DCT

2:23-cv-06208

Allergan Inc v. Amneal Pharma Of New York LLC

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 2:23-cv-06208, E.D.N.Y., 08/17/2023
  • Venue Allegations: Venue is alleged to be proper as to Amneal Pharmaceuticals of New York, LLC, because it has a regular and established place of business in the district. For the foreign defendants, venue is alleged to be proper in any judicial district.
  • Core Dispute: Plaintiffs allege that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of the ophthalmic solution LUMIGAN® 0.01% constitutes an act of infringement of twelve U.S. patents.
  • Technical Context: The technology concerns ophthalmic pharmaceutical formulations containing the active ingredient bimatoprost, used to treat glaucoma and ocular hypertension by reducing intraocular pressure.
  • Key Procedural History: The complaint notes that five of the asserted patents ('504, '353, '118, '605, and '479) were previously found valid and infringed in a separate litigation against Sandoz, Inc., a decision that was affirmed by the U.S. Court of Appeals for the Federal Circuit. This history may be relevant to claim construction and validity arguments in the present case.

Case Timeline

Date Event
2005-03-16 Priority Date for all Patents-in-Suit
2010-08-31 FDA Approval of LUMIGAN® 0.01%
2010-12-14 U.S. Patent No. *7,851,504* Issues
2012-10-02 U.S. Patent No. *8,278,353* Issues
2012-10-30 U.S. Patent No. *8,299,118* Issues
2012-11-13 U.S. Patent No. *8,309,605* Issues
2012-12-25 U.S. Patent No. *8,338,479* Issues
2013-09-03 U.S. Patent No. *8,524,777* Issues
2013-11-19 U.S. Patent No. *8,586,630* Issues
2014-07-08 U.S. Patent No. *8,772,338* Issues
2015-01-13 U.S. Patent Nos. *8,933,120* and *8,933,127* Issue
2015-10-13 U.S. Patent No. *9,155,716* Issues
2016-01-26 U.S. Patent No. *9,241,918* Issues
2023-07-05 Amneal sends Notice Letter to Plaintiffs regarding ANDA filing
2023-08-17 Complaint Filed

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

U.S. Patent No. 7,851,504 - "Enhanced bimatoprost ophthalmic solution"

The Invention Explained

  • Problem Addressed: The patent background describes commercial ophthalmic solutions containing prostaglandin analogs that require significant amounts of the preservative benzalkonium chloride (BAK), from 150-200 parts per million (ppm), to meet antimicrobial effectiveness standards (Compl. ¶34; ’504 Patent, col. 1:36-44). The implicit problem is creating a bimatoprost formulation that is both effectively preserved and bioavailable.
  • The Patented Solution: The invention is an aqueous ophthalmic solution containing a low concentration of bimatoprost (from 0.005% to 0.02%) combined with a relatively high concentration of BAK (from 100 ppm to 250 ppm) (’504 Patent, Abstract). The specification discloses that formulations with higher BAK concentrations resulted in higher permeability and increased concentration of bimatoprost's active acid metabolite in the aqueous humor, suggesting BAK acts as a penetration enhancer (’504 Patent, col. 4:56-61; Fig. 1).
  • Technical Importance: This formulation strategy sought to increase the ocular absorption of a lower-concentration bimatoprost solution, thereby maintaining therapeutic efficacy while potentially reducing concentration-dependent side effects (’504 Patent, col. 4:56-61).

Key Claims at a Glance

  • The complaint asserts at least Claim 1 (Compl. ¶56).
  • Independent Claim 1 requires:
    • A composition having a pH of about 7.3
    • which consists essentially of about 0.01% bimatoprost,
    • about 200 ppm benzalkonium chloride,
    • a phosphate buffer,
    • NaCl, and
    • water,
    • wherein said composition is an aqueous liquid which is formulated for ophthalmic administration.

U.S. Patent No. 8,278,353 - "Enhanced bimatoprost ophthalmic solution"

The Invention Explained

  • Problem Addressed: The technical problem is consistent with that of the ’504 Patent: formulating an effective ophthalmic solution for glaucoma that balances preservative efficacy, bioavailability, and side-effect profile (Compl. ¶35; ’353 Patent, col. 1:24-49).
  • The Patented Solution: The patent claims a method for lowering intraocular pressure by administering a specific formulation (about 0.01% bimatoprost and about 0.02% w/v BAK) (’353 Patent, Abstract). The key inventive step is the claimed functional outcome: the formulation not only lowers intraocular pressure but also "results in less hyperemia" (a common side effect involving eye redness) compared to a prior art formulation with higher bimatoprost and lower BAK concentrations (’353 Patent, col. 6:1-15).
  • Technical Importance: This invention claims a specific formulation that optimizes the therapeutic window for bimatoprost, providing a method that maintains pressure-lowering efficacy while reducing a known side effect by carefully selecting the concentrations of both the active ingredient and the preservative.

Key Claims at a Glance

  • The complaint asserts at least Claim 1 (Compl. ¶64).
  • Independent Claim 1 requires:
    • A first composition administered once daily for lowering intraocular pressure in a person with glaucoma or ocular hypertension,
    • the first composition comprising about 0.01% w/v bimatoprost and about 0.02% w/v benzalkonium chloride,
    • wherein the first composition lowers intraocular pressure and results in less hyperemia as compared to the once daily administration of a second composition comprising 0.03% w/v bimatoprost and 0.005% w/v benzalkonium chloride.

U.S. Patent No. 8,299,118 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent, a continuation of the same application family, claims a method for lowering intraocular pressure. The claimed method involves administering a specific bimatoprost and BAK composition that is asserted to be effective while causing less hyperemia than a prior art formulation (Compl. ¶36, ¶72).
  • Asserted Claims: Independent Claim 1 (Compl. ¶72).
  • Accused Features: The entirety of Amneal's proposed generic formulation and its intended use (Compl. ¶72).

U.S. Patent No. 8,309,605 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims an aqueous ophthalmic solution with specific concentrations of bimatoprost and BAK, along with a citric acid buffer. The invention is directed at a specific formulation for treating glaucoma (Compl. ¶37, ¶80).
  • Asserted Claims: Independent Claim 1 (Compl. ¶80).
  • Accused Features: The specific chemical composition of Amneal's proposed generic product (Compl. ¶80).

U.S. Patent No. 8,338,479 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a composition for treating elevated intraocular pressure containing about 0.01% bimatoprost, about 200 ppm BAK, and at least one buffer. The claims are directed to the chemical formulation itself (Compl. ¶38, ¶88).
  • Asserted Claims: Independent Claim 1 (Compl. ¶88).
  • Accused Features: The chemical composition of Amneal's proposed generic product (Compl. ¶88).

U.S. Patent No. 8,524,777 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a method of treating glaucoma by applying a solution with about 0.01% to 0.015% bimatoprost and about 0.02% BAK. The claim requires that this method result in reduced side effects compared to a 0.03% bimatoprost formulation (Compl. ¶39, ¶96).
  • Asserted Claims: Independent Claim 1 (Compl. ¶96).
  • Accused Features: The proposed use of Amneal's generic product to treat glaucoma (Compl. ¶96).

U.S. Patent No. 8,586,630 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a method of lowering elevated intraocular pressure with a composition of about 0.01% bimatoprost and about 200 ppm BAK, further specifying a phosphate buffer. The claims are directed to a method of use with a specific formulation (Compl. ¶40, ¶104).
  • Asserted Claims: Independent Claim 1 (Compl. ¶104).
  • Accused Features: The intended use of Amneal's proposed generic formulation to lower intraocular pressure (Compl. ¶104).

U.S. Patent No. 8,772,338 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a method of lowering intraocular pressure by administering a 0.01% bimatoprost / 0.02% BAK solution that is as effective as, but causes less hyperemia than, a 0.03% bimatoprost solution. The claims focus on the method and its functional, comparative advantages (Compl. ¶41, ¶112).
  • Asserted Claims: Independent Claim 1 (Compl. ¶112).
  • Accused Features: The intended method of use for Amneal's proposed generic product (Compl. ¶112).

U.S. Patent No. 8,933,120 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims an ophthalmic composition with a specific narrow range of bimatoprost (0.01%-0.015%) and BAK (0.02%). The claims are directed to the formulation itself, defining specific component concentrations (Compl. ¶42, ¶120).
  • Asserted Claims: Independent Claim 1 (Compl. ¶120).
  • Accused Features: The specific chemical composition of Amneal's proposed generic product (Compl. ¶120).

U.S. Patent No. 8,933,127 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a first composition for treating glaucoma that is administered once daily and is asserted to be as effective as a second, prior art composition. The claims focus on the composition and its therapeutic equivalence to a higher-strength formulation (Compl. ¶43, ¶128).
  • Asserted Claims: Independent Claim 5 (Compl. ¶128).
  • Accused Features: Amneal's proposed generic product formulation and its intended therapeutic use (Compl. ¶128).

U.S. Patent No. 9,155,716 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a method of treating glaucoma or ocular hypertension by administering a specific bimatoprost/BAK composition that results in less hyperemia than a prior art formulation. The claim is directed to a method of use with a specified clinical outcome (Compl. ¶44, ¶136).
  • Asserted Claims: Independent Claim 1 (Compl. ¶136).
  • Accused Features: The intended therapeutic use and functional outcome of Amneal's proposed generic product (Compl. ¶136).

U.S. Patent No. 9,241,918 - "Enhanced bimatoprost ophthalmic solution"

  • Technology Synopsis: This patent claims a specific ophthalmic composition for treating glaucoma that includes bimatoprost, BAK, and a phosphate buffer. The claims are directed to the formulation itself, reciting its constituent components (Compl. ¶45, ¶144).
  • Asserted Claims: Independent Claim 1 (Compl. ¶144).
  • Accused Features: The specific chemical composition of Amneal's proposed generic product (Compl. ¶144).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Amneal's ANDA Product," a generic version of LUMIGAN® 0.01% for which Amneal has filed Abbreviated New Drug Application No. 217289 with the U.S. FDA (Compl. ¶1-2).

Functionality and Market Context

  • The product is an ophthalmic solution formulated to reduce elevated intraocular pressure in patients suffering from open angle glaucoma or ocular hypertension (Compl. ¶3-4). The complaint alleges the ANDA Product is a generic version of Plaintiffs' "successful pharmaceutical product" and that its potential market entry prior to patent expiration would cause injury to Plaintiffs (Compl. ¶1, ¶28). The act of infringement alleged is the statutory act of filing the ANDA under 35 U.S.C. § 271(e)(2)(A), which seeks approval to market this generic product before the patents-in-suit expire (Compl. ¶2).

No probative visual evidence provided in complaint.

IV. Analysis of Infringement Allegations

7,851,504 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition having a pH of about 7.3 The complaint alleges Amneal's ANDA Product meets every limitation of Claim 1, which requires this pH. ¶56 col. 2:50-54
which consists essentially of about 0.01% bimatoprost, The complaint alleges Amneal's ANDA Product meets this limitation. ¶56 col. 2:55-59
about 200 ppm benzalkonium chloride, The complaint alleges Amneal's ANDA seeks approval for a product that contains "about 200 ppm benzalkonium chloride." ¶56 col. 2:50-54
a phosphate buffer, NaCl, and water, The complaint alleges Amneal's ANDA Product meets these limitations. ¶56 col. 2:50-54
wherein said composition is an aqueous liquid which is formulated for ophthalmic administration. The product is an aqueous ophthalmic solution. ¶56 col. 1:64-65

8,278,353 Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A first composition administered once daily for lowering intraocular pressure... The proposed product is intended for once-daily administration for lowering intraocular pressure. ¶64 col. 6:1-3
the first composition comprising about 0.01% w/v bimatoprost The complaint alleges Amneal's ANDA Product meets this limitation. ¶64 col. 6:8-10
and about 0.02% w/v benzalkonium chloride, The complaint alleges Amneal's ANDA seeks approval for a product that contains "about 0.02% w/v benzalkonium chloride." ¶64 col. 6:8-10
wherein the first composition lowers intraocular pressure and results in less hyperemia as compared to the once daily administration of a second composition comprising 0.03% w/v bimatoprost and 0.005% w/v benzalkonium chloride. The complaint alleges Amneal's ANDA Product meets this functional limitation. ¶64 col. 6:11-15
  • Identified Points of Contention:
    • Scope Questions: Across multiple infringement counts, the complaint states that Amneal's Notice Letter "disputes" that its ANDA product contains the claimed concentration of benzalkonium chloride (e.g., "about 200 ppm" or "about 0.02% w/v"), yet Plaintiffs allege the ANDA seeks approval for a product that does contain this concentration (Compl. ¶56, ¶64, ¶72, etc.). This structure suggests the central dispute will be the proper construction of the term "about" and whether Amneal's actual formulation falls within the scope of that term.
    • Technical Questions: For method claims requiring a functional outcome, such as Claim 1 of the ’353 Patent which requires that the composition "results in less hyperemia" than a comparator, a key question arises: what evidence is required to prove infringement in the context of an ANDA filing? The analysis may depend on bioequivalence data, clinical studies submitted in the ANDA, or other expert evidence regarding the properties of the proposed generic product.

V. Key Claim Terms for Construction

  • The Term: "about"
  • Context and Importance: This term appears in the concentration limitations for both the active ingredient (bimatoprost) and the preservative (benzalkonium chloride) in the independent claims of numerous asserted patents (e.g., ’504 Patent, Claim 1; ’353 Patent, Claim 1). The complaint repeatedly indicates that the concentration of benzalkonium chloride is a point of dispute raised in Amneal's pre-suit Notice Letter (Compl. ¶56, ¶64). Therefore, the scope of "about" will be critical to determining infringement for many, if not all, of the asserted patents. Practitioners may focus on this term because its construction could resolve the core technical dispute presented in the pleadings.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The specifications of the patents-in-suit provide ranges for the components, such as "from 0.005% to 0.02% bimatoprost" and "from 100 ppm to 250 ppm benzalkonium chloride" (’504 Patent, col. 1:60-63). This use of ranges may support a construction where "about" is not limited to the precise recited value but encompasses a reasonable range around it, consistent with the patent's broader disclosure.
    • Evidence for a Narrower Interpretation: The specifications also disclose specific formulations with precise values, such as "0.01% Bimatoprost, 0.02% Benzalkonium Chloride" (’504 Patent, col. 2:63-64). A party might argue that in the context of pharmaceutical chemistry, where concentrations can have significant clinical effects, "about" should be construed narrowly to cover only minor variations consistent with standard manufacturing tolerances, and that the specific examples define the core of the invention.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that if Amneal's ANDA is approved, its commercial manufacture, use, or sale of the product would induce and/or contribute to infringement by others, such as patients and doctors following the product's instructions (Compl. ¶55, ¶63). The basis for these allegations is the filing of the ANDA itself, which seeks approval for a product with a label that will presumably instruct users to perform the patented methods.
  • Willful Infringement: The complaint alleges that Amneal had "actual and constructive notice" of the patents-in-suit prior to filing its ANDA (Compl. ¶57, ¶65). This allegation of pre-suit knowledge is based on the requirement that ANDA filers certify to patents listed in the FDA's "Orange Book," where Plaintiffs' patents are listed for LUMIGAN® 0.01% (Compl. ¶1-2).

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

  • A core issue will be one of definitional scope: can the term "about," as used to define the concentration of benzalkonium chloride in the asserted claims, be construed to read on the concentration in Amneal’s proposed generic product? The resolution of this claim construction dispute may be determinative for a majority of the asserted patents.
  • A key evidentiary question will be the standard of proof for functional limitations in an ANDA case: for the asserted method claims that require a specific clinical outcome (e.g., "results in less hyperemia"), what type of evidence—such as data from Amneal's ANDA filing or new comparative studies—will be necessary to establish that the proposed generic product would, in fact, meet these functional requirements upon administration to patients?
  • A central procedural question will be the impact of prior litigation: to what extent will the prior judicial findings—that five of the patents-in-suit are valid and were infringed by another generic product—and any claim constructions from that case be applied in the current litigation, potentially streamlining or shaping the legal and factual disputes before the court?