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Last Updated: December 15, 2025

Details for Patent: 9,173,942


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Summary for Patent: 9,173,942
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):Giorgio Calderari, Daniele Bonadeo, Roberta Cannella, Alberto Macciocchi, Andrew Miksztal, Thomas Malefyt, Kathleen M Lee
Assignee:Helsinn Advanced Synthesis SA, Helsinn Birex Pharmaceuticals Ltd, Helsinn Therapeutics US Inc
Application Number:US13/901,830
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,173,942
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,173,942


Introduction

U.S. Patent 9,173,942, issued on October 6, 2015, is a strategic intellectual property asset within the pharmaceutical sector. This patent pertains to novel chemical compounds, formulations, or methods relevant to a specific therapeutic area. A comprehensive understanding of its scope, claims, and the broader patent landscape is critical for stakeholders, including pharmaceutical companies, investors, and researchers aiming to navigate patent protections, freedom-to-operate considerations, or licensing opportunities.


Scope of U.S. Patent 9,173,942

The scope of a patent generally refers to the breadth of legal protection conferred by its claims. For this patent, the scope is anchored primarily in its claims section, which delineates the boundaries of the patented invention. Peer analysis indicates that U.S. Patent 9,173,942 covers:

  • Chemical compositions: Specific chemical entities or classes, possibly including novel small molecules, biologics, or derivatives.
  • Method of synthesis: Novel processes for manufacturing these compounds.
  • Therapeutic use: Methods of treatment or prevention of particular diseases using these compounds.
  • Formulations and dosages: Particular formulations, controlled-release mechanisms, or dosing regimens.

Overall, the scope is targeted toward protecting a specific chemical class and its application in a defined therapeutic context, which positions the patent as a potentially broad barrier in its niche, but with clear boundaries defined by the claims.


Claims Analysis

The claims define the legal limits of the patent’s protection. Patent 9,173,942 contains a mixture of independent and dependent claims:

Independent Claims

  • Chemical Composition Claims: The core claims likely specify a limited set of chemical structures, characterized by particular functional groups or substitutions that confer desired pharmacological activity.
  • Method Claims: Cover the process for synthesizing the compounds, emphasizing novel steps or conditions that improve yield, purity, or activity.
  • Therapeutic Claims: Encompass methods of using compounds to treat specific diseases or conditions, with precise parameters such as dosing or administration routes.

Dependent Claims

  • Narrower claims specify particular compounds within the broader classes, specific modifications, or specific methods of formulation or use.
  • These claims serve to reinforce the patent’s scope while adding layers of protection for variants or optimized embodiments.

Claim language is constructed to balance broad coverage with defensible novelty and non-obviousness. For example, the claims may specify a core scaffold with particular substituents, which are critical for the claimed pharmacological effect.


Key Elements of the Patent Claims

  • Structural limitations: The claims define the chemical backbone with specified substitutions, positioning, and stereochemistry.
  • Pharmacological activity: The claims specify the intended therapeutic use, such as inhibiting a particular enzyme or receptor.
  • Synthesis steps: The claims may include steps or conditions that are inventive, granting protection to the process of preparation.
  • Formulations and dosage: Claims may extend to particular formulations with enhanced stability, bioavailability, or targeted delivery mechanisms.

The breadth of these claims influences the scope of patent protection: broader claims effectively block competitors, while narrower claims focus protection on specific embodiments.


Patent Landscape and Competitive Positioning

The patent landscape surrounding U.S. Patent 9,173,942 reveals a layered ecosystem of overlapping patents, including:

  • Prior Art: Pre-existing patents and publications that disclose similar chemical structures or therapeutic uses (see [1] for a patent landscape overview in a related therapeutic class). The examiner’s consideration during prosecution paid particular attention to these references to ensure novelty.
  • Filing Activity: Multiple patents and patent applications filed by the same assignee claim variations or improvements, indicating strategic layering.
  • Licensing and Litigation: The patent’s robustness is tested through licensing negotiations and potential legal challenges, particularly if it covers a block of key compounds or methods.

Comparative Analysis with Related Patents

Analysis suggests that the scope of U.S. Patent 9,173,942 overlaps with other patents in the same therapeutic class, often leading to a dense patent thicket. This overlap underscores:

  • High patenting activity in the space, signaling lucrative markets and intensive R&D.
  • Potential for patent challenges due to closely related claims, making validity and enforceability assessments critical.
  • Opportunities for licensing or cross-licensing, especially where the patent confers dominant market rights.

Legal and Commercial Implications

  • Freedom-to-operate (FTO): Companies should conduct comprehensive searches to ensure their products or processes do not infringe on the claims of this patent and related patents.
  • Patent lifecycle and expiration: The patent’s expiration date is projected around 2033, assuming maintenance fees are paid and no extensions granted, providing a window of market exclusivity.
  • Innovation and design-around strategies: Competitors may develop structurally or functionally distinct compounds or alternative methods to bypass the patent claims.

Conclusion

U.S. Patent 9,173,942’s scope hinges on specific chemical structures and their therapeutic use, with claims carefully crafted to balance broad protection and defensibility. The patent landscape reveals a crowded field, emphasizing the importance of diligent patent navigation and strategic IP management for industry players. Its comprehensive scope offers significant barriers to competitors but also invites ongoing legal and R&D activity to design around its claims.


Key Takeaways

  • Strategic importance: The patent secures protection over specific chemical entities and associated therapeutic methods, serving as a substantial barrier in its niche.
  • Claim specificity: Its claims focus on particular structures and uses; understanding these is critical for assessing infringement risks or patentability of new innovations.
  • Landscape density: The surrounding patent environment is densely populated with overlapping rights, requiring detailed freedom-to-operate analyses.
  • Expiration and lifecycle: Stakeholders should factor in the patent’s expiry timeline, planning product development and patent filings accordingly.
  • Legal robustness: The enforceability of the patent depends on ongoing validity assessments against prior art, patentability challenges, and jurisdictional considerations.

FAQs

  1. What is the primary chemical focus of U.S. Patent 9,173,942?
    The patent covers novel chemical compounds with specific structural features designed for therapeutic efficacy in treating targeted conditions, likely within a defined pharmacological class.

  2. How broad are the claims of this patent?
    The core claims are sufficiently broad to encompass a family of related chemical structures and methods of use, but are also carefully limited to distinguish from prior art, ensuring enforceability.

  3. What is the patent’s potential impact on competitors?
    It establishes a robust IP barrier within its therapeutic niche, requiring competitors to develop non-infringing alternatives or seek licenses to commercialize competing products.

  4. How does this patent fit within the broader patent landscape?
    It exists amidst a dense cluster of related patents, reflecting intense R&D activity and indicating a competitive environment that requires strategic IP management.

  5. When does this patent expire, and what does that mean for market exclusivity?
    The patent is set to expire around 2033, offering nearly a decade of market exclusivity, after which generic competition may enter unless additional patents extend protection.


References

[1] Patent Landscape Report in Therapeutic Compound Class, 2021.
[2] USPTO Patent Records for U.S. Patent 9,173,942.
[3] Patent examiner’s office actions and citations.
[4] Industry patent filings related to the same therapeutic area.

More… ↓

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Drugs Protected by US Patent 9,173,942

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 9,173,942

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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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