DCT
1:17-cv-00799
Omeros Corp v. Sandoz Inc
Key Events
Complaint
I. Executive Summary and Procedural Information
- Parties & Counsel:
- Plaintiff: Omeros Corporation (Washington)
- Defendant: Sandoz Inc. (Colorado)
- Plaintiff’s Counsel: Morris, Nichols, Arsht & Tunnell LLP; Covington & Burling LLP
- Case Identification: 1:17-cv-00799, D. Del., 06/21/2017
- Venue Allegations: Plaintiff alleges venue is proper in the District of Delaware because Defendant Sandoz has agreements with retailers, wholesalers, or distributors operating in the state and holds a "Pharmacy – Wholesale" license from the State of Delaware.
- Core Dispute: Plaintiff alleges that Defendant’s submission of an Abbreviated New Drug Application (ANDA) to the FDA for a generic version of Plaintiff’s OMIDRIA® product constitutes an act of infringement of six patents related to ophthalmologic irrigation solutions.
- Technical Context: The technology concerns pharmaceutical compositions used for continuous irrigation of the eye during intraocular surgery, such as cataract removal, to simultaneously prevent pupil constriction (miosis) and reduce post-operative pain.
- Key Procedural History: This action was initiated under the Hatch-Waxman Act following Defendant’s Paragraph IV certification, which alleges that the patents-in-suit will not be infringed by its proposed generic product. The complaint notes that Defendant’s notice letter contained a detailed statement asserting the patents are invalid, unenforceable, and/or not infringed, but allegedly did not provide any specific theory of non-infringement for most of the asserted patents.
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 | OMIDRIA® New Drug Application Approved by FDA |
| 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 |
| 2017-05-09 | Defendant sends Paragraph IV Notice Letter to Plaintiff |
| 2017-06-21 | Complaint Filed |
II. Technology and Patent(s)-in-Suit Analysis
U.S. Patent No. 8,173,707 - "Ophthalmologic Irrigation Solutions and Method"
Issued May 8, 2012 (’707 Patent)
The Invention Explained
- Problem Addressed: The patent describes the challenge of delivering multiple therapeutic agents to the eye during surgery in a controlled manner to achieve different physiological effects simultaneously, such as pupil dilation (mydriasis) and inflammation control, which conventional drop-wise or injectable drug delivery methods do not achieve effectively (’707 Patent, col. 2:28-48).
- The Patented Solution: The invention is a method for delivering a combination of therapeutic agents directly to the surgical site via a continuous irrigation solution. This approach uses a low concentration of multiple agents—specifically an anti-inflammatory (ketorolac) and a mydriatic (phenylephrine)—in a balanced salt solution carrier to maintain a constant therapeutic effect throughout the surgical procedure, preemptively inhibiting inflammation and maintaining pupil dilation (’707 Patent, col. 4:11-25; col. 27:60-65).
- Technical Importance: This method provided a way to maintain stable pupil dilation and control inflammation intraoperatively, potentially reducing surgical complications and post-operative pain associated with procedures like cataract surgery (’707 Patent, col. 6:31-40).
Key Claims at a Glance
- The complaint asserts infringement of one or more claims of the ’707 Patent without specifying particular claims (Compl. ¶35). Independent claim 1 is representative.
- Claim 1 (Method):
- 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.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 8,586,633 - "Ophthalmologic Irrigation Solutions and Method"
Issued November 19, 2013 (’633 Patent)
The Invention Explained
- Problem Addressed: The patent addresses the same technical problem as the ’707 Patent: the need for a more effective perioperative ocular drug delivery system that can simultaneously address multiple physiological needs like pain, inflammation, and pupil dilation during surgery (’633 Patent, col. 2:20-28).
- The Patented Solution: The invention is a pharmaceutical composition, rather than a method, for use in intraocular irrigation. It comprises the specific combination of ketorolac (an anti-inflammatory) and phenylephrine (a mydriatic) within a physiologic balanced salt solution, formulated for direct intraocular delivery to maintain mydriasis and reduce postoperative pain (’633 Patent, col. 4:50-59; col. 28:44-52).
- Technical Importance: This composition provides a ready-to-use or concentrated formulation that combines two active agents with different functions, intended to improve the safety and efficacy of ophthalmologic surgeries by preemptively managing common intraoperative challenges (’633 Patent, Abstract).
Key Claims at a Glance
- The complaint alleges infringement of one or more claims of the ’633 Patent without further specification (Compl. ¶52). Independent claim 1 is representative.
- Claim 1 (Composition):
- A composition for use in perioperatively inhibiting ocular inflammation and maintaining mydriasis during an intraocular ophthalmologic procedure,
- 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 the maintenance of mydriasis and reduction of postoperative pain.
- The complaint does not explicitly reserve the right to assert dependent claims.
U.S. Patent No. 9,066,856 - "Stable Preservative-Free Mydriatic and Anti-inflammatory Solutions for Injection"
Issued June 30, 2015 (’856 Patent)
- Technology Synopsis: This patent addresses the problem of creating a stable, preservative-free, and antioxidant-free liquid formulation of ketorolac and phenylephrine suitable for injection into an intraocular irrigation solution (’856 Patent, col. 1:15-21). The solution involves using a specific buffer system, such as a sodium citrate buffer, to maintain stability for at least six months at controlled temperatures (’856 Patent, col. 3:55-68).
- Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶69).
- Accused Features: The accused feature is the Sandoz ANDA product, which is a solution containing phenylephrine and ketorolac for injection, alleged to be a generic version of OMIDRIA® (Compl. ¶22, ¶69).
U.S. Patent No. 9,278,101 - "Ophthalmologic Irrigation Solutions and Method"
Issued March 8, 2016 (’101 Patent)
- Technology Synopsis: This patent is directed to methods of irrigating intraocular tissues with a solution containing ketorolac and phenylephrine, wherein the solution may also contain an agent for decreasing intraocular pressure, such as a beta adrenergic receptor antagonist like timolol (’101 Patent, col. 27:29-34). The invention provides a multi-agent therapeutic approach for use during eye surgery.
- Asserted Claims: The complaint specifically alleges infringement of at least claims 1-3 and 8-13 (Compl. ¶85). Independent claims 1 and 8 are asserted.
- Accused Features: The accused instrumentality is the Sandoz ANDA product and the act of seeking FDA approval for its use, which would allegedly induce physicians to perform the claimed method of irrigation during surgery (Compl. ¶86, ¶87).
U.S. Patent No. 9,399,040 - "Ophthalmologic Irrigation Solutions and Method"
Issued July 26, 2016 (’040 Patent)
- Technology Synopsis: This patent covers a composition comprising ketorolac and phenylephrine in a balanced salt solution. The claims specify that the composition is formulated for intraocular delivery at concentrations less than those used for conventional topical delivery, for the purpose of maintaining mydriasis and reducing postoperative pain (’040 Patent, col. 27:41-52).
- Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶103).
- Accused Features: The accused feature is the Sandoz ANDA product, which is a solution containing ketorolac and phenylephrine intended for intraocular administration during surgery (Compl. ¶22, ¶103).
U.S. Patent No. 9,486,406 - "Stable Preservative-free Mydriatic and Anti-inflammatory Solutions for Injection"
Issued November 8, 2016 (’406 Patent)
- Technology Synopsis: This patent is directed to a sterile liquid pharmaceutical formulation that includes phenylephrine and ketorolac in a buffer system. A key aspect is that the formulation is stable for at least 24 months when stored at controlled temperatures without preservatives or antioxidants, making it suitable for single-use injection (’406 Patent, col. 27:32-42).
- Asserted Claims: The complaint alleges infringement of one or more claims (Compl. ¶120).
- Accused Features: The accused feature is the Sandoz ANDA product, a solution for injection containing phenylephrine and ketorolac, which Plaintiff alleges will be commercially manufactured upon FDA approval (Compl. ¶22, ¶120).
III. The Accused Instrumentality
- Product Identification: The accused instrumentality is the pharmaceutical product described in Defendant Sandoz’s ANDA No. 207841 (the "ANDA Product") (Compl. ¶1, ¶4).
- Functionality and Market Context: The ANDA Product is identified as a "Ketorolac-Phenylephrine Ophthalmic Solution" containing 0.3% w/v of ketorolac and 1% w/v of phenylephrine (Compl. ¶23). It is a purported generic version of Omeros’s OMIDRIA® product, a combination drug used during cataract surgery or intraocular lens replacement (Compl. ¶11, ¶22). The product is intended to be added to an irrigation solution for intraocular use to maintain pupil size by preventing miosis and to reduce postoperative pain (Compl. ¶11). The complaint alleges that Sandoz seeks FDA approval to commercially manufacture, use, and sell this product in the United States prior to the expiration of the patents-in-suit (Compl. ¶23).
IV. Analysis of Infringement Allegations
No probative visual evidence provided in complaint.
The complaint does not provide specific, element-by-element infringement allegations. The infringement theory is based on 35 U.S.C. § 271(e)(2)(A), where the submission of an ANDA for a generic version of a patented drug is itself an act of infringement. The following charts summarize the infringement theory by mapping the claim elements to the description of the ANDA Product in the complaint.
’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, | The ANDA Product is intended for use during cataract surgery or intraocular lens replacement to maintain pupil size and reduce postoperative pain and inflammation. | ¶11, ¶22 | col. 4:50-59 |
| comprising irrigating intraocular tissues... with a solution | Sandoz seeks approval to market an ophthalmic solution for injection. The product label will allegedly instruct healthcare professionals on using and administering the product for irrigation. | ¶22, ¶36 | col. 4:11-15 |
| wherein the anti-inflammatory agent comprises ketorolac | The ANDA Product is a solution containing ketorolac tromethamine. | ¶23 | col. 7:65-67 |
| and the mydriatic agent comprises phenylephrine. | The ANDA Product is a solution containing phenylephrine hydrochloride. | ¶23 | col. 9:47-49 |
- Identified Points of Contention:
- Scope Questions: The case may explore whether the specific concentrations, excipients, and pH of the Sandoz ANDA Product fall within the scope of what the patent teaches and claims for a "solution" used in the claimed method.
- Technical Questions: A key question will be whether the administration of the Sandoz ANDA product as described in its application and proposed label would directly result in the performance of every step of the claimed method, including "perioperatively inhibiting... inflammation and maintaining mydriasis."
’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 during an intraocular ophthalmologic procedure, | The ANDA Product is described as a generic version of OMIDRIA®, which is used to prevent miosis and reduce postoperative pain during cataract surgery. | ¶11, ¶22 | col. 4:50-59 |
| comprising ketorolac and phenylephrine | The ANDA Product is a solution containing ketorolac tromethamine and phenylephrine hydrochloride. | ¶23 | col. 28:45-47 |
| in a physiologic balanced salt solution for intraocular delivery, | Sandoz seeks approval for an ophthalmic solution for injection, which is intended for intraocular use during surgery. | ¶1, ¶22 | col. 6:53-62 |
| wherein the agents are included... in a therapeutically effective amount for the maintenance of mydriasis and the reduction of postoperative pain. | The ANDA Product is a 1%/0.3% solution of phenylephrine and ketorolac, intended for the same purpose as OMIDRIA®. | ¶1, ¶11 | col. 28:48-52 |
- Identified Points of Contention:
- Scope Questions: The infringement analysis will likely focus on whether the specific formulation of the ANDA Product, including its carrier and the precise chemical forms of the active ingredients, meets the definition of a "composition... in a physiologic balanced salt solution" as construed from the patent.
- Technical Questions: A central issue may be whether the concentrations of ketorolac and phenylephrine in the Sandoz product, once diluted for use, are "therapeutically effective" for both "maintenance of mydriasis" and "reduction of postoperative pain" as required by the claim.
V. Key Claim Terms for Construction
The complaint does not provide sufficient detail for analysis of specific claim terms that will be in dispute. However, based on the asserted patents, certain terms may become central to the litigation.
The Term: "comprising irrigating intraocular tissues" (’707 Patent, Claim 1)
- Context and Importance: This method step defines the act of infringement. Practitioners may focus on this term because the scope of "irrigating"—for example, its duration, continuity, and manner—will be critical to determining whether the instructions on the ANDA Product's label would induce direct infringement.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification describes irrigation as the "flushing of a wound or anatomic structure with a stream of liquid," which could be read broadly to cover various forms of application during surgery (’707 Patent, col. 5:1-3).
- Evidence for a Narrower Interpretation: The patent repeatedly emphasizes "continuous irrigation" and maintaining a "constant concentration" throughout the procedure, suggesting that intermittent or brief flushing might not meet the claim limitation (’707 Patent, col. 5:3-12; col. 5:25-29).
The Term: "physiologic balanced salt solution" (’633 Patent, Claim 1)
- Context and Importance: This term defines the carrier for the active ingredients. Its construction will be key to determining if the Sandoz ANDA Product, which is a concentrated solution diluted into a separate irrigation carrier, meets this limitation as claimed.
- Intrinsic Evidence for Interpretation:
- Evidence for a Broader Interpretation: The specification states the carrier is "suitably an aqueous solution that may include physiologic electrolytes, such as normal saline or lactated Ringer's solution," which could encompass a wide range of standard surgical carriers (’633 Patent, col. 6:55-58).
- Evidence for a Narrower Interpretation: The patent later describes a "preferred balanced salt solution" in more detail, including specific electrolytes, a cellular energy source, a buffering agent, and a free-radical scavenger, which might be used to argue that a simple saline solution does not meet the "physiologic balanced salt solution" limitation (’633 Patent, col. 24:30-47).
VI. Other Allegations
- Indirect Infringement: The complaint alleges that upon FDA approval, Sandoz will induce infringement by marketing and distributing the ANDA Product with a product label and insert that will include instructions for using and administering the product in a manner that directly infringes the asserted method claims (Compl. ¶36, ¶53, ¶70, ¶87, ¶104, ¶121). It is also alleged that Sandoz will contribute to infringement (Compl. ¶35, ¶52, ¶69, ¶86, ¶103, ¶120).
- Willful Infringement: The complaint does not use the term "willful infringement" but alleges that Sandoz’s conduct renders the case "exceptional" under 35 U.S.C. § 285, which provides a basis for attorneys' fees (Compl. ¶39, ¶56, ¶73, ¶90, ¶107, ¶124). This allegation is based on Sandoz having had "actual and constructive notice" of the patents prior to filing its ANDA and filing "without adequate justification" (Compl. ¶37, ¶39, ¶54, ¶56).
VII. Analyst’s Conclusion: Key Questions for the Case
- A core issue will be one of compositional scope: does the specific formulation detailed in the Sandoz ANDA, including its carrier and any excipients, fall within the literal scope of the composition claims, particularly terms like "physiologic balanced salt solution"?
- A key evidentiary question will be one of induced infringement: will the proposed label and instructions for the Sandoz ANDA Product inevitably lead healthcare professionals to perform every step of the asserted method claims, and does the method as practiced provide both "maintenance of mydriasis" and "inhibition of... inflammation" as claimed?
- The case may also turn on questions of validity, as suggested by Sandoz’s notice letter. While not detailed in the complaint, the dispute will likely involve Sandoz’s arguments that the claimed combination of known drugs (ketorolac and phenylephrine) for known purposes was obvious at the time of the invention.