DCT

1:19-cv-00203

AstraZeneca Ab v. Mylan Pharma Inc

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Key Events
Complaint

I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:19-cv-00203, D. Del., 10/11/2018
  • Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware based on Defendants' extensive and systematic business contacts with the state, including the incorporation of numerous affiliates, a history of litigating patent challenges in the district, and the intent to market and sell the accused products in Delaware upon approval.
  • Core Dispute: Plaintiff AstraZeneca alleges that Defendant Mylan's submission of an Abbreviated New Drug Application (ANDA) to market generic versions of the asthma and COPD drug Symbicort® constitutes a statutory act of infringement of four patents covering the drug's formulation and its delivery device.
  • Technical Context: The technology concerns stable pharmaceutical compositions for pressurized metered-dose inhalers (pMDIs) and the mechanical design of the inhaler device, a critical field for the effective delivery of respiratory medications.
  • Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act, triggered by a Notice Letter from Mylan dated August 30, 2018. The letter contained a Paragraph IV certification alleging that AstraZeneca's patents are invalid, unenforceable, or will not be infringed by Mylan's proposed generic product, which is the statutorily required step for a generic manufacturer seeking to challenge existing patents.

Case Timeline

Date Event
1997-11-14 ’011 Patent Priority Date
2002-02-01 ’328, ’239, ’137 Patents Priority Date
2006-07-21 FDA approves NDA for Symbicort
2010-07-20 ’328 Patent Issue Date
2011-06-28 ’011 Patent Issue Date
2012-03-27 ’239 Patent Issue Date
2013-11-05 ’137 Patent Issue Date
2018-08-30 Mylan sends Paragraph IV Notice Letter
2018-10-11 Complaint Filing Date

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

U.S. Patent No. 7,759,328 - "Composition for Inhalation," issued July 20, 2010

The Invention Explained

  • Problem Addressed: The patent addresses the critical technical challenge of ensuring the physical stability of a pharmaceutical suspension within a pressurized metered-dose inhaler (pMDI). For combination drug products, it is vital that the active ingredients do not separate from the propellant, as this can lead to inconsistent and inaccurate dosing for the patient (’328 Patent, col. 1:20-24).
  • The Patented Solution: The invention is a specific pharmaceutical formulation that combines two active ingredients, formoterol and budesonide, with a hydrofluoroalkane (HFA) propellant and two key excipients: polyvinylpyrrolidone (PVP) and polyethylene glycol (PEG) (’328 Patent, Abstract). The specification asserts that this combination of excipients, at particular concentrations, creates an unexpectedly stable suspension, solving the problem of the active drugs settling out of the propellant over time (’328 Patent, col. 2:25-34, 48-51).
  • Technical Importance: The development of stable HFA-based pMDI formulations was a significant hurdle for the pharmaceutical industry during the transition away from ozone-depleting chlorofluorocarbon (CFC) propellants, and this invention provided a method for delivering a key combination therapy in this modern format (’328 Patent, col. 2:25-34).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims (Compl. ¶98). The lead independent claim is Claim 1.
  • Essential elements of Claim 1 include:
    • A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, HFA227, PVP K25, and PEG-1000.
    • The formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml.
    • The budesonide is present at a concentration in the range of 1 mg/ml to 8 mg/ml.
    • The PVP K25 is present at a concentration of 0.001% w/w.
    • The PEG-1000 is present at a concentration of 0.3% w/w.
  • The complaint reserves the right to assert other claims, including dependent claims.

U.S. Patent No. 8,143,239 - "Composition for inhalation," issued March 27, 2012

The Invention Explained

  • Problem Addressed: Like its parent, the '239 patent addresses the need to create a physically stable suspension of formoterol and budesonide particles in a pMDI to ensure that patients receive a consistent and reliable dose with each actuation ('239 Patent, col. 1:25-30).
  • The Patented Solution: The invention claimed is the final product: a pressurized metered-dose inhaler that contains the stabilized suspension composition. The claims are directed to the inhaler device pre-loaded with a formulation comprising formoterol, budesonide, HFA227 propellant, PVP, and PEG ('239 Patent, Abstract). Critically, the claims define the invention not just by the concentration of ingredients within the canister, but by the specific dose of the active ingredients "delivered" upon actuation of the inhaler ('239 Patent, col. 9:11-14).
  • Technical Importance: This patent protects the integrated drug-device combination as sold to patients, linking the novel formulation directly to its intended function within a specific delivery system for treating respiratory diseases like asthma and COPD ('239 Patent, col. 2:9-13).

Key Claims at a Glance

  • The complaint asserts infringement of one or more unspecified claims (Compl. ¶115). The lead independent claim is Claim 1.
  • Essential elements of Claim 1 include:
    • A pressurized metered dose inhaler containing a suspension composition of formoterol, budesonide, HFA227, PVP, and PEG.
    • The budesonide concentration is in the range of 1 mg/ml to 8 mg/ml.
    • The PVP concentration is in the range of 0.001% to 0.01% w/w.
    • The PEG concentration is in the range of 0.05 to 0.5% w/w.
    • An actuation of the inhaler "delivers" 4.5 µg of formoterol and 40 to 320 µg of budesonide.
  • The complaint reserves the right to assert other claims, including dependent claims.

Multi-Patent Capsule: U.S. Patent No. 8,575,137

  • Patent Identification: U.S. Patent No. 8,575,137, "Composition for inhalation," issued November 5, 2013 (Compl. ¶20).
  • Technology Synopsis: This patent relates to the same family as the '328 and '239 patents and addresses the technical problem of formulation stability in pMDIs. It claims a pharmaceutical suspension composition comprising formoterol, budesonide, an HFA propellant, PVP, and PEG. The claims specify concentrations and ranges for these components, intended to maintain a stable suspension for consistent drug delivery upon inhalation (Compl. ¶20; '137 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" (Compl. ¶132).
  • Accused Features: The complaint alleges that the formulation of Mylan's proposed generic product, as detailed in its ANDA, will infringe the claimed composition (Compl. ¶¶130, 133).

Multi-Patent Capsule: U.S. Patent No. 7,967,011

  • Patent Identification: U.S. Patent No. 7,967,011, "Inhalation device," issued June 28, 2011 (Compl. ¶22).
  • Technology Synopsis: This patent focuses on the mechanical design of the inhaler actuator rather than the drug formulation. The invention is an actuator featuring a main body, an ovoid mouthpiece, and a removable protective cap. The key inventive concept resides in the cap's attachment mechanism, which includes at least one "release button" designed to elastically deform a portion of the cap to disengage it from the mouthpiece, aiming for a secure but user-friendly design (Compl. ¶22; '011 Patent, Abstract).
  • Asserted Claims: The complaint asserts infringement of "one or more claims" (Compl. ¶149).
  • Accused Features: The complaint alleges that the inhaler device intended for use with Mylan's generic product will infringe the claimed structural and functional features of the actuator and its protective cap (Compl. ¶¶147, 150). The complaint notes that specifications for the inhaler were absent from the heavily redacted portion of the ANDA provided to AstraZeneca (Compl. ¶29).

III. The Accused Instrumentality

  • Product Identification: The accused instrumentalities are "Mylan's ANDA Products," which are generic versions of AstraZeneca's Symbicort® Inhalation Aerosol (Compl. ¶¶ 24, 25).
  • Functionality and Market Context: The products are identified as "Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol" formulated for use in a pressurized metered-dose inhaler (pMDI) (Compl. ¶24). They are intended for the treatment of asthma and chronic obstructive pulmonary disease (COPD) (Compl. ¶13). Mylan seeks approval for two dosage forms: 80 mcg budesonide/4.5 mcg formoterol and 160 mcg budesonide/4.5 mcg formoterol per actuation (Compl. ¶24). The complaint positions these products as direct generic competitors intended to launch prior to the expiration of the patents-in-suit (Compl. ¶1, 25).

IV. Analysis of Infringement Allegations

The complaint, filed at an early stage, does not contain a detailed element-by-element infringement analysis or a claim chart. The infringement allegations are based on the statutory act of filing ANDA No. 211699, which seeks approval for a product that, on information and belief, will contain the elements of the asserted claims upon manufacture and sale (Compl. ¶¶ 98, 115). No probative visual evidence provided in complaint.

’328 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pharmaceutical composition comprising formoterol fumarate dihydrate, budesonide, 1,1,1,2,3,3,3-heptafluoropropane (HFA227), PVP K25... and PEG-1000... The complaint alleges, on information and belief, that the Mylan ANDA Products will contain these active ingredients and excipients. ¶¶16, 24, 97-99 col. 8:15-22
wherein the formoterol fumarate dihydrate is present at a concentration of 0.09 mg/ml The complaint alleges the Mylan ANDA Products will contain formoterol at the claimed concentration. ¶¶16, 97-99 col. 8:22-23
the budesonide is present at a concentration in the range of 1 mg/ml to 8 mg/ml The complaint alleges the Mylan ANDA Products will contain budesonide at a concentration within the claimed range. ¶¶16, 97-99 col. 8:23-25
the PVP K25 is present at a concentration of 0.001% w/w The complaint alleges the Mylan ANDA Products will contain PVP K25 at the claimed concentration. ¶¶16, 97-99 col. 8:25-27
and the PEG-1000 is present at a concentration of 0.3% w/w The complaint alleges the Mylan ANDA Products will contain PEG-1000 at the claimed concentration. ¶¶16, 97-99 col. 8:27-29
  • Identified Points of Contention:
    • Technical Question: A primary question for discovery will be whether the specific excipients (PVP K25, PEG-1000) and their exact concentrations (0.001% w/w for PVP, 0.3% w/w for PEG) in Mylan's proposed product precisely match the claim limitations.
    • Scope Question: The claims recite specific grades of excipients ("PVP K25" and "PEG-1000"). A potential dispute may arise if Mylan’s product uses different grades of PVP or molecular weights of PEG, raising the question of whether such alternatives fall within the literal scope of the claims or could be considered equivalents.

’239 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A pressurized metered dose inhaler containing a suspension composition comprising formoterol fumarate dihydrate... budesonide... HFA227; polyvinyl pyrrolidone (PVP); and polyethylene glycol (PEG) The complaint alleges that Mylan's ANDA Products consist of an inhaler containing a composition with these components. ¶¶18, 24, 113-116 col. 9:1-5
wherein the budesonide is present... at a concentration in the range of 1 mg/ml to 8 mg/ml The complaint alleges Mylan's product will have a budesonide concentration within this specified range. ¶¶18, 113-116 col. 9:5-7
the PVP is present at a concentration in the range of 0.001% to 0.01% w/w The complaint alleges Mylan's product will have a PVP concentration within this specified range. ¶¶18, 113-116 col. 9:7-9
and the PEG is present at a concentration in the range of 0.05 to 0.5% w/w The complaint alleges Mylan's product will have a PEG concentration within this specified range. ¶¶18, 113-116 col. 9:9-11
and wherein an actuation of the inhaler delivers 4.5 µg formoterol fumarate dihydrate and 40 to 320 µg budesonide The complaint identifies Mylan's ANDA Products as having dosages of 4.5 mcg formoterol with either 80 mcg or 160 mcg of budesonide, which falls within the claimed delivered dose range. ¶¶18, 24, 113-116 col. 9:11-14
  • Identified Points of Contention:
    • Technical Question: A key factual question will be whether the measured dose delivered per actuation from Mylan's device meets the ranges required by the claim, especially after accounting for real-world variability in device performance and measurement techniques.
    • Scope Question: This claim recites concentration ranges for the excipients that are broader than the specific values in the ’328 patent. The dispute may focus on whether Mylan’s formulation, if it avoids infringement of the ’328 patent, nevertheless falls within these broader ranges.

V. Key Claim Terms for Construction

  • The Term: "pharmaceutical composition" ('328 Patent, Claim 1)

    • Context and Importance: This term defines the subject matter of the claim. In Hatch-Waxman litigation, the infringement analysis compares the claims to the product that will be made under the ANDA. The definition of the "composition"—whether it refers to the bulk formulation in the canister or the specific aerosolized dose—could be critical to the infringement analysis.
    • Evidence for a Broader Interpretation: A party could argue the term refers to the entire contents of the canister before actuation, citing specification language that describes the preparation of the bulk formulation for filling the device ('328 Patent, col. 7:25-30).
    • Evidence for a Narrower Interpretation: A party could argue the term must refer to the mixture as it exists in a stable suspension ready for delivery, pointing to the patent's repeated emphasis on "physical suspension stability" and the extensive experimental data measuring suspension behavior over time ('328 Patent, col. 2:32-34; col. 5:3-6).

  • The Term: "delivers" ('239 Patent, Claim 1)

    • Context and Importance: The claim requires that an actuation of the inhaler "delivers" a specific dose. This term links the formulation to the performance of the device, and its construction will determine how infringement is measured. Practitioners may focus on this term because dose delivery from pMDIs is a complex process, and the choice of measurement technique (e.g., metered dose from the valve vs. fine particle dose reaching the lungs) can be outcome-determinative.
    • Evidence for a Broader Interpretation: A party might argue "delivers" means the total amount of drug actuated from the valve (the "metered dose"), as this is a standard design parameter and the specification refers to dosages "per actuation" ('239 Patent, col. 2:19-21).
    • Evidence for a Narrower Interpretation: A party could argue "delivers" must be interpreted as the therapeutically relevant "fine particle dose," as this is the portion of the drug likely to reach the lungs. The patent's own performance tables, which include "Fine particle fraction" data, could be cited to support this narrower, more functional interpretation ('239 Patent, col. 8, tables).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendants will induce infringement upon approval of the ANDA. The alleged factual basis is that Mylan will "knowingly and intentionally" distribute its generic product with a label and insert that instruct healthcare professionals and patients on how to use the product in an infringing manner (Compl. ¶¶ 100, 117, 134, 150).
  • Willful Infringement: The complaint does not contain a formal count for willful infringement, but it lays the groundwork for an "exceptional case" finding under 35 U.S.C. § 285. It alleges that Defendants had "actual and constructive notice" of the patents before filing the ANDA and were aware that doing so would constitute infringement, and that they proceeded "without adequate justification" (Compl. ¶¶ 101-102, 118-119, 135-136, 151-152).

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

  • A central factual issue, currently obscured by the confidential and redacted nature of the ANDA, will be one of compositional identity: does the precise formulation of Mylan's proposed generic product—specifically its choice of excipients (PVP, PEG), their commercial grades, and their exact concentrations—fall within the literal scope of the patents' composition claims?
  • A key technical and legal question will be one of functional performance: does Mylan's complete product (device plus formulation) "deliver" the claimed drug dosage per actuation as defined by the '239 patent, and does its inhaler device incorporate the specific mechanical features of the "removable protection cap with release buttons" claimed in the '011 patent?
  • Given the family of patents with varying claim scopes (e.g., a specific concentration in the '328 patent versus a broader range in the '239 patent), a core strategic question will be whether Mylan's product, if designed to avoid infringement of one patent, can successfully navigate the scope of the others, or whether the patent portfolio creates an effective protective "thicket."