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

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

Docket		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	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
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	46		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	71	Stipulation of Dismissal	Paragraph III Certification with respect to U.S. Patents 8,173,707; 8,586,633; 9,066,856; 9,278,101…submitted a patent amendment to its pending ANDA 207841 in which it revised its Patent and Exclusivity… after the expiration of these patents, this action and all claims and defenses asserted…2017 25 July 2018 1:17-cv-00799 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document
2017-06-21	72	Order	Paragraph III Certification with respect to U.S. Patents 8,173,707; 8,586,633; 9,066,856; 9,278,101…submitted a patent amendment to its pending ANDA 207841 i.n which it revised its Patent and Exclusivity… after the expiration of these patents, this action and all claims and defenses asserted…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.: A Comprehensive Litigation Summary and Analysis

Background

The litigation between Omeros Corporation and Sandoz Inc. revolves around patent infringement issues related to Omeros's cataract surgery drug, Omidria. Here is a detailed summary and analysis of the key points in this case.

Nature of the Action

Omeros Corporation initiated the lawsuit against Sandoz Inc. under the patent laws of the United States, specifically alleging patent infringement. Sandoz had submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Omidria before the expiration of Omeros's patents[4].

Patent Involvement

The dispute centers on Omidria, a drug used in cataract surgery to reduce postoperative pain and inflammation. Omeros holds several patents related to the composition and method of use of Omidria, which Sandoz sought to challenge through its ANDA filing.

Litigation Proceedings

• Initial Filing: Omeros filed the lawsuit in response to Sandoz's ANDA submission, alleging that Sandoz's generic version would infringe on Omeros's patents.
• Settlement and Agreement: After the litigation began, the parties reached a settlement. Sandoz agreed to hold off on the launch of its generic version of Omidria until the relevant patents expire, which is expected to be in approximately 15 years[4].

Key Issues and Arguments

• Patent Validity: The primary issue was whether Sandoz's ANDA product would infringe on Omeros's valid patents. Omeros had to demonstrate that its patents were valid and that Sandoz's actions would constitute infringement.
• Generic Approval: Sandoz's ANDA filing was contingent on demonstrating that its product did not infringe on existing patents or that the patents were invalid or unenforceable.

Court Decisions and Outcomes

• Settlement Agreement: The case did not proceed to a full trial due to the settlement agreement. Sandoz agreed not to launch its generic version until the expiration of Omeros's patents, effectively resolving the dispute without a court ruling on the merits of the patent validity or infringement claims[4].

Impact and Implications

• Market Protection: The settlement ensures that Omeros retains market exclusivity for Omidria for an extended period, protecting its intellectual property and revenue stream.
• Generic Entry: The agreement delays the entry of a generic version of Omidria into the market, which could have significant implications for pricing and competition in the pharmaceutical sector.

Industry Perspective

• Patent Litigation: This case highlights the common practice of generic manufacturers challenging innovator companies' patents through ANDA filings. It also underscores the importance of patent litigation in protecting intellectual property in the pharmaceutical industry.
• Settlement Strategies: The settlement demonstrates a strategic approach where both parties can avoid the costs and uncertainties of litigation by reaching a mutually beneficial agreement.

Expert Insights

Industry experts often note that such settlements are common in pharmaceutical patent disputes, as they allow both parties to avoid lengthy and costly litigation. For innovator companies like Omeros, these agreements help maintain market exclusivity and protect their investment in research and development.

Statistics and Examples

• Patent Expiration: The agreement to delay the generic launch until patent expiration is a common strategy. For instance, in similar cases, generic manufacturers often agree to wait until the innovator's patents expire to avoid litigation costs and potential damages[4].

Key Takeaways

• Patent Protection: The case emphasizes the importance of robust patent protection for pharmaceutical companies.
• Settlement Agreements: Settlements can be a viable strategy to resolve patent disputes, avoiding the costs and uncertainties of litigation.
• Market Exclusivity: Innovator companies can maintain market exclusivity through effective patent litigation and strategic settlements.

FAQs

1. What is the main issue in the Omeros Corporation v. Sandoz Inc. litigation?

   • The main issue is whether Sandoz's generic version of Omidria infringes on Omeros's patents.

2. What was the outcome of the litigation?

   • Sandoz agreed to delay the launch of its generic version until the expiration of Omeros's patents.

3. Why did Sandoz file an ANDA for Omidria?

   • Sandoz filed an ANDA to seek FDA approval for a generic version of Omidria before the expiration of Omeros's patents.

4. What are the implications of the settlement for Omeros?

   • The settlement protects Omeros's market exclusivity for Omidria and ensures continued revenue from the drug.

5. How common are settlement agreements in pharmaceutical patent disputes?

   • Settlement agreements are relatively common in pharmaceutical patent disputes as they help avoid costly and lengthy litigation.

Cited Sources

1. Law360 - Omeros Corporation v. Sandoz Inc.

   • https://www.law360.com/cases/594bc7f629ae530cd8000001

2. Court of Appeals for the Federal Circuit - Various Cases

   • https://cafc.uscourts.gov/opinions-orders/

3. PharmaCompass - IMBRUVICA (Ibrutinib) Pharmacyclics v. Zydus Worldwide DMCC

   • https://www.pharmacompass.com/pdf/news/imbruvica-ibrutinib-pharmacyclics-v-zydus-worldwide-dmcc-1520247536.pdf