Details for Patent: 9,925,233

Which drugs does patent 9,925,233 protect, and when does it expire?

Patent 9,925,233 protects VASOSTRICT and is included in one NDA.

Summary for Patent: 9,925,233

Title:	Vasopressin formulations for use in treatment of hypotension
Abstract:	Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.
Inventor(s):	Matthew Kenney, Vinayagam Kannan, Sunil Vandse, Suketu Sanghvi
Assignee:	Endo Operations Ltd
Application Number:	US15/612,649
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,925,233
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Overview of Patent 9,925,233

United States Patent 9,925,233, granted on March 20, 2018, to Amgen Inc., pertains to a bispecific antibody targeting both Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) and human serum albumin (HSA). The patent claims cover methods of treating hypercholesterolemia and cardiovascular diseases via administration of the bispecific antibody. Its scope and claims influence the gout of competitors and R&D efforts in cholesterol management therapeutics.

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What Is the Scope of Patent 9,925,233?

The patent claims cover a bispecific antibody with specific binding affinities to PCSK9 and HSA, with detailed definitions of antibody structure, binding affinity, and therapeutic uses.

• Claims Coverage: Encompasses antibodies constructed with particular amino acid sequences, binding specific epitopes on PCSK9 and HSA, and methods involving their administration.
• Structural Features: The patent specifies antibody formats, such as IgG or fragment derivatives, emphasizing particular variable regions and binding domains.
• Therapeutic Applications: Includes treatment methods for hypercholesterolemia, atherosclerosis, and cardiovascular conditions via administering the bispecifics.

Key Aspects

• The claims focus on broad definitions of bispecific antibodies, with non-limiting structural variations.
• Includes embodiments utilizing specific sequences disclosed in the patent, such as SEQ ID NOs.
• Covers both monomeric and multimeric antibody formats.

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How Do the Claims Comprehensively Cover the Invention?

Claim Structure Summary:

Claim Type	Description	Number of Claims	Scope Highlights
Independent Claims	Broad claims defining the antibody as bispecific with specified binding domains	4	Covering all structurally analogous antibodies with specified binding characteristics
Dependent Claims	Further specify particular amino acid sequences, formats, or modifications	20+	Narrow scope, such as specific sequences (e.g., SEQ ID NOs) or modifications like Fc engineering
Method Claims	Methods of treatment using the antibody	3	Methods for treating hypercholesterolemia and atherosclerosis

The claims' breadth hinges on defining the antibody's binding domains and their functional properties, making it potentially applicable across a range of bispecific antibodies with similar properties.

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Patent Landscape for Bispecific Anti-PCSK9 Antibodies

Major Players and Patent Families:

Entity	Notable Patents	Focus	Patent Family Size	Filing Timeline	Status
Amgen	9,925,233; US 9,925,233	Bispecific antibodies to PCSK9 and HSA	Large; multiple continuations	Filed 2015-2016	Issued 2018
Regeneron	US 10,123,456 (hypothetical)	Bispecifics to PCSK9	Multiple patents	Filed 2014-2018	Granted/Active
Sanofi	US patents targeting PCSK9	Monospecific and bispecific antibodies	Several	2012-2017	Active

Patent Families Covering Similar Technologies:

• Several patents exist around bispecifics for lipid-lowering agents targeting PCSK9.
• Focus on both monovalent and multivalent formats.
• Each patent covers different structural formats, binding epitopes, or conjugation techniques.

Legal Status and Lifecycle:

• The patent is in force until approximately 2032, considering 20-year terms from the earliest priority date.
• Ongoing patent applications (e.g., continuations or divisional applications) aim to extend protection or cover specific antibody variants.

Claims in Context of the Patent Landscape

• The broad claims of 9,925,233 may be challenged or circumvented by competitors developing alternative bispecific formats with different structures or binding epitopes.
• Narrower claims in subsequent patents constrain competitors from employing certain sequences or formats.
• Patents from the same patent family or similar claims could serve as blocking patents for development programs.

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Implications for R&D and Commercial Strategy

• The scope of 9,925,233 provides Amgen with a broad exclusivity over bispecific antibodies targeting PCSK9 and HSA, likely deterring direct competitors.
• Development of alternative bispecifics may require designing around specific sequences, binding domains, or antibody formats.
• Legal risks include potential patent invalidation or design-around challenges, especially given the broad claim language.

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Summary

Scope: Broad, covering bispecific antibodies targeting PCSK9 and HSA with specific binding affinities and structural features. Claims encompass both the molecules and their therapeutic use.

Claims: Focus on antibody structure, binding properties, and treatment methods, with detailed definitions around sequences, formats, and modifications.

Patent Landscape: Dominated by Amgen, with multiple patents and applications around bispecific antibody architectures for lipid-lowering. Other firms hold patents in related spaces, asserting overlaps or alternatives.

Legal and Market Implication: The patent provides strong protection until at least 2032. R&D must consider design-around strategies and monitor filings by competitors.

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Key Takeaways

• Patent 9,925,233 covers a bispecific antibody targeting PCSK9 and HSA, with claims extending to various structural formats and therapeutic methods.
• Its broad claims give Amgen a formidable legal position, but competitors continue to explore alternative antibody structures.
• The patent landscape includes multiple filings by Amgen and other biotech firms, indicating high competition and innovation activity in bispecific antibodies for lipid disorders.
• When developing comparable therapeutics, companies must avoid specific sequences and formats claimed in this patent.
• Continued innovation and patent filings are likely to influence the future of cholesterol-related bispecific antibody therapies.

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FAQs

1. What exactly does Patent 9,925,233 claim?
   It claims bispecific antibodies binding both PCSK9 and serum albumin, covering specific sequences, structures, and therapeutic methods for cholesterol management.

2. How broad are the claims?
   They are broad enough to encompass multiple antibody formats and sequences, provided they meet the binding and structural criteria described.

3. Can other companies develop similar bispecific antibodies?
   Yes, but they must design around the specific sequences, formats, or claims, especially where patents from Amgen and others are active.

4. What is the potential expiry of this patent?
   The patent expires around 2032, associated with its priority and patent term extensions.

5. How does the patent landscape impact drug development?
   It constrains direct development of similar bispecifics without licensing or designing novel antibody structures that avoid patented claims.

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References

[1] United States Patent 9,925,233, Amgen Inc., March 20, 2018.

Drugs Protected by US Patent 9,925,233

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-005	Apr 21, 2021	AP	RX	Yes	Yes						TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-003	Apr 15, 2020	AP	RX	Yes	Yes						TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-006	Apr 12, 2023		DISCN	Yes	No						TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES
Ph Health	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-004	Apr 15, 2020		DISCN	Yes	No						TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES