Mylan Specialty LP v. Aurobindo Pharma USA Inc

I. Executive Summary and Procedural Information

• Parties & Counsel:
  • Plaintiff: Mylan Specialty L.P. (West Virginia)
  • Defendant: Aurobindo Pharma USA Inc. (Delaware / New Jersey)
  • Plaintiff’s Counsel: Saiber LLC; Katten Muchin Rosenman LLP
• Case Identification: 3:18-cv-15190, D.N.J., 10/22/2018
• Venue Allegations: Venue is alleged to be proper in the District of New Jersey because the Defendant has a regular and established place of business in the district and has committed acts of infringement there, including the development and filing of its Abbreviated New Drug Application (ANDA).
• Core Dispute: Plaintiff alleges that Defendant’s filing of an ANDA to market a generic version of Plaintiff's AccuNeb® product constitutes an act of infringement of a patent covering a pediatric albuterol inhalation solution.
• Technical Context: The technology concerns pharmaceutical formulations of albuterol sulfate, a bronchodilator, specifically developed in pre-measured, preservative-free, single-use vials for treating asthma in children.
• Key Procedural History: This lawsuit was initiated under the Hatch-Waxman Act following Defendant’s submission of an ANDA with a Paragraph IV certification. The certification alleges that U.S. Patent No. 6,702,997, which is listed in the FDA’s Orange Book as covering the reference drug AccuNeb®, is invalid, unenforceable, or will not be infringed by Defendant’s proposed generic product. The complaint was filed within the 45-day statutory window triggered by Defendant's notice letter, which preserves a potential 30-month stay of FDA approval for the generic.

Case Timeline

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

U.S. Patent No. 6,702,997 - “Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma”

Issued March 9, 2004 (’997 Patent)

The Invention Explained

• Problem Addressed: The patent identifies several risks associated with administering albuterol to children (’997 Patent, col. 1:52-65). Standard adult doses were potentially too high for pediatric patients, increasing adverse effects. The alternative—manually diluting adult-strength solutions—created risks of improper dosing and bacterial contamination (’997 Patent, col. 2:1-6). Furthermore, many existing solutions contained the preservative benzalkonium chloride (BAC), which the patent notes can itself cause paradoxical bronchoconstriction in asthmatic subjects (’997 Patent, col. 2:7-18).
• The Patented Solution: The invention is a sterile, premixed, premeasured, single-use inhalation solution of albuterol specifically formulated for pediatric patients aged 2 to 12 (’997 Patent, Abstract; col. 2:25-30). By providing specific, reduced pediatric dosages (e.g., 0.63 mg and 1.25 mg) in ready-to-use vials, the invention aims to eliminate the need for dilution, thereby enhancing dosing accuracy and safety (’997 Patent, col. 5:18-34). A key feature is that the solution is free of antimicrobial preservatives like BAC, which is intended to reduce the risk of treatment-related side effects (’997 Patent, col. 4:49-62).
• Technical Importance: The invention addressed a need for a safer and more convenient method of administering a first-line asthma treatment to children by providing a product designed to mitigate specific, known risks of overdosing, contamination, and preservative-induced adverse reactions (’997 Patent, col. 5:24-49).

Key Claims at a Glance

• The complaint asserts "one or more claims...including without limitation claim 1" (Compl. ¶28, ¶32). Independent claim 1 is a method claim.
• The essential elements of independent claim 1 are:
  • A method for inducing bronchodilation in a child 2-12 years of age with asthma, comprising the step of:
  • administering a single dispensing container comprising a sterile, benzalkonium chloride-free, premixed, premeasured aqueous inhalation solution;
  • the active ingredient consisting essentially of a unit dose of a therapeutically effective pediatric amount of racemic albuterol sulfate;
  • the dosage of racemic albuterol sulfate is from about 0.21 mg to about 1.90 mg;
  • the solution is suitable for nebulization; and
  • the solution is stable and therapeutically effective after 12 months of storage.
• The complaint reserves the right to assert other claims, which may include dependent claims or other independent claims directed to the composition, kit, or system.

III. The Accused Instrumentality

Product Identification

• Aurobindo’s proposed albuterol sulfate inhalation solution (EQ 0.021 % and EQ 0.042% base), for which it seeks FDA approval under ANDA No. 211888 (Compl. ¶1, ¶13).

Functionality and Market Context

• The complaint alleges the ANDA Product is a generic version of Mylan’s AccuNeb® product (Compl. ¶13). It is intended for the same approved indication: "relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease)" (Compl. ¶19). The complaint further alleges that Aurobindo's ANDA relies on the AccuNeb® NDA and contains data to demonstrate bioequivalence to AccuNeb® (Compl. ¶17). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a detailed claim chart. The infringement theory is based on the premise that by filing an ANDA for a generic version of AccuNeb® for the same pediatric indication, Aurobindo’s product and its proposed label will necessarily meet the limitations of the asserted claims upon approval. The following chart summarizes these allegations.

’997 Patent Infringement Allegations

• Identified Points of Contention:
  • Evidentiary Questions: The complaint was filed before Plaintiff obtained a copy of the ANDA submission (Compl. ¶15). A central question will be whether the ANDA itself, once produced in discovery, provides evidence that the proposed generic product meets every limitation of the asserted claims. Specifically, discovery will be needed to confirm the product's formulation (e.g., that it is "benzalkonium chloride-free"), its sterility, and its stability data.
  • Scope Questions: The claim phrase "consisting essentially of" restricts the active ingredient but allows for other substances that do not materially affect the "basic and novel properties" of the invention. A potential dispute may arise over whether any excipients in Aurobindo's formulation materially alter these properties, which the patent defines in part as being preservative-free and ready-to-use for pediatric administration (’997 Patent, col. 4:49-62; col. 5:18-34).

V. Key Claim Terms for Construction

• The Term: "consisting essentially of"

  • Context and Importance: This transitional phrase is narrower than "comprising" but broader than "consisting of." Its construction is critical because it will determine whether any unlisted excipients in Aurobindo's formulation place the product outside the claim's scope. Practitioners may focus on this term to dispute whether Aurobindo's formulation contains components that materially affect the invention's "basic and novel properties."
  • Intrinsic Evidence for a Broader Interpretation: The specification discloses that the formulation may include components beyond albuterol sulfate and water, such as sodium chloride to adjust isotonicity and sulfuric acid to adjust pH, suggesting that the presence of some additional, non-active ingredients is contemplated (’997 Patent, col. 5:40-45).
  • Intrinsic Evidence for a Narrower Interpretation: The patent repeatedly emphasizes that the invention’s novel properties are its preservative-free nature (specifically, BAC-free) and its provision as a pre-measured, sterile dose to avoid contamination and dosing errors (’997 Patent, col. 2:25-35; col. 4:49-62). An argument could be made that any unlisted ingredient that functions as a preservative or otherwise negates the ready-to-use pediatric safety benefits would materially alter these properties and thus fall outside the claim.

• The Term: "therapeutically effective pediatric amount"

  • Context and Importance: The definition of this term will determine whether infringement requires only meeting a specific dosage range or if it also imports qualitative concepts of safety and tolerability from the specification.
  • Intrinsic Evidence for a Broader Interpretation: The patent explicitly provides dosages of "about 0.63 mg or about 1.25 mg albuterol" as examples of a therapeutically effective pediatric amount, and claim 1 recites a specific numerical range (0.21 mg to 1.90 mg of the sulfate salt) (’997 Patent, col. 4:51-53; col. 17:14-16). This may support an interpretation that the term is primarily defined by these quantitative values.
  • Intrinsic Evidence for a Narrower Interpretation: The specification defines the phrase as "a safe and tolerable amount of albuterol for pediatric patients, as based on industry and/or regulatory standards," which is "sufficient to effectively induce bronchodilation" (’997 Patent, col. 4:44-49). This language could support an argument that the term is not merely a number but is tied to the specific safety and tolerability problems in the pediatric context that the patent claims to solve.

VI. Other Allegations

• Indirect Infringement: The complaint alleges induced infringement, stating that Aurobindo's prescribing information for the ANDA Product "will instruct users to administer the ANDA Product" in a manner that infringes, and will "substantially copy the instructions for AccuNeb®" (Compl. ¶24-25). It further alleges contributory infringement, asserting that Aurobindo knows its product is "especially made or adapted for use in a way that would infringe the '997 patent, and is not suitable for substantial non-infringing use" (Compl. ¶28).
• Willful Infringement: Willfulness is alleged based on Aurobindo's pre-suit knowledge of the ’997 Patent, which it necessarily had when it filed its ANDA containing a Paragraph IV certification against the patent (Compl. ¶20, ¶33). The complaint asserts that Aurobindo's infringement "has been, and continues to be, deliberate" (Compl. ¶33).

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

• A central issue will be one of evidentiary proof: As the complaint was filed without the benefit of discovery, the case will depend on whether the contents of Aurobindo’s ANDA—specifically its formulation details, stability data, and proposed labeling—confirm that the accused product and its intended use meet every limitation of the asserted claims.
• The case may also turn on a question of claim scope: Can the term "consisting essentially of" be construed to read on Aurobindo’s formulation? The answer will depend on a factual and legal determination of the patent’s "basic and novel properties" and whether any unlisted excipients in the generic product materially affect those properties.