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Astrazeneca LP v. Apotex

May 14, 2009

ASTRAZENECA LP AND ASTRAZENECA AB, PLAINTIFFS,
v.
APOTEX, INC. AND APOTEX CORP., DEFENDANTS.



The opinion of the court was delivered by: Bumb, United States District Judge*fn1

OPINION

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*fn2

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(r), 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(r). AstraZeneca began selling PULMICORT RESPULES(r) in September 2000. PULMICORT RESPULES(r) became the first and only*fn3 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(r) was a long-desired treatment of pediatric asthma, and it has played a unique role in such treatment. PULMICORT RESPULES(r) is given to children twelve months to eight years of age. PULMICORT RESPULES(r) 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(r): 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(r) 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 RESPULES(r) is often referred to as "budesonide inhalation suspension" or "BIS."

The label (approved by the Federal Drug Administration ("FDA")) for PULMICORT RESPULES(r) 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 0.5 mg total daily dose administered either once-daily or twice daily in divided doses Inhaled Corticosteroids 0.5 mg total daily dose 1 mg total daily dose administered either once-daily or twice daily in divided doses Oral Corticosteroids 1 mg total daily dose 1 mg total daily dose administered either as 0.5 mg twice daily or 1 mg once-daily The patient instruction sheet accompanying the PULMICORT RESPULES(r) 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 Hatch-Waxman Act. Specifically, 21 U.S.C. § 355(j) 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 prior 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.*fn4 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." (Compl. ¶ 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 RESPULES(r). 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." Abott 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 Pl. 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.*fn5

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." Abott 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. Abbot 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. Barnesandnoble.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 1350-31 (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.*fn6 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)*fn7 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)*fn8 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.*fn9

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, 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.*fn10 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 Ngai, 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, "[h]ere, 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?*fn11 "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 kit that did not exist in the prior art -- "a nebulized budesonide product that can be safely and effectively administered once-daily." (Pl. 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 "[b]oth 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 patentability to claims to the known composition"); see also, In re Haller, 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, '[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.'... 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 ...


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