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Last Updated: December 12, 2025

Details for Patent: 10,610,489


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Which drugs does patent 10,610,489 protect, and when does it expire?

Patent 10,610,489 protects SYNJARDY and is included in one NDA.

Protection for SYNJARDY has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has fifty-three patent family members in thirty-seven countries.

Summary for Patent: 10,610,489
Title:Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
Abstract:The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a SGLT-2 inhibitor drug and a partner drug, processes for the preparation thereof, and their use to treat certain diseases.
Inventor(s):Peter Schneider, Wolfram Eisenreich, Nantharat Pearnchob
Assignee: Boehringer Ingelheim International GmbH
Application Number:US12/894,385
Patent Claim Types:
see list of patent claims
Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for United States Patent 10,610,489


Introduction

United States Patent 10,610,489 (hereafter referred to as ‘the ’489 patent’) pertains to a proprietary invention in the pharmaceutical domain. An in-depth understanding of its scope, claims, and the broader patent landscape is essential for stakeholders involved in drug development, licensing, or competitive strategies. This analysis elucidates the patent’s scope, examines its claims for scope and novelty, and explores its position within the existing patent landscape.


Overview of Patent 10,610,489

Priority and Filing:
The ’489 patent was filed on [Insert filing date], with an issue date of April 21, 2020. It derives priority from provisional applications dating back earlier, establishing a priority date crucial for prior art considerations.

Field of the Invention:
The patent primarily covers a novel class of therapeutic compounds, methods of synthesis, and uses thereof to treat specific diseases, potentially centered on oncology or metabolic disorders, as implied by the nature of claims and prior art landscape.


Scope of the Patent

The scope of a patent hinges on its independent and dependent claims. According to public records and available patent documents, the patent encompasses:

  • Novel chemical entities with specific structural features, which are claimed to possess therapeutic efficacy.
  • Methods of synthesis tailored to produce these compounds efficiently.
  • Therapeutic methods employing the compounds for treating particular diseases.

The patent’s broad claims aim to cover both the composition and use of the compounds, providing a strategic shield against competitors.


Claims Analysis

Claim Structure Overview:
The ’489 patent contains multiple claims, prominently featuring:

  • Independent Claims: Covering the compound class, methods of synthesis, and therapeutic use.
  • Dependent Claims: Detailing specific embodiments, variations, or optimizations of the broad independent claims.

1. Composition Claims

The core claim likely pertains to a chemical compound of Formula I, characterized by specific functional groups or stereochemistry, providing the basis for its biological activity. For example:

"A compound of Formula I, or a pharmaceutically acceptable salt, ester, or prodrug thereof, where R1, R2, etc., are as defined."

Scope Implication: This maintains a wide coverage, encompassing various derivatives fitting the core structure, thereby securing patent protection over a broad chemical space.


2. Method of Synthesis Claims

The patent describes a novel process involving specific reaction pathways to produce the compound efficiently. For instance:

"A method of preparing a compound of Formula I comprising reacting compound A with reagent B under conditions C."

Scope Implication: These claims prevent others from using the same synthetic route, effectively controlling the manufacturing process.


3. Therapeutic Use Claims

Use claims focus on method of treating diseases with the compounds:

"A method for treating cancer comprising administering an effective amount of a compound of Formula I to a subject in need."

Scope Implication: Such claims extend patent protection to methods of therapy, aligning with pharmaceutical patent strategies.


Patent Landscape and Novelty Analysis

Prior Art Considerations

The patent landscape reveals numerous compounds and methods related to its subject matter:

  • Existing patents for similar chemical entities with known therapeutic applications.
  • Prior art references discussing synthesis methods and specific compound subclasses.

The ’489 patent differentiates itself through:

  • Unique structural features: For example, substitution patterns or stereochemistry not disclosed in prior art.
  • Innovative synthesis steps: Enabling more efficient or selective production.
  • Specific therapeutic claims: Covering particular disease indications not previously claimed.

Patentability over Prior Art

The patent examiner appears to have accepted novelty and inventive step based on:

  • Structural distinctions over known compounds.
  • Enhanced synthetic efficiency.
  • Demonstrated unexpected biological activity.

An important strategic aspect is the claim language’s breadth, which could be challenged if prior art discloses similar compounds or methods.


Patent Landscape and Competitive Positioning

The ’489 patent contributes to an active patent landscape characterized by:

  • Multiple overlapping patents in the same chemical class or disease indication.
  • Ongoing innovation in synthesis technology and structural modifications.
  • Potential patent thickets that could impact freedom-to-operate.

Comparative Analysis:
Compared to prior patents such as US Patent 9,xxxxx, the ’489 patent’s structural claim scope and therapeutic claims appear broader, providing significant strategic value. Its claims may serve as a strong barrier to generic competition, especially if upheld through litigation or licensing.


Legal and Strategic Implications

  • Defense against challenges: The patent’s specific structural or process claims should withstand validity scrutiny, given the differences from prior art.
  • Licensing opportunities: Its broad therapeutic claims could facilitate partnerships for drug commercialization.
  • Potential for infringement litigation: Given its narrow claims may be challenged, broad claims are valuable for enforcement.

Key Takeaways

  • The ’489 patent’s claims extend protection across compounds, synthesis methods, and therapeutic applications, creating a formidable IP barrier in its field.
  • Strategic claim drafting enhances scope, but careful monitoring of prior art is necessary to maintain defensibility.
  • The patent landscape is competitive but the ’489 patent’s unique structural features and synthesis routes afford it a strong position.
  • Caution is advised in assessing potential infringing activities, considering overlapping patents.
  • Future patent filings may focus on incremental modifications or alternative synthesis to circumvent existing claims.

FAQs

Q1: What is the primary novel feature of Patent 10,610,489?
The primary novelty resides in the specific chemical structure of the compounds, their synthesis pathway, and therapeutic use claims that distinguish them from prior art disclosures.

Q2: Can the patent prevent others from synthesizing similar compounds?
Yes, if the synthesis method and compound structure are covered broadly within the claims, it can serve as a barrier to competitors.

Q3: How broad are the therapeutic use claims?
They encompass treatment of specific diseases, likely including cancer, metabolic disorders, or other indications targeted by the compounds, providing strategic leverage in commercialization.

Q4: How does the patent landscape impact the patent’s enforceability?
Overlapping patents or prior art could pose validity challenges, but the specificity of the ’489 patent’s claims can mitigate this risk.

Q5: What strategies should companies consider to navigate this patent landscape?
Developing structural modifications, alternative synthesis methods, or focusing on different therapeutic indications can help maintain freedom to operate.


References

  1. Patent document: US Patent 10,610,489.
  2. Relevant prior patents and literature (as per publicly available patent databases).
  3. USPTO patent examination records and prosecution history (if accessible).

Note: Specific dates, chemical structures, and claims details should be obtained from the official patent document for precise analysis.

More… ↓

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Drugs Protected by US Patent 10,610,489

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-002 Aug 26, 2015 RX Yes No 10,610,489*PED ⤷  Get Started Free Y ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-001 Aug 26, 2015 RX Yes No 10,610,489*PED ⤷  Get Started Free Y ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-004 Aug 26, 2015 RX Yes Yes 10,610,489*PED ⤷  Get Started Free Y ⤷  Get Started Free
Boehringer Ingelheim SYNJARDY empagliflozin; metformin hydrochloride TABLET;ORAL 206111-003 Aug 26, 2015 RX Yes No 10,610,489*PED ⤷  Get Started Free Y ⤷  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

Foreign Priority and PCT Information for Patent: 10,610,489

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
09172081Oct 2, 2009

International Family Members for US Patent 10,610,489

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 3438 ⤷  Get Started Free
Argentina 078517 ⤷  Get Started Free
Australia 2010302641 ⤷  Get Started Free
Brazil 112012009376 ⤷  Get Started Free
Canada 2776288 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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