DCT

3:18-cv-02213

Sun Pharmaceutical Industries Ltd v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:18-cv-02213, D.N.J., 02/15/2018
  • Venue Allegations: Plaintiff alleges venue is proper because Defendant Lupin has committed an act of infringement in the district via its ANDA submission and maintains a "regular and established place of business" in Somerset, New Jersey.
  • Core Dispute: Plaintiff alleges that Defendant's filing of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's BromSite™ ophthalmic solution constitutes an act of infringement of a patent covering the drug's formulation.
  • Technical Context: The technology concerns aqueous ophthalmic compositions of the non-steroidal anti-inflammatory drug (NSAID) bromfenac, formulated with a mucoadhesive polymer to provide sustained release and improved drug retention in the eye.
  • Key Procedural History: Plaintiff’s product, BromSite™, was approved by the FDA following submission of New Drug Application (NDA) No. 206911. The patent-in-suit is listed in the FDA's "Orange Book" for BromSite™. Defendant submitted ANDA No. 211239 with a Paragraph IV certification, asserting that the patent-in-suit is invalid, unenforceable, and/or will not be infringed by its proposed generic product, prompting this lawsuit under the Hatch-Waxman Act.

Case Timeline

Date Event
2009-03-05 '999 Patent Priority Date
2014-07-15 '999 Patent Issue Date
2015-06-10 Plaintiff's NDA Submission for BromSite™
2016-04-08 FDA Approval of BromSite™
2018-01-03 Plaintiff's Receipt of Defendant's Paragraph IV Notice
2018-02-15 Complaint Filing Date

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

U.S. Patent No. 8,778,999 - “Non-Steroidal Anti-Inflammatory Ophthalmic Compositions”

  • Patent Identification: U.S. Patent No. 8,778,999, “Non-Steroidal Anti-Inflammatory Ophthalmic Compositions,” issued July 15, 2014 (’999 Patent).

The Invention Explained

  • Problem Addressed: The patent describes drawbacks with prior ophthalmic delivery systems for bromfenac, including the need for frequent dosing (e.g., every 12 hours) which may not provide consistent control over inflammation between doses (’999 Patent, col. 1:13-19, col. 4:35-43).
  • The Patented Solution: The invention combines bromfenac with a "flowable mucoadhesive polymer" in an aqueous solution. This polymer is designed to increase in viscosity upon contact with the eye's tear fluid, forming a gel that remains in place for a prolonged period. This mechanism provides for a sustained release of bromfenac, allowing for less frequent administration (e.g., once daily) while facilitating higher absorption and retention of the drug in the eye's aqueous humor (’999 Patent, Abstract; col. 2:25-33; col. 6:38-44).
  • Technical Importance: This sustained-release formulation aimed to improve therapeutic efficacy and patient convenience by enabling a once-daily dosing regimen that could maintain a higher and more stable concentration of the anti-inflammatory agent in the eye (’999 Patent, col. 4:44-51).

Key Claims at a Glance

  • The complaint alleges infringement of "the claims" of the ’999 Patent without specifying individual claims (Compl. ¶24). Independent claim 1 is representative of the core invention.
  • Independent Claim 1:
    • A topical ophthalmic composition formulated for application to the eye,
    • said composition comprising a therapeutically effective amount of bromfenac
    • and a flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer,
    • wherein the composition has a viscosity in the range of about 1,000 to about 3,400 cps
    • and a pH of about 7.4 to about 8.5.

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is "Lupin's proposed generic bromfenac ophthalmic solution, 0.075%" (Compl. ¶8).

Functionality and Market Context

  • The product is a generic drug for which Defendant seeks FDA approval via ANDA No. 211239 (Compl. ¶23). As a generic version of Plaintiff's BromSite™ product, it is intended to have the same active ingredient (bromfenac), concentration (0.075%), dosage form, and route of administration (Compl. ¶1). The act of infringement alleged in the complaint is the filing of the ANDA itself under 35 U.S.C. § 271(e)(2), which seeks approval to market the generic drug prior to the expiration of the ’999 Patent (Compl. ¶30).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart. The infringement allegations are based on the premise that Defendant's ANDA product, to be approved as a generic equivalent of BromSite™, must necessarily meet the limitations of the asserted claims.

No probative visual evidence provided in complaint.

’999 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A topical ophthalmic composition formulated for application to the eye... Defendant’s product is a proposed "bromfenac ophthalmic solution." ¶8 col. 1:5-8
...said composition comprising a therapeutically effective amount of bromfenac... The proposed generic product contains 0.075% bromfenac, the same concentration as Plaintiff's approved BromSite™ product. ¶8 col. 2:3-5
...and a flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer... The complaint alleges infringement by the proposed generic product, which, to be bioequivalent to BromSite™, is alleged to contain the claimed formulation, including the specified polymer system. ¶23, ¶31 col. 5:2-13
...wherein the composition has a viscosity in the range of about 1,000 to about 3,400 cps... The physical properties of the proposed generic product, such as viscosity, are alleged to meet the claim limitations by virtue of being a generic copy of BromSite™. ¶23, ¶31 col. 14:19-22
...and a pH of about 7.4 to about 8.5. The pH of the proposed generic product is alleged to fall within the claimed range, as it is intended to be a copy of BromSite™. ¶23, ¶31 col. 14:23-24
  • Identified Points of Contention:
    • Technical Questions: A primary factual dispute will be whether Defendant's proposed generic formulation, as described in its confidential ANDA, actually contains the specific "flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer" required by the claim. Does the accused product's formulation meet the claimed viscosity and pH parameters under the measurement conditions potentially outlined by the patent?
    • Scope Questions: The case may turn on the interpretation of the term "flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer." Does this term, as used in the patent, cover the specific excipients in Defendant's formulation, or could Defendant argue its polymer falls outside the scope of the claim as properly construed?

V. Key Claim Terms for Construction

  • The Term: "flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer"

  • Context and Importance: This term defines the novel delivery vehicle, which is the central inventive concept. Infringement will hinge on whether the polymer used in Defendant's formulation falls within the scope of this term.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification describes the polymer in general terms, such as "lightly crosslinked polymers of acrylic acid or the like" (’999 Patent, col. 5:3-5) and lists numerous carboxyl-containing monomers that can be used (’999 Patent, col. 10:35-46). Plaintiff may argue the term encompasses a functional class of polymers, not just the specific examples given.
    • Evidence for a Narrower Interpretation: The specification repeatedly refers to specific embodiments, such as "polycarbophil (Noveon® AA-1...)" and the "DuraSite®" delivery system (’999 Patent, col. 5:10-12; col. 5:16-20). Defendant may argue that the claim scope is implicitly limited to these specific polymers or those with identical structures and properties.

  • The Term: "viscosity in the range of about 1,000 to about 3,400 cps"

  • Context and Importance: This limitation defines a critical physical property of the final composition. The infringement analysis will require a factual determination of whether the accused product's viscosity falls within this numerical range.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The use of the word "about" suggests the numerical endpoints are not rigid and may encompass values reasonably close to the stated range.
    • Evidence for a Narrower Interpretation: Defendant may argue for strict adherence to the recited range. The specification provides context for viscosity measurement, such as using a "Brookfield cone and plate viscosity DV-II+ with the spindle No. CP-52 at 6 rpm" (’999 Patent, col. 12:30-34), which could be argued as the required methodology for determining infringement.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges that Defendant will induce and contribute to infringement upon approval of its ANDA (Compl. ¶¶ 33-34, 55, 59). The basis for this allegation is that Defendant knows its product is especially adapted for an infringing use and that its commercialization will cause physicians and patients to use the product in an infringing manner (Compl. ¶52). Knowledge is alleged based on the ’999 Patent's listing in the FDA Orange Book (Compl. ¶49).
  • Willful Infringement: The complaint alleges that Defendant's infringement is willful, wanton, and deliberate, based on its "actual notice of the '999 patent" prior to preparing to infringe (Compl. ¶44, ¶64). This allegation stems from the patent's Orange Book listing and Defendant's filing of a Paragraph IV certification acknowledging the patent.

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

  • A central issue will be one of technical identity: does the formulation in Defendant's confidential ANDA contain a polymer that is structurally and functionally equivalent to the "flowable crosslinked carboxy-containing polycarbophil mucoadhesive polymer" recited in the claims, and do its physical properties, such as viscosity, align with the claimed ranges?
  • A key legal question will be one of claim scope: can the term "polycarbophil mucoadhesive polymer," which is tied to the specific DuraSite® system in the patent's examples, be construed broadly enough to read on the excipients used in Defendant's formulation, or is it limited to the specific embodiments disclosed?
  • The litigation will also examine the basis for Defendant's non-infringement theory as stated in its Paragraph IV notice. The court will need to determine if Defendant's proposed generic product either "designs around" the patent claims by using a different, non-infringing formulation or if its non-infringement position relies on a narrow claim construction.