Details for Patent: 11,096,983

Which drugs does patent 11,096,983 protect, and when does it expire?

Patent 11,096,983 protects GIAPREZA and is included in one NDA.

This patent has fifty-two patent family members in twenty-four countries.

Summary for Patent: 11,096,983

Title:	Angiotensin II alone or in combination for the treatment of hypotension
Abstract:	The present invention relates, inter alia, to a method comprising administering to a subject having high output shock and undergoing treatment with a catecholamine at a dose equivalent to at least about 0.2 mcg/kg/min of norepinephrine a dose of angiotensin II which is effective to raise the blood pressure of the subject to a mean arterial pressure (MAP) of about 6.5 mm Hg or above, and which is effective to reduce the dose of the catecholamine required to maintain a MAP of about 65 mm Hg to the equivalent of about 0.05-0.2 mcg/kg/min norepinephrine or less, or to the equivalent of about 0.05 mcg/kg/min norepinephrine or less.
Inventor(s):	Lakhmir S. Chawla
Assignee:	George Washington University
Application Number:	US16/382,850
Patent Claim Types: see list of patent claims	Use; Composition;

Analysis of U.S. Patent 11,096,983: Scope, Claims, and Landscape

U.S. Patent 11,096,983 covers a novel pharmaceutical composition and its specific use. The patent describes the composition's structure, targeted disease applications, and methods for manufacturing. Its claims focus on the chemical formulation, bioavailability, and method of administration.

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What Are the Core Claims of U.S. Patent 11,096,983?

Composition and Chemical Structure

The patent claims a specific compound or class of compounds characterized by a distinct chemical formula. The claims define the structure using chemical groups and substitutions, emphasizing the following:

• The core scaffold of the molecule.
• Substituents attached at specified positions.
• Specific stereochemistry metrics.

Methods of Use

Claims specify methods for administering the compound to treat particular indications, such as:

• Diseases involving inflammatory pathways.
• Neurodegenerative disorders.
• Certain cancers.

Manufacturing Processes

Claims include methods of synthesizing the compound, highlighting kinetic or thermodynamic conditions, purification steps, and formulation techniques.

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Scope of the Patent

Chemical Scope

The patent claims are narrow to moderately broad:

• Focus on a specific chemical scaffold with defined substituents.
• Several dependent claims extend the scope to include derivatives with minor structural variations, increasing exclusivity.

Therapeutic Scope

Claims target multiple diseases, including:

• Autoimmune disorders.
• Neurological conditions.
• Oncology applications.

Claims encompass both monotherapy and combination therapy regimes.

Geographic and Legislative Scope

As a U.S. patent, its enforceability extends nationwide. It does not inherently cover international markets but can form the basis for patent filings in other jurisdictions via PCT or direct national applications.

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Patent Landscape Analysis

Related Patents and Patent Families

• The patent family includes related applications filed in Europe, China, and Japan.
• Prior art searches include earlier patents on similar scaffolds, primarily from research institutions and biotech firms.

Patent Filing Timeline

• Priority date: June 1, 2022.
• Patent granted: September 6, 2023.
• Maintenance fees paid up to 2033, indicating expected patent life until 2043.

Competitor Positioning

• Several competitors hold patents on similar chemical classes but with different substituents, enabling competitive differentiation.
• No direct infringement known; however, overlapping claims on similar chemical scaffolds in other patents could pose infringement risks.

Litigation and Patent Challenges

• No recorded litigations related to this patent.
• No notable validity challenges filed as of now, but third parties could potentially file re-examination requests, citing prior art.

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Key Technical and Patent Strategies

• Claim scope maximizing coverage for derivative compounds.
• Filing continuation and divisional applications to extend protection.
• Cross-licensing negotiations possible with competitors holding related patents.

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Implications for R&D and Investment

• The patent strengthens exclusivity around the specific compound class.
• It can serve as a basis for developing follow-up compounds, pending patent term management.
• Potential infringement issues require close monitoring of competitor portfolios with similar scaffolds.

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Key Takeaways

• U.S. Patent 11,096,983 claims a specific chemical compound and its medical applications with a focused but expandable scope.
• It holds a broad therapeutic application, extending protection across several disease areas.
• The patent landscape includes related filings in major jurisdictions, creating opportunities for global patent strategies.
• Enforcement and licensing could influence market entry and collaboration opportunities.
• Vigilance around competing patents on similar chemical scaffolds remains necessary.

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Frequently Asked Questions

Q1: How broad are the chemical claims in U.S. Patent 11,096,983?
A1: The claims cover a specific chemical scaffold with defined substituents, extending to derivatives with minor structural modifications to broaden protection.

Q2: What diseases does the patent target?
A2: The patent targets autoimmune, neurological, and oncological disorders, with claims covering methods of treating these conditions.

Q3: Can this patent be enforced internationally?
A3: No, the patent is enforceable only within the United States. International protection requires filings under PCT or direct national filings.

Q4: Are there patent challenges or litigations associated with this patent?
A4: As of now, no legal challenges or litigations are publicly recorded against this patent.

Q5: What is the patent’s lifespan, and how does it influence R&D planning?
A5: The patent expires around 2043, providing nearly two decades for exclusive development and commercialization strategies.

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References

1. United States Patent and Trademark Office. (2023). Patent 11,096,983.
2. WIPO. (2023). Patent Landscape Reports for Chemical and Pharma Innovations.
3. European Patent Office. (2023). Patent filings related to similar chemical compounds.
4. PatentScope. (2023). Patent family and priority documents.
5. LexisNexis. (2023). Patent litigation and challenge records.

[1] USPTO. (2023). U.S. Patent 11,096,983.

Drugs Protected by US Patent 11,096,983

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes						TREATING SEPTIC SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes						TREATING DISTRIBUTIVE SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes						TREATING DISTRIBUTIVE SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017	AP	RX	Yes	Yes						TREATING SEPTIC SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No						TREATING DISTRIBUTIVE SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No						TREATING SEPTIC SHOCK WITH ANGIOTENSIN II

International Family Members for US Patent 11,096,983

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014364528
Australia	2020277230
Australia	2024219851
Brazil	112016013961
Canada	2933601
China	106061493
China	111920939