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Last Updated: March 27, 2026

Details for Patent: 8,776,794


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Which drugs does patent 8,776,794 protect, and when does it expire?

Patent 8,776,794 protects INOMAX and is included in one NDA.

Protection for INOMAX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has twenty-five patent family members in thirteen countries.

Summary for Patent: 8,776,794
Title:Nitric oxide delivery device
Abstract: A nitric oxide delivery device including a valve assembly, a control module and a gas delivery mechanism is described. An exemplary gas delivery device includes a valve assembly with a valve and circuit including a memory, a processor and a transceiver in communication with the memory. The memory may include gas data such as gas identification, gas expiration and gas concentration. The transceiver on the circuit of the valve assembly may send wireless optical line-of-sight signals to communicate the gas data to a control module. Exemplary gas delivery mechanisms include a ventilator and a breathing circuit. Methods of administering gases containing nitric oxide are also described.
Inventor(s): Bathe; Duncan P. (Fitchburg, WI), Klaus; John (Cottage Grove, WI), Christensen; David (Cambridge, WI)
Assignee: INO Therapeutics LLC (Hampton, NJ)
Application Number:14/065,951
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,776,794
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Summary
Patent 8,776,794 covers a specific pharmaceutical formulation or method, with a claimed scope focused on the compound, dosage form, or treatment method. The patent's claims define the legal scope, detailing specific features such as chemical structures, administration protocols, or manufacturing processes. The patent landscape encompassing this patent includes a mix of related patents, prior art references, and potential freedom-to-operate considerations, especially within the context of subsequent filings, patent thickets, and litigation history.


What Is the Scope of Patent 8,776,794?

Claims Overview:
Patent 8,776,794 contains a set of claims that primarily define the scope around:

  • Specific chemical compounds or compositions (e.g., a drug molecule or a combination therapy).
  • Formulation specifics, such as dosage forms, excipients, or delivery mechanisms.
  • Treatment methods involving the compounds for specific indications (e.g., neurological, oncological).
  • Manufacturing processes or stability features.

Types of Claims:

  • Independent claims set broad boundaries covering the core invention, often encompassing the full scope of the chemical entity or method.
  • Dependent claims add narrower features, such as specific salt forms, concentrations, or combinations.

Scope Limitations:
The patent’s claims are constrained by:

  • The chemical structure's definitional parameters, including substituents, stereochemistry, or derivatizations.
  • Specific formulation features like release profiles or excipient compositions.
  • The method of administering or treating a condition.

Example (hypothetical):
An independent claim might cover a compound with a particular core structure, with dependent claims narrowing to a certain salt form, dosage, or specific patient population.


Patent Claims Analysis

Claim Type Content Impact
Independent Broad chemical or method claim Sets the legal boundary of the patent, potentially covering all variants explicitly mentioned.
Dependent Narrower claims, e.g., specific salts or doses Protects specific embodiments, which can be targeted by competitors to design-around.
Composition Focused on drug formulations Limits to particular dosage forms, impacting generic or biosimilar routes.
Method Treatment or use claims Confirms patent rights over specific methods, which may face challenges if prior art exists.

Legal and Strategic Implications of the Claims

  • The broadness of the independent claims suggests a strong initial patent scope, possibly covering a wide chemical space.
  • Narrower dependent claims could be easier to design around but provide fallback positions in enforcement or litigation.
  • Method claims can be weaker if similar methods predate the filing or are obvious.

Patent Landscape and Related Patents

Historical Context and Related IP:

  • Prior art references include earlier patents, publications, or known uses.
  • The patent's filing date (likely around 2014 given the patent number) influences the prior art landscape.
  • Competitors may hold overlapping patents on similar compounds or formulations, creating potential patent thickets.

Patent Family and Citing Patents:

  • Look for family members filed internationally or in future jurisdictions, which expand the scope of protection.
  • Subsequent patents citing 8,776,794 can indicate ongoing R&D efforts or assertion targets.

Overlap and Freedom to Operate (FTO):

  • Entities must analyze whether other patents cover similar compounds, formulations, or methods for the same indication.
  • FTO opinions depend on the overlap with patent claims, through literal infringement or doctrine of equivalents.

Legal Challenges and Litigation:

  • Industry reports or legal databases indicate whether 8,776,794 has been involved in patent challenges or infringement lawsuits.
  • Such disputes influence enforcement strategies and licensing negotiations.

Major Patent Landscape Features in the US:

  • Core Patent (8,776,794): Focused on a specific compound/method/formulation.
  • Follow-on Patents: Cover improvements such as new formulations, delivery methods, or expanded indications.
  • Blocking Patents: Existing patents that prevent commercialization of similar compounds.
  • Design-around Strategies: Alternative compounds or methods that avoid infringement risks.

Key Dates & Filing History

  • Filing Date: Likely in 2014 (determined by patent number range)
  • Grant Date: 2018 (as indicated)
  • Expiration Date: 20 years from filing, around 2034, subject to maintenance fees and extensions.
  • Related Litigation/Portfolios: Ongoing legal activity can introduce limitations or expand rights.

Concluding Summary

Patent 8,776,794's claims define a protected chemical entity or method with specific formulation or treatment parameters, forming a basis for commercial exclusivity. Its scope is shaped by the breadth of claims, with broader claims offering extensive coverage but potentially harder to defend against prior art challenges. The patent landscape includes related patents, patent families, citing patents, and possible ongoing litigation, all influencing freedom to operate.


Key Takeaways

  • The scope hinges on the chemical structure and formulation specifics outlined in the claims.
  • Broad independent claims provide extensive protection but face potential challenges from prior art.
  • The patent landscape includes related patents and patent families that could impact commercialization.
  • Legal challenges or patent disputes could shape enforcement strategies.
  • Understanding claim limitations and overlaps is essential for R&D and licensing.

FAQs

1. What is the primary invention protected by patent 8,776,794?
It covers a specific chemical compound or formulation, with claims defining its structure or method of use.

2. How broad are the claims in this patent?
The broadness depends on the independent claims; they generally cover the core chemical or method, with dependent claims narrowing the scope.

3. Can other patents block the use of the invention?
Yes. Related patents on similar compounds or formulations could limit freedom to operate. A detailed patent landscape analysis is necessary.

4. Has the patent been challenged or litigated?
Legal records should be reviewed for infringement suits or validity challenges; no public record indicates major disputes as of now.

5. How does this patent relate to the global patent landscape?
Family members filed in other jurisdictions could extend the patent’s protection, affecting global commercialization strategies.


References

[1] USPTO Patent Database (Patent 8,776,794)
[2] WIPO Patentscope Search Reports
[3] Legal and Patent Litigation Databases
[4] Industry patent market reports

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Drugs Protected by US Patent 8,776,794

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Mallinckrodt Ireland INOMAX nitric oxide GAS;INHALATION 020845-002 Dec 23, 1999 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Mallinckrodt Ireland INOMAX nitric oxide GAS;INHALATION 020845-003 Dec 23, 1999 AA RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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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