Last Updated: August 2, 2026

Litigation Details for SMITH v. NOVO NORDISK INC. (D.D.C. 2016)


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SMITH v. NOVO NORDISK INC. (D.D.C. 2016)

Docket 1:16-cv-01605 Date Filed 2016-08-08
Court District Court, District of Columbia Date Terminated 2019-07-25
Cause 31:3729 False Claims Act Assigned To Reggie B. Walton
Jury Demand Plaintiff Referred To
Parties STATE OF TEXAS; UNITED STATES OF AMERICA
Patents 6,004,297; 6,235,004; 6,268,343; 6,458,924; 6,899,699; 7,235,627; 7,686,786; 8,114,833; 8,672,898; 8,684,969
Attorneys Darrell C. Valdez; Theodore L. Radway
Firms Office of the Texas Attorney General; U.S. Attorney's Office for the District of Columbia
Link to Docket External link to docket
Small Molecule Drugs cited in SMITH v. NOVO NORDISK INC.
The small molecule drugs covered by the patents cited in this case are ⤷  Start Trial , ⤷  Start Trial , and ⤷  Start Trial .

Details for SMITH v. NOVO NORDISK INC. (D.D.C. 2016)

Date Filed Document No. Description Snippet Link To Document
2016-08-08 External link to document
2016-08-08 5 Amended Complaint Pen is covered by US Patent Nos. 6,004,297, 6,235,004, 6,582,404 and other patents pending. © 2010 Novo…pen is covered by US Patent Nos. 6,004,297, 6,235,004, 6,582,404 and other patents pending. © 2010 Novo… covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending. Saxenda… covered by US Patent Nos. 6,899,699, 7,686,786, 8,672,898, 8,684,969 and other patents pending. …by US Patent Nos. 6,268,343, 6,458,924, 7,235,627 and 8,114,833 and other patents pending External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

Litigation summary and analysis for: SMITH v. NOVO NORDISK INC. (D.D.C. 2016)

Last updated: July 19, 2026

SMITH v. NOVO NORDISK INC. (1:16-cv-01605): Litigation Summary, Patent Issues, and Commercial Risk Analysis

What claims were at issue in SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific litigation summary can be produced from the information provided.

What patents were alleged in SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific patent identification (listed patents, asserted claims, or claim charts) can be produced from the information provided.

What was the procedural posture and key milestones in SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific procedural timeline (dismissals, Markman schedule, motions decided, trial dates, settlements, or final judgment) can be produced from the information provided.

How did infringement, validity, and enforceability arguments play out in SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific litigation analysis of infringement theories, anticipation/obviousness grounds, or enforceability defenses can be produced from the information provided.

What settlement terms (if any) were reached in SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific settlement details (agreement date, parties, noninfringement/non-admission terms, covenants not to sue, or license scope) can be produced from the information provided.

What FDA/Orange Book context drove SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific FDA linkage (Orange Book patents, ANDA/BLA references, Paragraph IV notice content, 505(b)(2) or 351 pathway, or FDA approval dates) can be produced from the information provided.

When did exclusivity or patent expiration affect SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific exclusivity or patent expiration timeline can be produced from the information provided.

Which generic or biosimilar entry risks were implicated by SMITH v. NOVO NORDISK INC. 1:16-cv-01605?

No complete, case-specific entry-risk analysis (launch timing, design-around pathways, manufacturing/IP barriers) can be produced from the information provided.

How does SMITH v. NOVO NORDISK INC. 1:16-cv-01605 compare with other Novo Nordisk patent litigations?

No complete, case-specific comparison can be produced from the information provided.


Key Takeaways

  • A litigation-summary and patent-issue analysis for SMITH v. NOVO NORDISK INC., 1:16-cv-01605 cannot be completed from the provided input without case-specific records such as the complaint, asserted patents, docket milestones, and judgment/settlement documents.

FAQs

  1. What is the docket status of 1:16-cv-01605 involving Novo Nordisk?
  2. Which patents were asserted in SMITH v. NOVO NORDISK INC., 1:16-cv-01605?
  3. Was the case resolved by settlement or final judgment?
  4. Did the litigation involve ANDA Paragraph IV or a biosimilar pathway?
  5. What is the commercial impact of the outcome for Novo Nordisk’s product portfolio?

References

No sources were provided or cited.

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