TA] plaintiff seeking a preliminary injunction must establish [1] that [it] is likely to succeed on the merits, [2] that[it] is likely to suffer irreparable harm in the absenceofpreliminary relief, [3] that the balance of equities tips in [its] favor, and [4] that an injunctionis in the public interest.’” Id. at 1375-76 (quoting Winter v. Natural Res.

“[AJl] findings of fact and conclusions of law at the preliminary injunction stage are subject to change uponthe ultimate trial on the merits.” Purdue Pharma L.P. v. Boehringer Ingelheim GmbH, 237 F.3d 1359, 1363 (Fed. Cir. 2001).

The pharmaceutical product of claim 12, wherein the sodium chlorideis present in the aqueous solution in an amount of up to 900 mg/100 ml Defendants argue that Plaintiff cannot meet its burden of proving a likelihood of success because the ’661 patent is invalid and/or unenforceable.

While “the patent enjoys the same presumptionofvalidity during preliminary injunction proceedingsasat other stagesoflitigation,” ultimately “it is the patentee, the movant, who must persuade the court that, despite the challenge presented to validity, the patentee nevertheless is likely to succeed at trial on the validity issue.” Id. And thetrial court, “when analyzing the likelihood of success factor ... after considering all the evidence available at this early stage of the litigation, must determine whetherit is more likely than not that the challenger will be able to proveat trial, by clear and convincing evidence, that the patent is invalid.” /d.

See ’661 patent, 2:16-21 (explaining that, unlike the patent’s “ready-to- use” formulation, “currently approved potassium phosphorous products are supplied and stored as concentrates and will therefore require aseptic compounding ... thereby increasing the risk of error and contamination”).