DCT
1:08-cv-01512
AstraZeneca LP v.BREATH Ltd
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: AstraZeneca LP (Delaware) and AstraZeneca AB (Sweden)
- Defendant: Breath Limited (United Kingdom)
- Plaintiff’s Counsel: McCARTER & ENGLISH, LLP; Ropes & Gray LLP
- Case Identification: 1:08-cv-01512, D.N.J., 03/19/2008
- Venue Allegations: Venue is based on Defendant's consent to jurisdiction in the District of New Jersey for any patent infringement action arising from its Abbreviated New Drug Application (ANDA) submission.
- Core Dispute: Plaintiff alleges that Defendant's filing of an ANDA to market a generic version of Plaintiff's PULMICORT RESPULES® (budesonide inhalation suspension) constitutes an act of infringement of two patents covering methods of using the drug.
- Technical Context: The technology concerns a specific dosing regimen for budesonide, a glucocorticosteroid administered via nebulizer for the maintenance treatment of asthma, particularly in pediatric patients.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant's submission of ANDA No. 78-404 and its subsequent notification letter to AstraZeneca, which asserted that the patents-in-suit are invalid, unenforceable, and/or not infringed.
Case Timeline
| Date | Event |
|---|---|
| 1997-12-31 | Earliest Priority Date for ’603 and ’099 Patents |
| 2003-07-29 | U.S. Patent No. 6,598,603 Issued |
| 2005-05-31 | U.S. Patent No. 6,899,099 Issued |
| 2008-02-07 | Defendant sends ANDA Notification Letter |
| 2008-03-19 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 6,598,603, "METHOD FOR TREATING RESPIRATORY DISEASES" (Issued Jul. 29, 2003)
The Invention Explained
- Problem Addressed: The patent identifies a "significant difficulty in the treatment of young children, including infants" with respiratory diseases like asthma, where frequent and repeated drug administration leads to problems with patient "compliance and convenience" (’603 Patent, col. 1:10-16). It states that existing methods for intrapulmonary drug delivery are "not optimal for use in infants and young children" (’603 Patent, col. 1:20-22).
- The Patented Solution: The invention is a method of treatment that simplifies the dosing schedule. It involves administering a nebulized budesonide composition "not more than once per day" in a continuing regimen (’603 Patent, Abstract; col. 1:24-27). This approach is intended to improve compliance and is particularly suited for young children, as delivery via a nebulizer with a face mask does not require the complex coordination of propellant-based inhalers (’603 Patent, col. 1:39-44).
- Technical Importance: The invention proposed a shift from multi-dose daily regimens to a once-daily treatment for pediatric asthma, aiming to improve patient adherence and, consequently, clinical outcomes (’603 Patent, col. 1:27-30).
Key Claims at a Glance
- The complaint asserts "one or more claims" without specifying them (Compl. ¶11). Independent claim 1 is representative.
- Independent Claim 1:
- A method of treating a patient suffering from a respiratory disease,
- the method comprising administering to the patient a nebulized dose of a budesonide composition
- in a continuing regimen
- at a frequency of not more than once per day.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 6,899,099, "METHOD FOR TREATING A RESPIRATORY DISEASE" (Issued May 31, 2005)
The Invention Explained
- Problem Addressed: As a continuation of the application leading to the ’603 Patent, the ’099 Patent addresses the same problem: the difficulty of ensuring patient compliance with multi-dose asthma treatments, especially in pediatric populations (’099 Patent, col. 1:15-25).
- The Patented Solution: The patented solution is a method of administering nebulized budesonide at a low frequency. The core concept of once-daily administration is maintained, but the claims add a further limitation (’099 Patent, col. 1:26-34). The specification notes that "Evening administration can result in better control of nocturnal and early morning symptoms which are frequent problems in asthma" (’099 Patent, col. 4:11-14).
- Technical Importance: This patent refines the once-daily method by specifying the time of administration, potentially to enhance efficacy against nighttime asthma symptoms, a common clinical challenge (’099 Patent, col. 4:11-14).
Key Claims at a Glance
- The complaint asserts "one or more claims" without specifying them (Compl. ¶11). Independent claim 1 is representative.
- Independent Claim 1:
- A method of treating a patient suffering from a respiratory disease,
- the method comprising administering to the patient a nebulized dose of a budesonide composition
- in a continuing regimen at a frequency of not more than once per day,
- wherein the administration is in the evening.
- The complaint does not explicitly reserve the right to assert dependent claims.
III. The Accused Instrumentality
- Product Identification: Defendant’s budesonide inhalation suspension, 0.25 mg/2ml and 0.5 mg/2ml, for which it submitted ANDA No. 78-404 to the FDA (Compl. ¶10).
- Functionality and Market Context: The accused product is a generic version of Plaintiff’s PULMICORT RESPULES® (Compl. ¶10). The complaint alleges that the ANDA filing demonstrates the product is bioequivalent to, and has the same active ingredient, dosage form, and strength as, PULMICORT RESPULES® (Compl. ¶12). A central allegation is that the defendant's product will be sold with "the same, or substantially the same, proposed labeling" as the brand-name drug, which is used for the maintenance treatment of asthma (Compl. ¶¶7, 12). The infringement theory rests on this proposed label instructing an infringing use.
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), where the filing of the ANDA is the statutory act of infringement. The substantive infringement theory is that the label for the proposed generic product will induce physicians and patients to practice the patented methods.
’603 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a patient suffering from a respiratory disease... | Defendant’s ANDA seeks approval to market its budesonide suspension for the maintenance treatment of asthma. | ¶¶7, 10 | col. 1:10-12 |
| ...the method comprising administering to the patient a nebulized dose of a budesonide composition... | Defendant’s product is a budesonide inhalation suspension intended for administration via nebulizer. | ¶10 | col. 1:24-26 |
| ...in a continuing regimen... | The product is indicated for the maintenance treatment of asthma, which implies a series of administrations over time. The patent defines "continuing regimen" as a series of administrations over days, weeks, or longer. | ¶¶7, 12 | col. 1:53-56 |
| ...at a frequency of not more than once per day. | The complaint alleges that the proposed label for Defendant's product is the same or substantially the same as the label for PULMICORT RESPULES®, which provides for once-daily dosing. | ¶12 | col. 1:26-27 |
’099 Patent Infringement Allegations
| Claim Element (from Independent Claim 1) | Alleged Infringing Functionality | Complaint Citation | Patent Citation |
|---|---|---|---|
| A method of treating a patient... in a continuing regimen at a frequency of not more than once per day... | The allegations for these elements are the same as for the ’603 Patent, as described above. | ¶¶7, 10, 12 | col. 1:26-32 |
| ...wherein the administration is in the evening. | The complaint alleges that the proposed label will be the same or substantially the same as the PULMICORT RESPULES® label, which would form the basis for alleging inducement of this specific administration time. | ¶12 | col. 4:11-14 |
- Identified Points of Contention:
- Scope Questions: A primary issue will be whether the language of Defendant's final, FDA-approved label will be sufficient to prove inducement of infringement. Does the label actively encourage or instruct a once-daily regimen, or does it present it as one of several options? For the ’099 Patent, does the label specifically recommend or require administration "in the evening"? The complaint does not contain the proposed label, leaving this as a central question of fact.
- Technical Questions: The dispute may not center on the technical operation of the drug itself, but on the clinical instructions for its use. A key question for the court will be whether the medical and commercial context makes a once-daily regimen the default or expected method of use, even if the label provides other options. The defendant’s assertion of non-infringement in its notice letter suggests it may argue its label does not meet the legal standard for inducement (Compl. ¶13).
V. Key Claim Terms for Construction
The Term: "continuing regimen" (’603 Claim 1; ’099 Claim 1)
Context and Importance: This term is central to defining the nature of the treatment as a long-term or multi-dose therapy, which is consistent with a maintenance drug for asthma. A defendant might seek to argue that a prescription does not inherently establish a "continuing regimen" to avoid infringement.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent provides an explicit and broad definition: "A ‘continuing regimen,’ is a treatment regimen of a series of two or more administrations that occur over days, weeks, months, or years" (’603 Patent, col. 1:53-56). This explicit definition strongly supports the patentee's position and may make the term difficult to challenge.
- Evidence for a Narrower Interpretation: The complaint does not provide sufficient detail for analysis of evidence supporting a narrower interpretation, as the patent’s express definition appears controlling.
The Term: "administering... in the evening" (’099 Claim 1)
Context and Importance: The infringement case for the ’099 Patent hinges entirely on this limitation. Practitioners may focus on this term because its ambiguity could be outcome-determinative. Whether the generic label induces infringement will depend on how specifically this term is construed.
Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The patent does not provide an explicit definition, which could support an argument for giving the term its plain and ordinary meaning, such as the time between late afternoon and midnight.
- Evidence for a Narrower Interpretation: The specification provides functional context: "Evening administration can result in better control of nocturnal and early morning symptoms" (’099 Patent, col. 4:11-14). A defendant could argue this ties the term to a specific therapeutic purpose (controlling nighttime symptoms), implying administration should occur shortly before sleep, rather than anytime during the evening.
VI. Other Allegations
- Indirect Infringement: The complaint is premised on induced infringement. It alleges that Defendant's acts of manufacturing and selling its generic drug, combined with its proposed product labeling, will cause doctors and patients to use the drug in a manner that directly infringes the patented methods (Compl. ¶15). The basis for this allegation is the assertion that the proposed label will be the same or substantially the same as that for PULMICORT RESPULES® (Compl. ¶12).
- Willful Infringement: Willfulness is alleged based on Defendant’s pre-suit knowledge of the patents, evidenced by the ANDA Notification letter sent to AstraZeneca on February 7, 2008 (Compl. ¶¶13, 16). The complaint alleges that despite this awareness, Defendant is proceeding with its infringing activity, rendering the infringement "willful and deliberate" and the case "exceptional" under 35 U.S.C. § 285 (Compl. ¶16).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of induced infringement: Will the final, FDA-approved label for Defendant's generic product contain instructions and recommendations that are specific enough to meet the legal standard for inducing infringement of the "once per day" and, more critically for the ’099 patent, the "in the evening" method limitations?
- A key evidentiary question will be one of label equivalence: Does the Defendant's proposed product labeling, which is not included in the complaint, in fact mirror the innovator's label to an extent that it encourages, rather than merely permits, the patented methods of use?
- While not detailed in the complaint, a central defense will likely concern validity: Was the claimed once-daily dosing regimen for nebulized budesonide an obvious therapeutic choice to one of ordinary skill in the art at the time of the invention, potentially rendering the patent claims invalid?