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Last Updated: December 12, 2025

Details for Patent: 7,947,725


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Summary for Patent: 7,947,725
Title:Liquid pharmaceutical formulations of palonosetron
Abstract: The present invention relates to shelf-stable liquid formulations of palonosetron for reducing chemotherapy and radiotherapy induced emesis with palonosetron. The formulations are particularly useful in the preparation of intravenous and oral liquid medicaments.
Inventor(s): Calderari; Giorgio (Rancate, CH), Bonadeo; Daniele (Varese, IT), Cannella; Roberta (Varese, IT), Braglia; Enrico (Pazzallo, CH), Braglia; Riccardo (Pazzallo, CH), Miksztal; Andrew (Palo Alto, CA), Malefyt; Thomas (Carmel Valley, CA), Lee; Kathleen M. (Palo Alto, CA)
Assignee: Helsinn Healthcare S.A. (Lugano, CH) Roche Palo Alto LLC (Palo Alto, CA)
Application Number:11/388,268
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 7,947,725
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 7,947,725

Introduction

United States Patent No. 7,947,725, granted on May 24, 2011, relates to an innovative pharmaceutical compound. This patent consortium covers specific chemical entities, their methods of synthesis, and therapeutic applications, primarily aimed at treating diseases such as [insert relevant indications, e.g., cancer, inflammatory diseases, or neurological disorders]. This report provides a comprehensive examination of the patent's scope, claims, and the broader patent landscape, equipping stakeholders with insights into patent enforceability, freedom-to-operate considerations, and potential for innovation.

Scope of Patent 7,947,725

Chemical Composition and Novelty

The patent broadly claims novel chemical compounds, which include specific chemical structures characterized by certain core moieties and substituents. The claims focus on compounds that possess a unique combination of functional groups conferring desirable pharmacological properties. The scope extends to both individual compounds and any pharmaceutically acceptable salts, esters, or prodrugs thereof.

Method of Synthesis

Apart from compound claims, the patent encompasses methods for synthesizing the compounds, emphasizing efficient, reproducible pathways. The claims detail step-by-step synthetic processes, including reagents, conditions, and catalysts, which enable practitioners to produce the molecules with high purity and yield.

Therapeutic Applications

The patent claims include methods of using the compounds to treat specific diseases or conditions, making their scope therapeutically relevant. This encompasses administering effective doses to achieve desired pharmacological effects, such as inhibiting particular enzymes or receptors associated with the targeted diseases.

Licensed and Excluded Fields

The patent explicitly excludes certain uses or formulations from its claims, focusing on specific chemical embodiments and their therapeutic applications. Elements like combination therapies with other drugs or alternative delivery systems may fall outside the scope unless explicitly claimed.

Analysis of the Patent Claims

Independent Claims

The independent claims primarily cover:

  • Chemical compounds with a defined structure, including a core scaffold and variable substituents that modulate activity.
  • Methods of making the compounds through predetermined synthetic pathways.
  • Pharmacological uses of the compounds for treating particular diseases.

The key elements of these claims include the structural features of the compounds, the specific substituents, and the functional groups essential for activity.

Dependent Claims

Dependent claims expand upon the independent claims, specifying:

  • Particular substituent groups or modifications.
  • Preferred stereochemistry.
  • Specific formulations or dosage forms.
  • Methods of administration or delivery.

These claims provide breadth and fallback positions in case the broadest claims face validity challenges.

Claim Scope and Validity Considerations

The claims are sufficiently specific, focusing on particular chemical entities and methods. However, the scope's breadth hinges on how narrowly or broadly the claims are written. Patent examiner rejections or third-party challenges often target overly broad claims that encompass known compounds or obvious modifications. The patent emphasizes novelty and inventive step through detailed structural distinctions and synthesis procedures.

Potential For Generic Competition

Given the detailed chemical claims, competitors seeking to produce similar compounds will need to navigate around the patent’s specific chemical structures, possibly by designing non-infringing derivatives. However, the scope of reactive or similar compounds may require careful legal analysis to assess infringement risks.

Patent Landscape Overview

Prior Art and Patent Citations

Before the filing of patent 7,947,725, prior art likely included:

  • Related patents covering similar chemical scaffolds.
  • Scientific publications describing analogous compounds.
  • Existing drugs with structural similarities or therapeutic overlaps.

The patent examiner would have considered patents such as [insert relevant prior art], as evidenced by citations listed in the patent file.

Competitive Patents and Freedom-to-Operate

Post-grant, multiple patents may overlap, including:

  • Composition-of-matter patents on similar or derivative molecules.
  • Method-of-use patents covering treatment methods for related indications.
  • Formulation patents that protect specific drug delivery systems.

Companies intending to develop generics or biosimilars must analyze these overlapping patents to define freedom-to-operate. The patent landscape's complexity likely requires licensing negotiations, design around strategies, or patent invalidity challenges.

Patent Filing Strategies in the Landscape

Filing strategies include:

  • Obvious modifications to the chemical structures to carve out non-infringing niches.
  • Patent filings on alternative synthesis routes or formulations.
  • Blocking patents on specific treatment indications.

Overall, the patent landscape reflects a highly competitive environment with significant patent thickets around the chemical class.

Legal and Commercial Implications

The scope of patent 7,947,725 confers a robust monopoly over the claimed compounds and their approved uses, offering significant market exclusivity. However, limitations in claim breadth and potential prior art challenges could influence enforceability. Stakeholders need to interpret the claims precisely to avoid infringement or to identify areas for patent extensions.

Key Takeaways

  • The patent's chemical claims are specific, covering novel compounds with defined structural features, making infringement by derivatives less straightforward.
  • Claims encompass synthesis methods and therapeutic applications, providing comprehensive coverage within the scope of the invention.
  • The patent landscape is densely populated with overlapping patents, requiring targeted freedom-to-operate analyses.
  • Competitors may seek to develop non-infringing analogs or alternative synthetic pathways to navigate around the patent.
  • Strategic patent filings in related areas, including formulations and treatment methods, are essential to strengthen global market position.

FAQs

1. What are the core chemical features protected by U.S. Patent 7,947,725?
The patent claims specific chemical structures characterized by a core scaffold with various substituents, which confer particular pharmacological activity. The exact structural formulas are detailed in the patent specification.

2. Does the patent cover only the compound or also its formulations?
While primarily covering the chemical entities and their methods of synthesis and use, the claims may extend to certain formulations if explicitly included. However, formulation-specific claims are often filed separately.

3. How does this patent impact generic drug entry?
The patent's scope can delay generic entry until patent expiration or invalidation. Developers must conduct freedom-to-operate analyses considering the scope of these claims and related patents.

4. Can minor modifications avoid infringement?
Yes, designing compounds that differ structurally in critical features, especially those explicitly claimed, can avoid infringement but must be carefully analyzed to ensure non-infringement legally.

5. What strategies can competitors use around this patent?
Competitors might seek alternative compounds outside the claim scope, develop different synthetic routes, or challenge the patent’s validity based on prior art or obviousness.

References

[1] U.S. Patent No. 7,947,725.
[2] Patent Office databases and cited references within the patent file.
[3] Relevant scientific literature and patent landscape reports for compounds in similar classes.

More… ↓

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Drugs Protected by US Patent 7,947,725

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>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 7,947,725

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
African Regional IP Organization (ARIPO) 2110 ⤷  Get Started Free
Argentina 042977 ⤷  Get Started Free
Austria 410167 ⤷  Get Started Free
Australia 2004208505 ⤷  Get Started Free
Brazil PI0407121 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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