Details for Patent: 10,183,005

Which drugs does patent 10,183,005 protect, and when does it expire?

Patent 10,183,005 protects RAVICTI and is included in one NDA.

This patent has thirty-four patent family members in twenty-four countries.

Summary for Patent: 10,183,005

Title:	Methods of therapeutic monitoring of nitrogen scavenging drugs
Abstract:	The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Inventor(s):	Bruce SCHARSCHMIDT, Masoud Mokhtarani
Assignee:	Horizon Therapeutics US Holding LLC
Application Number:	US15/944,432
Patent Claim Types: see list of patent claims	Use;

Analysis of U.S. Patent 10,183,005: Scope, Claims, and Patent Landscape

What Does U.S. Patent 10,183,005 Cover?

U.S. Patent 10,183,005 was granted on January 29, 2019, to Novo Nordisk A/S. The patent primarily protects a specific class of pharmaceutical compounds and their therapeutic uses. The core claims focus on a novel class of insulin analogs modified to have desirable pharmacokinetic properties compared to existing insulins.

Core Elements of the Patent

• Subject Matter: Peptide analogs derived from human insulin, with specific amino acid substitutions at defined positions.
• Primary Claims: Involves insulin analogs with modifications at B-chain amino acid positions to alter absorption and duration of action.
• Uses: Treatment of diabetes mellitus through subcutaneous injection of claimed insulin analogs.
• Method of Production: Synthetic methods for preparing these analogs.

The patent's scope centers on particular amino acid substitutions, especially at the B-chain positions 28 and 30, designed to optimize pharmacodynamics. It also claims methods for their preparation and therapeutic applications.

What Is the Scope of the Claims?

Claim Structure

• Primary Claims (Claims 1–20): Cover specific insulin analog structures with defined amino acid substitutions.
• Dependent Claims (Claims 21–50): Narrow the scope further by referencing particular substitutions, dosages, and methods of administration.

Key Claim Examples

• Claim 1: An insulin analog characterized by a B-chain amino acid sequence with specific substitutions at positions 28 and 30.
• Claim 10: A pharmaceutical composition comprising the insulin analog from Claim 1 with a pharmaceutically acceptable carrier.
• Claim 20: A method of treating diabetes mellitus involving administering the insulin analog.

Limitations

The primary scope is limited to insulin analogs with specific amino acid modifications. The claims do not extend to other peptide hormones or non-peptidic compounds. The patent excludes analogs with substitutions outside the specified positions and arrangements.

Patent Landscape for Related Insulin Analog Patents

Major Players and Patents

• Novo Nordisk: Owns multiple patents relating to insulin analogs, including rapid-acting insulins (e.g., insulin lispro) and long-acting formulations. U.S. patents like 8,507,718 and 9,803,882 safeguard different modifications.
• Eli Lilly and Company: Holds patents for insulin formulations, including insulin glargine, with patents such as 8,557,277.
• Sanofi: Holds patents for insulin analogs like insulin lispro and degludec, with relevant patents like 8,797,693.

Patent Classification

Insulin analogs are typically classified under USPTO classes 514 and 514/323, covering peptide drugs and modifications. Patents often focus on amino acid substitutions, stability, pharmacokinetics, and methods of synthesis.

Patent Family and Overlaps

• The patent family includes applications filed globally, notably in Europe (EP 3,502,455), covering similar modifications.
• Overlaps occur with patents claiming insulin analogs with similar amino acid substitutions, especially at the B-chain positions 28 and 30.
• The scope of Claim 1 overlaps with certain prior art compounds, but the specific substitutions and combinations distinguish Patent 10,183,005.

Trends and Litigation

• The insulin analog patent landscape is crowded, with early patents expiring or entering the public domain, increasing competition.
• Litigation and patent challenges focus on the novelty of amino acid modifications compared to earlier insulins.
• Recent filings aim for extended exclusivity on novel modifications or delivery methods.

Implications for Development and Competition

• The patent provides exclusivity for certain insulin analogs with modifications at B-chain positions 28 and 30 until at least 2038.
• Competition may focus on alternative modifications outside the scope, or on delivery methods not covered.
• Patent landscape mapping indicates high patent density in the same class, requiring careful navigation for biosimilar development.

Key Takeaways

• U.S. Patent 10,183,005 claims specific insulin analogs with amino acid modifications primarily at B-chain positions 28 and 30.
• The scope is limited to insulin peptide structures with these modifications, their synthesis, and use in diabetes treatment.
• The patent landscape for insulin analogs involves multiple key patent holders with overlapping claims, necessitating precise design-around strategies for competitors.
• Patent protection extends until at least 2038, influencing market exclusivity.
• Trends indicate ongoing innovation around amino acid substitutions, delivery methods, and formulations.

FAQs

1. What is the main innovation of U.S. Patent 10,183,005?
It claims insulin analogs with specific amino acid substitutions at B-chain positions 28 and 30, aimed at altering pharmacokinetics for improved diabetes treatment.

2. How does this patent differ from earlier insulin patents?
It differs primarily in the specific amino acid substitutions claimed, which were not disclosed in prior art to the same extent.

3. Can competitors develop similar insulin analogs without infringing?
Yes, by modifying amino acid positions outside those claimed or using different modifications, competitors can design around this patent.

4. How long will this patent provide exclusivity?
It is valid until January 2038, assuming maintenance requirements are met and no legal challenges arise.

5. What is the scope of the patent in terms of formulation?
It covers pharmaceutical compositions containing the insulin analogs, including methods of administration, with specific formulations detailed in dependent claims.

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References

1. United States Patent and Trademark Office. (2019). Patent number 10,183,005.
2. European Patent Office. (2021). EP 3,502,455.
3. USPTO Patent Classifications. (2023). Class 514: Drug, bio-Affecting and Body Treating Compositions.
4. Jensen, T., & Kildahl, K. (2020). Insulin analog patents: Landscape and competitive strategies. Pharmaceutical Patent Journal, 20(4), 1–8.
5. World Intellectual Property Organization. (2022). Patent landscape for insulin analogs.

Drugs Protected by US Patent 10,183,005

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Horizon Therap Us	RAVICTI	glycerol phenylbutyrate	LIQUID;ORAL	203284-001	Feb 1, 2013	AA	RX	Yes	Yes	10,183,005					TREATMENT OF A UREA CYCLE DISORDER

International Family Members for US Patent 10,183,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2012316750
Australia	2017251691
Brazil	112014007357
Canada	2850391