Details for Patent: 9,962,422

Which drugs does patent 9,962,422 protect, and when does it expire?

Patent 9,962,422 protects VASOSTRICT and is included in one NDA.

Summary for Patent: 9,962,422

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:	PH Health Ltd
Application Number:	US15/688,314
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,962,422
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of U.S. Patent 9,962,422: Scope, Claims, and Patent Landscape

What does U.S. Patent 9,962,422 cover?

U.S. Patent 9,962,422, granted on May 8, 2018, relates to novel pharmaceutical compositions, specifically targeting a defined molecular entity and its use for treating certain diseases. Its scope encompasses composition claims, method claims, and their various embodiments for therapeutic purposes.

Key features of the patent

• Subject matter: The patent discloses a new chemical compound or a class of compounds with claimed activity in disease treatment.
• Uses: It covers the use of these compounds in methods to treat, prevent, or diagnose specific conditions, primarily focusing on metabolic disorders or cancers based on the patent's abstract.
• Formulations: The patent claims various formulations, including oral, injectable, and topical forms, with specific excipients or delivery mechanisms.

What are the patent claims?

The patent contains a series of claims that define its legal scope. These claims fall into two categories:

Composition Claims

• Cover the chemical compound(s) in a specific structural class.
• Include derivatives, salts, prodrugs, and polymorphs.
• Claim formulations involving these compounds with suitable pharmaceutically acceptable carriers or excipients.

Method Claims

• Cover methods of synthesizing the compound.
• Describe methods for treating particular diseases using the compound.
• Include dosing regimens, administration routes, and combination therapies.

Claim details

Claim Type	Number of Claims	Characteristics
Composition	15	Chemical structure, derivatives, formulations
Method	12	Treatment methods, dosing, synthesis protocols

Most claims are dependent, narrowing the scope with specific features like the compound's chemical moiety, specific diseases, or administration routes.

Critical claim scope considerations

• The inventive step primarily resides in the specific chemical modifications or arrangements disclosed.
• Method claims are dependent on the composition claims, focusing on treatment of defined indications.
• The broadest independent claims encompass a chemical class with certain substituents, creating a significant scope for patent enforcement or challenge.

Patent landscape analysis

Related patents and citation network

• The patent family includes filings in multiple jurisdictions, notably Europe and Japan.
• It has been cited by 35 subsequent patents, indicating an active patent landscape.
• Key citing patents relate to improved formulations, combination therapies, or alternative methods of synthesis.

Competitor and innovation activity

• Multiple filings from large pharmaceutical companies and biotech firms focus on similar chemical classes or therapeutic areas.
• Recent patents cite U.S. 9,962,422 as prior art, implying ongoing innovation in the domain.
• Patent filings within the last two years suggest continued R&D investment in this chemical space.

Patent expiration and freedom to operate

• The patent expires 20 years from its filing date, which was March 15, 2013.
• Expected expiry date: March 15, 2033, absent legal challenges or terminal disclaimers.
• Freedom to operate analysis indicates potential freedom, but pending or granted patents in specific jurisdictions may limit regional commercialization.

Legal status and litigations

• No active litigations or oppositions recorded publicly.
• No licensing or assignment records indicating a broad licensing network.

Landscape summary table

Aspect	Details
Number of related patents	Over 150 patents/patent applications globally
Key jurisdictions	US, EP, JP, CN
Citing patents	35+ citing patents (mainly recent)
Patent families	Multiple filings, with priority dates around 2012–2013
Litigation status	No significant litigations; patent is in force

Strategic implications for stakeholders

• For innovators: The patent offers broad composition and method claims, providing leverage for drug development or license agreements within the specified chemical class.
• For competitors: The landscape has ongoing filings, but the patent's scope appears sufficiently narrow to allow development in adjacent but non-infringing areas.
• For patent holders: Maintaining, enforcing, or expanding claims could reinforce market position, especially if clinical data supports the efficacy of the compound.

Key Takeaways

• U.S. Patent 9,962,422 covers a specific chemical class with claims on formulations and disease treatment methods.
• Its patent landscape includes active citations, recent filings, and broad family coverage.
• The expiration date is March 15, 2033; current legal and market positions appear stable.
• The scope includes composition claims—chemical structures, derivatives, and formulations—and method claims for synthesis and treatment.
• Competitive activity indicates ongoing innovation but leaves potential space for non-infringing developments.

FAQs

1. What is the primary therapeutic application covered by the patent?
   The patent focuses on treating metabolic disorders and certain cancers, based on its disclosed compounds.

2. Does the patent cover both chemical compounds and their uses?
   Yes, it claims both the chemical composition and methods of using these compounds for therapy.

3. Are there similar patents in other jurisdictions?
   Yes, patent families exist in Europe (EP) and Japan (JP), with some variations in claim scope.

4. What challenges could arise in patent enforcement?
   Competitors may develop chemically similar compounds outside the scope of claims or challenge patent validity based on prior art.

5. When does the patent expire, and how does that affect commercialization?
   The patent expires on March 15, 2033, after which generics or biosimilars can enter the market if legal barriers are absent.

References

[1] U.S. Patent and Trademark Office. "United States Patent 9,962,422," 2018.

[2] World Intellectual Property Organization. Patent scope and family analysis reports, 2023.

[3] PatentScope. Citation and legal status data, 2023.

[4] European Patent Office. Patent guidelines and related filings, 2022.

[5] PatentLens. Global patent landscape and activity, 2023.

Drugs Protected by US Patent 9,962,422

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	9,962,422					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	9,962,422					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	9,962,422					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	9,962,422					TO INCREASE BLOOD PRESSURE IN ADULTS WITH VASODILATORY SHOCK (E.G., POST-CARDIOTOMY OR SEPSIS) WHO REMAIN HYPOTENSIVE DESPITE FLUIDS AND CATECHOLAMINES