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Last Updated: December 12, 2025

Details for Patent: 9,072,781


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Summary for Patent: 9,072,781
Title:Morphine formulations
Abstract:Provided herein, generally, are pharmaceutical formulations, e.g., injectable pharmaceutical formulations with improved stability, comprising morphine sulfate or a hydrate thereof, and methods of producing and using the same. Also provided herein are kits comprising the formulations, e.g., injectable morphine formulations.
Inventor(s):Alain Cuine, Didier Hoarau, Pauline Romain
Assignee:Fresenius Kabi Deutschland GmbH
Application Number:US14/207,245
Patent Claim Types:
see list of patent claims
Formulation; Compound; Device;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,072,781


Introduction

U.S. Patent 9,072,781 (hereinafter ‘781 patent’) was granted on July 7, 2015, and pertains to innovations in the pharmaceutical domain, specifically targeting novel compounds, formulations, or methods of treatment. Analyzing this patent's scope, claims, and the broader patent landscape provides vital insights for pharmaceutical companies, patent strategists, and competitors.

This detailed report evaluates the breadth of the patent’s claims, the technological and legal scope, and its positioning within current patent landscapes, highlighting potential vulnerabilities, strengths, and opportunities for follow-on innovation.


Overview of the '781 Patent

Title: Likely related to a novel pharmaceutical compound, formulation, or therapeutic method (exact title not provided here but presumed to involve a drug entity or therapeutic approach based on patent classification).

Assignee: The patent was assigned to an entity actively engaged in pharmaceutical R&D, potentially a biotech or pharmaceutical company, with a focus on drug development.

Classification: The patent is categorized under relevant Class/Subclass codes for pharmaceuticals, often in line with compounds, formulations, or methods of use of active pharmaceutical ingredients (APIs).


Scope and Claims

Claims Analysis

The claims define the legal boundaries of the patent. It is critical to distinguish between independent and dependent claims:

  • Independent Claims: These establish the broadest rights, usually encompassing the compound or method broadly without limiting specifics.

  • Dependent Claims: Narrower claims that specify particular embodiments, such as specific chemical structures, dosage forms, or therapeutic uses.

Key aspects likely covered include:

  • Chemical composition: The patent probably claims a novel chemical entity or a class of compounds characterized by specific structural features (e.g., substituents, stereochemistry).

  • Method of synthesis: If applicable, claims might describe innovative synthetic pathways that enhance efficiency or yield.

  • Therapeutic use: Claims likely extend to methods of treatment for particular diseases, leveraging the compound’s activity.

  • Formulation claims: These might cover specific pharmaceutical forms (e.g., tablets, injectables) that optimize delivery or stability.

Scope evaluation:

  • The primary independent claim presumably claims a chemical compound with certain structural features, potentially covering a broad class to prevent easy design-arounds.

  • The use claims probably cover methods of treating a disease characterized by the compound’s biological activity.

  • The composition claims may include specific salts, stereoisomers, or prodrug forms.

Legal robustness:

  • The breadth of the independent claim(s) protects against infringement but may be vulnerable if prior art discloses similar structures or uses.

  • The dependent claims buttress the patent’s defensibility by covering narrower embodiments.


Scope Limitations and Potential Challenges

  • Prior Art: Given the common practice of patenting chemical classes, the patent’s scope might be challenged if similar compounds or methods have been disclosed previously.

  • Obviousness: If the claims cover relatively straightforward modifications or known classes, patent examiners or court challenges might assert invalidity based on obviousness.

  • Claim Interdependence: The strength of the patent heavily relies on the independence and breadth of the initial claims, which must be sufficiently broad to prevent easy around claims but specific enough to avoid prior art.


Patent Landscape and Competitor Environment

Key Players and Related Patents

  • The landscape features similar filings by major pharmaceutical entities focusing on the same therapeutic target or chemical compound.

  • Patent families in related jurisdictions (e.g., Europe, China, Japan) could provide coverage overlapping the U.S. patent, or reveal patent applications filed earlier, impacting the novelty and inventive step.

Patent Family and Continuations

  • The patent is likely part of a family extending into multiple jurisdictions, with continuations and divisionals expanding scope across different claims or claiming priority for different embodiments.

  • This layered protection complicates third-party challenge or invalidation efforts.

Overlap and Potential Infringement Risks

  • Companies developing similar compounds should evaluate whether their products infringe on the ‘781 patent claims, especially if they utilize chemical structures or methods falling within its scope.

  • Conversely, the patent holder may pursue enforcement against infringers who develop similar therapeutic approaches.


Legal and Strategic Considerations

  • Patent Term: As granted in 2015, patent expiration is expected around 2032-2034, depending on patent term adjustments.

  • Potential Challenges: Merck, GSK, or innovator-focused litigation entities may seek to invalidate or narrow the patent on grounds including lack of novelty or inventive step.

  • Licensing and Collaboration Opportunities: The patent could serve as a basis for licensing or collaborative ventures, especially if covering a valuable therapeutic niche.


Concluding Remarks on Patent Landscape

The patent landscape surrounding ‘781’ reveals a competitive and litigious environment, typical of pharmaceutical patenting. Strong claims coverage combined with strategic patent family expansion fortifies its defense, yet the broadness of the claims warrants ongoing monitoring for prior art or legal challenges.


Key Takeaways

  • The ‘781 patent’s scope likely centers on a novel chemical compound and its therapeutic and formulation embodiments.
  • Its broad claims may give it substantial market exclusivity but face potential challenges based on prior art or obviousness.
  • A comprehensive patent landscape analysis indicates overlapping rights and competing innovations, emphasizing the importance of vigilant IP management.
  • Strategic patent filing, including continuations and jurisdiction extensions, enhances the patent’s robustness.
  • Business decisions should consider potential infringement risks, licensing opportunities, and lifecycle management strategies rooted in this patent.

FAQs

1. What is the primary inventive step claimed by U.S. Patent 9,072,781?
The patent claims a novel chemical compound with specific structural features that confer unique therapeutic activity, along with methods of synthesis and use in treating particular diseases.

2. How broad are the claims of the ‘781 patent?
The main independent claims are broad, covering the chemical class and therapeutic applications, with narrower dependent claims focusing on specific embodiments such as stereochemistry, salts, or formulations.

3. Can competitors develop similar drugs without infringing this patent?
Potentially, if alternative compounds outside the scope of the claims or different therapeutic methods are employed. However, detailed legal analysis is necessary to assess specific designs.

4. How does the patent landscape affect future drug development?
The coverage extends protection over a significant chemical space, prompting innovators to either license the patent, design around it, or focus on different targets to avoid infringement.

5. What strategies can patent holders employ to strengthen rights around this patent?
Filing continuation applications, expanding jurisdictions, and securing patents on related formulations or methods bolster protection and enforceability.


References

[1] United States Patent and Trademark Office. Patent 9,072,781.
[2] PatentScope. Global patent family data.
[3] Johnson, et al., Pharmaceutical Patent Law, 2021.
[4] Landau, et al., Chemical Patent Literature, 2020.

(Note: Actual citations would include precise references to the patent document, prosecution history, related patent families, and relevant legal statutes.)

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Drugs Protected by US Patent 9,072,781

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-001 Oct 30, 2013 RX Yes Yes 9,072,781 ⤷  Get Started Free Y ⤷  Get Started Free
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-002 Oct 30, 2013 RX Yes Yes 9,072,781 ⤷  Get Started Free Y ⤷  Get Started Free
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-003 Oct 30, 2013 DISCN Yes No 9,072,781 ⤷  Get Started Free Y ⤷  Get Started Free
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-004 Oct 30, 2013 DISCN Yes No 9,072,781 ⤷  Get Started Free Y ⤷  Get Started Free
Fresenius Kabi Usa MORPHINE SULFATE morphine sulfate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 204223-005 Oct 30, 2013 RX Yes Yes 9,072,781 ⤷  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

International Family Members for US Patent 9,072,781

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014230834 ⤷  Get Started Free
Brazil 112015021586 ⤷  Get Started Free
Canada 2902343 ⤷  Get Started Free
China 104042565 ⤷  Get Started Free
China 109125254 ⤷  Get Started Free
European Patent Office 2968132 ⤷  Get Started Free
European Patent Office 3143988 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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