DCT

1:22-cv-00035

AstraZeneca Ab v. Mylan Pharma Inc

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:22-cv-00035, N.D.W. Va., 04/26/2022
  • Venue Allegations: Venue is alleged to be proper as to Mylan because it resides in the judicial district and maintains a regular and established place of business there. Venue is alleged as proper for Kindeva based on its commission of tortious acts of patent infringement within the district and its purported consent to venue.
  • Core Dispute: Plaintiff alleges that Defendants' filing of an Abbreviated New Drug Application (ANDA) to market a generic version of the asthma and COPD drug Symbicort® constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology involves pharmaceutical compositions for pressurized metered-dose inhalers (pMDIs), focusing on a specific combination of active ingredients and excipients designed to ensure the stability of the drug suspension.
  • Key Procedural History: The complaint notes this dispute follows extensive prior litigation between the parties over related patents from the same family. In that litigation, a five-day trial resulted in a judgment that the asserted claims were not obvious, a finding affirmed by the U.S. Court of Appeals for the Federal Circuit. The complaint also states that Defendants were notified of the allowed claims of the patent-in-suit before its issuance.

Case Timeline

Date Event
2002-02-01 '558 Patent Priority Date
2006-07-21 FDA approves New Drug Application for Symbicort®
2018-08-15 FDA sends Paragraph IV Acknowledgment Letter for ANDA No. 211699
2020-10-01 Trial commences on related patents ('328, '239, '137)
2021-02-19 District Court enters judgment of nonobviousness in prior litigation
2021-12-15 Federal Circuit affirms judgment of nonobviousness in prior litigation
2022-03-08 Plaintiff notifies Defendant of allowed claims of pending '558 patent application
2022-03-16 FDA approves Defendants' ANDA No. 211699
2022-04-26 U.S. Patent No. 11,311,558 issues
2022-04-26 Complaint filed

II. Technology and Patent(s)-in-Suit Analysis

U.S. Patent No. 11,311,558 - "Composition for Inhalation"

The Invention Explained

  • Problem Addressed: The patent identifies chemical and physical stability as a critical factor in developing multi-component pharmaceutical products, particularly for pressurized metered-dose inhalers (pMDIs), which may require specific excipients to function correctly ('558 Patent, col. 1:11-24).
  • The Patented Solution: The patent describes a pharmaceutical composition that combines two active ingredients (formoterol and budesonide) with a specific hydrofluoroalkane (HFA) propellant and a pair of excipients—polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG)—at specific concentration ranges. This particular combination is asserted to result in a pMDI formulation with "excellent physical suspension stability," which is crucial for delivering a consistent therapeutic dose ('558 Patent, col. 1:25-28, col. 1:32-38).
  • Technical Importance: The invention provided a stable formulation for a combination therapy used to treat respiratory diseases like asthma and COPD, allowing for consistent delivery via a pMDI device ('558 Patent, col. 2:1-4).

Key Claims at a Glance

  • The complaint asserts infringement of "one or more claims" of the '558 patent, with Claim 1 being the sole independent claim (Compl. ¶55; '558 Patent, col. 8:21-31).
  • The essential elements of independent Claim 1 are:
    • A pharmaceutical composition comprising formoterol,
    • budesonide or an epimer thereof,
    • 1,1,1,2,3,3,3-heptafluoropropane (HFA 227),
    • about 0.0005 to about 0.05% w/w polyvinyl pyrrolidone (PVP) K25, and
    • about 0.05 to about 0.35% w/w polyethylene glycol (PEG) 1000.
  • The complaint’s general allegation of infringing "one or more claims" suggests Plaintiff reserves the right to assert dependent claims.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentalities are "Mylan's ANDA Products," which are generic versions of Symbicort® (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol) identified by ANDA No. 211699 (Compl. ¶1, ¶15).

Functionality and Market Context

  • The products are inhalation aerosols formulated as pressurized metered-dose inhalers for the treatment of asthma and chronic obstructive pulmonary disease (COPD) (Compl. ¶8). The complaint alleges that the filing of the ANDA, which seeks FDA approval to market these generic products prior to the expiration of the '558 Patent, is an act of infringement under 35 U.S.C. § 271(e)(2) (Compl. ¶1, ¶55). The complaint frames the accused products as direct generic competitors to Plaintiff's branded Symbicort® product (Compl. ¶15).

IV. Analysis of Infringement Allegations

The complaint alleges that the submission of ANDA No. 211699 constitutes an act of infringement under 35 U.S.C. § 271(e)(2), but does not provide a detailed claim chart mapping the ANDA product's composition to the elements of the asserted claims (Compl. ¶55). The infringement theory appears to rely on the fact that the ANDA seeks approval for a generic version of Symbicort®, the composition of which Plaintiff alleges is covered by the '558 patent (Compl. ¶1, ¶15).

A key allegation supporting this theory is the reference to prior litigation on related patents, where Defendants allegedly "stipulated to infringement of the asserted claims," which are described as "similar to those of the '558 patent" and reciting the same key ingredients (HFA 227, PVP K25, and PEG 1000) (Compl. ¶28). This suggests Plaintiff's position is that the composition defined in the ANDA is unchanged from the one previously conceded to infringe similar claims.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Scope Questions: The complaint's narrative suggests that the primary dispute may not be over the technical elements of the composition itself, given the alleged prior stipulation to infringement. A potential point of contention could arise over the scope of the term "about" as it applies to the concentration ranges of the PVP K25 and PEG 1000 excipients.
    • Technical Questions: A latent technical question is whether the exact formulation specified in Defendants' ANDA falls within the claimed numerical ranges. The complaint does not present the specific formulation from the ANDA, but its reliance on the prior litigation history suggests a belief that the formulation is infringing.

V. Key Claim Terms for Construction

  • The Term: "about"
  • Context and Importance: This term modifies the numerical concentration ranges for both PVP K25 ("about 0.0005 to about 0.05% w/w") and PEG 1000 ("about 0.05 to about 0.35% w/w") in Claim 1. Its construction is critical because it determines the literal scope of the claimed ranges. Practitioners may focus on this term because the infringement analysis could turn on whether the accused product's specific excipient concentrations, if not identical to the recited numbers, are nevertheless captured by the flexibility that "about" provides.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The repeated use of "about" in the claims and specification suggests the inventors did not intend for the ranges to be strictly limited to their endpoints ('558 Patent, col. 1:35-38, col. 8:21-31). The specification also discusses experimental results across a spectrum of concentrations, which a party might use to argue that the invention is not limited to the precise recited values ('558 Patent, FIGS. 2-8).
    • Evidence for a Narrower Interpretation: The specification highlights the particular effectiveness of certain concentrations, such as 0.001% w/w PVP K25, which it notes "give[s] consistently stable formulations" ('558 Patent, col. 2:10-15, col. 5:40-42). A party could argue that such statements, along with specific data points in the patent's figures and tables, indicate the criticality of certain values and thus counsel for a narrow reading of "about," limiting it to little more than measurement error.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges induced infringement under 35 U.S.C. § 271(b). The factual basis alleged is that Defendants intend to market and distribute the ANDA products with a product label and insert containing instructions for administration, which will knowingly cause healthcare professionals and patients to use the product in an infringing manner (Compl. ¶57).
  • Willful Infringement: The complaint alleges Defendants' infringement is and will be willful. This allegation is based on both post-suit knowledge from the filing of the complaint and, notably, alleged pre-suit knowledge. The complaint asserts Defendants had knowledge via a letter sent on March 8, 2022, which notified them of the allowed claims of the application that would issue as the '558 patent, as well as the extensive history of litigation over the same technology (Compl. ¶31, ¶58).

VII. Analyst’s Conclusion: Key Questions for the Case

  • A core issue will be one of patent validity and preclusion: can Defendants mount a successful invalidity challenge to the '558 patent's claims, likely on obviousness grounds, or will the prior judicial findings of nonobviousness and "teaching away" in litigation over parent patents preclude them from re-litigating these same issues under the doctrine of collateral estoppel?
  • A second central question is one of infringement scope: assuming the ANDA product formulation is the same as in the prior litigation, the dispute may focus on claim construction. The case could turn on whether the term "about" is interpreted broadly enough to read on the accused formulation, or if any minute differences in the new patent's claims or the accused product provide a non-infringement argument not previously available.
  • Finally, a key question for damages and potential fee-shifting will be willfulness: did Defendants' decision to proceed in the face of the prior litigation results and the pre-issuance notice letter constitute egregious conduct sufficient to support a finding of willful infringement and an exceptional case?