DCT

3:17-cv-04595

Omeros Corp v. Lupin Ltd

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I. Executive Summary and Procedural Information

  • Parties & Counsel:
  • Case Identification: 3:17-cv-04595, D.N.J., 06/22/2017
  • Venue Allegations: Venue is alleged to be proper in the District of New Jersey because Defendant Lupin Pharmaceuticals, Inc. has a regular and established place of business in the state, and its parent company, Lupin Ltd., acts through this subsidiary.
  • Core Dispute: Plaintiff alleges that Defendants' submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking to market a generic version of Plaintiff's OMIDRIA® drug product, constitutes an act of patent infringement.
  • Technical Context: The technology involves ophthalmologic irrigation solutions containing a combination of active pharmaceutical ingredients used during cataract surgery to maintain pupil dilation and reduce post-operative pain.
  • Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendants' submission of ANDA No. 210183 with a Paragraph IV certification, alleging that the patents-in-suit are invalid, unenforceable, or will not be infringed by the proposed generic product. Plaintiff Omeros received FDA approval for its New Drug Application (NDA No. 205388) for OMIDRIA® in May 2014. The lawsuit was filed within the 45-day statutory window following Plaintiff's receipt of Defendants' notice letter.

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 OMIDRIA® (NDA No. 205388)
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 Defendants mail Plaintiff a Notice Letter regarding ANDA No. 210183
2017-06-22 Complaint Filed

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

No probative visual evidence provided in complaint.

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

The Invention Explained

  • Problem Addressed: The patent describes the limitations of conventional methods for delivering drugs to the eye during surgery, such as topical drops or injections (U.S. Patent No. 8,173,707, col. 2:28-38). These methods may result in inconsistent drug concentrations, potential toxicity, and a failure to effectively prevent surgically induced inflammation, pain, or pupil constriction (miosis) throughout the procedure (’707 Patent, col. 2:39-49).
  • The Patented Solution: The invention is a method of using a multi-component irrigation solution delivered continuously to the surgical site during an ophthalmologic procedure (’707 Patent, Abstract). This solution contains dilute concentrations of multiple therapeutic agents—specifically an anti-inflammatory (ketorolac) and a mydriatic (phenylephrine)—to preemptively inhibit pain and inflammation while actively maintaining pupil dilation (’707 Patent, col. 4:11-25).
  • Technical Importance: This approach of continuous, localized delivery of a combination of agents aims to maintain a constant therapeutic effect directly at the ocular tissues, potentially offering greater efficacy and safety compared to pre-operative or bolus drug administration (’707 Patent, col. 4:26-34).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not identify specific claims from the ’707 patent (Compl. ¶38). Independent claim 1 is a representative method claim.
  • Essential elements of independent claim 1 include:
    • A method for perioperatively inhibiting ocular inflammation and maintaining mydriasis during an intraocular ophthalmologic procedure.
    • The method comprises irrigating intraocular tissues during the procedure with a solution.
    • The solution includes at least an anti-inflammatory agent and a mydriatic agent in a liquid irrigation carrier.
    • The anti-inflammatory agent comprises ketorolac.
    • The mydriatic agent comprises phenylephrine.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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

The Invention Explained

  • Problem Addressed: Similar to the ’707 patent, the ’633 patent addresses the challenge of achieving consistent and effective delivery of therapeutic agents to control pain, inflammation, and pupil size during eye surgery (U.S. Patent No. 8,586,633, col. 2:28-38).
  • The Patented Solution: The invention claimed in the ’633 patent is a pharmaceutical composition, rather than a method. It comprises a combination of ketorolac and phenylephrine in a physiologic balanced salt solution specifically formulated for intraocular delivery to maintain mydriasis and reduce post-operative pain (’633 Patent, col. 28:44-51).
  • Technical Importance: The claimed composition provides the specific combination of active agents in a suitable carrier for use in the continuous irrigation methods described in related patents, aiming to improve surgical conditions and patient outcomes (’633 Patent, col. 4:11-25).

Key Claims at a Glance

  • The complaint alleges infringement of "one or more claims" but does not identify specific claims from the ’633 patent (Compl. ¶55). Independent claim 1 is a representative composition claim.
  • Essential elements of independent claim 1 include:
    • A composition for use in perioperatively inhibiting ocular inflammation and maintaining mydriasis during an intraocular ophthalmologic procedure.
    • The composition comprises ketorolac and phenylephrine.
    • The agents are in a physiologic balanced salt solution for intraocular delivery.
    • The agents are included at concentrations less than that used for conventional topical or systemic delivery.
    • The agents are in a therapeutically effective amount for the maintenance of mydriasis and reduction of postoperative pain.
  • The complaint does not explicitly reserve the right to assert dependent claims for this patent.

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

  • Technology Synopsis: This patent addresses the technical problem of creating a stable, injectable liquid formulation of phenylephrine and ketorolac that is free of preservatives and antioxidants, which can be associated with ocular toxicity (’856 Patent, col. 2:1-11). The solution involves specific buffer systems and pH ranges to maintain the chemical stability of the active ingredients for an extended shelf life (’856 Patent, col. 3:45-68).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. ¶72).
  • Accused Features: The accused feature is the entirety of the Defendants' proposed "ANDA Product," which is a solution containing phenylephrine and ketorolac for injection (Compl. ¶70, 72).

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

  • Technology Synopsis: This patent, related to the ’707 and ’633 patents, claims methods of irrigating intraocular tissues with a solution containing phenylephrine and ketorolac. The claims further specify the inclusion of other functional agents, such as an agent for decreasing intraocular pressure (’101 Patent, col. 28:28-67).
  • Asserted Claims: The complaint alleges that Defendants' notice letter fails to provide a non-infringement theory for claims 1-3 and 8-13 (Compl. ¶92).
  • Accused Features: The accused feature is the intended use of the ANDA Product as an irrigation solution during ophthalmic procedures (Compl. ¶89).

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

  • Technology Synopsis: This patent claims a composition for intraocular delivery comprising ketorolac and phenylephrine. The claims specify concentration ranges for the active ingredients that are less than those used for conventional topical or systemic delivery (’040 Patent, col. 28:29-47).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. ¶106).
  • Accused Features: The infringement allegation targets the composition of the Defendants' proposed generic solution containing phenylephrine and ketorolac (Compl. ¶104, 106).

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

  • Technology Synopsis: This patent, related to the ’856 Patent, claims stable, preservative-free, and antioxidant-free liquid formulations of phenylephrine and ketorolac. The claims focus on specific molar ratios of the active ingredients and the use of a citrate buffer system to ensure stability (’406 Patent, col. 27:6-28).
  • Asserted Claims: The complaint does not identify specific asserted claims (Compl. ¶123).
  • Accused Features: The accused feature is the formulation of the Defendants' proposed generic drug product (Compl. ¶121, 123).

III. The Accused Instrumentality

Product Identification

  • The accused instrumentality is Defendants' proposed generic version of OMIDRIA®, referred to as the "ANDA Product" (Compl. ¶8). The product is identified as a "ketorolac tromethamine, phenylephrine hydrochloride solution, 1%/0.3%" for which Defendants submitted ANDA No. 210183 to the FDA (Compl. ¶1, 25).

Functionality and Market Context

  • The complaint alleges that the ANDA Product is a purported generic version of OMIDRIA® and is intended for the same use: as a combination product added to an irrigation solution for use during cataract surgery or intraocular lens replacement (Compl. ¶14, 25). Its alleged functions are to maintain pupil size by preventing miosis (pupil constriction) and to reduce postoperative pain (Compl. ¶14). The filing of the ANDA itself suggests an intent to compete in the market for ophthalmic surgical solutions upon receiving FDA approval (Compl. ¶8, 26).

IV. Analysis of Infringement Allegations

The complaint does not contain a claim chart or provide element-by-element infringement allegations. The infringement theory is based on the statutory act of filing an ANDA for a product that is a generic equivalent of Plaintiff's OMIDRIA®, which is alleged to be covered by the patents-in-suit. The following tables summarize the core allegations by mapping the described functionality of the ANDA Product to representative claims.

’707 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A method for perioperatively inhibiting ocular inflammation and maintaining mydriasis during an intraocular ophthalmologic procedure, comprising irrigating intraocular tissues... The ANDA Product is intended for use as an irrigation solution during ophthalmic surgery to prevent miosis and reduce pain. ¶14, 25 col. 28:12-15
...with a solution including... an anti-inflammatory agent... and a mydriatic agent... The ANDA Product is a solution containing two active ingredients to perform these functions. ¶14, 25 col. 28:16-18
wherein the anti-inflammatory agent comprises ketorolac... The ANDA Product contains ketorolac tromethamine. ¶25 col. 28:19-20
and the mydriatic agent comprises phenylephrine. The ANDA Product contains phenylephrine hydrochloride. ¶25 col. 28:21-22

’633 Patent Infringement Allegations

Claim Element (from Independent Claim 1) Alleged Infringing Functionality Complaint Citation Patent Citation
A composition for use in perioperatively inhibiting ocular inflammation and maintaining mydriasis... The ANDA Product is intended to be used during surgery to prevent miosis and reduce pain. ¶14 col. 28:44-46
comprising ketorolac and phenylephrine... The ANDA Product is a solution containing ketorolac tromethamine and phenylephrine hydrochloride. ¶25 col. 28:47-48
in a physiologic balanced salt solution for intraocular delivery... The ANDA Product is a solution for injection that is added to an irrigation solution for intraocular use. ¶1, 14 col. 6:56-58
in a therapeutically effective amount for the maintenance of mydriasis during the procedure and the reduction of postoperative pain... The ANDA Product is a purported bioequivalent of OMIDRIA®, which is approved for these indications. ¶14, 15, 25 col. 28:49-51
  • Identified Points of Contention:
    • Scope Questions: The complaint does not provide sufficient detail on the formulation of the ANDA Product to identify specific points of contention regarding claim scope. A potential question for the court could be whether the specific carrier fluid or excipients used in the ANDA Product fall outside the scope of terms like "physiologic balanced salt solution" as defined in the patents.
    • Technical Questions: Since this is an ANDA litigation, the primary dispute is less likely to be over literal infringement (as the generic must be bioequivalent) and more likely to center on the validity of the patent claims (e.g., obviousness). The complaint does not detail validity issues, but it notes that Defendants' Notice Letter alleges non-infringement and/or invalidity (Compl. ¶26). The complaint's primary point of contention is procedural, repeatedly alleging that Defendants' "Detailed Statement" failed to provide any specific theory of non-infringement for most of the asserted patents (Compl. ¶29, 41, 58, 75, 109, 126).

V. Key Claim Terms for Construction

The complaint does not identify any specific claim terms as being in dispute. The following terms from the representative independent claims may become central to the case.

  • The Term: "perioperatively"

  • Context and Importance: This term defines the timeframe of the claimed method and the intended use of the composition. Its construction is critical because it dictates whether the claims cover a product used only during surgery, or if they also require pre- or post-operative administration. This will be compared against the instructions for use on the ANDA Product's proposed label.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The specification states that "the term 'perioperative' encompasses application intraprocedurally, pre- and intraprocedurally, intra- and postprocedurally, and pre-, intra- and postprocedurally" (’707 Patent, col. 5:25-28). This language suggests an expansive definition covering any combination of timeframes around the surgical procedure.
    • Evidence for a Narrower Interpretation: The specification repeatedly emphasizes the "preemptive" benefit of the invention, stating the solution is "most preferably applied to the wound or surgical site prior to the initiation of the procedure, or before substantial tissue trauma" (’707 Patent, col. 5:28-33). This could support an argument that the term requires, at a minimum, administration before the main surgical trauma begins.

  • The Term: "maintaining mydriasis"

  • Context and Importance: This term is a functional limitation describing the purpose and effect of the claimed method/composition. Practitioners may focus on this term because the dispute could turn on whether the accused product's effect constitutes "maintaining" pupil dilation as opposed to simply inducing it or slowing constriction. Evidence from clinical trials for both OMIDRIA® and the ANDA Product will be relevant.

  • Intrinsic Evidence for Interpretation:

    • Evidence for a Broader Interpretation: The patent's goal is to "effect mydriasis (dilation of the pupil)" (’707 Patent, col. 4:13-14). This could support a broad interpretation that any action resulting in a clinically useful level of pupil dilation meets the limitation.
    • Evidence for a Narrower Interpretation: The claims of related patents distinguish between providing for mydriasis and "inhibiting miosis" (e.g., ’707 Patent, col. 30:8-9). This suggests "maintaining" may require more than just inhibiting constriction; it may require actively preserving a specific degree of dilation throughout the procedure.

VI. Other Allegations

  • Indirect Infringement: The complaint alleges inducement of infringement. The basis for this allegation is that upon FDA approval, Defendants will market and distribute the ANDA Product with a product label and insert that will include instructions for healthcare professionals to use the product in a manner that directly infringes the method claims of the patents-in-suit (Compl. ¶39, 56, 73).
  • Willful Infringement: The complaint does not use the term "willful," but it repeatedly asserts that the case is "exceptional" under 35 U.S.C. § 285, which allows for an award of attorneys' fees (Compl. ¶42, 59, 76). The basis for this allegation is that Defendants had actual and constructive notice of the patents prior to filing the ANDA and filed their Paragraph IV certification "without adequate justification" (Compl. ¶40, 42). The complaint further supports this by alleging that Defendants' notice letter and "Detailed Statement" lacked any specific contention of non-infringement for numerous patents and claims (Compl. ¶41, 58, 75).

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

  • A central issue will be one of patent validity: can Defendants demonstrate through prior art or other evidence that the asserted claims—covering the combination of two well-known drugs (phenylephrine and ketorolac) in an ophthalmic solution for their known effects—would have been obvious to a person of ordinary skill in the art at the time of the invention?
  • A key procedural and evidentiary question will be the adequacy of Defendants' pre-suit investigation and notice: did Defendants possess a good-faith basis for their Paragraph IV certification, and what are the legal consequences, if any, of the alleged failure to provide a detailed basis for non-infringement in their notice letter, as repeatedly highlighted in the complaint?
  • The case may also turn on a question of claim scope: can the term "physiologic balanced salt solution" be construed narrowly enough, based on specific embodiments in the specification, to exclude the particular carrier formulation used in the Defendants' ANDA product, thereby creating a viable non-infringement defense?