DCT

3:19-cv-05501

Meda Pharma Inc v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:19-cv-05501, D.N.J., 02/12/2019
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey as Defendant Aurobindo Pharma USA, Inc. has its principal place of business in the state.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Astepro® nasal spray constitutes an act of infringement of three patents related to pharmaceutical compositions of azelastine.
  • Technical Context: The technology concerns formulations of azelastine hydrochloride, an antihistamine used in nasal sprays, designed to mask the active ingredient's inherent bitter taste and reduce post-nasal drip, thereby improving patient compliance.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act, triggered by a notice letter from Aurobindo dated January 3, 2019. The letter contained a Paragraph IV certification alleging that Plaintiff's patents-in-suit are invalid for obviousness under 35 U.S.C. § 103. The patents are listed in the FDA's "Approved Drug Products with Therapeutic Equivalence Evaluation" (the "Orange Book") as covering Meda's Astepro® product.

Case Timeline

Date Event
2004-11-24 Earliest Priority Date for ’073, ’919, and ’050 Patents
2008-10-15 FDA approval of Meda’s Astepro® New Drug Application
2011-12-06 U.S. Patent No. 8,071,073 Issued
2013-08-27 U.S. Patent No. 8,518,919 Issued
2018-03-20 U.S. Patent No. 9,919,050 Issued
2019-01-03 Aurobindo sends Paragraph IV Notice Letter to Meda
2019-02-12 Complaint Filed

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

U.S. Patent No. 8,071,073 - "Compositions comprising azelastine and methods of use thereof"

The Invention Explained

  • Problem Addressed: The patent describes that azelastine hydrochloride, an effective antihistamine, possesses a strong and intensely bitter taste. This taste becomes a significant issue for patient compliance when the medication, administered as a nasal spray, drips down into the pharynx (a phenomenon known as post-nasal drip). ( Compl. Ex. A, ’073 Patent, col. 2:5-15).
  • The Patented Solution: The invention is a specific pharmaceutical formulation that combines azelastine hydrochloride with sucralose, a taste-masking agent, and hypromellose, a viscosity-increasing agent. The increased viscosity is intended to reduce the amount of post-nasal drip, while the sucralose masks the bitter taste of any medication that does reach the pharynx, thereby improving the patient's experience and compliance. (’073 Patent, col. 2:41-3:15, Abstract).
  • Technical Importance: The solution addressed a key barrier to patient adherence for topical antihistamine therapies by mitigating a significant negative side effect directly related to the drug's formulation. (’073 Patent, col. 2:35-39).

Key Claims at a Glance

  • The complaint asserts infringement of Claim 1. (Compl. ¶30).
  • The essential elements of independent claim 1, a method claim, are:
    • A method of treating allergic rhinitis in an animal.
    • The method comprises administering a liquid pharmaceutical composition as a nasal spray or drops.
    • The composition comprises specific weight/volume percentages of eight ingredients: about 0.100% azelastine hydrochloride, about 0.100% hypromellose, about 0.05% disodium edetate, about 0.025% benzalkonium chloride 50% solution, about 0.150% sucralose, about 6.4% sorbitol 70%, about 0.068% sodium citrate dihydrate, and QS water. (’073 Patent, col. 51:12-25).
  • The complaint alleges infringement of "one or more claims," suggesting the right to assert dependent claims is reserved. (Compl. ¶30).

U.S. Patent No. 8,518,919 - "Compositions comprising azelastine and methods of use thereof"

The Invention Explained

  • Problem Addressed: The ’919 Patent addresses the same technical problem as the ’073 Patent: the intensely bitter taste of azelastine hydrochloride in nasal spray formulations, which can lead to an unpleasant patient experience due to post-nasal drip. (Compl. Ex. B, ’919 Patent, col. 2:5-15).
  • The Patented Solution: The invention claims a liquid pharmaceutical composition containing azelastine hydrochloride, the sweetener sucralose, and the polyol sorbitol. This combination is designed to mask the bitterness of the active ingredient when administered intranasally. (’919 Patent, Abstract; col. 2:55-64).
  • Technical Importance: This formulation provided a solution to the patient compliance problem by focusing on a specific combination of taste-masking and formulation agents. (’919 Patent, col. 2:35-39).

Key Claims at a Glance

  • The complaint asserts infringement of Claim 1. (Compl. ¶34).
  • The essential elements of independent claim 1, a composition claim, are:
    • A liquid pharmaceutical composition for treating allergic rhinitis or non-allergic vasomotor rhinitis.
    • The composition comprises a range of concentrations for three key ingredients: about 0.1% to about 0.15% (w/v) azelastine hydrochloride; about 0.1% to about 0.15% (w/v) sucralose; and about 0.1% to about 10% (w/v) sorbitol 70%.
    • The composition is formulated as a nasal spray or nasal drops. (’919 Patent, col. 87:1-9).
  • The complaint alleges infringement of "one or more claims," suggesting the right to assert dependent claims is reserved. (Compl. ¶34).

U.S. Patent No. 9,919,050 - "Compositions comprising azelastine"

The Invention Explained

  • The ’050 patent is directed to liquid intranasal pharmaceutical compositions that address the bitter taste of azelastine hydrochloride. The solution involves combining azelastine hydrochloride with specific concentrations of the taste-masking agent sucralose and the polyol sorbitol to improve patient acceptability. A certificate of correction was issued to amend the scope of claim 1. (Compl. Ex. C, ’050 Patent, Abstract, Certificate of Correction).

Key Claims at a Glance

  • Asserted Claims: The complaint asserts infringement of Claim 1. (Compl. ¶38).
  • Accused Features: The formulation of Aurobindo's generic azelastine hydrochloride nasal spray, 0.15%, as described in its ANDA, is alleged to infringe. (Compl. ¶25, 38).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Aurobindo’s azelastine hydrochloride nasal spray, 0.15%, 205.5 mcg per spray, as described in ANDA No. 212775 (the "ANDA Product"). (Compl. ¶25).

Functionality and Market Context

  • The ANDA Product is a generic version of Meda’s Astepro® nasal spray, which is used for the treatment of allergic rhinitis. (Compl. ¶1, 23, 25). The complaint alleges that Aurobindo filed its ANDA seeking FDA approval to manufacture and sell this generic version in the United States prior to the expiration of the patents-in-suit. (Compl. ¶25).

IV. Analysis of Infringement Allegations

The complaint does not provide an element-by-element breakdown of its infringement allegations or include a claim chart. Instead, it asserts infringement based on the statutory framework of the Hatch-Waxman Act, where the submission of an ANDA is itself an act of infringement if the product described therein would infringe an unexpired patent upon commercialization. (Compl. ¶30, 34, 38; 35 U.S.C. § 271(e)(2)(A)). The central allegation is that the formulation of the ANDA Product, if approved and marketed, would meet all the limitations of the asserted claims.

No probative visual evidence provided in complaint.

  • Identified Points of Contention:
    • Statutory Infringement vs. Validity: The complaint establishes a cause of action based on the artificial act of infringement under § 271(e)(2)(A). However, it also notes that Aurobindo’s Paragraph IV certification asserts that the patents-in-suit are invalid for obviousness. (Compl. ¶26). This suggests the primary legal battle may not be over whether the ANDA product meets the claim limitations, but whether those claims are valid in the first place.
    • Claim Scope: A potential point of contention for infringement could be the interpretation of the term "about" as it modifies the specific concentrations in the asserted claims. The dispute would center on whether the precise concentrations of ingredients in Aurobindo's ANDA Product fall within the scope of the claimed ranges, as construed by the court.

V. Key Claim Terms for Construction

  • The Term: "about"
  • Context and Importance: This term appears in the independent claims of both the ’073 and ’919 patents, modifying the specific weight/volume percentages of the formulation's ingredients (e.g., "about 0.150% (w/v) sucralose"). (Compl. Ex. A, ’073 Patent, col. 51:12-25; Compl. Ex. B, ’919 Patent, col. 87:1-9). Practitioners may focus on this term because its construction will define the permissible range of deviation from the recited concentrations. The infringement analysis will depend on whether the concentrations disclosed in Aurobindo's confidential ANDA filing fall within the scope of the term "about" as construed.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The patents do not explicitly define "about." A party could argue that the term should be interpreted to encompass normal manufacturing tolerances and variations understood by a person of ordinary skill in the art of pharmaceutical formulation.
    • Evidence for a Narrower Interpretation: A party could argue that the precision of the values recited in the claims (e.g., to three decimal places) implies that "about" should be construed narrowly. The specific examples in the specification, which use precise values, may also be cited to support a more limited scope that does not extend far beyond the stated numbers. (e.g., ’073 Patent, col. 80:1-15).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges infringement under 35 U.S.C. § 271(e)(2)(A), which is a statutory act of direct infringement, and does not contain separate counts for indirect infringement.
  • Willful Infringement: The complaint alleges that Aurobindo had "knowledge of the ’073, ’919, and/or ’050 patents when it submitted and filed ANDA No. 212775." (Compl. ¶27, 31, 35, 39). It further alleges that the infringement "has been, and continues to be, deliberate," forming a basis for a potential claim of willfulness. (Compl. ¶31, 35, 39).

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

  • A central issue will be one of validity: can Aurobindo demonstrate with clear and convincing evidence that the claimed formulations—which combine the known drug azelastine with specific taste-masking and other excipients—were obvious to a person of ordinary skill in the art at the time of the invention, as it alleged in its Paragraph IV certification?
  • A threshold question for infringement will be one of claim scope: how will the court construe the term "about" as it applies to the recited concentrations, and does the precise formulation detailed in Aurobindo's confidential ANDA fall within the scope of that term?
  • A key question for potential damages and remedies will be one of intent: do the circumstances of Aurobindo's ANDA filing, particularly its knowledge of the Orange Book-listed patents, support a finding of deliberate or willful infringement?