404 patents as drug product patents. The district court went on to explain that such an "appropriate certification” would have to be either a Paragraph IV certification or "a request for FDA approval for a 'carve out’ label that did not overlap with the patented methods of use,” and that plaintiffs' allegations that the generics could have relied on Section viii' statements were "inconsistent with the applicable statutory requirements[.]”
      This, however, is not correct. Indeed, as the district court recognized elsewhere, a Section viii statement is a request for a label carving out non-patented uses, so to the extent the district court treated them separately, it erred. See Caraco, 132 S.Ct. at 1677 ("[Wlhether section viii is available to a generic manufacturer depends on how the brand describes its patent.”). We do not reach Takeda’s-broader argument that the generics would have been required to submit Park-graph IV certifications in any event, and leave that issue for the district court to address in the first instance.

      . Takeda also asks that we affirm the dismissal of the claims plaintiffs did not pursue on appeal, including the portions of the monopolization and attempted monopolization claims premised on supposedly anticompeti-tive settlements. Because these questions are not properly before us, we decline to do so.


source: Caselaw Access Project

author: KEARSE, Circuit Judge:

license: Public Domain

text:
    Frantz COUTARD, Plaintiff-Appellant, v. MUNICIPAL CREDIT UNION, Defendant-Appellee.
    Docket No. 15-1113
    August Term, 2015
    United States Court of Appeals, Second Circuit.
    Argued: February 10, 2016
    Decided: February 9, 2017

      ABDUL K. HASSAN, Queens Village, New York (Abdul Hassan Law Group, Queens Village, New York, on the brief), for Plaintiff-Appellant.

    DOUGLAS E. MOTZENBECKER, New York, New York (Gordon & Rees, New York, New York, on the brief), for Defendantr-Appellee.

    Before: KEARSE, POOLER, and SACK, Circuit Judges.
   KEARSE, Circuit Judge:

Plaintiff Frantz Coutard appeals from a judgment of the United States District Court for the Eastern District of New York, Eric N. Vitaliano, Judge, dismissing his complaint alleging that his employer defendant Municipal Credit Union (“MCU”) denied him leave and terminated his employment in violation of the Family and Medical Leave Act of 1993 (“FMLA” or the “Act”), 29 U.S.C. § 2601 et seq., after Coutard sought leave to take care of his seriously ill grandfather who, in loco parentis, had raised him as a child. The district court granted MCU’s motion for summary judgment dismissing the complaint on the ground that, although the FMLA provides that an eligible employee may be entitled to take leave in order to care for a person -with whom he had an in loco parentis relationship as a child, Cou-tard had informed MCU merely that he needed to take care of his grandfather without informing MCU of the in loco parentis relationship. On appeal, Coutard contends principally that the district court erred in ruling that his failure to mention the nature of the relationship was disposi-tive, given the undisputed facts that MCU did not inform its employees that an in loco parentis relationship could entitle them to FMLA leave, did not inquire whether Coutard had such a relationship with his grandfather, and, when he requested FMLA leave, responded categorically that the FMLA did not entitle him to such leave to care for a grandparent. Cou-tard asks that we reverse the dismissal of his complaint and order that partial summary judgment on the issue of liability be granted in his favor. For the reasons that follow, we hold that because Coutard met the eligibility requirements for FMLA leave and requested that leave expressly to care for his seriously ill grandfather, MCU as an employer covered by the Act had an obligation to specify the additional information that it needed in order to determine whether he was entitled to such leave. We conclude that the district court erred in granting summary judgment to MCU on the basis that Coutard had failed to provide the necessary information, given MCU’s denial of Coutard’s request without requesting additional information. In light of other facets of the record, we conclude that Coutard was not entitled to partial summary judgment in his favor.

I. BACKGROUND

Coutard sought leave under the FMLA to care for his grandfather Jean Manesson Dumond. According to Coutard, Dumond had raised Coutard as his son from before the age of four, after Coutard’s father died, until Coutard was approximately 14. In January 2013 Dumond — who had suffered a stroke in 2011 — lived with Coutard, was 82 years old, and suffered from a number of chronic medical conditions, including diabetes, hypertension, asthma, prostate cancer, high cholesterol, and heart disease. On the evening of January 22, 2013, Dumond was taken to a hospital by ambulance; he was diagnosed with bronchitis, and was discharged on January 23. Coutard, believing that Dumond was seriously ill and should not be left unattended, determined to stay home and care for him until Coutard could secure the assistance of a home health aide, and he sought FMLA leave to do so. MCU denied him leave, and when he remained at home to care for Dumond, MCU terminated his employment.

In this action alleging that MCU’s actions interfered with and violated Cou-tard’s right under the FMLA, both sides moved for summary judgment. Certain of the facts, and the applicability of certain basic legal principles, are undisputed.

It is undisputed that MCU, a financial institution, was an employer to which the FMLA applied throughout January 2013; that Coutard was employed by MCU from July 18, 2011, to February 4, 2013; and that in the 12 months preceding his January 23, 2013 request for FMLA leave, Coutard worked for MCU for more than 1250 hours and was within the FMLA’s definition of employees who were “eligible,” 29 U.S.C. § 2611(2)(A), to take leave in order to care for a person deemed a family member by the FMLA, see id. § 2612(a)(1). Such persons include a grandfather who stood in loco parentis to the employee when the employee was a child under the age of 18. See id. §§ 2612(a)(1)(C), 2611(7), 2611(12)(A).

In granting MCU’s motion for summary judgment, the district court also found it undisputed that

Coutard was raised by his maternal grandfather, Jean Manesson Dumond, after his biological father passed away before Coutard’s fourth birthday. Du-mond acted in all respects as [Coutard’s] father — feeding him, clothing him, paying for his education, taking him to school, providing emotional and social support. In fact, Dumond referred to Coutard as his son.

Memorandum and Order dated April 9, 2015 (“D.Ct. Ord.”), at 1-2 & n.1 (internal quotation marks and citations to Plaintiffs Rule 56 Statement of Material Undisputed Facts (“Coutard’s Rule 56.1 Statement”) omitted).

In January 2013, when Coutard requested FMLA leave to care for Dumond, it is undisputed that “MCU informed Coutard that he could not take FMLA leave to care for his grandfather, because the statute does not apply to grandparents.... ” (Defendant’s Statement of Undisputed Facts in Support of Its Motion for Summary Judgment (“MCU’s Rule 56.1 Statement”) ¶ 12 (emphases added).) The district court stated as follows:

On January 23, 2013, following Du-mond’s bronchitis episode, plaintiff took leave from MCU to care more intensively for him.... To provide th[e necessary] level of care for his grandfather, Coutard absented himself from work from January 23, 2013 to February 4, 2013. °
Prompted by his grandfather’s bout with bronchitis, plaintiff requested to take FMLA leave from MCU, but it was denied on the ground that grandparents are not covered under the Act. Critically, although defendant never informed Cou-tard that grandparents could be covered under the FMLA, depending on the circumstances, Coutard admits that he never notified MCU, at the time he made the FMLA request or at any relevant point thereafter, that Dumond had raised him as if he were his father. Specifically, Coutard admits, he merely asked MCU whether he would be permitted to take leave for his grandfather and did not provide MCU with specific information about his personal circumstances or suggest that his grandfather might stand in loco parentis with him. Following his inquiry, though MCU did not permit him to take FMLA leave, it did advise him to apply for a short-term leave of absence under a separate MCU personnel policy. Coutard then took no action, applying neither for the FMLA leave nor the short-term company leave.
.... Because he was absent for more than two consecutive days without leave, on February 4, 2013, MCU notified him by letter that his employment was terminated due to job abandonment.

D.Ct. Ord. at 3-4 (internal quotation marks — as well as citations to Coutard’s Rule 56.1 Statement, MCU’s Rule 56.1 Statement, Defendant’s Counterstatement of Disputed Facts in Opposition to Plaintiffs Motion for Summary Judgment (“MCU’s Rule 56.1 Counterstatement”), and Plaintiffs Counterstatement of Facts in Response to Defendant’s Rule 56 Statement of Material Facts — omitted) (emphases added).

Coutard argued that he would have informed MCU about the in loco parentis relationship with his grandfather had he been asked or had he. known of those FMLA provisions. However, he stated,

[defendant ... never informed.me that grandfathers are in fact covered by the FMLA if an in loco parentis relationship exists. If defendant or [its benefits manager with whom Coutard spoke] had informed me about the FMLA’s in loco parentis coverage or had requested information as to whether grandpa Du-mond had an in loco parentis relationship with me when I was a child, I would have gladly and promptly provided such information.

(Declaration of Frantz Coutard dated May 12, 2014, ¶ 23.)

In response, MCU took the position that it was. not obligated to inform employees affirmatively of the FMLA’s coverage of in loco parentis relationships. (See, e.g., MCU Memorandum of Law in Opposition to Coutard’s Motion for Summary Judgment (“MCU’s Opposing Mem.”) at 1-2, 7-8.) MCU pointed out that United States Department of Labor (“DOL”) regulations promulgated under the FMLA allowed employers to post a DOL form provided in Appendix C to 29 C.F.R. Part 825 (“Appendix C”) in satisfaction of their duties to provide employees with “a notice explaining the Act’s provisions,” 29 C.F.R. § 825.300(a)(1); see id. § 825.300(a)(4). Based on part of the DOL form provided in Appendix C — submitted to the district court by MCU in support of its motion for summary judgment (see Declaration of Douglas E. Motzenbecker dated May 12, 2014 (“Motzenbecker Declaration”), Exhibit J) — MCU argued that the employee has the burden, at the time he requests FMLA leave, to provide all of the facts needed to show his entitlement to that leave. (See MCU’s Opposing Mem. at 2-3, 6-7.)

The district court agreed with MCU’s position. It stated that in order to prevail on his FMLA claim, Coutard was required to prove five elements, to wit,

(1) that he [wa]s an eligible employee; (2) that defendant constitute[d] an employer covered by the Act; (3) that he was entitled to leave; (4) that he gave notice to his employer of his intention to take leave; and (5) that his employer denied him benefits that he was entitled to under the Act,

D.Ct. Ord. at 8, “the only one in material controversy [being] the fourth,” id. at 9. The court framed the dispositive issue as “whether Coutard sufficiently notified MCU of Dumond’s in loco parentis relationship with him and that it was on that basis he sought FMLA leave,” id. It quoted a regulation that requires an employee to “ ‘provide sufficient information’ ” to indicate that “ ‘the FMLA may apply to the leave request,’ ” and requires the “ ‘employer’ ” to seek “ ‘any additional ... information’ ” needed for it to determine “ ‘whether the leave is FMLA-qualify-ing,’ ” id. at 11-12 (quoting 29 C.F.R. § 825.303(b) (emphases ours)). But the court concluded that the employee’s obligation is to provide the employer with all of the needed information “at or before the time he requests leave.” D.Ct. Ord. at 14. It stated:

Under 29 C.F.R. § 825.303(b), to seek leave for the unforeseeable illness of an immediate family member, such as a parent, an employee must “provide sufficient information for an employer to reasonably determine whether the FMLA may apply to the leave request.” Further, “[w]hen an employee seeks leave for the first time for a FMLA-qualifying reason, the employee need not expressly assert rights under the FMLA or even mention the FMLA." Id. “The employer will be expected to obtain any additional required information through informal means,” and “the employee has an obligation to respond to an employer’s questions designed to determine whether an absence is potentially FMLA-qual-ifying.” Id. ... Similarly, pursuant to 29 C.F.R. § 825.300(b), an employer becomes obligated to notify the employee of his eligibility to take FMLA leave “[w]hen an employee requests FMLA. leave, or when the employer acquires knowledge that an employee’s leave may be for an FMLA-qualifying reason.” The employer’s notification requirements come into effect once “the employer has enough information to determine whether the leave is being taken for a FMLA-qualifying reason.” Id. at § 825.300(d)(1), (2).
In determining the adequacy of the notice given by the employee, [t]he critical question is whether the information imparted to the employer is sufficient to reasonably apprise it of the employee’s request to take¡ time off.... While an employer’s duty to inquire may be predicated on statements made by the employee, the employer is not required to be clairvoyant.... An employer’s duty to conduct further inquiry into a request for leave is triggered when an employee gives sufficient notice of a ... need for the requested leave....
... FMLA is not triggered unless the employee can later show that the employer should have reasonably understood, at the time of the request, that the expressed need for leave was covered by FMLA....
Overall, an employee will be found to have failed to sufficiently explain his reasons for needed leave, and the burden of inquiry will not shift to the employer if he does not, at or before the time he requests leave, explain that his grandparent had raised him and it was that relationship, as opposed to the blood-grandfather relationship, that brought his request under the FMLA umbrella.

D.Ct. Ord. at 11-15 (footnote and other internal quotation marks omitted (emphases ours)).

Because Coutard did not inform MCU of the in loco parentis relationship when he requested FMLA leave, the court granted MCU’s motion for summary judgment and dismissed the complaint. This appeal followed.

II. DISCUSSION

On appeal, Coutard contends principally that he provided MCU with sufficient information to permit it to understand that his leave request was potentially within the scope of the FMLA, and that if he did not provide sufficient information it was only because MCU failed in its obligations (a) to provide him with information as to his right to seek such leave under the Act’s in loco parentis provision, and (b) to request further information from him. For the reasons that follow, we conclude that MCU was required to make further inquiry of Coutard before denying his request for FMLA leave, and we vacate the judgment and remand for further proceedings. We reject MCU’s contention that the district court’s dismissal of the complaint can be upheld on other grounds, see Part II.C. below; and we reject Coutard’s request that we order the grant of partial summary judgment on the issue of liability in his favor, see Part II.D.

A. The FMLA and the Regulations Implementing It

The FMLA provides generally that a covered employer is required to grant an eligible employee up to a total of 12 weeks of leave during any 12-month period for personal or family needs indicated in the Act. See 29 U.S.C. § 2612(a). There are four principal facets to the scope of the Act: (1) the employers to which it applies, (2) the employees who are eligible for FMLA leave, (3) the personal or family relationship in question, and (4) the qualifying reasons for the requested leave.

An FMLA-covered “employer” includes “any person engaged in commerce or in any industry or activity affecting commerce who employs 50 or more employees for each working day during each of 20 or more calendar workweeks in the current or preceding calendar year.” 29 U.S.C. § 2611(4)(A)(i). With respect to a covered employer that has at least 50 employees within 75 miles of the employee’s worksite, see id. § 2611(2)(B)(ii), the Act defines an “eligible employee,” in pertinent part, as an employee who has been employed—

(i) for at least 12 months by the employer with respect to whom leave is requested under section 2612 of this title; and
(ii) for at least 1,250 hours of service with such employer during the previous 12-month period,

id. § 2611(2)(A); see also 29 C.F.R. § 825.110(a) (so defining “eligible employee”).

In general, with respect to “Entitlement to leave,” the FMLA provides in part that (subject to the employer’s right to request certification from a health care provider, see 29 U.S.C. § 2613),

an eligible employee shall be entitled to a total of 12 workweeks of leave during any 12-month period for one or more of the following:
(C) In order to care for the spouse, or a son, daughter, or parent, of the employee, if such spouse, son, daughter, or parent has a serious health condition,

id. § 2612(a)(1)(C) (emphases added). The term “parent” is defined to include not only the employee’s biological parent but also “an individual who stood in loco parentis to an employee when the employee was a son or daughter,” id. § 2611(7); “son or daughter,” to the extent pertinent here, is defined to include “a child[,] of a person standing in loco parentis, who is ... under 18 years of age,” id. § 2611(12).

The FMLA provides that covered employers must conspicuously “post ... a notice, to be prepared or approved by the [DOL], setting forth excerpts from, or summaries of, the pertinent provisions of th[e Act],” id. § 2619(a), and that it is “unlawful for any employer to interfere with, restrain, or deny the exercise of or the attempt to exercise, any right provided under th[e Act],” id. § 2615(a)(1).

With respect to interference claims under the FMLA, our Court has “formally adopt[ed]” the “standard regularly used by district courts of this Circuit” — which was used by the district court in this case— that is, that to prevail on an interference claim,

a plaintiff must establish: 1) that she is an eligible employee under the FMLA; 2) that the defendant is an employer as defined by the FMLA; 3) that she was entitled to take leave under the FMLA; 4) that she gave notice to the defendant of her intention to take leave-, and 5) that she was denied benefits to which she was entitled under the FMLA.

Graziadio v. Culinary Institute of America, 817 F.3d 415, 424 (2d Cir. 2016) (“Graziadio”) (emphasis added). We did not, however, have occasion to consider what constitutes notice that is sufficient. See id. at 425 (“Defendants have not questioned the adequacy of Graziadio’s notice.... ”). Although the adequacy of notice is usually a fact-specific question, the determinative issue on this appeal is whether the district court correctly interpreted the DOL regulations in determining what kind of notice Coutard was required to provide.

The regulations in effect at the time Coutard requested FMLA leave from MCU, see 29 C.F.R. pt. 825 (2009), include instructions as to the proper timing and contents of the notice that an employee is required to give an employer in order to take such leave, and the notice that employers must provide to employees as to their rights under the Act. As pertinent here, the regulation governing the notice that an employee must give the employer as to his need for leave that was not foreseeable provided as follows:

(a) Timing of notice. When the approximate timing of the need for leave is not foreseeable, an employee must provide notice to the employer as soon as practicable....
(b) Content of notice. An employee shall provide sufficient information for an employer to reasonably determine whether the FMLA may apply to the leave request. Depending on the situation, such information may include ... whether the employee or the employee’s family member is under the continuing care of a health care provider ... or if the leave is for a family member that the condition renders the family member unable to perform daily activities.... When an employee seeks leave for the first time for a FMLA-qualifying reason, the employee need not expressly assert rights under the FMLA or even mention the FMLA.... The employer will be expected to obtain any additional required information through informal means.

29 C.F.R. §§ 825.303(a) and (b) (emphases added); see also id. § 825.302(c) (with respect to foreseeable needs, “the employer should inquire further of the employee if it is necessary to have more information about whether FMLA leave is being sought”).

The regulation in 29 C.F.R. § 825.300 prescribed the notice that must be given by a covered employer:

(a) General notice. (1) Every employer covered by the FMLA is required to post and keep posted on its premises, in conspicuous places where employees are employed, a notice explaining the Act’s provisions....
(3) If an FMLA-covered employer has any eligible employees, it shall also provide this general notice to each employee by including the notice in employee handbooks or other written guidance to employees concerning employee benefits or leave rights, if such written materials exist, or by distributing a copy of the general notice to each new employee upon hiring. In either case, distribution may be accomplished electronically.
(4) To meet the requirements of paragraph (a)(3) of this section, employers may duplicate the text of the notice contained in Appendix C of this part or may use another format so long as the information provided includes, at a minimum, all of the information contained in that notice.

29 C.F.R. §§ 825.300(a)(1), (3), and (4) (emphases added).

(b) Eligibility notice. (1) When an employee requests FMLA leave, or when the employer acquires knowledge that an employee’s leave may be for an FMLA-qualifying reason, the employer must notify the employee of the employee’s eligibility to take FMLA leave within five business days, absent extenuating circumstances.

29 C.F.R. § 825.300(b)(1) (emphases added); see also id. § 825.300(c)(5) (“Employers are also expected to responsively answer questions from employees concerning their rights and responsibilities under the FMLA.”); id. § 825.300(e) (“Failure to follow the notice requirements set forth in this section may constitute an interference with, restraint, or denial of the exercise of an employee’s FMLA rights.”).

“Appendix C to Part 825 — Notice to Employees of Rights under FMLA (WH Publication 1420),” referred to above in § 825.300(a)(4), provides a form (“DOL Form” or “Form”), that employers may use to inform employees of their rights under the FMLA. The DOL Form is titled “EMPLOYEE RIGHTS AND RESPONSIBILITIES . UNDER THE FAMILY AND MEDICAL LEAVE ACT” and includes sections headed “Basic Leave Entitlement,” “Eligibility Requirements,” “Employee Responsibilities,” and “Employer Responsibilities.”

Under “Basic Leave Entitlement,” the DOL Form states, in pertinent part, as follows:

FMLA requires covered employers to provide up to 12 weeks of unpaid job-protected leave to eligible employees for the following reasons:
• to care for the employee’s spouse, son or daughter, or parent, who has a serious health condition....

29 C.F.R. pt. 825, App’x C. As this “Basic Leave Entitlement” section of the DOL Form does not mention that the term “parent” includes a person who, when the employee was a child, served in loco par-entis to the employee, MCU argues that it was not required to inform employees of those provisions of the Act.

However, the DOL Form, after defining or describing, inter alia, eligibility requirements, protections, and serious health conditions, goes on to describe the notice responsibilities of employees and employers, in pertinent part, as follows:

Employee Responsibilities

Employees must provide sufficient information for the employer to determine if the leave may qualify for FMLA protection ....

Employer Responsibilities

Covered employers must inform employees requesting leave whether they are eligible under FMLA. If they are, the notice must specify any additional information required....

29 C.F.R. pt. 825, App’x C (emphases added).

Thus, the “Responsibilities” sections of the DOL-prescribed notice and the related regulations establish that if an eligible employee provides sufficient information for the employer reasonably to determine that the requested leave “may” qualify for FMLA protection, the employer “must” specify whether, and what, additional information is required for a determination of whether the employee is entitled to such leave. Id.; see 29 C.F.R. § 825.303(b).

An employer is not required to use the DOL Form; but if it does not, “the information provided” by the employer must “indudei ], at a minimum, all of the information contained in that [Appendix C] notice.” 29 C.F.R. § 825.300(a)(4) (emphases added). Thus, whether or not the DOL Form is used, a covered employer “must” 'inform employees both (a) that they need provide only sufficient information to show that the requested leave reasonably “may” be FMLA-qualifying, and (b) that if an eligible employee provides such information and the employer needs additional information it is the employer’s responsibility to seek such additional information. 29 C.F.R. pt. 825, App’x C; see 29 C.F.R. § 825.300(a)(4); id. § 825.303(b).

In light of these regulations, we conclude that the obligation of an employee to give notice of his need for FMLA leave is not the obligation, imposed by the district court on Coutard, to provide the employer with all of the necessary details to permit a definitive determination of the FMLA’s applicability at or before the time of the request. Rather, in the absence of a request for additional information, an employee has provided sufficient notice to his employer if that notice indicates reasonably that the FMLA may apply. See, e.g., Lichtenstein v. University of Pittsburgh Medical Center, 691 F.3d 294 (3d Cir. 2012) (interpreting the 2009 version of § 825.303).

In Lichtenstein, the district court had summarily dismissed an FMLA claim because the notice given by the employee had described a circumstance that “ ‘might not’ ” qualify for FMLA leave, id. at 304. The Third Circuit reversed the grant of summary judgment. In considering “the specificity of information employees must provide to adequately notify employers of unforeseeable FMLA leave,” id. at 296, the court of appeals concluded that

the District Court answered the wrong question. The question is- not whether the information conveyed to the employer necessarily rules out non-FMLA scenarios. The question is whether the information allows an employer to “reasonably determine whether the FMLA may apply.” 29 C.F.R. § 825.303(b) (emphases added). Reasonableness does not require certainty, and “may” does not mean “must,”

691 F.3d at 304.

We note that a prior version of § 825.303 did not contain the above “FMLA may apply” language; it provided that an employee, in giving notice, “need not expressly assert rights under the FMLA or even mention the FMLA, but may only state that leave is needed,” and that “[t]he employer will be expected to obtain any additional required information through informal means,” 29 C.F.R. § 825.303(b) (1995). But even that earlier regulation’s less specific language has been interpreted as meaning that an employee need only provide the employer with sufficient information to understand that the circumstances indicate that the FMLA “may” apply. See, e.g., Rask v. Fresenius Medical Care North America, 509 F.3d 466, 471 (8th Cir. 2007) (“[T]he employer’s duties are triggered when the employee provides enough information to put the employer on notice that the employee may be in need of FMLA leave.” (internal quotation marks omitted (emphasis ours))), cert. denied, 554 U.S. 919, 128 S.Ct. 2965, 171 L.Ed.2d 887 (2008); Burnett v. LFW Inc., 472 F.3d 471, 479 (7th Cir. 2006) (“The employee’s notice obligation is satisfied so long as he provides information sufficient to show that he likely has an FMLA-qualifying condition.... [T]he employee’s duty is merely to place the employer on notice of a probable basis for FMLA leave.... [Ejmployers ... are entitled to the sort of notice that will inform them ... that the FMLA may apply.” (internal quotation marks omitted (emphases in Burnett))); Bachelder v. America West Airlines, Inc., 259 F.3d 1112, 1130-31 (9th Cir. 2001) (“[I]t is the employer’s responsibility, not the employee’s, to determine whether a leave request is likely to be covered by the Act.... Employees need only notify their employers that they will be absent under circumstances which indicate that the FMLA might apply.... In short, the employer is responsible, having been notified of the reason for an employee’s absence, for being aware that the absence may qualify for FMLA protection.” (emphasis added)).

We conclude that the district court erred in ruling that Coutard was required, at the time of his request, to provide MCU with all of the information it needed to determine with certainty that his requested leave was within the FMLA.

MCU asks us to reach the contrary conclusion, relying principally on Sherrod v. Philadelphia Gas Works, 57 Fed.Appx. 68 (3d Cir. 2003), in which the Third Circuit upheld summary judgment dismissing an FMLA complaint because the plaintiffs request for leave in order to care for her grandmother had not specified “that her grandmother had raised her,” see id. at 72. The regulation applied in that case, however, was § 825.208(a)(1), which required the employee to “ ‘explain the reasons for the needed leave so as to allow the employer to determine that the leave qualifies under the Act,’ ” 57 Fed.Appx. at 72 (quoting 29 C.F.R. § 825.208(a)(1) (2002) (emphasis ours)). Section 825.208(a)(1) was withdrawn effective January 16, 2009; and although it was revised and renumbered 825.301, the revised version adds the caveat that the employee’s notice must “satisfy the notice requirements set forth in § 825.302 or § 825.303,” 29 C.F.R. § 825.301(b) (2009).

Section 825.303, the regulation relevant to Coutard, required him initially, as discussed above, only to provide sufficient information to indicate that the FMLA “may” apply.

B. The Sufficiency of Coutard’s Notice

There can be no serious question that an employee’s request for leave to care for his seriously ill grandfather seeks leave that “may” qualify for FMLA protection. Although MCU argues that it was not required to inquire as to whether Coutard had a “[ujnique” relationship with his grandfather (MCU brief on appeal at 27), a grandparent’s raising of a child in loco parentis is hardly unique. The very reason that Congress in the FMLA defined “parent” and “son or daughter” to include, respectively, “an individual who stood in loco parentis to an employee when the employee” was “under 18 years of age,” 29 U.S.C. §§ 2611(7) & 2611(12)(A) (emphasis added), and “a child of a person standing in loco parentis,” 29 U.S.C. § 2611(12), was to “reflect the reality that many children in the United States today do not live in traditional ‘nuclear’ families with their biological father and mother,” and are increasingly raised by others including “their grandparents,” S. Rep. No. 103-3, at 22 (1993), reprinted in 1993 U.S.C.C.A.N. 3, 24 (other internal quotation marks omitted (emphases ours)).

Indeed, MCU, in support of its summary judgment motion, submitted a July 2010 DOL “Fact Sheet #28C” — attached to the Motzenbecker Declaration as Exhibit K— titled “FMLA leave to care for a parent with a serious health condition on the basis of an in loco parentis relationship.” That general-information document stated that

[i]n enacting the FMLA, Congress recognized the changing needs of the American family, including the growing need for wage earners to provide care both for their children and for their parents.
This Fact Sheet provides guidance on an employee’s entitlement to FMLA leave to care for an individual who stood in loco parentis to the employee when the employee was a child....

Examples of in loco parentis

Examples of situations in which FMLA leave to care for a parent may be based on an in loco parentis relationship include:
An employee may take leave to care for her grandmother with a serious health condition if the grandmother assumed responsibility for raising the employee after the death of her parents when the employee was a child.

DOL Fact Sheet #28C at 1-2 (emphasis added). Both the express provisions in the FMLA for coverage with respect to in loco parentis relationships and the express example of a grandmother in the publication available to employers on the DOL website — submitted to the district court by MCU — made it reasonable for MCU to understand that Coutard’s request for leave in order to take care of his seriously ill grandfather might come within the FMLA.

We conclude that the district court erred in ruling that Coutard’s notice to MCU was deficient because he did not specify the in loco parentis relationship with his grandfather at or before the time he requested FMLA leave, and in ruling that MCU was entitled as a matter of law to deny Coutard FMLA leave without requesting additional information.

C. MCU’s Alternative Grounds for Affir-mance

MCU contends that we can affirm the judgment dismissing the complaint on alternative grounds, including Coutard’s alleged failure to provide certification that Dumond had a serious health condition and his failure to mitigate damages. These contentions are meritless.

In urging that the complaint was properly dismissed because Coutard failed to proffer medical proof of Dumond’s health, MCU relies on the FMLA provision that “[a]n employer may require that a request for leave under” 29 U.S.C. § 2612(a)(1)(C) for a “parentfs]” serious health condition “be supported by a certification issued by the [relevant] health care provider,” 29 U.S.C. § 2613(a). However, “[u]nder the FMLA, an employee seeking leave need not submit a medical certification unless and until one is specifically requested by her employer.” Graziadio, 817 F.3d at 426 (emphasis in original). Although the record indicates that MCU may have requested evidence of Dumond’s health in suggesting that Coutard apply for leave that would not be protected by the FMLA, it does not indicate that MCU made any request pursuant to the FMLA. Instead, “MCU informed Coutard that ... the statute does not apply to grandparents .... ” (MCU’s Rule 56.1 Statement ¶ 12.) MCU not having requested information pursuant to the FMLA — and having wrongly indicated to Coutard that the FMLA cannot be applied to a grandfather — MCU is not entitled to defend this FMLA claim on the ground that Coutard did not provide information that the FMLA would have required if MCU had requested it.

In urging that Coutard failed to mitigate damages, MCU relies principally on the fact that he did not accept MCU’s conditional offer of reinstatement. MCU’s letter communicating that offer, however— sent by its attorneys to Coutard’s attorney after the commencement of the present lawsuit (see Motzenbecker Declaration ¶ 5) — proposed a “resolution of the case .... without an admission of fault or liability on the part of either party” (see id. Exhibit D). Such an offer could not properly be the basis for affirmance of summary judgment, as “[t]he evidence considered on summary judgment must generally be admissible evidence,” LaSalle Bank National Ass’n v. Nomura Asset Capital Corp., 424 F.3d 195, 205 (2d Cir. 2005); see Fed. R. Civ. P. 56(c)(4) (“declaration used to support or oppose a motion [for summary judgment] must ... set out facts that would be admissible in evidence”), and offers of compromise are not admissible in evidence to “disprove the validity or amount of a disputed claim,” Fed. R. Evid. 408(a) (emphasis added). MCU’s offer is inadmissible for the purpose proffered here. The letter offered reinstatement in exchange for settlement of the pending lawsuit; it stated that it was being sent “[p]ursuant to FED. EVID. R. 408”; and it is proffered here with respect to the amount of damages Coutard could receive.

MCU’s other contentions in support of the grant of summary judgment in its favor have no greater merit and do not warrant discussion.

D. Coutard’s Request for Partial Summary Judgment in His Favor

We also reject Coutard’s contention that because MCU failed in its obligations (a) to provide him with notice of his right to seek FMLA leave under the Act’s in loco parentis provision, and (b) to request further information from him upon his request for leave, he was entitled to partial summary judgment in his favor on the issue of liability. The fact that both sides have moved for summary judgment does not guarantee that there is no material issue of fact to be tried and that one side or the other is entitled to that relief. See, e.g., Eastman Machine Co. v. United States, 841 F.2d 469, 473 (2d Cir. 1988). In considering such motions and determining whether there is a genuine issue of fact to be tried, “the court must evaluate each party’s motion on its own merits, taking care in each instance to draw all reasonable inferences against the party whose motion is under consideration.” Schwabenbauer v. Board of Education, 667 F.2d 305, 314 (2d Cir. 1981); see, e.g., United States v. Diebold, Inc., 369 U.S. 654, 655, 82 S.Ct. 993, 8 L.Ed.2d 176 (1962) (the evidence must be viewed in the light most favorable to the party opposing the motion under consideration).

Here, in addition to the unresolved issue of whether the state of Dumond’s health met FMLA standards, MCU did not in fact concede the truth of Coutard’s assertions that Dumond had raised him in loco parentis. Rather, it objected to the in loco parentis characterization as asserting a conclusion of law (see MCU’s Rule 56.1 Counterstatement ¶ 14) and denied knowledge or information as to the truth of the underlying factual assertions (see id. ¶¶ 17-24). Thus, although it was proper for the district court to accept Coutard’s assertions as true when it was deciding the summary judgment motion of MCU, it could not properly accept them as true in deciding the motion by Coutard. A jury would not be compelled to accept such testimony by Coutard; his credibility is a matter for assessment by the factfinder; and his childhood relationship with Du-mond remains one of the issues for trial.

CONCLUSION

We have considered all of MCU’s arguments in support of the judgment and all of Coutard’s arguments in support of his request for partial summary judgment in his favor, and have found in them no merit. The judgment dismissing the complaint is vacated; the matter is remanded for further proceedings not inconsistent with this opinion.