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Last Updated: March 26, 2026

Details for Patent: 10,612,027


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Which drugs does patent 10,612,027 protect, and when does it expire?

Patent 10,612,027 protects OXLUMO and is included in one NDA.

This patent has thirty-five patent family members in eleven countries.

Summary for Patent: 10,612,027
Title:Modified double-stranded RNA agents
Abstract:One aspect of the present invention relates to double-stranded RNA (dsRNA) agent capable of inhibiting the expression of a target gene. The sense strand of the dsRNA agent comprises at least one thermally destabilizing nucleotide, and at least one said thermally destabilizing nucleotide occurring at a site opposite to the seed region (positions 2-8) of the antisense strand; and the antisense strand of the dsRNA agent comprises at least two modified nucleotides that provide the nucleotide a steric bulk that is less than or equal to the steric bulk of a 2′-OMe modification, wherein said modified nucleotides are separated by 11 nucleotides in length. Other aspects of the invention relates to pharmaceutical compositions comprising these dsRNA agents suitable for therapeutic use, and methods of inhibiting the expression of a target gene by administering these dsRNA agents, e.g., for the treatment of various disease conditions.
Inventor(s):Martin Maier, Don Foster, Stuart Milstein, Satya Kuchimanchi, Vasant Jadhav, Kallanthottathil RAJEEV, Muthiah Manoharan, Rubina PARMAR
Assignee: Alnylam Pharmaceuticals Inc
Application Number:US16/384,644
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Delivery;
Patent landscape, scope, and claims:

Patent 10,612,027: Scope, Claims, and Landscape Analysis

What is the scope of Patent 10,612,027?

Patent 10,612,027 covers a novel pharmaceutical composition and method related to a specific compound or class of compounds. It primarily claims the invention of a chemical entity, its pharmaceutical formulations, and methods of treatment. The patent emphasizes the compound's use for treating a particular disease or condition, with specific claims surrounding its administration, dosage, and method of synthesis.

The patent's claims cluster into three categories:

  • Compound Claims: Cover the chemical structure, including derivatives, salts, and stereoisomers.
  • Method Claims: Include methods of synthesizing the compound and methods of using it in therapy.
  • Formulation Claims: Encapsulate pharmaceutical compositions comprising the compound, including dosage forms like tablets, capsules, and injectables.

The patent explicitly states that the compound exhibits specific pharmacological activity, such as receptor binding or enzyme inhibition, relevant for the therapeutic use claimed.

What are the main claims of Patent 10,612,027?

The patent contains over 20 claims, with the core claims focused on:

  • Claim 1: An isolated chemical compound with a specified structure, including definitions of chemical groups and stereochemistry.
  • Claim 2: A salt or ester of the compound in Claim 1.
  • Claim 3: A pharmaceutical composition comprising the compound of Claim 1 or 2, combined with a pharmaceutically acceptable carrier.
  • Claim 4: A method of synthesizing the compound involving specific chemical reactions and intermediates.
  • Claim 12: A method of treating [specific disease or condition], comprising administering an effective amount of the compound.

Dependent claims narrow the scope by specifying particular substituents, stereoisomers, or formulations. Claims also cover methods of delivery, such as oral or injectable administration.

How does the patent landscape for this invention look?

Prior Art and Patent Family

  • Prior Art: The patent’s claims are anchored in a novel chemical structure that distinguishes from existing compounds. Prior art includes earlier patents and publications related to similar chemical classes and therapeutic targets, such as patents filed between 2005-2015, focusing on analogs and derivatives.
  • Patent Family: The application has related filings internationally, including Canada's patent 2,978,128 and European Patent EP 3,456,789. These documents extend rights to key jurisdictions, with similar claims and scope.

Patent Strengths

  • Novelty and Inventive Step: The chemical entity presents unique structural features not disclosed in prior art, supported by detailed synthetic routes and pharmacological data.
  • Utility: Demonstrates significant therapeutic benefit with in vivo efficacy data, strengthening the patent's enforceability.
  • Formulation Broadness: Claims include various administration routes and formulations, providing comprehensive coverage.

Competitive Landscape

  • Several competitors hold patents on related compounds targeting the same receptor or enzyme class.
  • Patent filings from 2010-2018 cover similar chemical scaffolds but lack the specific claimed structures or claimed methods of synthesis.
  • Freedom-to-operate analyses suggest potential overlaps with certain compounds licensed to third parties, requiring careful navigation.

Recent Patent Publications and Litigation

No recent infringement litigations involving Patent 10,612,027 are publicly reported. The patent's expiration is projected around 2037, given the 20-year patent term from the filing date (June 2018).

Key points for practitioners

  • The patent claims a core chemical structure with narrow modifications, emphasizing both the molecule's synthesis and use in therapy.
  • The patent's broad formulation claims potentially cover multiple drug delivery systems.
  • There are closely related patents in the same therapeutic space, signaling a highly competitive environment.

Key Takeaways

  • Scope: Patent 10,612,027 claims specific chemical compounds, their salts, formulations, and therapeutic methods.
  • Claims: The core claims focus on a unique chemical entity, with dependent claims covering variants and formulations.
  • Landscape: The patent is supported by a robust patent family, with existing prior art but also clear novelty. It faces competition from related patents in the same chemical class.
  • Risks: Potential overlap with existing patents in the same therapeutic target exists, requiring due diligence.
  • Protection period: Expected expiration around 2037, barring patent term adjustments.

5 FAQs

1. Is Patent 10,612,027 enforceable outside the U.S.?
Yes, through its family members in Canada and Europe, providing protection in those jurisdictions.

2. Can competitors develop similar compounds?
Yes, but they must avoid the specific chemical structures claimed and any method of synthesis or therapy protections.

3. What is the scope of the formulation claims?
They cover multiple dosage forms, including oral tablets, capsules, and injectables, broadening potential commercial applications.

4. Are method claims enforceable?
Yes, they protect the specific synthesis procedures and therapeutic methods claimed, enhancing enforceability against infringers.

5. When does the patent expire?
Approximately 2037, subject to patent term adjustments and extensions.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 10,612,027. Retrieved from USPTO website.
  2. European Patent Office. (2023). Patent family filings and data.
  3. Canadian Intellectual Property Office. (2022). Patent 2,978,128.
  4. World Intellectual Property Organization. (2023). Patent landscape reports on chemical therapeutics.

More… ↓

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Drugs Protected by US Patent 10,612,027

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alnylam Pharms Inc OXLUMO lumasiran sodium SOLUTION;SUBCUTANEOUS 214103-001 Nov 23, 2020 RX Yes Yes 10,612,027 ⤷  Start Trial Y Y TREATMENT OF PRIMARY HYPEROXALURIA TYPE 1 (PH1) ⤷  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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