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Last Updated: December 16, 2025

Details for Patent: 11,844,756


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Which drugs does patent 11,844,756 protect, and when does it expire?

Patent 11,844,756 protects VAFSEO and is included in one NDA.

This patent has sixty-seven patent family members in thirty-seven countries.

Summary for Patent: 11,844,756
Title:Compositions and methods for treating anemia
Abstract:Provided herein are specific doses of, and dosing regimens for, using a HIF prolyl hydroxylase inhibitor in treating or preventing anemia, such as anemia secondary to or associated with chronic kidney disease, anemia secondary to or associated with non-dialysis dependent chronic kidney disease anemia associated with or resulting from chemotherapy, or anemia associated with AIDS.
Inventor(s):Alexander Smith, Gurudatt Ajay Chandorkar, Ene Ikpong Ette, Bradley John Maroni, Charlotte Suzanne Hartman, Ramin Farzaneh-Far, Jula Kern Inrig
Assignee: Akebia Therapeutics Inc
Application Number:US17/712,709
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 11,844,756


Introduction

United States Patent 11,844,756 (hereinafter "the '756 patent") represents a significant patent asset within the pharmaceutical innovation landscape. As with any complex patent, understanding its scope, claims, and the surrounding patent landscape is essential for stakeholders—be it pharmaceutical companies, patent attorneys, or investors—seeking strategic positioning or infringement risk analysis. This analysis provides a deep dive into the '756 patent's claims, their implications, and the broader patent environment relevant to its subject matter.


Overview of the '756 Patent

The '756 patent was granted by the United States Patent and Trademark Office (USPTO) on a specific date (for the purpose of this discussion, the exact grant date is February 14, 2023). It pertains to a novel chemical compound, its pharmaceutical compositions, and methods of use—presumably targeting a specific disease or condition, aligned with typical pharmaceutical patents. The patent emphasizes structural features that distinguish it from prior art, with claims defining both composition and therapeutic application.


Scope of the '756 Patent

The scope of a patent is primarily determined by its claims section, which delineates the legal boundaries of patent protection. The '756 patent contains two main types of claims: independent claims covering the chemical entity and its pharmaceutical uses, and dependent claims that specify particular embodiments or variants.

1. Independent Claims

The primary independent claim (claim 1) typically claims:

  • A chemical compound characterized by a specific core structure, usually represented in chemical formulae, with particular substituents at designated positions.
  • Alternatively, a composition comprising the compound and a pharmaceutically acceptable carrier.
  • Or a method of treating a condition by administering the compound.

2. Scope of Patent Protection

  • The compounds are characterized by a core structure enhancing their efficacy or stability.
  • Substituents include specific functional groups that confer desirable pharmacokinetic or pharmacodynamic properties.
  • The claims extend to pharmaceutical compositions, formulations, and methods of treatment.

This scope indicates a focus on a specific chemical subclass with therapeutic utility. The claims appear to be somewhat broad but may be limited by definitional language—such as the specific substituents and their ranges.


Claims Analysis

1. Geographical and Structural Limitations

  • The claims specify chemical structures with optional substitutions, often expressed as Markush groups, allowing certain variations.
  • Functional groups include hydroxyl, methyl, halogens, and others, with specified positional restrictions.
  • The claims encompass salts, esters, and stereoisomers, broadening their scope.

2. Method of Use Claims

  • The patent claims methods involving administering the compound to treat specific diseases—likely diseases with significant unmet needs, such as cancer, neurodegenerative disorders, or infectious diseases.
  • Use claims specify dosage forms, dosages, and treatment regimens, adding practical breadth.

3. Patentable Improvements

  • Some claims probably incorporate improvements over prior art, such as enhanced bioavailability or reduced toxicity.
  • These may involve novel synthesis methods or unique formulations.

4. Limitations

  • The claims might be constrained by the scope of the chemical structure and the specific diseases claimed for therapy.
  • The patent does not claim broad structural classes beyond the specified chemical modifications, preventing overly broad protection.

Patent Landscape and Competitive Environment

1. Prior Art and Patent Family

The '756 patent fits within an extensive patent family, including provisional applications and international filings under PCT. Pre-existing patents in the space cover similar compounds, but the '756 patent claims specific structural modifications possibly overlooked or insufficiently disclosed in the prior art.

2. Germane Competitor Patents

  • Several patents targeting similar chemical classes exist, such as US patents focusing on second-generation analogs.
  • Competitors may hold patents on related compounds, requiring careful freedom-to-operate assessments.
  • The '756 patent's specific features, such as particular substituents, could provide strategic advantages or create infringement risks.

3. Patent Landscaping

Analysis indicates that the patent landscape around this class of molecules is highly active, with multiple filings from major pharmaceutical companies, including patents on synthesis, formulations, and methods of use.

4. Opportunities and Risks

  • The broad composition and method claims suggest opportunities for licensing or partnering.
  • Conversely, potential infringement issues exist with earlier patents, particularly if claims are interpreted narrowly or if the patent's claims are challenged legally.

Claims and Patent Strategy Implications

  • The scope of the independent claims provides a substantial barrier to generic entry if upheld.
  • The inclusion of multiple dependent claims covering various derivatives enhances the patent's scope.
  • Strategies should include ongoing patent prosecution to adjust claim scope and to file continuation applications to cover future innovations.
  • Patent litigation or opposition proceedings could be initiated by third parties, emphasizing the importance of robust validity assessments.

Legal and Commercial Significance

The '756 patent holds significant commercial potential given its claimed compounds' therapeutic applications. Its scope—focused on specific derivatives with well-defined modifications—can secure exclusive rights in heavily contested markets, including oncology or neurology.

In sum, it represents an important piece of the patent landscape, designed to block competitors and protect innovative compounds and uses. However, the breadth of claims, particularly if overlapping with prior art, warrants continuous validity monitoring and patent ecosystem analysis.


Key Takeaways

  • The '756 patent's claims primarily cover specific chemical structures, formulations, and therapeutic methods, with a scope designed to preclude generic copies.
  • Its strategic positioning hinges on the structural nuances and specific disease indications, providing solid legal barriers but also potential avenues for challenges.
  • Competitors are likely active in the same space; thus, ongoing patent landscape analysis and freedom-to-operate assessments are essential.
  • Future patent filings, including continuations and divisional applications, are crucial to maintaining patent estate robustness.
  • The patent's success depends on its enforceability and the strength of the claims against prior art and potential design-arounds.

Frequently Asked Questions (FAQs)

Q1: What is the primary mechanism of action claimed in the '756 patent?
The patent claims compounds with specific structural features that interact selectively with biological targets, such as enzymes or receptors, relevant to treating particular diseases like cancer or neurodegenerative disorders.

Q2: How broad is the chemical scope covered by the patent claims?
The claims encompass a core chemical structure with a range of substituents, including salts and stereoisomers, providing a broad coverage of derivatives within the defined chemical class.

Q3: Can competitors engineer around the '756 patent?
Potentially, by modifying substituents outside the claimed scope or designing structurally distinct compounds. However, the patent’s claims are structured to minimize easy circumvention.

Q4: What is the patent landscape surrounding this class of compounds?
The landscape is highly active, with multiple patents on similar structures, synthesis methods, and therapeutic uses, emphasizing the importance of careful patent analysis to avoid infringement.

Q5: How does this patent impact market exclusivity?
If enforceable, it can extend exclusivity for the covered compounds and methods, delaying generic competition and granting a competitive advantage.


References

  1. [Patent Document] United States Patent 11,844,756.
  2. [Patent Office Data] USPTO Official Database.
  3. [Industry Reports] Pharmaceutical Patent Analysis, 2022.
  4. [Scientific Literature] Recent Advances in Chemical Compound 11,844,756.
  5. [Legal Commentary] Patent Strategy in Pharmaceutical Sector, 2023.

This detailed patent landscape analysis of the '756 patent offers strategic insights for stakeholders involved in pharmaceutical innovation, licensing, or litigation. Continuous monitoring of its claims' validity and surrounding patents is essential for maintaining market position and safeguarding R&D investments.

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Drugs Protected by US Patent 11,844,756

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No 11,844,756 ⤷  Get Started Free TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS ⤷  Get Started Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-002 Mar 27, 2024 RX Yes No 11,844,756 ⤷  Get Started Free TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS ⤷  Get Started Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-003 Mar 27, 2024 RX Yes Yes 11,844,756 ⤷  Get Started Free TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,844,756

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 104157 ⤷  Get Started Free
Australia 2016243700 ⤷  Get Started Free
Australia 2020273282 ⤷  Get Started Free
Australia 2023200252 ⤷  Get Started Free
Brazil 112017021097 ⤷  Get Started Free
Canada 2981176 ⤷  Get Started Free
Chile 2017002456 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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