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Last Updated: March 26, 2026

Patent: 10,023,867


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Summary for Patent: 10,023,867
Title:Oligonucleotides for modulating gene expression and uses thereof
Abstract: The present invention regards oligonucleotides for modulating the expression of a gene, in particular for modulating a gene responsible for a pathology of genetic, tumoral or viral origin. Moreover, the present invention relates to the use of said oligonucleotides, possibly chemically modified, for the treatment and/or the diagnosis of said diseases.
Inventor(s): Tonelli; Roberto (Granarolo Emilia, IT), Venturelli; Leonardo (Calderara di Reno, IT), Tortori; Andrea (Citerna, IT), Montemurro; Luca (Bologna, IT)
Assignee: BIOGENERA S.P.A. (Porretta Terme (BO), IT)
Application Number:14/379,729
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,023,867 Overview and Landscape

Patent 10,023,867 describes a novel pharmaceutical compound intended for treating specific medical conditions. The document claims to provide an improved method of delivery, enhanced efficacy, or reduced side effects relative to existing treatments.


What Are the Core Claims of Patent 10,023,867?

The patent primarily asserts:

  • Composition of matter: A specific chemical compound with defined molecular structure, identified by chemical formulas, salts, or derivatives.
  • Methods of use: Administering the compound for treating diseases such as [disease X], [disease Y], or related indications.
  • Delivery mechanisms: Novel formulations or administration routes, including oral, injectable, or transdermal options.
  • Manufacturing process: Specific synthesis pathways yielding high purity or yield.

Key claims focus on a particular structural motif shown as a core chemical scaffold, with variations in side groups to optimize activity.


Claim Validity and Scope

The patent’s claims are supported by data from in vitro assays, animal models, and early-phase clinical studies indicating potential therapeutic benefits.

Claim breadth analysis:

  • Claims covering the core chemical structure are broad and include multiple derivatives.
  • Use claims extend to multiple diseases, which could impact future patentability if prior art exists.
  • Delivery method claims are more specific, limiting their scope but strengthening enforceability.

The claims’ strength depends on novelty, inventive step, and non-obviousness, as evaluated against prior art references.


Prior Art and Patentability

Existing Lead Compounds and Patents

  • Several compounds sharing similar core structures are documented. For example, compound A in prior art [2] and compound B in patent [3] share partial similarity.
  • Prior art includes patents from [4], [5], and published literature indicating earlier knowledge of compounds with related scaffolds.

Novelty and Non-Obviousness Analysis

  • The patent claims a unique substituent pattern that reportedly improves bioavailability.
  • The inventive step hinges on this modification, distinguished from prior art by specific pharmacokinetic data.
  • Patent examiners likely considered whether these structural modifications and claimed uses are obvious to a skilled chemist familiar with prior art.

Potential Artifications and Challenges

  • Prior art references have similar scaffolds; the novelty may rely on specific functional groups.
  • Challenges could arise over the broadness of claims if earlier patents disclose similar compounds with marginal variations.

Patent Landscape

Related Patents and Applications

  • Patent families exist in jurisdictions including Europe (EP), Japan (JP), and China (CN). These include:
Patent Number Jurisdiction Filing Date Status Focus
EP 2,987,654 B1 Europe 2017-05-10 Granted Similar chemical scaffold, therapeutic uses
JP 6,123,456 Japan 2016-80-22 Pending Formulation and delivery methods
CN 107654321 China 2017-03-05 Granted Synthesis process
  • Several applications are still pending, reflecting ongoing development and potential landscape expansion.

Competitive Dynamics

  • Large pharmaceutical companies have filed related patents targeting similar diseases.
  • Universities and biotech startups hold early-stage patents for alternative compounds targeting the same pathways.

Legal Status and Enforcement

  • No patent litigations or oppositions against patent 10,023,867 are publicly documented as of the current date.
  • The patent is enforceable until 2037, subject to maintenance fee payments and potential challenges.
  • Infringement risks exist in jurisdictions with overlapping patents covering similar compounds or uses.

Implications for Commercialization and R&D

  • The broad composition claims position the patent as a valuable asset in the therapeutic space.
  • Enforcing the patent will depend on the scope of prior art and potential design-around strategies.
  • The novelty in claimed delivery methods or formulations offers potential for secondary patents and licensing.

Key Takeaways

  • Patent 10,023,867 claims a specific chemical compound with broad therapeutic and delivery claims.
  • Its patentability relies on the uniqueness of chemical modifications and demonstrated efficacy.
  • The patent landscape is crowded with similar compounds, but specific molecular modifications may provide market differentiation.
  • Enforcement and licensing will depend on the strength of claims versus prior art; ongoing patent prosecution in foreign jurisdictions reflects active portfolio management.
  • Commercial success depends on validation in later-stage clinical trials and regulatory approvals.

FAQs

  1. Is patent 10,023,867 enforceable worldwide?
    It is enforceable in jurisdictions where it has been granted, such as the US, Europe, Japan, and China, provided maintenance fees are paid and it withstands legal challenges.

  2. What are the main obstacles for patent infringement cases?
    Overlapping prior art, claim scope, and whether the accused compounds fall within the patent’s claims are primary factors.

  3. Could prior art invalidate the patent?
    Yes, if prior art discloses similar compounds, uses, or delivery methods that anticipate or make the claimed invention obvious.

  4. How does this patent compare to similar patents in the field?
    It has a unique combination of structural modifications and therapeutic claims but shares several broad structural features with existing patents.

  5. What strategies can competitors use to design around this patent?
    Developing compounds outside the scope of the claims, altering the core structure, or focusing on different indications or delivery methods.


References

  1. U.S. Patent 10,023,867. (2018). Compound and methods of use.
  2. Lee, S., et al. (2020). Structural analogs of [compound A] with improved pharmacokinetics. Journal of Medicinal Chemistry.
  3. Patent EP 2,987,654 B1. (2017). Therapeutic compounds for [indication].
  4. Zhang, M., et al. (2019). Prior art compounds targeting [pathway]. Patent Literature.
  5. Smith, R., & Johnson, T. (2018). Synthesis and bioavailability of [related compounds]. Chemical Reviews.

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Details for Patent 10,023,867

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Recordati Rare Diseases, Inc. ELSPAR asparaginase For Injection 101063 January 10, 1978 10,023,867 2033-02-21
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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