DCT

1:17-cv-00803

Omeros Corp v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 1:17-cv-00803, D. Del., 06/22/2017
  • Venue Allegations: Venue is alleged to be proper in the District of Delaware because Defendant Lupin Pharmaceuticals, Inc. is a Delaware corporation with a regular and established principal place of business in the district, and because the court has personal jurisdiction over its parent company, Lupin Ltd.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to market a generic version of Plaintiff's OMIDRIA® product constitutes an act of patent infringement.
  • Technical Context: The technology involves ophthalmologic solutions used during cataract surgery to simultaneously prevent pupil constriction (miosis) and reduce post-operative pain.
  • Key Procedural History: The litigation was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 210183 with a Paragraph IV certification, seeking FDA approval to market a generic product before the expiration of Plaintiff's patents. Plaintiff received a notice letter regarding the ANDA filing on or about May 12, 2017.

Case Timeline

Date Event
2002-07-30 Earliest Priority Date for ’707, ’633, ’101, and ’040 Patents
2012-05-08 U.S. Patent No. 8,173,707 Issues
2012-10-24 Earliest Priority Date for ’856 and ’406 Patents
2013-11-19 U.S. Patent No. 8,586,633 Issues
2014-05-01 FDA approves New Drug Application for OMIDRIA (approx. date)
2015-06-30 U.S. Patent No. 9,066,856 Issues
2016-03-08 U.S. Patent No. 9,278,101 Issues
2016-07-26 U.S. Patent No. 9,399,040 Issues
2016-11-08 U.S. Patent No. 9,486,406 Issues
2017-05-12 Plaintiff receives Notice Letter of Defendants' ANDA filing (approx. date)
2017-06-22 Complaint Filing Date

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

U.S. Patent No. 8,173,707 - "Ophthalmologic Irrigation Solutions and Method"

  • Issued: May 8, 2012

The Invention Explained

  • Problem Addressed: The patent's background section describes limitations in conventional ocular drug delivery during surgery, where topical medications are often washed away and injectable drugs lose their therapeutic effect quickly due to the eye's natural circulatory process (’707 Patent, col. 2:38-46, col. 2:63-67).
  • The Patented Solution: The invention provides a method for delivering multiple therapeutic agents through a continuous irrigation solution directly to the surgical site. This approach is designed to maintain a constant, controlled concentration of agents to inhibit inflammation and maintain pupil dilation (mydriasis) throughout the surgical procedure (’707 Patent, Abstract; col. 4:11-29).
  • Technical Importance: This method of continuous, local delivery allows for the use of lower drug concentrations compared to systemic or pre-operative drop-wise applications, thereby increasing efficacy and reducing the risk of ocular toxicity (’707 Patent, col. 4:11-20).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Independent method claim 1 is representative.
  • The essential elements of independent claim 1 include:
    • A method for perioperatively inhibiting ocular inflammation and maintaining mydriasis during an intraocular ophthalmologic procedure,
    • comprising irrigating intraocular tissues during the procedure with a solution including at least an anti-inflammatory agent and a mydriatic agent in a liquid irrigation carrier,
    • wherein the anti-inflammatory agent comprises ketorolac and the mydriatic agent comprises phenylephrine,
    • and wherein each agent is included in a therapeutically effective amount for the inhibition of inflammation and maintenance of mydriasis.

U.S. Patent No. 8,586,633 - "Ophthalmologic Irrigation Solutions and Method"

  • Issued: November 19, 2013

The Invention Explained

  • Problem Addressed: The patent, which is a continuation of the '707 Patent, addresses the same technical problem of achieving stable, therapeutic concentrations of multiple drugs at an ocular surgical site (’633 Patent, col. 2:38-46).
  • The Patented Solution: The invention is a composition for use in an irrigation solution, rather than a method of use. It claims a specific combination of an anti-inflammatory agent (ketorolac) and a mydriatic agent (phenylephrine) within a physiologic balanced salt solution, intended for intraocular delivery to maintain mydriasis and reduce post-operative pain (’633 Patent, Abstract; col. 27:44-51).
  • Technical Importance: By claiming the composition itself, the patent provides protection for the drug product formulation used in the irrigation procedure, complementing the method claims of the parent patent (’633 Patent, col. 27:44-51).

Key Claims at a Glance

  • The complaint does not identify specific asserted claims. Independent composition claim 1 is representative.
  • The essential elements of independent claim 1 include:
    • A composition for use in perioperatively inhibiting ocular inflammation and maintaining mydriasis,
    • comprising ketorolac and phenylephrine,
    • in a physiologic balanced salt solution for intraocular delivery,
    • wherein the agents are included at concentrations less than that used for conventional topical or systemic delivery and in a therapeutically effective amount for maintaining mydriasis and reducing postoperative pain.

U.S. Patent No. 9,066,856 - "Stable Preservative-Free Mydriatic and Anti-inflammatory Solutions for Injection"

  • Issued: June 30, 2015 (Compl. ¶22)
  • Technology Synopsis: This patent addresses the need for a stable liquid pharmaceutical formulation of ketorolac and phenylephrine that is free of preservatives and antioxidants. Such formulations avoid the potential toxicity associated with preservatives and antioxidants when used in intraocular irrigation solutions (’856 Patent, col. 2:1-11).
  • Asserted Claims: The complaint does not identify specific asserted claims but generally alleges infringement of "one or more claims" (Compl. ¶73).
  • Accused Features: The accused feature is the formulation of Defendants' ANDA Product, which is a purported generic version of OMIDRIA® (Compl. ¶26, ¶71-73).

U.S. Patent No. 9,278,101 - "Ophthalmologic Irrigation Solutions and Method"

  • Issued: March 8, 2016 (Compl. ¶23)
  • Technology Synopsis: This patent, part of the same family as the '707 and '633 patents, claims methods of using an ophthalmologic irrigation solution containing ketorolac and phenylephrine. The claims are directed to inhibiting miosis during a surgical procedure.
  • Asserted Claims: The complaint notes that Defendants' Paragraph IV notice letter failed to provide a non-infringement theory for claims 1-3 and 8-13, suggesting these are the claims at issue (Compl. ¶30, ¶93).
  • Accused Features: The accused instrumentality is the proposed use of Defendants' ANDA product in accordance with its label, which will allegedly instruct users to perform the claimed method steps (Compl. ¶91).

U.S. Patent No. 9,399,040 - "Ophthalmologic Irrigation Solutions and Method"

  • Issued: July 26, 2016 (Compl. ¶24)
  • Technology Synopsis: This patent, also in the family of the '707 and '633 patents, claims a composition for intraocular delivery comprising ketorolac and phenylephrine in a physiologic solution. The claims specify particular concentration ranges for the active ingredients after dilution in an irrigation carrier.
  • Asserted Claims: The complaint does not identify specific asserted claims but generally alleges infringement of "one or more claims" (Compl. ¶107).
  • Accused Features: The formulation of Defendants' ANDA Product, which, when diluted as instructed, will allegedly meet the claimed concentration limitations (Compl. ¶105, ¶108).

U.S. Patent No. 9,486,406 - "Stable Preservative-free Mydriatic and Anti-inflammatory Solutions for Injection"

  • Issued: November 8, 2016 (Compl. ¶25)
  • Technology Synopsis: This patent, a continuation of the '856 patent, is directed to stable liquid formulations of phenylephrine and ketorolac that are free of both preservatives and antioxidants. The claims cover specific molar ratios of the active ingredients within a buffered aqueous carrier.
  • Asserted Claims: The complaint does not identify specific asserted claims but generally alleges infringement of "one or more claims" (Compl. ¶124).
  • Accused Features: The formulation of Defendants' ANDA Product is alleged to contain the claimed components in the specified ratios (Compl. ¶122, ¶125).

III. The Accused Instrumentality

Product Identification

The accused instrumentality is the pharmaceutical product described in Defendants' Abbreviated New Drug Application No. 210183 (the "ANDA Product") (Compl. ¶1, ¶26).

Functionality and Market Context

The ANDA Product is a "ketorolac tromethamine, phenylephrine hydrochloride solution" intended as a generic version of Omeros's OMIDRIA® product (Compl. ¶26). OMIDRIA® is described as the first FDA-approved product for intraocular use during cataract surgery that both prevents intraoperative miosis (pupil constriction) and reduces postoperative pain (Compl. ¶16). The ANDA Product is intended for the same use, to be administered via an irrigation solution during ophthalmic surgery (Compl. ¶15, ¶40).

IV. Analysis of Infringement Allegations

The complaint does not provide a claim chart or sufficient technical detail to construct a claim chart summary. The central theory of infringement is statutory, arising from the act of filing an ANDA. Under 35 U.S.C. § 271(e)(2)(A), submitting an ANDA seeking approval to market a generic version of a branded drug before the expiration of patents covering that drug is a technical act of infringement (Compl. ¶38, ¶55, ¶72, ¶89, ¶106, ¶123). The complaint alleges that if the FDA approves the ANDA, the commercial manufacture, use, and sale of the ANDA Product in accordance with its proposed labeling will directly and indirectly infringe the patents-in-suit (Compl. ¶39-40, ¶56-57).

No probative visual evidence provided in complaint.

Identified Points of Contention

  • Scope Questions: A potential dispute may arise over the scope of claim terms such as "physiologic balanced salt solution" as used in the composition claims (e.g., ’633 Patent). The definition of this term could determine whether the carrier fluid in Defendants' ANDA product falls within the claim scope.
  • Technical Questions: For the method claims (e.g., '707 Patent), a key question will be whether the instructions on the proposed label for the ANDA Product will induce medical professionals to perform every step of the claimed method of "irrigating intraocular tissues" in an infringing manner. The complaint alleges this inducement will occur based on the product label and insert (Compl. ¶40).

V. Key Claim Terms for Construction

Term: "irrigating intraocular tissues" (from '707 Patent, claim 1)

  • Context and Importance: This term is central to the asserted method claims. Its construction will determine what actions constitute infringement. Practitioners may focus on this term because the scope could turn on whether "irrigating" implies a minimum duration, flow rate, or continuous application throughout a "substantial portion of the procedure," as described in the specification (’707 Patent, col. 6:34-36).
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The claim language itself does not specify a duration or flow rate, which may support an interpretation covering any application of the solution to flush tissues during surgery.
    • Evidence for a Narrower Interpretation: The specification repeatedly emphasizes "continuous irrigation" and maintaining a "constant concentration" throughout the procedure (’707 Patent, col. 4:25-29, col. 5:59-64). This language could support a narrower construction requiring sustained application rather than intermittent flushing.

Term: "physiologic balanced salt solution" (from '633 Patent, claim 1)

  • Context and Importance: This term defines the carrier for the active ingredients in the asserted composition claims. The dispute may center on whether the carrier in the ANDA Product meets this limitation.
  • Intrinsic Evidence for Interpretation:
    • Evidence for a Broader Interpretation: The term is a generally understood term of art in the pharmaceutical field, which might support a construction that is not limited to the specific examples in the patent. The specification refers to carriers such as "normal saline or lactated Ringer's solution" as suitable options (’633 Patent, col. 6:56-59).
    • Evidence for a Narrower Interpretation: The patent's detailed description provides a specific recipe for a "preferred balanced salt solution" including electrolytes, a buffer, a cellular energy source, and a free-radical scavenger (’633 Patent, col. 24:35-47). This detailed example could be used to argue that the term should be construed more narrowly to include these specific types of components.

VI. Other Allegations

Indirect Infringement

The complaint alleges that upon FDA approval, Defendants will induce infringement by marketing and distributing the ANDA Product with a label and product insert that will include instructions for administering the product in a manner that infringes the asserted method claims (Compl. ¶40, ¶57, ¶74, ¶91, ¶108, ¶125).

Willful Infringement

The complaint does not explicitly use the word "willful." However, it alleges that Defendants had "actual and constructive notice" of the patents prior to filing the ANDA and that they filed the ANDA "without adequate justification for asserting the... Patent to be invalid, unenforceable, and/or not infringed" (Compl. ¶41, ¶43). This conduct is alleged to render the case "exceptional" under 35 U.S.C. § 285, which is the statutory basis for an award of attorneys' fees often associated with findings of willful infringement or litigation misconduct.

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

  • A core issue will be one of claim construction: how will the court define key limitations such as "irrigating intraocular tissues" in the method claims and "physiologic balanced salt solution" in the composition claims? The outcome of these definitions may be dispositive of infringement for the respective patents.
  • A key evidentiary question will be one of inducement: what will the proposed label for Defendants' generic product instruct medical professionals to do? The infringement analysis for the method patents will depend on whether those instructions teach all steps of a claimed method.
  • A central theme of the case will be the adequacy of Defendants' pre-suit investigation. The complaint repeatedly alleges that Defendants' Paragraph IV notice letter and its accompanying "Detailed Statement" were deficient and lacked any non-infringement contention for numerous patents and claims, raising the question of whether Defendants had a good faith basis for their certification (Compl. ¶30, ¶42, ¶59, ¶76, ¶93, ¶110, ¶127).