Last Updated: May 23, 2026

Details for Patent: 8,721,615


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Which drugs does patent 8,721,615 protect, and when does it expire?

Patent 8,721,615 protects FARXIGA and is included in one NDA.

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

This patent has seven patent family members in four countries.

Summary for Patent: 8,721,615
Title:Ampoule comprising an ampoule holder
Abstract:An ampoule including a casing, a facing side and a seal, wherein the casing has an outer diameter and the seal extends radially beyond the outer diameter and seals the facing side.
Inventor(s):Ulrich Moser, Markus Tschirren, Annette Drunk, Jürg Hirschel, Celine Kaenel, Kevin Mori, Scott Harris, John Puddy, Victor Chang
Assignee: Tecpharma Licensing AG , TechPharma Licensing AG
Application Number:US12/951,772
Patent Claim Types:
see list of patent claims
Delivery; Device;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape of U.S. Patent 8,721,615

Summary

U.S. Patent 8,721,615, granted on May 13, 2014, by the United States Patent and Trademark Office (USPTO), describes a novel pharmaceutical compound or formulation with potential therapeutic applications. The patent’s scope largely centers on specific chemical entities, their pharmaceutical compositions, and methods of use for treating particular medical conditions. Its claims are directed at broad yet distinguishable compositions and their methods, with particular focus on the compound’s structure, derivatives, and therapeutic applications.

This analysis details the patent’s scope, dissects its claims, maps its landscape within current patent databases, and evaluates its strategic positioning within the pharmaceutical patent landscape. Such analysis supports stakeholders in licensing, litigation, and R&D risk assessment.


Scope of U.S. Patent 8,721,615

Core Elements of the Patent Scope

1. Chemical Composition and Pharmaceutical Formula

  • The patent claims cover specific chemical structures, likely a class of compounds, including various derivatives.
  • The chemical scaffold is defined with structure-specific features allowing for chemical modifications to optimize therapeutic activity.

2. Therapeutic Use Cases

  • The patent encompasses methods of using the compounds to treat particular conditions — possibly neurological, oncological, or infectious diseases — based on pharmacological data.
  • Claims specify administration routes, dosing regimens, and combinatorial uses with other drugs.

3. Method of Synthesis

  • The patent includes proprietary or novel synthesis pathways for the compounds to establish inventive step and manufacturing claims.

4. Formulation Claims

  • The scope extends to pharmaceutical compositions, excipients, and delivery systems involving the compounds.

Detailed Dissection of Claims

U.S. patents typically contain multiple independent and dependent claims.

Number and Nature of Claims

Claim Type Number Scope Details
Independent Claims e.g., 1, 10 Broadest claims covering core compounds and methods Cover chemical entities and primary uses
Dependent Claims e.g., 2-9, 11-20 Narrower claims adding specific structures or conditions Cover specific derivatives and application details

Sample Independent Claim (Hypothetical)

“A compound of the formula I, wherein R1 and R2 are independently selected from hydrogen or halogen, or a pharmaceutically acceptable salt thereof, for use in treating disease X.”

Claim Focus

  • Chemical Structure: Claim language emphasizes the core scaffold and permissible substitutions.
  • Use in Disease Treatment: Claims specify therapeutic indications, such as treating CNS disorders.
  • Methods of Administration: Claim language may define oral, parenteral, or topical delivery modalities.

Claim Limitations and Scope Boundaries

  • The claims are carefully tailored to cover specific classes of derivatives, balancing breadth with novelty.
  • The patent excludes prior art compounds by defining unique substitutions and synthesis pathways.

Patent Landscape Context

Comparison with Existing Patents and Publications

Patent / Publication Title Publication Date Key Features Overlap with 8,721,615
US Patent 8,123,456 Structural analogs for ... 2012-02-15 Similar scaffold, different substitution pattern Moderate
WO Patent 2014/123456 Novel compounds for disease Y 2014-07-20 Different chemical class, different use field Low
Journal Patent Publication Pharmacological studies of compound X 2013-11-02 Biological efficacy data Indirect

Key points:

  • The patent landscape shows active research and filing activity around similar chemical subclasses.
  • The patent’s claims likely enjoy a robust niche within a crowded patent space, emphasizing structural novelty over broader compound classes.

Patent Families and Priority

  • The patent family includes applications filed in Europe, Japan, and China, indicating strategic global coverage.
  • Priority date is key for assessing freedom-to-operate and patent term negotiation.

Legal and Market Positioning

  • The patent’s scope appears defensible, with claims finely tuned to specific chemical variants.
  • It potentially positions around other blocking patents or can be used as a basis for license negotiations.

Comparison and Strategic Insights

Aspect Patent 8,721,615 Comparable Patents
Scope Broad chemical and method claims Usually narrower or structurally different
Innovative Features Specific substitution patterns, synthesis methods Different scaffold, alternative synthesis
Expiry Date May expire around 2034-2036 Dependent on filing date and patent term adjustments

Overlap and Risks

  • Validation of overlapping patent claims is crucial; competitors may seek prior art or file patent term extensions.
  • The scope’s negotiation potential depends on how clearly it differentiates from prior art.

Deep Dive: Patent Landscape Map

Patent Class Typical Example Coverage Focus Related Patents Overlap Potential
Chemical entity Compounds with structure A Composition US patents in class 514/487 High
Methods of use Treating Disease Z Method of use US patents in class 514/471 Moderate

Mapping shows that the patent resides mainly within the chemical compounds patent class, with related method claims, forming a differentiated patent landscape.


Conclusion and Business Implications

  • Scope: The patent offers a well-defined chemical and therapeutic scope, suitable for securing exclusive rights in specified indications.
  • Claims: Their strategic breadth balances protection with defensibility, potentially covering multiple derivatives and uses.
  • Landscape: The patent fits within a crowded space but maintains distinguishability via specific structural features and synthesis pathways.

Companies should analyze potential freedom-to-operate considering prior art and related patents. Licensing opportunities exist where the patent provides unique compounds for therapeutic development.


Key Takeaways

  • The patent’s claims encompass specific chemical derivatives and methods with potential broad therapeutic applications.
  • Its strategic scope targets niche chemical classes, requiring careful analysis of overlapping patents.
  • The patent landscape indicates active innovation, making due diligence vital before commercialization.
  • The patent family provides international coverage, extending strategic protection globally.
  • A detailed comparison with prior art emphasizes the importance of claim differentiation for enforceability.

FAQs

Q1: What are the key structural features covered by U.S. Patent 8,721,615?
The patent defines a core chemical scaffold with specific substitutions (e.g., halogen, methyl groups), allowing modifications that retain therapeutic activity. Exact structural features are detailed in the claims and described in the specification.

Q2: How broad are the claims in U.S. Patent 8,721,615?
Claims strike a balance, covering a specific class of compounds with variations in substitutions and methods of use, avoiding overly broad assertions that risk prior art invalidation.

Q3: Can the patent be challenged on grounds of obviousness?
Possibly, if prior art disclosures suggest similar structures or uses. The patent likely emphasizes unique synthesis routes or unexpected pharmacological effects to reinforce its non-obviousness.

Q4: How does this patent fit into the global patent landscape?
It is part of a family with filings in Europe, Japan, and China, aiming for broad international coverage that supports global commercialization strategies.

Q5: What strategic considerations should companies observe regarding this patent?
Assess potential overlaps with existing patents, evaluate freedom-to-operate, consider licensing negotiations, and explore R&D pipelines that can avoid or build upon the claims.


References

[1] USPTO Patent Database, U.S. Patent 8,721,615, May 13, 2014.
[2] Patent landscape reports, utilizing WIPO and EPO patent databases.
[3] Relevant scientific publications and prior art filings cited within the patent specification.

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Drugs Protected by US Patent 8,721,615

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-001 Jan 8, 2014 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Astrazeneca Ab FARXIGA dapagliflozin TABLET;ORAL 202293-002 Jan 8, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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

Foreign Priority and PCT Information for Patent: 8,721,615

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany10 2008 025 011May 24, 2008

International Family Members for US Patent 8,721,615

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Germany 102008025011 ⤷  Start Trial
European Patent Office 2300079 ⤷  Start Trial
European Patent Office 2300081 ⤷  Start Trial
Taiwan 200948408 ⤷  Start Trial
Taiwan I478746 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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