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 thirty-nine patent family members in twenty-three 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):	Chawla; Lakhmir S. (McLean, VA)
Assignee:	The George Washington University a Congressionally Chartered Not-for-Profit Corporation (Washington, DC)
Application Number:	16/382,850
Patent Claim Types: see list of patent claims	Use; Composition;

United States Patent 11,096,983: A Detailed Analysis of Scope and Claims

Introduction

The United States Patent 11,096,983, titled "Angiotensin II alone or in combination for the treatment of hypotension," is a significant patent in the medical field, particularly in the treatment of hypotension and related cardiovascular conditions. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Context

Hypotension, or low blood pressure, can be a critical condition, especially in patients undergoing high output shock or other severe medical conditions. The patent in question addresses this issue by introducing a method involving the administration of angiotensin II, either alone or in combination with other substances, to treat hypotension effectively.

Scope of the Patent

The scope of the patent is broad and encompasses several key aspects:

Angiotensin II Variants

The patent includes various forms of angiotensin II, such as 5-valine angiotensin II, 5-valine angiotensin II amide, 5-L-isoleucine angiotensin II, and 5-L-isoleucine angiotensin II amide, or their pharmaceutically acceptable salts. These variants can be used individually or in combination[1].

Administration Methods

The patent specifies that the angiotensin II compositions can be administered parenterally, including injection or intravenous infusion. The formulations can be sterile injectable solutions or suspensions in various diluents such as water, Ringer's solution, or isotonic sodium chloride solution[1].

Pharmaceutical Carriers and Excipients

The compositions may include a range of excipients, such as co-solvents, solubilizing agents, buffers, pH adjusting agents, bulking agents, surfactants, and stabilizers. These components are crucial for maintaining the pharmacological activity of the active ingredient[1].

Claims of the Patent

The patent includes several claims that define the invention's scope:

Independent Claims

• The patent claims methods for treating hypotension by administering angiotensin II to patients, particularly those undergoing high output shock.
• It also claims compositions comprising angiotensin II in various forms and combinations, suitable for parenteral administration[1].

Dependent Claims

• These claims further specify the types of angiotensin II variants, the methods of administration, and the pharmaceutical carriers and excipients used in the compositions.
• For example, dependent claims may detail the specific percentages of different angiotensin II forms in a mixture or the use of particular diluents and solvents[1].

Patent Landscape

The patent landscape surrounding US 11,096,983 is complex and involves several key areas:

Related Patents

• Other patents in the cardiovascular field may overlap or complement this invention. For instance, patents related to non-specific cardiovascular stimulants or antihypotensive drugs could be relevant[1].

Competing Technologies

• The use of other vasoconstrictors like norepinephrine is common in treating hypotension. This patent differentiates itself by focusing on angiotensin II and its combinations, offering a unique therapeutic approach[1].

Regulatory Environment

• The patent's validity and enforcement are subject to regulatory scrutiny. For example, the patent must comply with current good manufacturing practices (cGMP) and other regulatory standards[1].

Industry Impact

The impact of this patent on the medical industry is significant:

Clinical Use

• The method described in the patent provides a new or improved treatment option for patients with hypotension, particularly in critical care settings.
• Clinicians can now consider angiotensin II as a viable alternative or adjunct to other treatments, potentially improving patient outcomes[1].

Research and Development

• This patent can spur further research into the use of angiotensin II and its variants in various cardiovascular conditions.
• Pharmaceutical companies may invest in developing new formulations and delivery methods based on this patent[1].

Economic Considerations

The economic implications of this patent are multifaceted:

Market Potential

• The treatment of hypotension is a significant market, and a new, effective treatment can capture a substantial share.
• Pharmaceutical companies holding this patent can benefit from licensing agreements, sales, and market exclusivity[1].

Cost and Accessibility

• The cost of developing and manufacturing angiotensin II compositions must be balanced against the potential benefits and market demand.
• Accessibility to this treatment could be influenced by factors such as insurance coverage and regulatory approvals[1].

Legal and Intellectual Property Aspects

The legal and intellectual property aspects surrounding this patent are crucial:

Inventorship and Ownership

• The patent lists the true and only inventors, which is a critical aspect of US patent law. Correct determination of inventorship is essential to avoid legal disputes[5].

Patent Eligibility and Validity

• The patent must pass the test of patent eligibility, ensuring it does not claim abstract ideas or natural phenomena.
• The patent's validity can be challenged in court, and its enforcement may involve litigation to protect against infringement[2].

Future Directions

The future of this patent involves several potential directions:

Clinical Trials and Approval

• Further clinical trials may be necessary to fully establish the safety and efficacy of angiotensin II in treating hypotension.
• Regulatory approvals from agencies like the FDA will be crucial for widespread adoption[1].

Technological Advancements

• Advances in pharmaceutical technology could lead to improved formulations, delivery methods, and combinations with other drugs.
• Personalized medicine approaches might also be explored, tailoring the treatment to individual patient needs[1].

Key Takeaways

• The patent US 11,096,983 introduces a novel method for treating hypotension using angiotensin II.
• The scope includes various forms of angiotensin II and different administration methods.
• The patent has significant clinical, economic, and legal implications.
• Future directions include further clinical trials, technological advancements, and regulatory approvals.

Frequently Asked Questions (FAQs)

What is the primary use of the invention described in US 11,096,983?

The primary use is the treatment of hypotension, particularly in patients undergoing high output shock.

What forms of angiotensin II are included in the patent?

The patent includes 5-valine angiotensin II, 5-valine angiotensin II amide, 5-L-isoleucine angiotensin II, and 5-L-isoleucine angiotensin II amide, or their pharmaceutically acceptable salts.

How can the angiotensin II compositions be administered?

The compositions can be administered parenterally, including injection or intravenous infusion, using various diluents and solvents.

What are the potential economic benefits of this patent?

The patent could capture a significant market share in the treatment of hypotension, leading to substantial revenue through sales and licensing agreements.

What are the legal considerations for this patent?

The patent must comply with US patent law, including correct inventorship determination, and must pass the test of patent eligibility to ensure it does not claim abstract ideas or natural phenomena.

Cited Sources:

1. US Patent 11,096,983 - Angiotensin II alone or in combination for the treatment of hypotension.
2. AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC. - Federal Circuit Court decision on patent eligibility.
3. Patent Claims and Patent Scope - SSRN paper on measuring patent scope.
4. Innoviva INC Form 10-Q - Financial report including patent-related information.
5. Determining Inventorship for US Patent Applications - Oregon State University document on inventorship in US patent law.

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	11,096,983					TREATING SEPTIC SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	11,096,983					TREATING DISTRIBUTIVE SHOCK WITH ANGIOTENSIN II
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	11,096,983					TREATING DISTRIBUTIVE 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