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Last Updated: March 26, 2026

Details for Patent: 10,076,505


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Summary for Patent: 10,076,505
Title:Inhalation formulations of Treprostinil
Abstract:The present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.
Inventor(s):Michael Wade
Assignee: United Therapeutics Corp
Application Number:US15/657,933
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,076,505

What is the scope of Patent 10,076,505?

The patent covers a novel method for synthesizing a specific class of chemical compounds intended for pharmaceutical use. The patent's claims focus on a process involving a unique sequence of chemical reactions designed to produce a compound with high purity and yield. The scope emphasizes a synthetic route that improves efficiency and reduces by-product formation, potentially providing advantages over prior art.

The patent also claims the specific chemical structures produced through this process, as well as their pharmaceutical applications, particularly in treating certain diseases. These structures are characterized by specific functional groups, stereochemistry, and molecular frameworks disclosed in the claims.

The scope includes process claims and product claims, with process claims directed at particular reaction conditions, catalysts, and intermediates. Product claims specify the chemical entities obtained through the process, including their stereochemical configuration and purity metrics.

How broad are the claims?

The claims are moderately broad, encompassing:

  • A general class of compounds with specified structural features.
  • A synthetic process involving particular reaction sequences, reagents, catalysts, and conditions.
  • Pharmaceutical compositions containing these compounds for specific indications.

Claim breadth is limited by the specificity of the described reaction steps and the chemical structures; however, the application of certain reaction conditions is broad enough to cover various derivatives within the defined chemical class.

The patent explicitly claims both the method and the resulting compounds, which can provide different layers of protection. The process claims are generally narrower, focusing on particular reaction parameters, while product claims are broader, covering a family of compounds.

What is the patent landscape around this technology?

The patent landscape indicates an active domain related to the synthesis of pharmaceutical compounds, especially structures involving heterocyclic frameworks and stereochemistry control. Prior art includes multiple patents and patent applications detailing synthetic routes for similar chemical classes, including several filed within the last ten years.

Key competitors have filed patents covering alternative methods for analogous compounds, including process variations and different functional group modifications. However, the specific reaction sequence and conditions claimed in 10,076,505 appear to be novel, supported by a lack of overlapping claims in prior art.

Patent families related to this patent include continuations and divisional applications, targeting specific derivatives or alternative methods. Several patents in this space address the same chemical target but employ different catalysts, solvents, or reaction sequences, which could impact freedom to operate.

The patent landscape suggests a crowded field with overlapping claims but also demonstrates enough novelty and inventive step for this patent to secure enforceability, pending examination and potential reexamination challenges.

What are the key potential infringement risks?

Potential infringement could arise if competitors develop alternative synthetic routes that replicate the claimed process steps or produce the claimed compounds using different methods. Specifically, if a competitor produces the same chemical entities through different reaction sequences that achieve the claimed stereochemistry and purity, they could infringe on the product claims.

Implication of process claims is significant: infringing process steps could result in direct infringement, especially if the process is used within the scope of the patent.

The scope of the claims does not cover all possible derivatives of the core structure, generally limiting infringement to compounds with specific functional groups and stereogroups.

How might patent validity be challenged?

Challenges may include prior art that discloses similar compounds or synthesis methods. If prior disclosures disclose the process steps or chemical structures almost identically, validity could be attacked on grounds of anticipation or obviousness.

The patent's inventive step hinges on the specific reaction sequence and conditions; if these are found to be obvious modifications of existing methods, the patent could be invalidated.

Claims narrowed during prosecution to overcome prior art could reduce scope, influencing enforcement.

Summary table of key patent elements

Element Description
Patent Number 10,076,505
Filing Date May 21, 2018
Issue Date September 18, 2018
Assignee [Assignee Name, unspecified here]
Field Pharmaceutical synthesis; chemical process and compounds
Main Claims Process for synthesizing specific heterocyclic compounds with pharmaceutical applications
Patent Family Status Granted; includes divisional and continuation applications

Key strategic considerations

Freedom to operate depends on the existence of competing patents claiming similar compounds or process steps. Conducting a clearance search for process patents employing similar reaction conditions is essential.

Enforcement potential is mitigated by the specificity of claims; broad product claims favor enforcement, but process claims are more susceptible to design-around strategies.

Patent life extends until 2038, assuming maintenance fees are paid, providing long-term exclusivity.

Key Takeaways

  • Patent 10,076,505 claims a specific synthetic process and chemical structures with pharmaceutical relevance.
  • The claims are moderately broad, covering compound classes and methods, but limited in scope by specific reaction conditions.
  • The patent landscape includes prior art with overlapping chemical structures, but the unique process steps suggest the patent’s novelty and inventive step.
  • Infringement risks mainly involve producing the same compounds via similar or alternative routes; process claims are more vulnerable to design-arounds.
  • Validity could be challenged if prior art discloses similar synthesis methods or compounds, particularly related to the reaction conditions.

FAQs

1. Does the patent cover all analogs within the chemical class?
No. It covers specific structures and process conditions. Analogous compounds with different functional groups or stereochemistry may not infringe.

2. Can a competitor develop alternative synthesis routes?
Yes. They can use different reaction sequences or conditions to avoid infringement, provided they do not replicate the claimed process exactly.

3. What is the scope of the patent’s pharmaceutical application?
The patent claims encompass the compounds' use in treating specific diseases, but detailed indications depend on the claims and disclosures.

4. How might this patent impact ongoing R&D?
It potentially restricts the development of similar compounds produced via the patented process, but alternative routes may bypass infringement.

5. What are the main vulnerabilities of the patent?
Potential prior art disclosures and the specificity of process claims could be used to challenge enforceability or invalidate some claims.


References
[1] United States Patent and Trademark Office. (2018). Patent No. 10,076,505.
[2] Patent Scope. (2023). Analysis of chemical process patents.
[3] WIPO. (2023). Patent landscape reports on pharmaceutical synthesis.

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Drugs Protected by US Patent 10,076,505

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 10,076,505

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria E473736 ⤷  Start Trial
Canada 2549724 ⤷  Start Trial
China 101647792 ⤷  Start Trial
China 1917866 ⤷  Start Trial
Germany 602004028155 ⤷  Start Trial
European Patent Office 1696900 ⤷  Start Trial
Spain 2347254 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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