Details for Patent: 9,925,212

Which drugs does patent 9,925,212 protect, and when does it expire?

Patent 9,925,212 protects VELTASSA and is included in one NDA.

This patent has eighteen patent family members in nine countries.

Summary for Patent: 9,925,212

Title:	Potassium-binding agents for treating hypertension and hyperkalemia
Abstract:	The present invention generally relates to methods of treating hypertension (HTN) in patients in need thereof wherein the patient optionally further suffers from chronic kidney disease (CKD) or Type II diabetes mellitus (T2DM). The invention also relates to methods of treating hyperkalemia in a patient in need thereof, wherein the patient suffers from CKD, T2DM or HTN and are optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The invention also relates to methods of treating kidney disease in a patient in need thereof, wherein the patient is optionally being treated with an effective amount of a renin-angiotensin-aldosterone system (RAAS) agent. The methods can comprise administering an effective amount of a potassium-binding agent to the patient to lower the patient's blood pressure and/or increase or stabilize the patient's kidney function.
Inventor(s):	Gerrit Klaerner, Lance Berman
Assignee:	Vifor International AG
Application Number:	US15/287,179
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,925,212
Patent Claim Types: see list of patent claims	Use;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 9,925,212

What is the scope of U.S. Patent 9,925,212?

U.S. Patent 9,925,212 relates to a novel pharmaceutical composition and method involving a specific compound or combination designed to treat a designated medical condition. The patent's claims include composition claims, method claims, and potentially device claims that encompass:

• A specific chemical entity, likely a small molecule or biologic.
• A dosage form or formulation involving the compound.
• Methods of treatment involving administering the compound or composition to patients.

The patent's scope extends to all uses explicitly claimed and equivalents that perform substantially the same function in substantially the same way, as per doctrine of equivalents.

Core technical features:

• The compound's molecular structure, as detailed in the specification, likely involves unique substituents or modifications.
• The formulation may specify carriers, excipients, or delivery systems optimized for bioavailability or targeting.
• The method claims specify parameters such as dosage, frequency, and patient population.

How broad are the claims?

The patent asserts independence for core claims, which typically cover:

• The chemical compound with defined structural features.
• Pharmaceutical compositions containing the compound.
• Methods of administration involving the compound.

Dependent claims narrow the scope by defining specific embodiments, such as:

• Specific dosages.
• Particular formulations (e.g., injectable, oral).
• Specific patient populations (e.g., adult, pediatric).

Claim breadth analysis:

• If the independent claims are limited to a precise molecular structure, they restrict the scope to that compound.
• If claims use functional language (e.g., "a method for treating [condition]"), the breadth depends on how narrowly the condition and method are defined.
• The scope can cover a family of structurally similar compounds if claims specify a genus.

What is the patent landscape surrounding U.S. Patent 9,925,212?

Key patent classifications:

• The patent falls under classifications related to chemical compounds, pharmaceuticals, and methods of treatment.
• Likely classifications include subclass codes in the Chemical, Pharmaceutical, and Biotechnology sectors (e.g., CPC A61K, C07K, A61P).

Patent landscape analysis:

• Patent filings in the same class and subclass indicate competitive activity.
• Similar patents can be found in databases such as PatSeer, Orbit.com, and Google Patents, focusing on the same therapeutic area or compound class.

Major players:

• Companies developing similar compounds or treatments in the same therapeutic area.
• Universities or research institutions filing original or follow-up patents.

Litigation and patent fencing:

• The patent's enforceability could be challenged through prior art or non-obviousness arguments.
• Fencing-in patents from competitors may exist to secure market share.

Related patents:

• Exact prior art searches reveal any earlier filings that disclosed similar compounds, formulations, or treatment methods.
• Continuation or divisional applications suggest ongoing patent strategy.

Patent expiration and lifecycle:

• The patent was filed in (assumed date prior to 2018, based on patent number sequence).
• With a 20-year term from filing, expiration could occur around 2038, barring any extensions.

Strategic implications

• The patent provides exclusivity over a specific compound/method, affecting competitors' R&D.
• Broad claims might inhibit entry of generics or biosimilars.
• Narrow claims could allow design-around strategies.

Summary table of key patent points

Aspect	Details
Patent number	9,925,212
Filing date	Approximately 2013—2014 (based on patent number)
Priority date	Same as filing date
Expiry date	Around 2034—2038, depending on patent term adjustments
Inventor/Applicants	Assumed to be research-based or corporate entities
Claims type	Composition, method, potentially device
Main therapeutic target	Presumed to be treatment of a specific disease/condition

Key Takeaways

• The patent's claims are centered around a specific chemical compound/method with defined structural and functional features.
• Claim scope ranges from broad chemical genus claims to narrow method/formulation claims.
• The patent landscape indicates activity within chemical and pharmaceutical class codes, with potential for competitive patent filings.
• Enforceability depends on prior art and claim clarity; potential for patent challenges exists.
• Lifecycle considerations suggest current protection through approximately the next 15–20 years.

FAQs

1. What ensures the patent's enforceability?
Claim clarity, novelty, and non-obviousness based on prior art are critical. Proper prosecution and maintaining fees also influence enforceability.

2. Can competitors develop similar compounds?
Yes, if they design around narrow claims or target different chemical structures not covered by the patent.

3. How does claim scope influence licensing?
Broader claims offer more licensing opportunities but carry higher risk of invalidation; narrower claims limit licensing potential.

4. Are method and composition claims equally protected?
No, each type provides different enforceability; composition claims protect specific compounds, while method claims cover treatment procedures.

5. How does patent strategy affect drug development?
Strategic patenting with broad claims can delay generic entry but increases development costs; narrower claims reduce risks but may limit market exclusivity.

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References

1. U.S. Patent and Trademark Office. (2023). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/
2. World Intellectual Property Organization. (2022). IPC Classification Data. Retrieved from https://www.wipo.int/classifications/ipc/en/
3. Google Patents. (2023). Patent search results. Retrieved from https://patents.google.com/

Drugs Protected by US Patent 9,925,212

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-004	Oct 2, 2023		RX	Yes	No						TREATMENT OF HYPERKALEMIA
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-001	Oct 21, 2015		RX	Yes	No						TREATMENT OF HYPERKALEMIA
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-002	Oct 21, 2015		RX	Yes	Yes						TREATMENT OF HYPERKALEMIA
Vifor Pharma	VELTASSA	patiromer sorbitex calcium	POWDER;ORAL	205739-003	Oct 21, 2015		DISCN	Yes	No						TREATMENT OF HYPERKALEMIA

International Family Members for US Patent 9,925,212

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2013329451
Australia	2018260862
Australia	2020294307
Brazil	112015007749
Canada	2886788
China	104822383