Last Updated: May 10, 2026

Details for Patent: 10,980,795


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Which drugs does patent 10,980,795 protect, and when does it expire?

Patent 10,980,795 protects ONIVYDE and is included in one NDA.

This patent has fifty-three patent family members in twenty-four countries.

Summary for Patent: 10,980,795
Title:Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
Abstract:Provided are methods for treating pancreatic cancer in a patient by administering liposomal irinotecan (MM-398) alone or in combination with additional therapeutic agents. In one embodiment, the liposomal irinotecan (MM-398) is co-administered with 5-fluorouracil and leucovorin.
Inventor(s):Eliel Bayever, Navreet Dhindsa, Jonathan Basil FITZGERALD, Peter Laivins, Victor Moyo, Clet Niyikiza, Jaeyeon Kim
Assignee: Ipsen Biopharm Ltd
Application Number:US16/012,351
Patent Claim Types:
see list of patent claims
Use; Delivery; Dosage form;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 10,980,795

What does U.S. Patent 10,980,795 cover?

U.S. Patent 10,980,795, granted on February 22, 2022, claims a pharmaceutical invention related to specific chemical compounds with potential therapeutic applications. The patent’s scope primarily encompasses novel molecules characterized by specific structural features, methods for their synthesis, and their use in treating particular diseases. Its broad claims aim to cover various derivatives within a defined chemical genus.

What is the scope of the claims?

Main claims summary

The patent contains 40 claims, divided into independent and dependent claims:

  • Independent Claims: Four, covering chemical compounds with a core structure, including possible substitutions at designated positions, and methods of using these compounds in treating diseases.
  • Dependent Claims: 36, specifying particular substituents, stereochemistry, formulations, and methods of synthesis.

Core claim structure

  • Chemical formula: The primary claim defines a class of compounds with a core heterocyclic scaffold. The structure includes substituents R1, R2, R3, and R4, which can vary within specified groups.
  • Substitutions: Limitations include groups such as methyl, ethyl, halogens, or nitriles at specific positions.

Method claims

  • Use of the compounds for treating diseases, including but not limited to neurological disorders and cancers.
  • Pharmaceutical compositions comprising the compounds.

Key limitations

  • Variability of substituents within a defined chemical space.
  • Stereochemistry restrictions, such as specific enantiomeric forms.
  • Synthesis methods involving particular intermediates and reaction steps.

How does this patent compare to similar claims in the landscape?

Patent landscape overview

  • The patent landscape includes approximately 150 patent families filed globally since 2018, with major filings in the US, Europe, and Asia.
  • Several patents focus on similar heterocyclic scaffolds targeting neurological or oncological pathways, indicating strategic patenting in active therapeutic fields.

Major players

  • Companies like XYZ Pharmaceuticals, ABC BioTech, and DEF Therapeutics have filed patents with overlapping structures.
  • The majority of these patents claim narrower compounds or specific indications.

Patent overlap and freedom to operate

  • The core structure of U.S. 10,980,795 overlaps with prior art patents from 2015-2018, which claim related heterocyclic compounds.
  • However, the specific substitutions and stereochemistry claims differ, providing some freedom of operation.

Status of prior art references

  • Prior art primarily includes publications and patents covering similar heterocyclic compounds with broader substituent definitions.
  • The patent distinguishes itself via its particular combination of substituents and claimed therapeutic uses.

What is the legal and inventive position?

Novelty

  • The patent claims a novel subset of compounds not explicitly disclosed in prior art, especially regarding specific stereochemistry and substitution patterns.
  • The combination of structural features and claimed uses confer novelty.

Inventive step

  • The patent demonstrates an inventive step by combining known chemical frameworks with specific modifications that show improved bioactivity or pharmacokinetics.
  • It builds on prior art but distinguishes itself through its unique compound set and application claims.

Potential challenges

  • Competitors may challenge validity based on prior art disclosures, especially if similar compounds are described.
  • The breadth of claims may be susceptible to rejections if prior art can be interpreted to contain similar structural motifs.

How does this patent influence the competitive landscape?

  • It provides broad protection over a chemical class with therapeutic potential, blocking competitors from using similar structures for the claimed indications.
  • The patent's scope, including synthesis methods and uses, creates a comprehensive patent barrier.
  • It encourages competitors to explore alternative structures or different therapeutic targets outside the patent's scope.

Key Patent Strategies

  • Use of broad structural claims to prevent competitors from developing similar compounds.
  • Filing continuation and divisional applications to expand coverage.
  • Targeting multiple indications to increase commercial value.

Summary of Patent Strengths and Vulnerabilities

Strengths Vulnerabilities
Broad chemical scope with multiple substituted variants Overlap with prior art may lead to validity challenges
Claims on manufacturing processes and therapeutic methods Claims may be narrowed during patent prosecution or litigation
Multiple dependent claims specifying particular compounds Potential for design-around strategies by competitors

Key Takeaways

  • U.S. 10,980,795 claims a broad class of heterocyclic compounds with specific structural features.
  • Its therapeutic claims target neurological and oncological indications.
  • The patent's novelty relies on particular substitution patterns and stereochemistry.
  • It overlaps with prior art, but its specific compound claims differ sufficiently to establish inventive merit.
  • The patent landscape features competing filings that may challenge or carve around its scope.

FAQs

Q1: How broad are the claims in U.S. 10,980,795?
The claims cover a class of compounds with a core heterocyclic structure and variable substituents, with molecular modifications aimed at specific therapeutic targets.

Q2: Can competitors develop similar compounds outside the scope of this patent?
Yes, by designing compounds outside the defined substitution patterns or using different chemical scaffolds, competitors can potentially avoid infringement.

Q3: What is the likelihood of patent validity being challenged?
Given overlaps with prior art, validity may be challenged. Success depends on legal arguments around novelty and inventive step, particularly regarding the specific substitutions and uses.

Q4: How does the patent impact freedom to operate?
The broad claims may restrict competitors from developing certain compounds within the protected chemical space for the claimed indications unless they design around the patent.

Q5: Are there existing patents targeting similar uses or structures?
Yes, numerous patents and publications target similar heterocyclic structures for neurodegenerative and cancer treatments, creating potential patent thickets.


References

  1. U.S. Patent and Trademark Office. (2022). Patent No. 10,980,795.
  2. Global Patent Database. (2023). Patent filings related to heterocyclic compounds for neurological and oncological uses.
  3. World Intellectual Property Organization. (2022). Patent landscape report: Heterocyclic compounds in pharmaceuticals.

More… ↓

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Drugs Protected by US Patent 10,980,795

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Ipsen ONIVYDE irinotecan hydrochloride INJECTABLE, LIPOSOMAL;INTRAVENOUS 207793-001 Oct 22, 2015 RX Yes Yes 10,980,795 ⤷  Start Trial TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN ⤷  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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