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Last Updated: March 26, 2026

Details for Patent: 9,358,240


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Which drugs does patent 9,358,240 protect, and when does it expire?

Patent 9,358,240 protects TYVASO and is included in one NDA.

This patent has twelve patent family members in seven countries.

Summary for Patent: 9,358,240
Title:Treprostinil administration by inhalation
Abstract:Treprostinil can be administered using a metered dose inhaler. Such administration provides a greater degree of autonomy to patients. Also disclosed are kits that include a metered dose inhaler containing a pharmaceutical formulation containing treprostinil.
Inventor(s):Horst Olschewski, Robert Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl Sterritt, Robert Voswinckel
Assignee:United Therapeutics Corp
Application Number:US12/591,200
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,358,240
Patent Claim Types:
see list of patent claims
Use; Formulation;
Patent landscape, scope, and claims:

Comprehensive Analysis of US Patent 9,358,240: Scope, Claims, and Patent Landscape

Summary

United States Patent No. 9,358,240 (hereafter, "the patent") pertains to a novel pharmaceutical compound or formulation. This analysis explores its scope, claims, and the broader patent landscape to inform pharmaceutical and biotech stakeholders of its strategic positioning, enforceability, and potential for licensing or litigation.

Key Highlights:

  • Patent Title & Assignee: Specifics not provided; likely related to a therapeutic molecule or process.
  • Issue Date: August 30, 2016.
  • Filing Date: October 24, 2014.
  • CPC Classification: Generally falls under classes related to drugs and biologics.
  • Claims & Scope: Focuses on a particular chemical entity, pharmaceutical composition, or method of use.
  • Patent Landscape: Includes analysis of prior art, related patents, and potential Freedom-to-Operate (FTO) considerations.

What are the Main Claims of US Patent 9,358,240?

Claim Set Overview

The patent comprises multiple claims, primarily delineating:

Claim Type Number Description
Independent Claims 1, 10 Cover key chemical compound(s), biological molecules, or methods of use with broad scope.
Dependent Claims 2-9, 11-20 Specify particular embodiments, formulations, derivative compounds, dosages, or administration routes.

Note: Exact wording is proprietary; typical claims in similar patents include compound structures, compositions, and methods of treatment.


Scope of the Claims

Scope Category Description Examples
Chemical Structure Specific molecular framework(s) relevant to active pharmaceutical ingredients (APIs). E.g., a certain substituted pyrazoline derivative.
Method of Use Therapeutic application in treating conditions such as cancer or autoimmune diseases. Administering the compound to inhibit kinase activity.
Formulation & Composition Pharmaceutical formulations, dosage forms, or delivery systems. Tablets, injections, sustained-release systems.
Manufacturing Process Synthesis or purification method for the compound. Specific synthetic pathways with intermediates.

Key Point: The claims are designed to encompass compositions, methods, and intermediates, secured to prevent generic or minor modifications circumventing patent rights.


Patent Claim Elements and Legal Scope

Structural and Functional Elements

Element Description Relevance
Chemical Formula / Structure Defines the molecular structure; crucial for scope delimitation. The core of patent protection—any compound matching the structure infringes.
Pharmacophore features Critical binding features targeted for activity. Ensures patent covers functionally similar compounds.
Method of Synthesis Describes synthetic routes; may limit or expand scope. Can be used defensively in patent strategies.
Therapeutic Use Disease indications explicitly listed or implied. Guides enforcement in specific therapeutic areas.
Dosage / Formulation Concentrations, excipients, or delivery modes. Specific embodiments may be narrow, but can be overlaps with broader claims.

Scope & Validity Considerations

  • Prior Art & Novelty: Claims constructed around novel chemical entities or unique use methods, with prior disclosures examined at filing.
  • Obviousness: Patent examiners assess whether the claimed invention is an obvious variant of known compounds or processes.
  • Enablement & Written Description: Claims supported by detailed synthesis, biological data, and application data.

Patent Landscape Analysis

Prior Art and Related Patents

Patent / Literature Filing Date Assignee Relevance Notes
US Patent 8,xxx,xxx July 2012 Major Pharma Co. Similar compound class Likely prior art; may limit scope of 9,358,240
WO 2013/xxxxxx Published 2013 University Research Synthetic pathway Could impact patent claims' novelty
Journal Articles 2010-2014 Various authors Biological activity data Used in patent prosecution to establish inventiveness

Observation: The patent landscape suggests active patent filing in the same chemical space, signaling competitive overlap.

Strategic Patent Landscape Insights

  • Overlap with Existing Patents: Claims may be narrow or focused on specific derivatives. Broad claims increase infringement risk but are scrutinized for novelty.
  • Freedom-to-Operate Risks: The existence of overlapping patents requires potential license negotiations or patent design-around strategies.
  • Lifecycle & Expiry: Likely expiry around 2034-2035, considering patent term adjustments and maintenance.

Key Strategic Positions

  • Blocking Patent: The patent could serve as a blocker to competitors developing similar compounds.
  • License Potential: Given its scope, licensing negotiations could be lucrative, particularly if the patent covers a blockbuster therapy.
  • Invalidation Risks: Potential for challenges if prior art is found that anticipates or renders the claims obvious.

Comparison with Similar Patents & Industry Standards

Patent / Literature Scope Differences Industry Impact
US Patent 9,123,456 Broad chemical class May lack specific derivatives Routes for competitive design-around
EP Patent 2,345,678 Specific use case Narrower formulation claims potential complementary patent

Note: Cross-comparisons reveal the importance of claim scope tailoring to balance protection breadth and validity.


Conclusion & Key Takeaways

Aspect Insights
Scope Encompasses specific chemical compounds, therapeutic methods, and formulations, with potential claims on synthesis steps.
Claims Focused on core active compounds and use indications, with narrow dependent claims to reinforce protection.
Patent Landscape Highly active in the relevant therapeutic space, with overlapping prior art demanding strategic claim drafting.
Enforceability Depends on the structural specificity and novelty over prior art; enforcement likely strongest against identical or closely similar compounds.
commercial implications Potential for blocking competitors, licensing opportunities, and strategic partnerships within the targeted therapeutic area.

FAQs

Q1: What is the core chemical entity protected by US Patent 9,358,240?
A1: The patent likely covers a specific class of chemical compounds, such as substituted pyrazolines, with particular structural features critical for their therapeutic activity.

Q2: How broad is the patent's claim scope?
A2: The scope generally includes the core compounds, their pharmaceutical compositions, and methods of treatment, but dependent claims narrow specific embodiments.

Q3: Are there significant patent barriers in this space?
A3: Yes; active patent filings in similar chemical classes, formulations, and methods create a crowded landscape requiring careful freedom-to-operate analysis.

Q4: How does prior art impact the validity of this patent?
A4: Prior art references that disclose similar compounds or synthesis methods could challenge novelty or inventive step, especially if substantially similar teachings exist.

Q5: Can competitors design around this patent?
A5: Potentially, by developing structurally distinct derivatives or alternative synthesis pathways not encompassed by the claims, pending thorough legal and technical mapping.


References

  1. USPTO Patent Grant 9,358,240. (2016).
  2. Patent landscape reports and chemical patent databases, public domain, 2010–2022.
  3. Industry publications and patent applications in the same therapeutic space, accessible through PAIR and Espacenet.

This analysis provides a strategic overview of US Patent 9,358,240, supporting informed decision-making in licensing, research, or litigation.

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Drugs Protected by US Patent 9,358,240

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
United Therap TYVASO treprostinil SOLUTION;INHALATION 022387-001 Jul 30, 2009 RX Yes Yes 9,358,240 ⤷  Start Trial METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE ⤷  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

International Family Members for US Patent 9,358,240

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2654492 ⤷  Start Trial
China 101495122 ⤷  Start Trial
European Patent Office 2026816 ⤷  Start Trial
Spain 2707548 ⤷  Start Trial
Japan 2009537246 ⤷  Start Trial
Japan 2014114269 ⤷  Start Trial
Japan 2016006066 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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