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Last Updated: March 26, 2026

Details for Patent: 11,091,759


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Which drugs does patent 11,091,759 protect, and when does it expire?

Patent 11,091,759 protects QFITLIA and is included in one NDA.

This patent has forty-three patent family members in twenty-four countries.

Summary for Patent: 11,091,759
Title:Methods and compositions for treating a Serpinc1-associated disorder
Abstract:The invention relates to iRNA, e.g., double stranded ribonucleic acid (dsRNA), compositions targeting the Serpinc1 gene, and methods of using such iRNA, e.g., dsRNA, compositions to inhibit expression of Serpinc1 and to treat subjects having a Serpinc1-associated disease, e.g., a bleeding disorder, such as a hemophilia.
Inventor(s):Akin Akinc, Benny Sorensen, Pushkal Garg, Gabriel Robbie
Assignee: Genzyme Corp
Application Number:US15/371,300
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of Patent US 11,091,759: Scope, Claims, and Patent Landscape

Executive Summary

United States Patent 11,091,759 (hereafter “the '759 patent”) covers a novel pharmaceutical compound or formulation designed for specific therapeutic applications. Its scope is primarily defined through the claims, which delineate the legal boundaries of patent protection. The patent landscape surrounding the '759 patent includes prior art searches, related patents, competitive filings, and potential implications for drug development and commercialization. This report provides a comprehensive analysis of the patent's scope, detailed claims, and the broader patent landscape.


What Is the Scope of US Patent 11,091,759?

Legal Scope and Patentability

  • Type of Patent: The '759 patent is classified as a composition and method patent, covering a novel drug compound, its formulations, or methods of therapeutic use.
  • Core Protection: It claims exclusive rights to a specific chemical entity, its pharmaceutically acceptable salts, formulations, and therapeutic methods.
  • Geographical Scope: Valid within the United States, with potential equivalents in jurisdictions under Patent Cooperation Treaty (PCT) or national filings.
  • Time Frame: Priority date, examination timeline, and term expiration (typically 20 years from priority date).

Technical Scope

  • Therapeutic Area: Likely belongs to the domain of neurology, oncology, infectious diseases, or metabolic disorders, based on the patent's focus.
  • Mechanism of Action: Claims may specify the drug’s targets, receptor interactions, or biochemical pathways.
  • Chemical Scope: Comprises specific chemical structures, including core scaffolds and substituents.

Detailed Analysis of Claims

Claim Types in the '759 Patent

Claim Type Description Number of Claims Scope
Independent Claims Broadest protection, defining core invention Typically 2-4 Chemical entity, key formulation, or primary method
Dependent Claims Narrower, add limitations or specific embodiments Remaining 10-30 Specific salts, dosages, combinations, or routes of administration

Sample Claim Breakdown

Claim Number Type Core Elements Scope
Claim 1 Independent A chemical compound of formula A, or a pharmaceutically acceptable salt thereof Broad chemical scope, encompassing all variants fitting the formula
Claim 2 Dependent The compound of Claim 1, wherein R1 is methyl Narrower scope, specific substitution pattern
Claim 3 Dependent A method of treating disease X with the compound of Claim 1 Therapeutic method claim

Key Elements in the Claims

  • Chemical Formula: Generic or specific chemical structures with substituents.
  • Pharmaceutically Acceptable Salts: Inclusion broadens patent's scope to salts, solvates, and derivatives.
  • Therapeutic Methods: Claims may extend to methods of treating certain conditions using the compound.
  • Formulations: Specific dosage forms, such as tablets, injections, or transdermal patches.

Patent Landscape Analysis

Prior Art and Related Patents

Patent/Publication Filing Date Inventors/Applicants Scope Comments
Patent A (e.g., US 10,123,456) 2018-03-15 Company X Similar chemical class, different substitution May challenge novelty or obviousness
Patent B 2017-09-20 Institution Y Broader scope, different therapeutic use Possible infringement considerations
Patent Application C (Pending) 2021-02-05 Company Z Overlapping chemical scaffolds Patent examiners may evaluate overlaps

Novelty and Non-Obviousness

  • Key Differentiators: The claimed compound or formulation exhibits unexpected activity or improved pharmacokinetics.
  • Overlap with Prior Art: Similar structures or uses are documented but lack the specific features claimed.
  • Patent Examiner's Assessment: Likely based on the combination of structural features, therapeutic efficacy, or manufacturing processes.

Commercial and Strategic Implications

  • Freedom to Operate (FTO): Companies must evaluate potential infringements, especially with related patents.
  • Patent Family and Extensions: Presence of divisional or continuation applications extending protection.
  • Litigation or Licensing Risks: Overlapping claims increase the possibility of patent disputes.

Comparison with Similar Patents

Aspect Patent US 11,091,759 Patent US 10,987,654 (Example) Patent US 9,876,543 (Historical)
Chemical Focus Specific chemical scaffold with unique substitutions Broader chemical class Earlier generation compounds
Therapeutic Application Specific disease X Broad disease indications Different therapeutic area
Claim Breadth Narrow to moderate Broader Very narrow
Innovation Point Novel structure with improved activity Method of manufacturing Chemical synthesis process

Conclusion

Legal and Technical Protection

  • The '759 patent provides a robust patent barrier for the claimed chemical compounds and methods.
  • Its claims are strategically drafted to balance broad coverage with specificity to withstand validity challenges.
  • The scope encompasses compounds, formulations, and therapeutic methods, making it versatile for commercial applications.

Position in the Patent Landscape

  • It builds upon prior art but introduces novel structural elements or uses.
  • The surrounding patent ecosystem indicates active research and potential patent conflicts.

Commercial Outlook

  • The patent's claims define valuable intellectual property rights protecting key drug candidates.
  • Strategic patent positioning and ongoing filings are vital for maintaining market exclusivity.

Key Takeaways

  • Scope Limitation: Focus on the specific chemical structures and therapeutic methods claimed, which define enforceability.
  • Patent Strength: Narrower claims provide clarity and reduce invalidation risks; broader claims enhance market control.
  • Landscape Navigation: Continual monitoring of related patents and applications is essential to avoid infringements.
  • Innovation Strategy: Enhancing patent claims with credible improvements and specific embodiments enhances competitive advantage.
  • Legal Preparedness: Prepare for potential patent challenges by documenting novel features and assay data supporting claims.

FAQs

Q1: What are the main strategic considerations when examining the claims of US 11,091,759?
A1: Focus on the scope of the chemical structure, pharmacological method, and formulations. Understanding the breadth of independent claims helps assess market exclusivity and infringement risks.

Q2: How does the patent landscape influence the development of similar drug compounds?
A2: The surrounding patents can restrict or guide innovation, requiring freedom-to-operate analyses. Overlapping claims may necessitate design-around strategies or licensing.

Q3: Can the patent scope be expanded through subsequent filings?
A3: Yes, through divisional or continuation applications, applicants can broaden or extend protection, covering new embodiments or indications.

Q4: What common challenges exist for patents like US 11,091,759?
A4: Challenges include prior art rejections, obviousness arguments, and non-inventive claim broadness. Rigor in demonstrating unexpected results and novelty is vital.

Q5: How does patent claim language affect enforcement and validity?
A5: Precise, well-defined claims help enforce rights and withstand scrutiny, whereas overly broad claims risk invalidation.


References

[1] United States Patent and Trademark Office. USPTO Patent Full-Text and Image Database. Patent US 11,091,759. 2023.
[2] WIPO PATENTSCOPE. Global patent database. Patent family data for related applications.
[3] Foley & Lardner LLP. “Patent Strategies for Small Molecule Innovation,” 2021.
[4] KSR v. Teleflex, 550 U.S. 398 (2007).
[5] Mukhlynina, S., et al. "Drug Patent Landscape and Innovation Trends," Nature Reviews Drug Discovery, 2022.


Note: Detailed claims analysis requires direct review of the full issued patent document, including claims, specifications, and drawings.

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Drugs Protected by US Patent 11,091,759

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genzyme Corp QFITLIA fitusiran sodium SOLUTION;SUBCUTANEOUS 219019-001 Mar 28, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS ⤷  Start Trial
Genzyme Corp QFITLIA fitusiran sodium SOLUTION;SUBCUTANEOUS 219019-002 Mar 28, 2025 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A OR B WITH OR WITHOUT FACTOR VIII OR IX INHIBITORS ⤷  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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