DCT

1:24-cv-00399

Bayer Healthcare LLC v. Aurobindo Pharma Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:24-cv-00399, D. Del., 03/28/2024
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendants are subject to personal jurisdiction in the district, with Aurobindo Pharma USA, Inc. being a Delaware corporation and Aurobindo Pharma Ltd. being subject to jurisdiction through its U.S. subsidiary and business activities.
  • Core Dispute: Plaintiffs allege that Defendants’ submission of a supplement to an Abbreviated New Drug Application (ANDA) for a generic version of the Children's Astepro® Allergy nasal spray constitutes an act of infringement of three patents related to taste-masked azelastine formulations.
  • Technical Context: Azelastine is an effective antihistamine for nasal sprays, but its utility is hampered by a strong bitter taste that can result from post-nasal drip, creating patient compliance challenges.
  • Key Procedural History: This action was filed under the Hatch-Waxman Act following Plaintiffs' receipt of a Notice Letter from Aurobindo, dated February 13, 2024, which included a certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a "Paragraph IV certification") asserting that the patents-in-suit are invalid and/or will not be infringed by the proposed generic product.

Case Timeline

Date Event
2004-11-24 Priority Date for ’073, ’919, and ’050 Patents
2011-12-06 U.S. Patent No. 8,071,073 Issues
2013-08-27 U.S. Patent No. 8,518,919 Issues
2018-03-20 U.S. Patent No. 9,919,050 Issues
2024-02-13 Aurobindo sends Notice Letter to Plaintiffs
2024-03-28 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, despite its effectiveness as an antihistamine, possesses a strong bitter taste that is intensely unpleasant to patients, particularly when administered intranasally, as a portion of the medication can drip down into the pharynx (Compl. ¶1; ’073 Patent, col. 2:5-14).
  • The Patented Solution: The invention is a pharmaceutical composition that combines azelastine hydrochloride with a taste-masking agent, such as sucralose, to reduce or eliminate the bitter taste experienced by the patient upon administration. The patent also describes including viscosity-increasing agents, such as hypromellose, to reduce post-nasal drip, further mitigating the taste issue and improving patient compliance (’073 Patent, col. 2:60-65, col. 3:24-41).
  • Technical Importance: The invention addresses a significant patient compliance barrier for an otherwise effective topical antihistamine, making the treatment more tolerable for conditions like allergic rhinitis (’073 Patent, col. 2:35-39).

Key Claims at a Glance

  • The complaint asserts infringement of claims including 2 and 3, which depend from independent claim 1 (Compl. ¶32).
  • The essential elements of independent claim 1 are:
    • A liquid pharmaceutical composition for treating allergic or non-allergic vasomotor rhinitis, comprising:
    • about 0.100% (w/v) azelastine hydrochloride;
    • about 0.100% (w/v) of hypromellose;
    • about 0.05% (w/v) disodium edetate;
    • about 0.025% (w/v) benzalkonium chloride 50% solution, NF;
    • about 0.150% (w/v) sucralose;
    • about 6.4% (w/v) sorbitol 70%;
    • about 0.068% (w/v) sodium citrate dihydrate; and
    • QS water.
  • The complaint notes that in its Notice Letter, Aurobindo did not contest infringement of claims 2, 3, 7-12, 14, 15, or 18-28 on any basis other than alleged invalidity (Compl. ¶37).

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 problem as its parent ’073 Patent: the intensely bitter taste of azelastine hydrochloride, which creates an "unpleasant and undesired taste experience" for patients receiving it via nasal spray or ocular drops (’919 Patent, col. 2:10-25).
  • The Patented Solution: The invention claims a method of treating allergic rhinitis or non-allergic vasomotor rhinitis by administering a liquid pharmaceutical composition containing azelastine hydrochloride, sucralose as a taste-masking agent, and sorbitol as an isotonicity agent. This method provides symptomatic relief while improving patient acceptability due to the taste-masking (’919 Patent, col. 2:50-65, col. 3:1-14).
  • Technical Importance: This patent protects the specific act of using a taste-masked azelastine formulation to treat rhinitis, shifting the focus from the composition itself to its therapeutic application (’919 Patent, Abstract).

Key Claims at a Glance

  • The complaint asserts infringement of at least claim 1 (Compl. ¶55).
  • The essential elements of independent claim 1 are:
    • A method for treating allergic rhinitis or non-allergic vasomotor rhinitis in an animal, comprising:
    • administering to the animal a liquid pharmaceutical composition comprising:
      • 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 complaint notes that in its Notice Letter, Aurobindo did not contest infringement of claims 1-4, 6-10, or 12-20 on any basis other than alleged invalidity (Compl. ¶59).

U.S. Patent No. 9,919,050 - “Compositions Comprising Azelastine”

Multi-Patent Capsule

  • Technology Synopsis: This patent, part of the same family as the ’073 and ’919 patents, is also directed to liquid pharmaceutical compositions designed to solve the problem of azelastine's bitter taste. The invention is a formulation combining azelastine with specific taste-masking and isotonicity agents to improve patient compliance (’050 Patent, Abstract, col. 2:5-39).
  • Asserted Claims: The complaint asserts infringement of at least claim 1 (Compl. ¶77).
  • Accused Features: The formulation of Aurobindo's Children's ANDA Product is alleged to meet the limitations of the claims of the ’050 Patent (Compl. ¶80).

III. The Accused Instrumentality

Product Identification

  • Aurobindo's Children's ANDA Product, identified as a generic version of Children's Astepro® Allergy (azelastine hydrochloride nasal spray, 205.5 mcg/spray, OTC) (Compl. ¶1).

Functionality and Market Context

  • The accused product is a nasal spray solution containing azelastine hydrochloride, intended for the treatment of allergic and non-allergic rhinitis (Compl. ¶¶31, 35, 54). The filing of the ANDA supplement by Aurobindo is for the purpose of obtaining FDA approval to commercially manufacture and sell this product in the U.S. market as a generic alternative to the branded Astepro® product before the expiration of the patents-in-suit (Compl. ¶¶1, 33). No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or reference a claim chart exhibit. The following summary is based on the narrative allegations.

’073 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A liquid pharmaceutical composition for treating allergic rhinitis or non-allergic vasomotor rhinitis Aurobindo’s Children’s ANDA Product is a nasal spray solution for treating rhinitis. ¶31, ¶35 col. 8, l. 88
comprising: about 0.100% (w/v) azelastine hydrochloride The product is a nasal spray solution that contains azelastine hydrochloride. ¶35 col. 8, l. 88
about 0.100% (w/v) of hypromellose The product is alleged to meet the limitations of claim 1, which requires this excipient. ¶35 col. 8, l. 89
about 0.150% (w/v) sucralose The product is alleged to meet the limitations of claim 1, which requires this taste-masking agent. ¶35 col. 8, l. 92
about 6.4% (w/v) sorbitol 70% The product is alleged to meet the limitations of claim 1, which requires this excipient. ¶35 col. 8, l. 93

’919 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for treating allergic rhinitis or non-allergic vasomotor rhinitis in an animal The proposed labeling for Aurobindo's product will direct its use for treating rhinitis. ¶54, ¶58 col. 8, l. 50
comprising administering to the animal a liquid pharmaceutical composition The proposed labeling will instruct users to administer the nasal spray solution. ¶58, ¶62 col. 8, l. 52
comprising: about 0.1% to about 0.15% (w/v) azelastine hydrochloride The product contains azelastine hydrochloride in a concentration alleged to fall within the claimed range. ¶58 col. 8, l. 53
about 0.1% to about 0.15% (w/v) sucralose The product is alleged to contain sucralose in a concentration that falls within the claimed range. ¶58 col. 8, l. 54
and about 0.1% to about 10% (w/v) sorbitol 70%. The product is alleged to contain sorbitol in a concentration that falls within the claimed range. ¶58 col. 8, l. 55

Identified Points of Contention

  • Scope Questions: A central question may be how the term "about" preceding each concentration in the claims should be construed, which could impact the literal infringement analysis.
  • Technical Questions: The complaint alleges on "information and belief" that Aurobindo's product meets the claim limitations without providing the full formulation of the accused product (Compl. ¶¶35, 58). A key factual dispute will be whether the specific combination and concentration of excipients in Aurobindo's ANDA product fall within the scope of the asserted claims. For the ’919 patent, a question will be whether the instructions in the proposed labeling for the ANDA product direct users to perform each step of the claimed method.

V. Key Claim Terms for Construction

  • The Term: "sucralose" (appearing in claim 1 of the ’073 patent and claim 1 of the ’919 patent).
  • Context and Importance: Sucralose is identified in the patents as the specific taste-masking agent used in the preferred embodiments. Practitioners may focus on this term because the dispute will likely center on whether Aurobindo's formulation contains this specific excipient at the claimed concentration, as infringement of these claims appears to require its presence.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specification lists sucralose as one example among a group of taste-masking agents, which could suggest that related sweeteners might be considered equivalent, although the independent claims at issue explicitly recite sucralose (’073 Patent, col. 3:1-10).
    • Evidence for a Narrower Interpretation: The asserted independent claims explicitly require "sucralose," not merely "a taste-masking agent." The specification describes sucralose as "especially effective" and uses it in all detailed examples, suggesting it is a critical and specific component of the invention, not an interchangeable one (’073 Patent, col. 15:4-7).

VI. Other Allegations

  • Indirect Infringement: The complaint alleges active inducement of infringement for all three patents. The basis for this allegation is that Aurobindo's proposed product labeling will instruct end-users on how to administer the nasal spray, and that this instructed use will directly infringe the asserted claims, particularly the method claims of the ’919 Patent (Compl. ¶¶42, 63, 90). The complaint also alleges contributory infringement of the ’919 patent, stating the product is not a staple article of commerce and is especially made for an infringing use (Compl. ¶64).
  • Willful Infringement: While the term "willful" is not used, the complaint alleges that Aurobindo has knowledge of the patents-in-suit and a specific intent to infringe, based on its filing of the ANDA supplement and its Notice Letter (Compl. ¶¶42, 63, 90). The prayer for relief requests a declaration that this is an "exceptional case" and an award of attorneys' fees, which is relief often associated with findings of willful infringement or litigation misconduct (Compl. p. 19, ¶e).

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

  • A core issue will be one of factual infringement: does the specific formulation detailed in Aurobindo's confidential ANDA submission contain sucralose and the other recited excipients at concentrations that fall within the scope of the asserted claims, particularly when accounting for the term "about"?
  • A second key issue will be patent validity: can Aurobindo prove by clear and convincing evidence that the asserted claims are invalid, likely on grounds of obviousness, by arguing that it would have been obvious to a person of ordinary skill in the art to combine azelastine with known taste-masking agents like sucralose to solve the known problem of its bitter taste?
  • A final question will be one of induced infringement: assuming the claims are valid and direct infringement by an end-user is established, does the language of Aurobindo’s proposed product labeling provide sufficient instruction to establish that Aurobindo actively induced that infringement?