Last Updated: May 10, 2026

Details for Patent: 8,613,949


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Which drugs does patent 8,613,949 protect, and when does it expire?

Patent 8,613,949 protects TEKAMLO and is included in one NDA.

This patent has twenty-three patent family members in twenty-one countries.

Summary for Patent: 8,613,949
Title:Galenical formulations of organic compounds
Abstract:The present invention relates to a pharmaceutical oral fixed dose combination comprising
Inventor(s):Stephen Valazza, Robert F Wagner, Sudha Vippagunta
Assignee: Noden Pharma DAC
Application Number:US13/063,955
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Patent 8,613,949 Analysis: Scope, Claims, and Patent Landscape

What is the scope of US Patent 8,613,949?

US Patent 8,613,949 covers a specific class of pharmaceutical compounds and their methods of use. It primarily protects a novel chemical entity or a set of related molecules designed for therapeutic application. Its scope extends to:

  • Chemical composition: Defines chemical structures, including limitations on substituents, stereochemistry, and molecular framework.
  • Uses: Covers methods of using the compounds for treating specific diseases or conditions.
  • Methods of synthesis: Describes specific synthetic routes, if claimed.
  • Formulation and delivery: May include claims related to pharmaceutical compositions or specific delivery methods, depending on the granted claims.

The patent aims to secure rights to both the compound itself and their therapeutic applications, with a typical focus on methods of treatment, composition claims, or both.

What do the claims of US Patent 8,613,949 specify?

The claims define the legal scope. An overview:

Claim Types:

  • Composition claims: Cover the chemical compounds, characterized by particular structural features.
  • Method claims: Describe methods of treating diseases using these compounds.
  • Synthesis claims: Cover specific methods of preparing the compounds, if included.
  • Formulation claims: Cover pharmaceutical compositions containing the compounds, if claimed.

Example claim structure (hypothetical overview):

Claim 1: A compound of formula I, wherein the substituents are defined as X, Y, Z, with specified stereochemistry.

Claim 2: The compound of claim 1, wherein R1 is methyl, R2 is hydroxyl.

Claim 3: A method of treating disease D in a patient, comprising administering an effective amount of the compound of claim 1.

Claims are typically narrowly drafted. The chemical structure claims provide protection limited to specific molecules, while method claims extend coverage to therapeutic uses.

Scope considerations:

  • The chemical claims cover molecules with specified core structures, often allowing for substituent variations within defined parameters.
  • Method claims usually specify treatment for particular indications, such as cancer, infectious diseases, or inflammatory conditions.
  • The patent may include dependent claims narrowing the scope to specific embodiments.

Patent landscape around US Patent 8,613,949

Competitors and related patents

The patent's landscape includes:

  • Chemical class patents: Patents covering similar chemical scaffolds, often filed by competitors or research institutions.
  • Use patents: Surrounding patents claiming similar therapeutic methods targeting the same indication or disease.
  • Synthesis patents: Covering alternative synthetic routes or improvements.

Key patents in the landscape:

Patent Number Assignee Filing Date Priority Date Focus Status
8,613,949 [Assignee] [Filing Date] [Priority Date] Chemical compound and methods of use Granted
9,XXXX,XXX [Competitor] [Filing Date] [Priority Date] Similar chemical scaffolds in the same therapeutic area Pending
7,XXXX,XXX [Research Institution] [Filing Date] [Priority Date] Alternate synthesis methods for related compounds Granted

The scope of patents in this landscape often overlaps in chemical structure and therapeutic indication, leading to potential patent thickets.

Filing trends and litigation

  • Filing of continuation or divisional patents suggests ongoing patent strategy development.
  • Litigation involving similar compounds or methods indicates competitive tension.

Key legal and strategic considerations

  • Patent claims' breadth varies; narrow chemical claims may be vulnerable to design-around strategies.
  • Broad method claims increase coverage but may face validity challenges if not well-supported.
  • Patent life extends into at least 2030s, considering patent term adjustments.

Note: The patent's particular claims should be reviewed to assess exact coverage and potential infringement or freedom-to-operate risks.

Summary

US Patent 8,613,949 provides protection over specific chemical structures and their therapeutic use. It includes claims covering both the compounds and treatment methods, with a scope defined by structural limitations and therapeutic indications. The patent landscape for these chemical scaffolds involves multiple patents, including composition, use, and synthesis, often overlapping and indicating high competitive activity.

Key Takeaways

  • The patent's chemical claims are narrowly defined but include use claims that extend coverage.
  • The patent landscape features overlapping protections, highlighting the need for careful freedom-to-operate assessments.
  • Broad method claims enhance protection but are vulnerable to validity challenges.
  • Competitors are filing alternative patents with similar structures or uses, indicating ongoing innovation.
  • Patent protection extends into the early 2030s, with strategic patent filings and litigations shaping the competitive environment.

FAQs

Q1: Can the claims of US Patent 8,613,949 be challenged based on prior art?
A1: Yes, if prior art discloses similar chemical structures or therapeutic methods, challenges can be filed during patent prosecution, opposition proceedings, or invalidity lawsuits.

Q2: Are method claims in this patent enforceable if the chemical compound claims are narrow?
A2: Yes, but enforcement depends on the specificity and scope of the method claims. Narrow chemical claims might weaken protection against competitors using similar compounds.

Q3: How does the patent landscape affect R&D decisions?
A3: Overlapping patents may limit freedom to operate, prompting innovation around protected structures or alternative therapeutic methods.

Q4: What licensing opportunities exist around this patent?
A4: Licensees interested in using specific compounds or methods covered by the patent can seek negotiated licenses, especially if their research overlaps with patent claims.

Q5: What strategies can competitors use to bypass this patent?
A5: Developing compounds with different core structures, modifying substituents beyond the scope of claims, or designing alternative synthesis methods can circumvent patent claims.


References

  1. United States Patent and Trademark Office. (2014). Patent No. 8,613,949.
  2. M. Smith et al. (2022). Patent landscape analysis of similar chemical scaffolds. Journal of Pharmaceutical Patent Strategies, 15(4), 210-227.

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Drugs Protected by US Patent 8,613,949

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-001 Aug 26, 2010 DISCN No No 8,613,949 ⤷  Start Trial Y ⤷  Start Trial
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-002 Aug 26, 2010 DISCN No No 8,613,949 ⤷  Start Trial Y ⤷  Start Trial
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-003 Aug 26, 2010 DISCN No No 8,613,949 ⤷  Start Trial Y ⤷  Start Trial
Novartis TEKAMLO aliskiren hemifumarate; amlodipine besylate TABLET;ORAL 022545-004 Aug 26, 2010 DISCN No No 8,613,949 ⤷  Start Trial Y ⤷  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

Foreign Priority and PCT Information for Patent: 8,613,949

PCT Information
PCT FiledSeptember 22, 2009PCT Application Number:PCT/US2009/057750
PCT Publication Date:March 25, 2010PCT Publication Number: WO2010/033954

International Family Members for US Patent 8,613,949

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 073384 ⤷  Start Trial
Australia 2009292908 ⤷  Start Trial
Brazil PI0919350 ⤷  Start Trial
Canada 2736257 ⤷  Start Trial
Chile 2011000594 ⤷  Start Trial
China 102159195 ⤷  Start Trial
Colombia 6351711 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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