Astrazeneca Lp v. Apotex, Inc.
| Decision Date | 14 May 2009 |
| Docket Number | Civil Action No. 09-1518 (RMB). |
| Citation | 623 F.Supp.2d 579 |
| Parties | ASTRAZENECA LP and Astrazeneca AB, Plaintiffs, v. APOTEX, INC. and Apotex Corp., Defendants. |
| Court | U.S. District Court — District of New Jersey |
Andrew T. Berry, Esquire, Mark H. Anania, Esquire, McCarter & English, LLP, Newark, NJ.
Denise L. Loring, Esquire, Pablo D. Hendler, Esquire, Christopher J. Harnett, Esquire, Derek M. Kato, Esquire, Ropes & Gray, LLP, New York, NY.
Eric I. Abraham, Esquire, Hill Wallack, LLP, Princeton, NJ.
Richard J. Basile, Esquire, David W. Aldrich, Esquire, St. Onge Steward Johnson & Reens, LLC, Stamford, CT.
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.
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.
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.
This case involves AstraZeneca's revolutionary invention of a once-daily inhaled corticosteroid under the trade name PULMICORT RESPULES®. AstraZeneca began selling PULMICORT RESPULES® in September 2000. PULMICORT RESPULES® became the first and only3 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 RESPULES® is given to children twelve months to eight years of age. PULMICORT 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 RESPULES® 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 administered 0.5 mg total daily dose
either once-daily or twice
daily in divided doses
____________________________________________________________________________________________
Inhaled Corticosteroids 0.5 mg total daily dose administered 1 mg total daily dose
either once-daily or twice
daily in divided doses
____________________________________________________________________________________________
Oral Corticosteroids 1 mg total daily dose administered 1 mg total daily dose
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.)
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.4 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.).
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®. In its motion, AstraZeneca contended that it...
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