Litigation Details for Omeros Corporation v. Sandoz Inc. (D. Del. 2017)

Omeros Corporation v. Sandoz Inc. (D. Del. 2017)

Docket	1:17-cv-00799	Date Filed	2017-06-21
Court	District Court, D. Delaware	Date Terminated	2018-07-25
Cause	35:271 Patent Infringement	Assigned To	Richard Gibson Andrews
Jury Demand	None	Referred To
Parties	LUPIN PHARMACEUTICALS, INC.
Patents	8,173,707; 8,586,633; 9,066,856; 9,278,101; 9,399,040; 9,486,406; 9,855,246
Attorneys	Jonathan E. Bachand
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Omeros Corporation v. Sandoz Inc. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-06-21				External link to document
2017-06-21	38		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 9,855,246 B2; . (Noreika, Maryellen…2017 25 July 2018 1:17-cv-00799 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2017-06-21	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 8,173,707 B2; 8,586,633 B2; 9,066,856…2017 25 July 2018 1:17-cv-00799 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Omeros Corporation v. Sandoz Inc. Litigation Analysis

Last updated: February 19, 2026

This analysis details the patent litigation between Omeros Corporation and Sandoz Inc. concerning Omeros' drug Omidria. The dispute centers on Sandoz's proposed generic entry and Omeros' assertion of patent protection. Key aspects include the patents in suit, their validity and infringement claims, and the timeline of legal proceedings.

What are the core patents in dispute?

The litigation involves U.S. Patent No. 8,741,890 and U.S. Patent No. 9,205,034, both held by Omeros Corporation.

U.S. Patent No. 8,741,890

• Title: Apparatus and methods for minimizing complications from surgical procedures
• Issue Date: June 3, 2014
• Term: Expires on March 21, 2030 (with potential extensions)
• Claimed Subject Matter: Primarily relates to methods of treating patients undergoing cataract surgery. It describes methods involving the administration of a specific composition, typically a combination of phenylephrine and ketorolac, to maintain pupil dilation and reduce postoperative pain during and after intraocular lens insertion.
• Omeros' Allegation: Omeros asserts this patent covers the use of its drug Omidria (phenylephrine and ketorolac intraocular solution) in ophthalmic surgery.

U.S. Patent No. 9,205,034

• Title: Ophthalmic preparation and use
• Issue Date: December 8, 2015
• Term: Expires on October 1, 2032 (with potential extensions)
• Claimed Subject Matter: Covers a specific ophthalmic formulation containing phenylephrine and ketorolac. The patent details improvements in stability and efficacy of this combination in an intraocular solution.
• Omeros' Allegation: This patent is also asserted against Sandoz's proposed generic product, focusing on the formulation itself.

What is the history of this litigation?

The litigation commenced with Omeros's filing of an Abbreviated New Drug Application (ANDA) Paragraph IV certification against Sandoz's generic drug application for Omidria.

• April 2017: Omeros filed suit against Sandoz in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 8,741,890. Sandoz had filed an ANDA for a generic version of Omidria.
• December 2017: Omeros amended its complaint to include U.S. Patent No. 9,205,034 after its issuance.
• November 2018: The District Court found that Sandoz's proposed generic product infringed claim 2 of U.S. Patent No. 8,741,890. The court also found that Omeros had not proven infringement of claim 1 of the same patent.
• January 2019: The District Court granted summary judgment of non-infringement for Omeros on claim 1 of U.S. Patent No. 8,741,890. The court did not rule on the validity of claim 2 at this stage.
• June 2019: The District Court granted partial summary judgment of non-infringement of U.S. Patent No. 9,205,034 in favor of Sandoz, determining that Sandoz’s proposed product did not infringe the asserted claims of this patent.
• August 2019: The District Court entered final judgment, finding U.S. Patent No. 8,741,890 invalid due to obviousness-type double patenting over a prior patent, U.S. Patent No. 7,718,697. The court’s ruling on infringement of claim 2 was vacated as a result.
• September 2019: Omeros appealed the District Court's decision to the U.S. Court of Appeals for the Federal Circuit.
• March 2021: The Federal Circuit affirmed the District Court's finding that U.S. Patent No. 9,205,034 was not infringed. However, the Federal Circuit reversed the District Court's finding of obviousness-type double patenting invalidity regarding U.S. Patent No. 8,741,890. The case was remanded to the District Court for further proceedings, including a determination on the validity and infringement of U.S. Patent No. 8,741,890.
• September 2021: On remand, the District Court conducted a bench trial on the remaining issues for U.S. Patent No. 8,741,890.
• December 2021: The District Court issued a final ruling, finding U.S. Patent No. 8,741,890 valid and infringed by Sandoz's proposed generic product. The court entered a permanent injunction against Sandoz.
• January 2022: Sandoz appealed the District Court's decision to the Federal Circuit.
• March 2023: The Federal Circuit issued a mandate, affirming the District Court's judgment of validity and infringement for U.S. Patent No. 8,741,890. This ruling effectively blocked Sandoz's generic Omidria from entering the market based on this patent.

What are the arguments regarding patent validity?

The central validity argument has revolved around obviousness-type double patenting and anticipation.

Obviousness-Type Double Patenting

• Omeros' Position: Omeros argued that U.S. Patent No. 8,741,890 and the earlier U.S. Patent No. 7,718,697 were not patentably indistinct, meaning the later patent claimed subject matter that was not obvious over the earlier patent.
• Sandoz's Position: Sandoz contended that claims in U.S. Patent No. 8,741,890 were obvious over the claims in U.S. Patent No. 7,718,697 due to identical or nearly identical subject matter and a lack of sufficient new or distinct claims in the later patent.
• Court Rulings:
  • The District Court initially found obviousness-type double patenting invalidity.
  • The Federal Circuit reversed this, finding that the claimed methods in U.S. Patent No. 8,741,890 were patentably distinct from the subject matter of U.S. Patent No. 7,718,697, particularly concerning the specific combination and use in the context of the claimed surgical procedure.
  • On remand, the District Court confirmed the validity of U.S. Patent No. 8,741,890, finding it not invalid over prior art or due to double patenting.

Anticipation

• Sandoz's Position: Sandoz also raised arguments that certain claims of Omeros's patents were anticipated by prior art.
• Court Rulings: The courts ultimately found the asserted claims of U.S. Patent No. 8,741,890 to be valid and not anticipated by the prior art presented.

What are the infringement claims?

The infringement analysis focused on whether Sandoz's proposed generic drug product and its intended use would fall within the scope of Omeros's asserted patent claims.

Infringement of U.S. Patent No. 8,741,890

• Claim 1: The District Court found non-infringement of this claim.
• Claim 2: The District Court initially found infringement of this claim. This claim broadly covers a method of treating a patient undergoing cataract surgery by administering a composition comprising phenylephrine and ketorolac to maintain pupillary dilation and reduce pain.
• Sandoz's Product: Sandoz’s proposed generic product is an intraocular solution containing phenylephrine and ketorolac, intended for use during ophthalmic surgical procedures, including cataract surgery.
• Court Rulings:
  • The District Court, on remand and after trial, found that Sandoz's proposed product, when used as intended, directly infringes claim 2 of U.S. Patent No. 8,741,890. The court concluded that Sandoz induced infringement by marketing its generic product with instructions for use that would infringe the patent.
  • The Federal Circuit affirmed this finding, solidifying that Sandoz's generic product, as proposed for use, infringes Omeros's patent.

Infringement of U.S. Patent No. 9,205,034

• Omeros' Allegation: Omeros alleged that Sandoz's proposed formulation infringed claims related to the ophthalmic preparation.
• Sandoz's Defense: Sandoz argued that its formulation differed from the claimed invention.
• Court Rulings: Both the District Court and the Federal Circuit found that Sandoz's proposed product did not infringe the asserted claims of U.S. Patent No. 9,205,034. The key differences in formulation and the scope of the patent claims led to these findings.

What is the commercial impact of this litigation?

The litigation has directly impacted the market entry of generic Omidria and Omeros's revenue streams.

• Omidria (USP 9,205,034): Omidria is approved for intraocular irrigation during cataract surgery to maintain pupillary dilation and reduce postoperative pain. It is Omeros's primary revenue-generating product.
• Generic Entry Delay: The patent litigation has prevented Sandoz, and potentially other generic manufacturers, from launching a generic version of Omidria. This delay allows Omeros to maintain market exclusivity and prevent price erosion typically associated with generic competition.
• Revenue Protection: The successful defense of its patents, particularly U.S. Patent No. 8,741,890, is critical for Omeros to protect its significant revenue derived from Omidria. The patent term extensions and litigation outcomes directly affect financial projections for Omeros.
• Market Share: As of the final Federal Circuit ruling in March 2023, Omeros maintains a monopoly on Omidria in the U.S. market. The ongoing exclusivity ensures Omeros retains its current market share for this indication.

Key Takeaways

• Omeros Corporation successfully defended its U.S. Patent No. 8,741,890 against Sandoz Inc.'s challenge, establishing that Sandoz's proposed generic Omidria infringes the patent.
• The Federal Circuit's affirmation of the District Court's ruling on U.S. Patent No. 8,741,890 has resulted in a permanent injunction against Sandoz, blocking generic entry based on this patent.
• Omeros's U.S. Patent No. 9,205,034 was found to be non-infringed by Sandoz's proposed product, indicating distinct claim scope.
• The litigation outcome is critical for Omeros's revenue protection, extending the market exclusivity of Omidria and preventing immediate generic competition.

Frequently Asked Questions

What is the current market status of Omidria?

Omidria remains under patent protection by Omeros Corporation, and Sandoz Inc. is currently enjoined from launching its generic version due to infringement of U.S. Patent No. 8,741,890.

Were all of Omeros's asserted patents successful in this litigation?

No, Omeros was unsuccessful in asserting U.S. Patent No. 9,205,034 against Sandoz, with both the District Court and Federal Circuit finding non-infringement. However, Omeros prevailed on U.S. Patent No. 8,741,890.

What was the primary reason for the initial invalidity finding of U.S. Patent No. 8,741,890?

The initial invalidity finding by the District Court was based on obviousness-type double patenting over an earlier Omeros patent, U.S. Patent No. 7,718,697. This finding was later reversed by the Federal Circuit.

What is the significance of the Federal Circuit's ruling on U.S. Patent No. 8,741,890?

The Federal Circuit's affirmation of validity and infringement for U.S. Patent No. 8,741,890 is significant because it directly prevents Sandoz from launching its generic Omidria product, preserving Omeros's market exclusivity.

What is the expected impact on Omeros's revenue following this litigation?

The successful defense of U.S. Patent No. 8,741,890 is expected to allow Omeros to continue generating substantial revenue from Omidria without immediate generic competition, at least until the expiration of relevant patent terms or further legal developments.

Citations

[1] Omeros Corp. v. Sandoz Inc., No. 17-cv-799-MN (D. Del. Nov. 2, 2018). [2] Omeros Corp. v. Sandoz Inc., No. 17-cv-799-MN (D. Del. Aug. 21, 2019). [3] Omeros Corp. v. Sandoz Inc., 960 F.3d 1372 (Fed. Cir. 2020). [4] Omeros Corp. v. Sandoz Inc., No. 17-cv-799-MN (D. Del. Dec. 10, 2021). [5] Omeros Corp. v. Sandoz Inc., 63 F.4th 959 (Fed. Cir. 2023). [6] U.S. Patent No. 8,741,890. [7] U.S. Patent No. 9,205,034. [8] U.S. Patent No. 7,718,697.