Kopycake Enter. Inc., 302 F.3d 1352, 1356 (Fed. Cir. 2002). The Court must evaluate and balance the above factors against each other and also weigh the form and magnitude of the relief requested in determining whether to issue a preliminary injunction. Polymer Techs., Inc. v. Bridwell, 103 F.3d 970, 977 (Fed. Cir. 1996); Hybritech, Inc. v. Abbot Labs., 849 F.2d 1446, 1451 (Fed. Cir. 1988). Though no single factor is dispositive, a preliminary injunction cannot issue if the patentee has not established the first two prongs of the analysis, i.e. likelihood of success on the merits and irreparable harm. Amazon.com v. Barnesandnoble.com, 239 F.3d 1343, 1350 (Fed. Cir. 2001).²

LIKELIHOOD OF SUCCESS ON THE MERITS

                   In order to determine the likelihood of success on the merits the Court considers both patent validity and infringement. See Id. (“[The patentee] must show that, in light of the presumptions and burdens that will inhere at trial on the merits, (1) [the patentee] will likely prove that [the defendant] infringes the [] patent and (2) [the patentee’s] infringement claim will likely withstand [defendant’s] challenge[] to the validity and enforceability of the [] patent.”). If the non-movant “raises a substantial question concerning either infringement or validity, i.e. asserts an infringement or invalidity defense that the patentee cannot prove lacks substantial merit” the preliminary injunction will not issue. Id. at 1350-51 (citations omitted).

                   Infringement is determined through a two-step process: first, the claims are construed, and second, the properly construed claims are compared to the accused infringing method. Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir.

1995). The patentee must present a clear case supporting the validity of the patent in suit, which may be done through a showing that the patent has withstood previous validity challenges or has gone unchallenged by the relevant industry for a long period. Id. at 1359 (citations omitted).³

                   Novo contends that the ’620 patent is entitled to a presumption of validity and furthermore satisfies a long-felt need for an alternative method of insulin delivery. (See Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 16-17.) Novo alleges the ’620 patent is infringed by Exubera because Exubera’s instructions for use, which tell the user to “breathe normally,” requires the user to breathe in a “determined volume of air” which the ’620 patent calls for. (See Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 19.) Novo’s definition of a “determined volume of air” is that one knows “the point from which the exhalation started, [and one] know[s] the point from where the exhalation ends.” (Prelim. Inj. Hr’g Tr. 24.) Novo has conceded that if Exubera’s instructions did not direct the user to “breathe out normally” at the outset of the insulin treatment session, Exubera would not infringe on the ’620 patent’s mandate to use a determined volume of air during the breathing method. (Prelim. Inj. Hr’g Tr. 40.)

                   To buttress its construction, Novo presents the deposition testimony of Dr. Ronald Crystal who compared the claims of the ’620 patent to the infringing method. Dr. Crystal concludes that Pfizer’s instructions for Exubera’s use, which tell a patient to breathe out normally, inhale deeply, and breathe out normally again, “instructs or will instruct its

users of Exubera to inhale insulin using the Exubera device in the manner claimed by claim 1 of the ’620 [patent].” (Pl.’s Mem. in Supp. of its Mot. for Prelim. Inj. at 19.)

                   Pfizer argues that it raises a “substantial question” concerning either infringement or validity and that Novo has not proved Pfizer’s defenses lack “substantial merit.” (See Pfizer Inc.’s Mem. in Opp’n at 10.) Pfizer contends that Exubera does not infringe upon the ’620 patent because the patent does not cover Exubera’s breathing instructions and, in the alternative, if the ’620 patent does cover Exubera it is invalid because it is anticipated by the prior art.⁴ (Id.)

                   At the outset Pfizer takes issues with Novo’s definition of “determined volume of air.” Pfizer argues that under Novo’s construction, anytime a patient is instructed to inhale and exhale in a certain manner, this results in the patient inhaling or exhaling a determined volume inhalation. (Id.). Pfizer argues that such a construction of the ’620 patent would embrace prior art breathing techniques such as the sort used for the treatment of asthma. (Id.)

                   Pfizer also argues that if Novo’s definition of “determined volume of air” covers Exubera, then the ’620 patent is anticipated by prior art in the field of inhalable insulin and is obvious to those with an ordinary level of skill in the field. Pfizer cites the “Laube JAMA” study (published in 1993) which it believes “expressly discloses each and every element of claim 1 of the ’620 patent, as interpreted by Novo.” (Id. at 18.) Dr. Joseph Brain, Pfizer’s expert, states that construing the ‘620 patent’s use of “determined volume of air” in the manner proffered by Novo results in the Laube study serving as prior art for the ’620 patent. (Id. at 18-19.) Novo disagrees, arguing that the Laube article does not disclose exhaling a determined volume of air or disclose that repetition of inhalation and

exhalation of determined volume of air is the key obtaining consistent results. (Prelim. Inj. Hr’g Tr. 45.)

                   The Court finds that the parties’ competing interpretations of the construction of the ’620 patent as well as the voluminous testimony related to contested methods of prior art raises substantial questions as to the alleged infringement by Pfizer, and the validity of the ’620 patent, one which will be best served through closer inspection at trial. The Court next considers the three remaining prongs of the preliminary injunction standard.

IRREPARABLE HARM

                   When the patentee makes a clear showing of likelihood of success on the merits, the patentee is entitled to a presumption of irreparable harm. Smith International, Inc., v. Hughes Tool Co., 718 F.2d 1573, 1581 (Fed. Cir. 1983). This is not the case here; therefore Novo is not entitled to the presumption of irreparable harm. Novo may still establish irreparable harm without the aid of the presumption by showing that it will suffer harm not compensable in monetary terms. Atlas Power Co. v. Ireco Chem., 773 F.2d 1230, 1233 (Fed. Cir. 1985). “The patent statute provides injunctive relief to preserve the legal interests of the parties against future infringement which may have market effects never fully compensable in money.” Hybritech, Inc., 849 F.2d at 1457. Novo must provide “[s]ome evidence and reasoned analysis” for the conclusion that monetary recompense is inadequate. Nutrition 21 v. United States, 930 F.2d 867, 871 (Fed. Cir. 1991).

                   Novo argues that as a “niche player” focusing on diabetes treatment, it has developed a reputation as an innovator with quality products. (Prelim. Inj. Hr’g Tr. 63)