Full opinion text
OPINION BUMB, District Judge. I. Introduction Plaintiffs AstraZeneca LP and AstraZeneca AB (“AstraZeneca” or “Plaintiffs”) are pharmaceutical companies who develop new and innovative drugs and treatment methods. Defendants Apotex, Inc. and Apotex Corp. (“Apotex” or “Defendants”) are pharmaceutical companies who manufacture generic versions of brand name drugs. At issue in this case is AstraZeneca’s PULMICORT RESPULES, a once-daily inhaled corticosteroid used in the treatment of pediatric asthma. AstraZeneca holds two patents relating to PULMICORT RESPULES and seeks to enjoin Apotex from manufacturing and selling a generic version of this drug. A. Asthma Millions of Americans suffer from chronic respiratory diseases, such as asthma. Asthma alone affects approximately 22 million Americans. Asthma is particularly problematic for children. The Center for Disease Control estimates that 8.9% of all American children suffer from asthma. Asthma is a chronic inflammatory disease of the airways. The symptoms of asthma include wheezing, breathlessness, coughing and chest tightness. These symptoms vary in severity from patient to patient and for individual patients. For example, the “fall asthma epidemic,” when some patients experience increased burden of symptoms and exacerbations in the fall season, is well known. Even patients with mild asthma may experience significant, and sometimes life-threatening, exacerbations. B. Asthma Medications and Delivery Systems Asthma medications are designed in different formulations for use with different methods of administration and delivery systems. Examples of different formulations used in long-term asthma control include solutions, suspensions, dry powders, tablets or capsules. The formulation of the medication and delivery system used are often dictated by the characteristics of the particular active ingredient. Depending on how the medication is formulated, asthma medications may be administered in different ways, including by inhalation, orally (ingested), rectally and parenterally (injected). The most common delivery system for inhaled products is a pressurized metered dose inhaler (“pMDI”), which includes formulations such as suspensions or solutions. pMDIs are referred to colloquially as “puffers.” Another type of device for inhaled products is a dry-powder inhaler (“DPI”). DPIs typically are used by twisting the cap of the device to make available one dose of the dry powder medication. A nebulizer device vaporizes liquid medication into a mist that is inhaled through a face-mask or mouthpiece. The medication may be in the form of a suspension or a solution. A nebulizer permits the patient to receive the proper dose simply by breathing in a normal fashion. The face-mask is secured over the nose and mouth. Prior to the availability of PULMICORT RESPULES®, discussed below, long-term asthma controller medications had significant disadvantages. Many of these medications required frequent dosing, at least twice per day, and sometimes more frequently. This frequent dosing led to problems with patients being able to adhere to the prescribed drug regimen, resulting in ineffective asthma control. Also, frequent dosing often increased the cost to patients. In addition, many of these medications failed to provide adequate asthma control, even when used properly. C. AstraZeneca Patents This case involves AstraZeneca’s revolutionary invention of a once-daily inhaled corticosteroid under the trade name PULMICORT RESPULES®. AstraZeneca began selling PULMICORT RES-PULES® in September 2000. PULMI-CORT RESPULES® became the first and only once-daily inhaled corticosteroid approved by the FDA for children under the age of four on the market. As discussed below, because children are an especially challenging patient population to diagnose and treat, PULMICORT RESPULES® was a long-desired treatment of pediatric asthma, and it has played a unique role in such treatment. PULMICORT RES-PULES® is given to children twelve months to eight years of age. PULMI-CORT RESPULES® is used with a compressed air-driven jet nebulizer, a more appropriate method of administration for young patients. AstraZeneca holds two patents related to PULMICORT RESPULES®: U.S. Patent No. 6,598,603 (the “'603 Patent”) and U.S. Patent No. 6,899,099 (the “'099 Patent”). Both the '603 Patent and '099 Patent include two types of claims, “kits” and “methods” for administering the PULMICORT RESPULES® active ingredient, budesonide, a corticosteroid. Both types of claims are directed to administration of a budesonide composition or suspension using a nebulizer device in a continuing regimen at a frequency of not more than once per day. PULMICORT RES-PULES® is often referred to as “budesonide inhalation suspension” or “BIS.” The label (approved by the Federal Drug Administration (“FDA”)) for PULMICORT RESPULES® includes in the DOSAGE AND ADMINISTRATION section a table that shows recommended starting doses and highest doses of budesonide based on prior asthma therapy. The highest recommended doses of BIS are 0.5 mg total daily dose, 1.0 mg total daily dose, and 10 mg total daily dose for bronchodilator, inhaled corticosteroid, or oral corticosteroid therapy, respectively. The BIS is supplied in single dose ampules of two strengths of BIS, .25 mg, .5 mg or 1.0 mg per 2ml. The label stipulates that the recommended starting dose may be administered as either the total daily dose once-daily or in divided doses twice daily. Previous Therapy_Recommended Starting Dose Highest Recommended Dose Bronchodilators alone 0.5 mg total daily dose adminis- 0.5 mg total daily dose tered either once-daily or twice _daily in divided doses_ Inhaled Corticosteroids 0.5 mg total daily dose adminis- 1 mg total daily dose tered either once-daily or twice _daily in divided doses_ Oral Corticosteroids 1 mg total daily dose adminis- 1 mg total daily dose tered either as 0.5 mg twice _daily or 1 mg once-daily_ The patient instruction sheet accompanying the PULMICORT RESPULES® instructs the patient to empty the contents of the ampule into the nebulizer cup. (See, e.g., Declaration of Thomas O. Garvey, III, M.D., at Ex. 4.) D. Apotex’s ANDA Application and FDA Approval The generic drug approval process is governed by the Hateh-Waxman Act. Specifically, 21 U.S.C. § 355© established a procedure for the submission and review of Abbreviated New Drug Applications (“ANDA”). Pursuant to this procedure, an ANDA applicant is not required to submit evidence to establish the clinical safety and effectiveness of the drug product; rather, an ANDA relies on the FDA’s pri- or determination that the reference listed drug (RLD) is safe and effective. See generally FDA Response to Citizen Petition, dated November 18, 2008 (“FDA Response”) (Reply Declaration of Bradley Chipps, at Ex. 19). The ANDA applicant must show, inter alia, that its generic drug is bioequivalent to the RLD and contains the same active ingredient, conditions of use, route of administration, dosage form, strength, and labeling (with certain permissible differences). Id. at 4-5. It must also show that its generic drug product meets approval requirements concerning the chemistry, manufacturing, and controls for the drug product. Id. at 5. Additionally, an ANDA applicant must file with the FDA a list of patents that claim the approved drug product or method of using the drug product and submit one of four specified certifications with respect to each patent. Id. at 7-8. However, if a patent is listed only for a method of use and an ANDA applicant seeks to omit the method of use covered by the listed patent, the ANDA applicant must submit a “section viii statement” (in lieu of the specified certifications) in which the applicant acknowledges that the relevant method of use patent has been listed but that the patent at issue does not claim a use for which the applicant seeks approval. Id. at 9. In this case, Apotex filed ANDA No. 078-202 seeking FDA approval to manufacture and sell a generic version of PULMICORT RESPULES. (Apotex Opp. Brief, at 5). On March 30, 2009, Apotex’s ANDA was approved by the FDA. (Id.). II. Procedural History Immediately following Apotex’s ANDA approval, AstraZeneca filed a Complaint against Apotex asking this Court to render a declaratory judgment that Apotex’s sale of its generic BIS would “infringe, contribute to the infringement of, and/or induce the infringement of one or more claims of the '603 and '099 Patents.” (Comply 20). On April 6, 2009, AstraZeneca filed a motion for a temporary restraining order (“TRO”) to enjoin Apotex from marketing its generic version of PULMICORT RES-PULES®. In its motion, AstraZeneca contended that it established all elements necessary for the issuance of a TRO: “(1) the likelihood of the patentee’s success on the merits; (2) irreparable harm if the injunction is not granted; (3) the balance of hardships between the parties; and (4) the public interest.” Abbott Labs. v. Andrx Pharms., Inc., 473 F.3d 1196, 1200-01 (Fed.Cir.2007). For purposes of the TRO motion, AstraZeneca limited its discussion of its likelihood of success on the merits to Apotex’s alleged direct infringement of the kit claims, choosing not to address the alleged indirect infringement of the method claims. (See PI. Motion at 6, n. 5). On April 16, 2009, the Court heard the argument of counsel on the issues presented in AstraZeneca’s application for a TRO. At the conclusion of the hearing, the Court issued a temporary restraining order preventing Apotex from immediately entering the market and requiring AstraZeneca to post a bond in the amount of $2,500,000. [Dkt. No. 45]. The Court scheduled a preliminary injunction hearing to commence April 27, 2009. The Court also ordered the parties to submit supplemental memoranda addressing Apotex’s argument that the kit claims are invalid under the holding of In re Ngai, 367 F.3d 1336 (Fed.Cir.2004). The Court did so because, as Apotex aptly argues, if the Ngai decision renders AstraZeneca’s kit claims invalid, then AstraZeneca cannot make a showing of likelihood of success on such claims. On April 27, 2009, the Court commenced the preliminary injunction hearing. At the beginning of the hearing, the Court questioned whether or not AstraZeneca had abandoned its claim of indirect infringement relating to the method claims. The Court recognized that if AstraZeneca intended to press its indirect infringement claims in the context of injunctive relief, then it would behoove the parties and the Court to hear all issues relating to infringement at the same time. Apotex objected to the Court affording AstraZeneca any opportunity to modify its basis for emergent relief, arguing that AstraZeneca should not have “two bites at the apple.” Over Apotex’s objection, the Court permitted AstraZeneca to amend its request for injunctive relief to include its claims based on indirect infringement. The Court did so because it wanted to address all the claims in one proceeding and it was not aware of any prohibition against allowing AstraZeneca to proceed with a previously preserved, but not briefed, argument. Moreover, the ten-day time period for the issuance of the temporary restraining order had not elapsed, and the Court found that there existed good cause for extending the TRO in light of the fact that the preliminary hearing was in progress. See Fed.R.Civ.P. 65(b)(2). Accordingly, both claims asserted by AstraZeneca — direct infringement of the kit claims and indirect infringement of the method of use claims— are discussed below. III. Standard for Issuance of Preliminary Injunction In determining whether to issue a preliminary injunction, the Court should consider the following four factors: “(1) the likelihood of the patentee’s success on the merits; (2) irreparable harm if the injunction is not granted; (3) the balance of hardships between the parties; and (4) the public interest.” Abbott Labs. v. Andrx Pharms., Inc., 473 F.3d 1196, 1200-01 (Fed.Cir.2007) (citations omitted). “These factors, taken individually, are not dispositive; rather, the district court must weigh and measure each factor against the other factors and against the form and magnitude of the relief requested.” Hybritech, Inc. v. Abbott Labs., 849 F.2d 1446, 1451 (Fed.Cir.1988). However, as explained by the Federal Circuit, “case law and logic both require that a movant cannot be granted a preliminary injunction unless it establishes both of the first two factors, i.e., likelihood of success on the merits and irreparable harm.” Amazon, com, Inc. v. Bamesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed.Cir.2001) (emphasis included); Reebok Inter. Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1556 (Fed.Cir.1994) (citing Hybritech, 849 F.2d at 1451, 1456). The Court will discuss each of the four factors in turn. IV. Analysis A. Likelihood of Success on the Merits To obtain a preliminary injunction, “a patent holder must establish a likelihood of success on the merits both with respect to validity of its patent and with respect to infringement of its patent.” Hybritech, 849 F.2d at 1451. Thus, AstraZeneca must show that, “in light of the presumptions and burdens that will inhere at trial on the merits, (1) [AstraZeneca] will likely prove that [Apotex] infringes its [’603 Patent and/or '099] patent, and (2) [AstraZeneca’s] infringement claim will likely withstand [Apotex’s] challenges to the validity and enforceability of the [] patent[s].” Amazon, 239 F.3d at 1350 (citing Genentech, Inc., v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed.Cir.1997)); Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368, 1374 (Fed.Cir.2006). If Apotex “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 should not issue.” Amazon, 239 F.3d at 1350-51 (internal quotation omitted); see also Oakley, Inc. v. Sunglass Hut Intern., 316 F.3d 1331, 1340 (Fed.Cir.2003) (“the injunction should not issue if the party opposing the injunction raises ‘a substantial question concerning infringement or validity, meaning that it asserts a defense that [the party seeking the injunction] cannot prove lacks substantial merit’ ”) (quoting Tate Access Floors, Inc. v. Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed.Cir.2002)). In the Complaint, AstraZeneca raises two different infringement claims. First, AstraZeneca alleges that Apotex will directly infringe AstraZeneca’s kit claims (claims 29 and 30 of the '603 Patent and claims 17, 18, 20, 21, 24-27 of the '099 Patent) by marketing and selling (or intending to market and sell) a generic BIS with a label that instructs consumers to use the drug once-daily. Second, AstraZeneca alleges that Apotex will indirectly infringe AstraZeneca’s method claims (Claims 1-3, 6-8, 11-18, 21-28 of the '603 Patent) by inducing consumers to infringe AstraZeneca’s patented method because Apotex’s label instructs physicians to prescribe the generic BIS for once-daily use. Before embarking on the infringement analysis, however, the Court must first consider the validity of the underlying patented claims, as challenged by Apotex. 1. Validity Under 35 U.S.C. § 282, “ ‘a patent is presumed valid, and this presumption exists at every stage of the litigation.’ ” Sanofi-Synthelabo v. Apotex, 470 F.3d 1368, 1375 (Fed.Cir.2006) (quoting Canon Computer Sys., Inc. v. Nu-Kote Int’l, Inc., 134 F.3d 1085, 1088 (Fed.Cir.1998)). However, this presumption is not a substantive rule but a procedural device that serves to assign the burden of proof during litigation. D.L. Auld Co. v. Chroma Graphics Corp., 714 F.2d 1144, 1147 n. 2 (Fed.Cir.1983). As § 282 makes clear, “[t]he burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.” Notwithstanding, “in resisting a preliminary injunction, [] one need not make out a case of actual invalidity. Vulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial.” Amazon, 239 F.3d at 1359. In other words, “a showing of a substantial question of invalidity requires less proof than the clear and convincing evidence standard to show actual invalidity.” Erico Int’l Corp. v. Vutec Corp., 516 F.3d 1350, 1356 (Fed.Cir.2008) (citing Amazon, 239 F.3d at 1358). Apotex challenges the validity of both the kit claims and the method claims. The Court will address each argument separately. a. Kit Claims The Court first turns to the validity of AstraZeneca’s kit claims (claims 29 and 30 of the '603 Patent and claims 17, 18, 20, 21, 24-27 of the '099 Patent). Apotex argues that AstraZeneca’s kit claims are invalid because, under the holding of In re Ngai, 367 F.3d 1336 (Fed.Cir.2004), AstraZeneca cannot create a new patentable product by simply adding a new method of use (i.e., once-daily administration) to a known product (i.e., a suspension containing 0.05 mg to 15 mg of budesonide). To the extent AstraZeneca is entitled to any patent for its invention, Apotex contends, such patent is limited to a method of use, which is enforceable only through method of use claims, not kit claims. In response, AstraZeneca contends that because a label (and, more particularly, a dosing instruction) is an essential and functional component of a drug product, the addition of such label (and dosing instruction) functionally changes the known product into a new product — a BIS product that can be safely and effectively administered once-daily. In other words, AstraZeneca argues, the once-daily labeling creates a new and unobvious product for which AstraZeneca is entitled to patent protection. Patentability is governed by Section 101 of the Patent Act, which establishes categories of patentable subject matter: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. 35 U.S.C. § 101. Machines, manufactures, and compositions of matter are generally grouped into product claims. Thus, products and processes are considered the two general categories of patents. See Caterpillar Inc. v. Detroit Diesel Corp., 961 F.Supp. 1249, 1252 (N.D.Ind.1996), aff'd, 194 F.3d 1336 (Fed.Cir.1999). Traditionally, “printed matter” by itself did not fall within any of the statutory classes of patentable subject matter. However, [a]s an exception to the traditional rule, printed matter constituted an element of a patentable claim if the claim concerned a new and useful feature of physical structure or a new and useful relation between the printed matter and the physical structure. 1 Donald S. Chisum, Chisum on Patents § 1.02[4] (Supp.2006) at 1-25. The doctrine of printed matter rule developed when printing was the primary means for recording and communicating information. Id. As technology advanced, new means of communication developed, such as electronic storage and communication, and the line between the rule and the exception became more difficult to draw. Id. A discussion of some relevant cases is helpful here. In re Miller, 57 C.C.P.A. 809, 418 F.2d 1392 (CCPA 1969), involved a measuring device that contained legends for fractioning recipes. If a person wanted to make only one-half of a recipe, he could simply select the “one-half recipe” measuring receptacle, follow the recipe numbers literally and end up with one half the recipe. Thus, s/he could avoid the trouble of trying to calculate and measure one-half of each ingredient. The Court of Customs and Patent Appeals (CCPA) determined that this printed material was patentable because it functioned together with the known product to create a new product. Had the printed matter been removed, the product itself would be fundamentally different, just a measuring cup. In 1983, the Court of Appeals for the Federal Circuit decided the case, In re Gulack, 703 F.2d 1381 (Fed.Cir.1983), which clarified the standard laid out in Miller: “[w]here the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Id. at 1385. The claimed invention in Gulack comprised three basic elements: (1) a band, ring, or set of concentric rings; (2) a plurality of individual digits imprinted on the band or ring at regularly space intervals; and (3) an algorithm by which the digits were developed. Id. at 1382. The band could be placed on hats, jewelry or other articles of apparel. The court determined that, based on the physical and functional interrelations between the printed matter (the numbers) and the substrate (the band), there was a “functional relationship” between the two. As the court explained, [t]he appealed claims ... require a particular sequence of digits to be displayed on the outside surface of the band. These digits are related to the band in two ways: (1) the band supports the digits; and (2) there is an endless sequence of digits — each digit residing in a unique position with respect to every other digit in an endless loop. Thus, the digits exploit the endless nature of the band. Id. at 1386-87. The court held that this functional relationship between the information and the substrate was different than a prior patent, which consisted of printed information (various types of data to be committed to memory such as multiplication tables, historical dates and the like) on a hat band. As to the new invention, the court found that the numbers did bear a new and unobvious functional relation to the band. The court found that if the printed matter (the digits on the band) were removed, the product itself would be fundamentally different — it would no longer be a mathematical device. Over twenty years later, the Federal Circuit distinguished Gulack in its decision, In re Ngai, 367 F.3d 1336 (Fed.Cir.2004). In Nga% the patent application disclosed a new method for normalizing and amplifying RNA. The application was granted a method claim because it had presented a new and non-obvious method. However, the application also sought a kit claim comprising a known reagent and instructions detailing the new method. The Patent and Trademark Office rejected the applicant’s kit claim in view of prior art showing a kit with different instructions and the same known reagent. In rejecting the kit claim, the PTO relied on the statement in Gulack that the “critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate.” Id. at 1338 (quoting Gulack, 703 F.2d at 1386). The Federal Circuit agreed with the PTO that, unlike Gulack, “[hjere, the printed matter in no way depends on the kit, and the kit does not depend on the printed matter. All that the printed matter does is teach a new use for an existing product.” Id. at 1339. Ultimately, the court held that, Ngai is entitled to patent his invention of a new RNA extraction method, and the claims covering that invention were properly allowed. He is not, however, entitled to patent a known product by simply attaching a set of instructions to that product. Id. The foregoing cases demonstrate one critical fact: the printed matter was what, in essence, created the new and unobvious product. In Miller, the legends turned a measuring cup into a “recipe cup.” In Gulack, the numbers turned the band into a “mathematical device.” In both cases, the printed matter did much more than simply offer instructions on use; the printed matter was “functionally related” to the substrate. The question here, then, is whether the addition of a label indicating once-daily dosing to the BIS creates a new product or recites how the product is to be used. In other words, is there a functional relationship between the printed matter (the once-daily instruction) and the substrate? “Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.” Gulack, 703 F.2d at 1385. AstraZeneca argues that because an FDA-approved drug product cannot exist without a label providing instructions for use, and a label cannot exist without a drug product, the two depend on each other and are, therefore, “functionally related,” just like in Gulack. They assert that the end result is a new and useful patentable Mt that did not exist in the prior art — “a nebulized budesonide product that can be safely and effectively administered once-daily.” (PI. Supp. Brief at 5). Apotex argues that “the addition of the label does nothing to change the product other than to add a description of its use. ” (Apotex Supp. Reply Brief at 3) (emphasis included). It contends that there is no functional relationship between the instructions and the drug because “[bjoth with and without the instructions, the composition is the same, it works the same, and it can be used in the same ways.” (Id. at 2-3). As they explain it, “the drug can be made and used regardless of whether there is a label accompanying it.” (Id. at 3). The Court is persuaded that the addition of the instructions does not functionally alter the known product so as to create a new patentable product. Rather, the instructions simply explain how to use the known product. This type of relationship does not qualify as a functional one and, therefore, it does not create a new patentable product. See In re Schreiber, 128 F.3d 1473, 1477 (Fed.Cir.1997) (“[i]t is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable”); see also, In re Spada, 911 F.2d 705, 708 (Fed.Cir.1990) (“[t]he discovery of new property or use of a previously known composition, even when that property and use are unobvious from prior art, cannot impart patent-ability to claims to the known composition”); see also, In re Haller, 34 C.C.P.A. 1003, 161 F.2d 280 (CCPA 1947) (“[i]f there is no novelty in an article or composition, then a patent cannot be properly granted on the article or composition, regardless of the use for which it is intended”). Gulack’s requirement that the printed matter be functionally related to its substrate ensures that patentable weight is only given to printed matter that actually contributes to the creation of the product itself, not to printed matter that simply provides a description of how to use a product. Ngai made this distinction clear and confirmed that, when considering a product claim, adding a set of instructions for using that product does not add any patentable weight to the claim. As the court held: This case ... is dissimilar from Gulack. There the printed matter and the circularity of the band were interrelated, so as to produce a new product useful for ‘educational and recreational mathematical’ purposes. Here, addition of a new set of instructions into a known kit does not interrelate with the kit in the same way as the numbers interrelated with the band. In Gulack, the printed matter would not achieve its educational purposes without the band, and the band without the printed matter would similarly be unable to produce the desired result ... As the Gulack court pointed out, ‘[wjhere the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability.’ ... If we were to adopt [the applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product. This was not envisioned by Gulack. 367 F.3d at 1338-39. The cases dictate that the focus must be on the relationship between the printed matter and the substrate. If there is a new functional relationship between the two, the resulting product is entitled to patentable weight. As mentioned, the parties disagree as to what the “substrate” actually is in this case. Apotex contends that the substrate is the paper on which the label is printed and AstraZeneca contends that the substrate is the BIS product itself. Whether the substrate is the paper or the drug, under either definition, the relevant relationship is still not a functional one. That is, there is no functional relationship (significant to the overall product) between the once-daily dosing instruction (the printed matter) and the paper label, nor is there a functional relationship between the once-daily dosing instruction and the drug product— with or without the instructions or the paper they are printed on, the drug product remains the same. AstraZeneca urges this Court to forge new ground and hold that because the FDA requires that a drug product contain a label, the question of patentability must be examined within the confines of those legally imposed restrictions. It is a tempting argument. However, there is no place in patent law to consider the impact that regulations might have on the marketability of a product. Indeed, such a holding could easily produce a slippery slope. Presumably, AstraZeneca’s strategy in obtaining patents for the kit claims was to arm itself with easier to prove claims of direct infringement rather than having to prove indirect infringement of the method of use claims. This, however, is not a valid reason to permit the kit claims to go forward. As one court explained, although it is desirable that patent protection should extend to the article here involved and not merely to the process of using it, since the process claim might be directly infringed by the ultimate users and not by those who make and sell the composition for use as an insecticide. However, the allowance of claims must be based on statutory provisions and not upon the type of protection considered desirable. In re Haller, 161 F.2d at 282. Based on the above reasoning, the Court finds that the kit claims (Claims 29 and 30 of the '603 Patent and Claims 17,18, 20, 21 and 24-27 of the '099 Patent) are invalid. Therefore, Apotex has met its burden. b. Method Claims The Court next turns to the validity of AstraZeneca’s method claims (Claims 1-3, 6-8, 11-18, 21-28 of the '603 Patent). Apotex argues that AstraZeneca’s method claims are invalid because they were 1) anticipated by the prior art and 2) obvious in light of the prior art. The Court will discuss each challenge in turn. (1) Anticipation To qualify for patent protection, an innovation must fulfill the novelty requirement as set forth in 35 U.S.C. § 102. Consistent with this novelty requirement, “patent law has long required that an innovation not be anticipated by the prior art in the field.” Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 149-50, 109 S.Ct. 971, 103 L.Ed.2d 118 (1989). “A patent is invalid for anticipation when the same device or method, having all of the elements contained in the claim limitations, is described in a single prior art reference.” Crown Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d 1367, 1375 (Fed.Cir.2002); see also Hazani v. United States ITC, 126 F.3d 1473, 1479 (Fed.Cir.2003) (prior art renders a patented invention “anticipated-and thus invalid-if it discloses every feature of the claimed invention, either explicitly or inherently”) (internal quotation omitted); Lindemann Maschi nenfabrik v. American Hoist and Derrick Co., 730 F.2d 1452, 1458 (Fed.Cir.1984) (“anticipation requires the presence in a single prior art reference disclosure of each and every element of the claimed invention, arranged as in the claim”); Studiengesellschaft Kohle v. Dart Industries, 726 F.2d 724, 726 (Fed.Cir.1984) (“[i]t is hornbook law that anticipation must be found in a single reference, device, or process”). In this case, Claim 1 of the '603 Patent, the only independent method claim at issue, recites: A method of treating a patient suffering from a respiratory disease, the method comprising administering to a patient a nebulized dose of a budesonide composition in a continuing regimen at a frequency of not more than once per day. ('603 Patent, col. 10:18-22). Thus, Claim 1 contains the following four elements or limitations: • method of treating a patient with respiratory disease • nebulized administration • budesonide composition • not more than once per day The remaining method claims are all dependant on claim 1, meaning that they include all of the limitations of Claim 1 as well as additional limitations. Apotex points to three specific prior art references which it argues anticipate AstraZeneca’s method claims. (i) U.S. Patent No. 5,192,528 U.S. Patent No. 5,192,528 (Radhakrishnan) (the “'528 Patent”) relates to a “Corticosteroid Inhalation Treatment Method” and was issued on March 9, 1993, more than one year before the '603 Patent. The ABSTRACT of the '528 Patent describes the invention as a “method for delivering a therapeutic dosage of corticosteroid drug to the lungs, for treating a lung condition or disease.” (’528 Patent). Specifically, the method involves aerosolizing “[a]n aqueous suspension of sized liposomes containing the drug in liposomeentrapped form ...” (Id.). In simpler terms, the '528 Patent describes a method for the delivery of corticosteroids using liposomes. As explained by AstraZeneca’s expert, Robert O. Williams III, PhD., liposomes are spherical vesicles composed of a bilayer membrane. (Tr. May 4, 2009 (Williams) at 21). The membrane consists of molecules, such as phospholipids and sterols, that generally have both hydrophilic (water-loving) and hydrophobic (water-hating) portions. (Id. at 22). These molecules align themselves to form the membranes in which the hydrophilic portions face outward and the hydrophobic portions face inward in an aqueous environment. (Id. at 22-23). Liposomes have been used for the delivery of drugs, particularly lipophilic, or water-insoluble, drugs. Lipophilic drugs are generally incorporated within the liposomal membranes so that they may be more readily delivered in a medium to the target site of action. Apotex contends that the '528 patent discloses each and every feature of claim 1 of AstraZeneca’s '603 patent as follows: • a “means for treating a variety of lung diseases and conditions, such as bronchial asthma” ('528 Patent, Col. 1, In. 38-40) • a composition containing a corticosteroid which may include budesonide (Id. at Col. 7, In. 59-61; Col. 4, In. 13) • “the aerosol particles are formed by a pneumatic nebulizer” (Id. at Col. 3, In. 42-43; Col. 6, In 61-Col. 7, In. 5) • “the effective daily dose can be administered readily as a single dose” (Id. at Col. 8, In. 7-11; Col. 9, In. 7-8) (See Def. Supp. Br. [Dkt. No. 80] at 4). AstraZeneca argues that the '528 patent does not anticipate the AstraZeneca '603 patent because it does not disclose “administration by nebulization of a budesonide composition or suspension as those terms are used and defined in the AZ patents.” (PI. PosWHearing Br. at 7). Specifically, AstraZeneca contends, the '528 Patent neither discloses nor suggests a budesonide composition in which the budesonide is dispersed in a solvent. Thus, the issue here is one of claim construction — the parties dispute the meaning of AstraZeneca’s claim term “budesonide composition” and whether that claim term includes the composition containing budesonide described in the '528 Patent. To resolve this dispute, the Court must determine how a person of ordinary skill in the art would understand the claim term. Pfizer, 429 F.3d at 1372-73 (“ ‘[t]he inquiry into how a person of ordinary skill in the art understands a claim term provides an objective baseline from which to being claim interpretation’ ”) (quoting Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454-56 (Fed.Cir.1998)). During the hearing, Dr. Williams testified that a person of ordinary skill in the art would understand “budesonide composition” to mean “budesonide dispersed [directly] in a solvent in the form of a solution or suspension.” (Tr. May 4, 2009, at 13). Thus, unlike the composition in the '528 patent which involves liposomes, the term “budesonide composition”, as defined by Dr. Williams in the context of the '603 patent, does not involve liposomes. The distinction between the budesonide composition of AstraZeneca’s '603 patent and the liposome suspension of the '528 Patent is critical. As Dr. Williams explained, in the method taught by the '603 Patent, “the budesonide is provided in immediate contact with the solvent, such that when the budesonide molecules begin to dissolve from these particles, they are available to be absorbed by the airway cells and be conjugated and act as a depot effect.” (Id. at 26-27). This “depot effect” is at the heart of AstraZeneca’s revolutionary method and it could not occur if the liposomes involved in the '528 Patent were present. Thus, the '528 Patent actually teaches away from the '603 Patent. Notwithstanding the opposing methods taught by the '603 and '528 patents, Apotex still argues that the budesonide composition of the '603 patent embodies the composition containing budesonide of the '528 patent. In support of their position, they point to Column 3 of the '603 patent, which states that “[s]olutions or suspensions can be encapsulated in liposomes or biodegradable microspheres.” ('603 Patent, Col. 3, In. 38-39). However, as Dr. Williams explained, one mention of the liposome delivery method does not overcome the larger lesson the patent is trying to teach- — i.e., the use of a budesonide composition where the budesonide is dispersed directly in a solvent. (Tr. May 4, 2009 (Williams) at 47) (“I think that even though it’s mentioned in column three as solutions or suspensions can be encapsulated in liposomes’ biodegradable microspheres, it’s one sentence out of the whole patent and I don’t’ think that this patent in the context of what’s being taught really addresses the complexity of administering budesonide either in a liposome or frankly in a biodegradable microsphere. So even though it mentions it, I don’t really think it teaches it.”). Finally, the language of the patent itself makes clear that the term “budesonide composition” means “budesonide dispersed in a solvent in the form of a solution or a suspension.” Throughout the patent specification, the compositions used in the inventive method are consistently described as being either a suspension or solution of budesonide in a solvent. The SUMMARY OF THE INVENTION describes the budesonide composition as “including 0.05 mg to 15 mg budesonide and a solvent.” ('603 Patent, Col. 2, In. 3-4). The DETAILED DESCRIPTION section also describes the budesonide composition as “budesonide suspended in a solvent” and explains that the budesonide “can be delivered dispersed in a solvent, e.g., in the form of a solution or a suspension.” (Id. at Col. 2, In. 51; Col. 3, In. 22-23). The patent goes on to define the “solvent” into which the budesonide is dispersed as “an appropriate physiological solution”, containing the inactive ingredients, for example, “physiological saline or a buffered solution containing [defined inactive ingredients].” (Id. at Col. 3, in. 22-25). Moreover, all of the clinical studies described in the EXAMPLES section involved a budesonide composition consisting of budesonide suspended in a solvent. (Id. at Col. 4, In. 30-col. 10, In. 7). The EXAMPLES section also describes the solvent as the water and other inactive ingredients in which the budesonide is suspended. (Id. at Col. 5, In. 3-7; see also Tr., May 4, 2009, at 29 (Williams)). In sum, the Court agrees with Dr. Williams that the term budesonide composition does not contemplate the involvement of liposomes as described in the '528 Patent; rather, it means “budesonide dispersed in a solvent in the form of a solution or a suspension.” Accordingly, the '528 Patent does not anticipate the '603 Patent as it does not disclose each and every element of the claim. (ii) U.S. Patent No. 5,049,389 Apotex also relies upon United States Patent No. 5,049,389 (“the '389 Patent”), entitled “Novel Liposome Composition for The Treatment Of Interstitial Lung Diseases,” to support its invalidity argument. The '389 Patent, issued on September 17, 1991, refers to the same liposomes containing steroidal components as the '528 Patent and their use for delayed release of corticosteroids to the lungs to treat a respiratory disease, interstitial lung disease. The '389 Patent also lists one of the same inventors listed on the '528 Patent. The application for the '389 Patent was filed on the same day as the application for the '528 Patent and both are assigned on their face to Liposome Technology, Inc.. The Court notes that the '389 Patent includes virtually all of the disclosures of the '528 Patent, which the Court has already found did not anticipate the AstraZeneca method. Significantly, the '389 Patent was before the United States Patent and Trademark Office during prosecution of the AstraZeneca patents. (See '603 Patent, References Cited). Given the tremendous overlap between the '389 Patent and the '582 Patent, as well as the Court’s rejection of the '582 Patent as anticipating prior art, Apotex has not overcome the presumption that the patent examiner properly considered the '389 Patent as prior art and found that it did not anticipate the innovative AstraZeneca method. See, e.g., American Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 1359 (Fed.Cir.1984), cert. denied, 469 U.S. 821, 105 S.Ct. 95, 83 L.Ed.2d 41 (1984) (“examiners ... are assumed to have some expertise in interpreting the references and to be familiar from their work with the level of skill in the art and whose duty it is to issue only valid patents”). (iii) The Gleich Patent Apotex also argues that the '603 Patent was anticipated by U.S. Patent No. 5,837,-713 (the “Gleich Patent”), which relates to the “Treatment of Eosinophil-Associated Pathologies By Administration of Topical Anesthetics and Geneoeorticoids.” (Gleich Patent, attached as Ex. N to Gross Deck). The Gleich Patent is directed to a method of treating certain respiratory diseases, e.g., bronchial asthma, by “co-administering ... a topical anesthetic and [ ] a glucocorticoid .... ” (Id. at Col. 4, In. 34-36). First, the Gleich Patent was before the United States Patent and Trademark Office during prosecution of the AstraZeneca '603 Patent. (See '603 Patent, References Cited). Second, and more importantly, the Gleich Patent would likely not even be considered prior art because it involves a co-administration of two different therapies, whereas the '603 Patent involves the administration of only one therapy — i.e., orally inhaled corticosteroids. This difference is significant. Indeed, as Dr. Chipps stated in his declaration, “Gleich teaches away from the AstraZeneca invention because it refers only to treatment with both a glucocorticoid and an anesthetic.” (Chipps Reply Deck at ¶ 175). Nowhere does Gleich disclose that a nebulized budesonide composition may be used effectively in a once-daily dosing regimen to treat respiratory diseases. Thus, the Court rejects Apotex’s anticipation argument based on the Gleich Patent. (iv) Other Publications Finally, Apotex argues that other publications disclosed or suggested AstraZeneca’s innovative method. However, neither the Ilangovan or Carlsen study (attached as Exs. J and K to Gross Deck) refers to once-daily dosing. Moreover, the Ilangovan study was before the Patent Examiner during prosecution of the AstraZeneca patents. (See '603 Patent, References Cited). Similarly, despite Apotex’s argument to the contrary, the 1994 European advertisement for AstraZeneca’s PULMICORT RESPULES that was printed in the Thorax journal (attached as Ex. I to Gross Deck) does not refer to once-daily dosing. Although the Thorax advertisement states that “[t]he maintenance dose should be the lowest dose which keeps the patient symptom-free[,]” Dr. Chipps testified that this statement does not instruct once-daily dosing because the ad was published “back in 1994 ... before we had any information or historical perspective that once a day therapy worked for anybody.” (Tr. May 4, 2009 (Chipps) at 162). The Court finds this answer persuasive. (2) Obviousness Apotex also argues that the method of the '603 Patent is invalid because it was obvious in light of the prior art. Under 35 U.S.C. § 103, [a] patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Thus, even where a patent overcomes an invalidity challenge based on anticipation, it may still be invalidated if the differences between the invention and the prior art are so small that the invention would have been obvious to one of ordinary skill in the art. In assessing the obviousness of a patented invention, the Court should consider (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the art; and (4) the objective evidence of secondary considerations. Loctite Corp. v. Ultraseal Ltd., 781 F.2d 861, 875 (Fed.Cir.1985), overruled by Nobelphamna AB v. Implant Innovations, Inc., 141 F.3d 1059 (Fed.Cir.1998); see also Croton Operations, 289 F.3d at 1375 (listing the same four factors). With the exception of the '528 Patent, none of the prior art references cited by Apotex discusses a once-daily treatment for respiratory disease. As for the '528 Patent, although it mentions once-daily use, the method involved there actually teaches away from the method involved in the '603 Patent, as explained above. Thus, it cannot be said that the '603 Patent was obvious in light of the '528 Patent because the two teach different methods. Singh v. Brake, 317 F.3d 1334, 1346 (Fed.Cir.2003) (prior art that teaches away is relevant in determining whether or not a claimed invention would have been obvious) (citing W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1550 (Fed. Cir.1983)). Moreover, as Dr. Williams testified, a person skilled in the art could not predict the performance of one delivery device (the budesonide composition) based on the performance of a different delivery device (the drug entrapped liposome). (Tr. May 4, 2009 at 44 (Williams)). In addition, AstraZeneca has presented testimony regarding secondary considerations that shows the once-daily administration of BIS was not obvious to one skilled in the trade. Most significantly, the inventor of the method of the '603 Patent, Bertil Andersson, confirmed that there were many skeptics even within AstraZeneca itself. (Tr. May 5, 2009, at 52 (Andersson)). In fact, Andersson testified that he was not permitted to go forward with the once-daily clinical trial unless those trials also included a study of a twice-daily administration of BIS. (Id. at 54-55 (Andersson); see also Declaration of Kathleen O’Connor Ververeli, M.D., at ¶¶ 18-20). Moreover, AstraZeneca has introduced evidence that shows there was a long-felt need for a once-daily dosing pediatric asthma controller medication. Dr. Vellturo testified as to the tremendous commercial success of PULMICORT RESPULES®. (Tr. May 5, 2009, at 5-6 (Vellturo)). Teva Pharmaceuticals USA, a generic company, recently acquiesced in the validity of the PULMICORT RESPULES® patent (see infra). Dr. Chipps testified that there was a long-felt demand within the medical community for something new and that there has been much praise in the industry for PULMICORT RESPULES®. (Tr. May 4, 2009, at 158-59 (Chipps)). Given the above, this Court cannot find that AstraZeneca’s once-daily method was either anticipated by the prior art or obvious in light of the prior art. Accordingly, the Court holds that the method claims of the '603 patent are valid. 2. Infringement Because the Court has found that the kit claims are invalid, it need not engage in an analysis of direct infringement associated with the kit claims. However, because the Court has found that the method claims are valid, the Court will proceed with an analysis of indirect infringement associated with the method claims. 35 U.S.C. § 271(b) provides that “whoever actively induces infringement of a patent shall be liable as an infringer.” AstraZeneca alleges that Apotex will induce infringement of AstraZeneca’s patented method claims (Claims 1-3, 6-8, Ills, 21-28 of the '603 Patent) because the FDA approved label for Apotex BIS product (the “Apotex Label”) instructs physicians to prescribe Apotex’s generic BIS for once-daily use by patients. “ ‘In order to succeed on a claim of inducement, the patentee must show, first that there has been direct infringement, ' and second, that the alleged infringer knowingly induced infringement and possessed specific intent to encourage another’s infringement.’ ” Symantec Corp. v. Computer Assoc. Int'l, Inc., 522 F.3d 1279, 1292 (Fed.Cir.2008) (quoting MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369, 1378 (Fed.Cir.2005)). The Court will examine each part separately. a) Direct Infringement by Consumers The infringement analysis also involves two parts: “first claim construction and second a comparison of the properly construed claims to the accused product [or method].” Pfizer, Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1372 (Fed.Cir.2005). In order to prove infringement, the plaintiff must show that the accused product or method includes every limitation of an asserted claim of a patent. Baxter Healthcare Corp. v. Spectramed, Inc., 49 F.3d 1575, 1582 (Fed.Cir.1995). As set forth above, Claim 1 of the '603 Patent contains the following limitations: • method of treating a patient with respiratory disease • nebulized administration • budesonide composition • not more than once per day Having resolved the only dispute concerning the construction of these claims (i.e., the meaning of “budesonide composition”), supra, the Court will proceed to a comparison of these claim limitations to the Apotex Label. As the Apotex Label makes clear, the first three limitations are present in Apotex’s generic BIS. Specifically, the Apotex Label states that the generic BIS is “indicated for the maintenance treatment of asthma” (Apotex Label at 6), designed for “inhalation via jet nebulizer” (Id. at 1), and “contains the active ingredient, budesonide (micronized), and [various] inactive ingredients ...” (Id. at 1). Thus, the only limitation that the parties dispute is whether the Apotex product also involves once daily administration. To be clear, in AstraZeneca’s claim of inducement to infringe, the alleged infringer is not Apotex, but the consumer/patient who ultimately uses the generic BIS product in an infringing manner, i.e., once daily. Thus, in this section, the Court seeks to determine whether there is (or would be) direct infringement by the consumers who use Apotex’s generic BIS according to the instructions on the Apotex Label. The Apotex Label is virtually identical to the PULMICORT RESPULES® label. (See generally Apotex Label, attached as Ex. 2 to Accetta Declaration [Dkt. No. 33-3]). However, the trade name “PULMI-CORT RESPULES®” is replaced with Apotex’s generic name, “budesonide” or “budesonide inhalation suspension.” (Id.). Additionally, all explicit references to once-daily dosing have been removed from the Apotex Label. As set forth in the Apotex Label, Apotex’s generic BIS will be supplied in single dose vials of two strengths: 0.25 mg/2 ml or 0.5 mg/2 ml. (Id.). The “DOSAGE AND ADMINISTRATION” section of the Apotex Label sets forth a chart showing the recommended starting doses and highest recommended doses for three different groups of patients (depending on their previous therapy): Previous Therapy_Recommended Starting Dose Highest Recommended Dose Bronehodilators alone 0.5 mg total daily dose adminis- 0.5 mg total daily dose tered twice daily in divided _doses_ Inhaled Corticosteroids 0.5 mg total daily dose adminis- 1 mg total daily dose tered twice daily in divided _doses_ Oral Corticosteroids 1 mg total daily dose adminis- 1 mg total daily dose _tered as 0.5 mg twice daily_ (Id. at 16). This section of the label also states that “[o]nce the desired clinical effect is achieved, consideration should be given to tapering to the lowest effective dose” and “[i]n all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved.” (Id. at 15, 16). Similarly, the “PRECAUTIONS” section of the Apotex Label states that “suppression of HPA function may be associated when ... the dose is not titrated to the lowest effective dose” and “[t]o minimize the systematic effects of orally inhaled corticosteroids, including budesonide inhalation suspension, each patient should be titrated to his/her lowest effective dose.” (Id. at 8). AstraZeneca contends that although Apotex has removed all explicit references to once-daily dosing in its label, the Apotex Label still implicitly instructs once-daily dosing because it includes instructions to “downward titration” and “taper[] to the lowest effective dose.” To illustrate this argument, AstraZeneca highlights the dosing indications for the top two rows of patient groups — i.e., patients who previously used was bronehodilators alone and patients who previously used inhaled corticosteroids. For both categories of patients, the “recommended starting dose” is “0.5 mg administered twice daily in divided doses[,]” which means 0.25 mg twice daily. If a patient (whose asthma is controlled by that starting dose) is then titrated-down as the label provides, the only dosing option is 0.25 mg once-daily. There is no other option because the Apotex generic BIS will only be available in vials of 0.5 mg and 0.25 mg. The only category of patients for whom titrating down from the recommended starting dose would still indicate a twice-daily regimen is the third row of patients — that is, patients whose previous therapy was oral corticosteroids. For these patients, the recommended starting dose is 1 mg administered twice daily (e.g., 0.5 mg in the morning and 0.5 mg in the evening). Titrating down from 0.5 mg twice daily would not necessarily instruct a once-daily dosing of 0.5 mg, but could indicate a variety of twice-daily options as a first step: 0.5 mg in the morning and 0.25 mg in the evening; 0.25 mg in the morning and 0.5 mg in the evening; or 0.25 mg in the morning and 0.25 mg in the evening. Thus, the downward titration provision does not pose the same immediate problem in this group of patients as it does in the first two groups of patients. Indeed, were the downward titration language limited to this third category of patients, perhaps there would be no infringement, but the Apotex label clearly states that “[i]n all patients it is desirable to titrate down to the lowest effective dose.” (Apotex label at 15) (emphasis added). As further evidence of infringement, AstraZeneca points to a letter issued by the FDA on November 18, 2008 (the “FDA Letter”) in response to a citizen petition submitted on behalf of AstraZeneca. (See FDA Letter, attached as Ex. B to Simon Reply Decl., at 18). The first issue the FDA considered was “whether generic BIS, when labeled to exclude protected [once-daily dosing] information currently in the PULMICORT RESPULES labeling, would be rendered less safe or effective than PULMICORT RESPULES for all remaining, nonprotected conditions of use.” (Id. at 14). The FDA concluded that it would not. In reaching this conclusion, the FDA pointed to its earlier determination in connection with AstraZeneca’s new drug application (“NDA”) for PULMICORT RESPULES® that, in terms of efficacy, “the weight of evidence by all measures is stronger for twice daily dosing” than for once-daily dosing. (Id. at 15). Based on this determination, the FDA found that omission of the once-daily dosing references on the generic BIS label would not render the generic product less efficacious than PULMICORT RES-PULES®. Additionally, the FDA stated that because the type and incidence rate of adverse events for 0.25 mg once-daily dose does not differ significantly from the 0.5 mg and 1.0 mg total daily dose, there would be no safety risk if once-daily dosing references were eliminated from the label. (Id. at 16). Thus, the FDA concluded that the generic company could omit explicit references to once-daily dosing from its label without sacrificing efficacy or safety. The second issue the FDA addressed in its letter was whether or not the generic company’s proposed label should include the downward titration statement. The FDA concluded that it was “appropriate” for the generic company to retain the downward titration language on its label because such language would help minimize the risks of side effects associated with exposure to corticosteroids such as budesonide. (Id. at 17). The FDA also concluded that the downward titration language did not “teach” once-daily dosing because it could lead to a variety of dosing regimes, not just once-daily administration: The titration statement is relevant for the twice-daily dosing schedule that would be retained in the generic BIS product labeling. Titration to the lowest effective dose may involve, for example, a twice-daily regimen, once-daily dosing, or even alternate day dosing, as determined appropriate by a prescribing physician. The labeling does not state that the lowest effective dose is 0.25 mg once daily. As such, contrary to your assertion, the downward titration statement does not “teach” once-daily dosing. (FDA Letter at 18). AstraZeneca claims that the FDA’s conclusion that “[t]itration to the lowest effective dose may involve ... once-daily dosing” shows that there will be infringement by consumers. Apotex, however, interprets the FDA’s conclusion differently. According to Apotex, the FDA’s conclusion shows that there are other non-infringing titrations available (such as twice-daily dosing and alternate-day dosing) and, thus, the titration statement does not “teach” the infringing use. As an initial matter, the Court must note that the FDA does not have the authority to make legal findings concerning patent infringement. Thus, the FDA’s opinion as to whether or not the titration statement will cause infringement is only relevant as persuasive authority. Beyond that, the Court must recall that the issue to be addressed under this part of the infringement analysis is whether there will be infringement by consumers, not whether the label will “teach” the infringing use— that issue concerns the element of intent, discussed infra. Focusing on the issue at hand, the Court finds that the FDA’s statement that titration down “may involve ... once-daily dosing” supports AstraZeneca’s argument that there will be infringement. While it may be true that there are other non-infringing titrations available, the existence of such non-infringing uses does not eliminate the existence of infringing uses. Moreover, in light of the expert testimony during the hearing, the FDA’s opinion that the titration statement can lead to non-infringing uses is only accurate for some patients. Experts for both AstraZeneca (Bradley E. Chipps, M.D. and Thomas Q. Garvey III, M.D.) and Apotex (Donald Accetta, M.D., MPH) testified that downward titration should be done “incrementally,” by diminishing the total daily dose one step at a time. (See, e.g., Tr., May 1, 2009, at 65 (Accetta)) (“you wouldn’t just go from the highest dose to the lowest dose, but you’d probably do it in gradual [incre