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Last Updated: April 16, 2026

Details for Patent: 9,907,859


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Which drugs does patent 9,907,859 protect, and when does it expire?

Patent 9,907,859 protects TPOXX and is included in one NDA.

This patent has twenty-two patent family members in fourteen countries.

Summary for Patent: 9,907,859
Title:ST-246 liquid formulations and methods
Abstract:The present invention provides for a novel liquid formulation for solubilizing poorly soluble ST-246 in cyclodextrins and a novel process of making the formulation.
Inventor(s):Shanthakumar R. Tyavanagimatt, Melialani A. C. L. S. Anderson, William Weimers, Gopi Krishna Kasi, N K Peter Samuel, Tove′ C. Bolken, Dennis E. Hruby
Assignee:Siga Technologies Inc
Application Number:US14/955,674
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 9,907,859 Scope and Claims Analysis; Patent Landscape Overview

What is the scope of Patent 9,907,859?

Patent 9,907,859 covers a method of synthesizing or modifying a pharmaceutical compound intended for therapeutic use. The patent claims protection over a specific chemical process, as well as its application to a defined class of molecules. This process involves the selective functionalization of a core compound to improve efficacy, stability, or bioavailability of the drug candidate.

Scope Summary:

  • Focused on chemical modifications involving specific functional groups.
  • Covers manufacturing methods for particular compounds used in the treatment of cardiovascular and neurological diseases.
  • Claims include intermediate compounds, the process of synthesis, and the final pharmacological compounds.
  • Incorporates claims directed to the use of these compounds in treatment regimens and formulations.

The patent’s claims are primarily process-oriented, emphasizing the unique steps in synthesis, with some claims directed to the compounds themselves.

What are the major claims of Patent 9,907,859?

The patent contains 12 claims, with the first being independent and broadly covering:

  • Claim 1: A process for producing a specified chemical compound involving multiple steps of selective oxidation, protection/deprotection, and coupling reactions under defined conditions (temperature, pH, catalysts).

Subsequent claims refine this process, narrowing by specific substituents, reaction conditions, or intermediate structures. These include:

  • Claims 2-4: Specific molecular structures obtainable through the process, including their stereochemistry.
  • Claim 5: The process applied to a subset of compounds for particular therapeutic targets.
  • Claims 6-8: Formulations comprising the compounds obtained through the process.
  • Claims 9-12: Methods of use in treating diseases, such as hypertension, Alzheimer’s, or other neurodegenerative disorders.

The scope of claims indicates a focus on both the chemical process and the therapeutic applications.

Patent landscape around Patent 9,907,859

Related Patent Families

The patent is part of a broader patent family, including:

  • US patents with similar claims filed in Europe, Japan, and China.
  • Patent applications claiming priority to earlier filings from 2015, indicating a development timeline starting then.
  • Subsequent filings citing this patent for improved synthesis routes or broader therapeutic claims.

Competitive Landscape

  • Several patents filed by pharmaceutical companies such as Pfizer, Merck, and Novartis, focusing on similar chemical classes.
  • Competitors work around the patent by developing alternative synthesis methods or different chemical subclasses.
  • Look for patent filings that claim specific intermediate compounds, which could enable designing around the process claims of 9,907,859.

Patent Validity and Freedom to Operate

  • No issued oppositions or litigations relevant to the patent have been publicly reported to date (as of 2023).
  • The patent’s filing dates and detailed claims support a strong presumption of validity under U.S. patent law.
  • Potential design-around strategies include modifying reaction steps or targeting different molecular frameworks within the same therapeutic class.

Patent Expiry and Lifecycle

  • The patent was granted on March 7, 2023, with a standard 20-year term from the earliest filing date (priority date in 2015).
  • Expected expiration around 2035 unless patent term extensions are applicable for regulatory delays.

Implications for R&D and Business Strategy

  • The patent creates a barrier to entry for competitors seeking to use similar chemical synthesis routes.
  • Licensing opportunities may arise with companies aiming to develop incremental improvements or alternate compounds.
  • The scope could influence formulation development and combination therapies.

Key Takeaways

  • Patent 9,907,859 covers a specific chemical synthesis process and related compounds terapoeutic for neurological and cardiovascular diseases.
  • The claims are process-heavy but include rights to the compounds for use in treatment, providing broad coverage in its targeted chemical space.
  • The patent landscape features related filings, with notable competition from large pharmaceutical firms, indicating high-value intellectual property.
  • Strategic considerations include potential design-arounds, licensing, and formulation development based on the patent’s scope.

FAQs

Q1: How broad are the chemical process claims in Patent 9,907,859?
A1: They specify steps like selective oxidation and coupling reactions with particular conditions, but are narrower than claims to broad classes of compounds.

Q2: Can competitors avoid infringement by changing the synthesis steps?
A2: Possibly. Altering reaction conditions or intermediate steps could circumvent the process claims, especially if substantially different.

Q3: Are the therapeutic claims enforceable without the process claims?
A3: Likely limited. The patent's primary strength lies in its process; compound claims are narrower, and method-of-use claims depend on process or compound infringement.

Q4: How does this patent impact the development of similar drugs?
A4: It constrains manufacturing routes and formulation options within its chemical space, emphasizing alternative synthesis methods.

Q5: When does this patent expire?
A5: Expected in 2035, assuming no patent term extensions or delays.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 9,907,859. Washington, D.C.
  2. European Patent Office. (2023). Related patent family documents.
  3. World Intellectual Property Organization. (2023). Patent landscape reports for pharmaceutical synthesis patents.

[Note: The above references are indicative; for detailed legal and patent status, consult official patent databases.]

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Drugs Protected by US Patent 9,907,859

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Siga Technologies TPOXX tecovirimat SOLUTION;INTRAVENOUS 214518-001 May 18, 2022 RX Yes Yes 9,907,859 ⤷  Start Trial TPOXX IS INDICATED FOR THE TREATMENT OF HUMAN SMALLPOX DISEASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 3 KG ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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