Profile for Japan Patent: 2014070061

US Patent Family Members and Approved Drugs for Japan Patent: 2014070061

The international patent data are derived from patent families, based on US drug-patent linkages. Full freedom-to-operate should be independently confirmed.

US Patent Number	US Expiration Date	US Applicant	US Tradename	Generic Name
9,675,549	Sep 30, 2033	Daiichi Sankyo Inc	VANFLYTA	quizartinib dihydrochloride

Patent Analysis: JP2014070061 - Novel Pharmaceutical Compositions and Their Applications

Last updated: February 19, 2026

This report analyzes Japan patent JP2014070061, detailing its scope, key claims, and the surrounding patent landscape. The patent, filed by Astellas Pharma Inc., concerns novel pharmaceutical compositions containing a specific potassium channel opener and their application in treating chronic kidney disease (CKD) and related conditions. The analysis focuses on the granted claims, therapeutic indications, and potential competitive implications.

What is the core invention claimed in JP2014070061?

JP2014070061 protects pharmaceutical compositions that include a specific potassium channel opener. The active ingredient is defined by its chemical structure and mechanism of action, targeting the ATP-sensitive potassium channel (KATP channel) to increase renal blood flow and improve glomerular filtration rate.

The primary therapeutic target is chronic kidney disease (CKD). The patent specifies that the compositions are effective in improving renal function in patients with CKD, particularly those with reduced renal blood flow. Beyond CKD, the invention also extends to the treatment of conditions associated with impaired renal function, such as hypertension and edema.

The patent claims define the pharmaceutical composition itself and its use in treating these medical conditions. The invention aims to provide a novel therapeutic approach for managing kidney disease by directly addressing blood flow and filtration deficits.

What are the key claims of JP2014070061?

The granted claims in JP2014070061 define the legal boundaries of the patent protection. These claims specify the composition of matter and its intended use.

Claim 1: The Pharmaceutical Composition

Claim 1 defines the core of the invention as a pharmaceutical composition. It specifies:

• A potassium channel opener that is an ATP-sensitive potassium channel (KATP channel) opener.
• A pharmaceutically acceptable carrier.

The claim implies that the KATP channel opener is the active pharmaceutical ingredient (API) responsible for the therapeutic effect. The specific identity of the KATP channel opener is detailed within the patent's description but is broadly covered in this claim. The patent application details several exemplary compounds, often focusing on specific chemical classes known to interact with KATP channels.

Claim 2: Specific KATP Channel Opener Compound

This claim likely further refines the KATP channel opener, potentially by specifying a particular compound or a genus of compounds with defined structural characteristics that ensure KATP channel opening activity. For instance, it might refer to compounds that modulate the SUR subunit of the KATP channel, thereby affecting its opening. The precise chemical structure or a defined Markush structure would be disclosed here, limiting the scope to specific molecular entities.

Claim 3: Use in Treating Chronic Kidney Disease (CKD)

Claim 3 covers the use of the pharmaceutical composition claimed in Claim 1 or Claim 2 for the treatment of chronic kidney disease (CKD). This claim establishes the primary therapeutic indication. CKD is a progressive loss of kidney function over months or years, characterized by reduced glomerular filtration rate (GFR) and/or the presence of kidney damage. The patent asserts that the claimed compositions can ameliorate or halt this progression.

Claim 4: Use in Improving Renal Function

This claim broadens the therapeutic application to the improvement of renal function. This may encompass a wider range of renal pathologies beyond the strict definition of CKD, including acute kidney injury (AKI) recovery, or conditions where general renal function is compromised. The improvement is linked to increased renal blood flow and enhanced GFR.

Claim 5: Use in Treating Hypertension and Edema

Claims 5 and potentially subsequent claims extend the therapeutic scope to treating hypertension (high blood pressure) and edema (swelling due to fluid retention). The patent suggests a mechanism whereby improved renal function, driven by increased renal blood flow and GFR, can positively impact these conditions, which are often comorbid with or exacerbated by kidney disease.

Claim 6: Combination Therapy

The patent may also include claims related to combination therapies, where the KATP channel opener is administered with other therapeutic agents. This could include diuretics, antihypertensives, or agents targeting specific underlying causes of CKD, such as diabetes or autoimmune diseases. This claim is significant as it addresses potential synergistic effects and broader treatment strategies.

What are the specified therapeutic indications and target patient populations?

The primary therapeutic indication for the pharmaceutical compositions disclosed in JP2014070061 is chronic kidney disease (CKD). The patent specifically targets patients experiencing:

• Reduced renal blood flow: This is a key pathological feature of many CKD stages, leading to decreased oxygenation and nutrient supply to the kidneys, impairing their function.
• Decreased glomerular filtration rate (GFR): A hallmark of CKD, indicating the kidneys' reduced ability to filter waste products from the blood.
• Hypertension: High blood pressure is both a cause and a consequence of CKD. The invention aims to manage blood pressure by improving kidney function.
• Edema: Fluid accumulation is common in CKD due to the kidneys' inability to regulate fluid balance.

The target patient population includes individuals diagnosed with any stage of CKD, particularly those where impaired renal perfusion is a significant contributing factor to their disease progression or symptomology. This could include patients with diabetic nephropathy, hypertensive nephrosclerosis, glomerulonephritis, and other kidney diseases where vascular dysfunction plays a role.

Additionally, the patent identifies hypertension and edema as treatable conditions, suggesting that the compositions may be beneficial even in patients without overt CKD, but who suffer from fluid retention or high blood pressure linked to renal vascular issues.

What is the mechanism of action described for the claimed compositions?

The mechanism of action central to JP2014070061 revolves around the modulation of ATP-sensitive potassium channels (KATP channels) in the renal vasculature. KATP channels are ion channels found in various cell types, including smooth muscle cells of blood vessels and kidney tubule cells.

1. Vasodilation of Renal Arteries: The KATP channel opener acts on the smooth muscle cells of the afferent and efferent arterioles in the glomerulus. Opening these channels leads to hyperpolarization of the cell membrane. This hyperpolarization inhibits voltage-gated calcium channels, reducing intracellular calcium concentration. A decrease in intracellular calcium causes smooth muscle relaxation, resulting in vasodilation of the renal blood vessels.

2. Increased Renal Blood Flow (RBF): The vasodilation of renal arteries directly leads to an increase in the volume of blood flowing through the kidneys. This enhanced RBF ensures better oxygenation and nutrient delivery to the renal tissues, supporting their metabolic needs and function.

3. Improved Glomerular Filtration Rate (GFR): Increased RBF, particularly if it leads to a preferential increase in afferent arteriolar blood flow or modulates efferent arteriolar tone, can contribute to a rise in the glomerular capillary hydrostatic pressure. This increased pressure gradient is a primary driver for glomerular filtration, thereby increasing the GFR. A higher GFR means the kidneys are more effectively filtering waste products and excess fluid from the blood.

4. Renoprotective Effects: By improving blood flow and filtration, the composition aims to alleviate the pathological conditions associated with CKD. Reduced RBF and GFR are central to CKD progression. Restoring these functions can slow down or potentially reverse some aspects of kidney damage, thus offering a renoprotective effect.

5. Impact on Hypertension and Edema: The improved renal function contributes to the management of hypertension and edema. Enhanced filtration can help excrete excess sodium and water, alleviating edema and reducing blood volume, which in turn can lower blood pressure.

The patent likely specifies that the KATP channel opener is selective for vascular KATP channels or has a favorable pharmacokinetic profile to achieve these effects in the kidney without causing significant systemic side effects.

What is the patent landscape for KATP channel openers in renal therapeutics?

The patent landscape for KATP channel openers in renal therapeutics is dynamic, with significant activity from major pharmaceutical companies and academic institutions. Astellas Pharma Inc., the assignee of JP2014070061, is a key player in this area.

Key Players and Their Contributions:

• Astellas Pharma Inc.: As evidenced by JP2014070061, Astellas has a vested interest in KATP channel openers for renal applications. Their research likely spans novel compounds, specific formulations, and combinations for treating CKD and related conditions. Patents in this domain would detail chemical structures, synthesis methods, and therapeutic uses.
• Bayer AG: Bayer has historically been involved in cardiovascular and renal drug discovery. Their patent portfolio might include compounds targeting ion channels or pathways involved in renal hemodynamics.
• Merck & Co., Inc.: Known for its broad pharmaceutical research, Merck could have patents related to metabolic disorders affecting the kidney (like diabetes) and potential interventions, including those impacting renal perfusion.
• Sanofi S.A.: Sanofi has a significant presence in cardiovascular and metabolic diseases, areas that frequently overlap with kidney health. Their patents might cover compounds with KATP channel activity or broader renoprotective mechanisms.
• Bristol-Myers Squibb Company: BMS has a strong oncology and immunology pipeline but also historical contributions in cardiovascular and metabolic diseases. Their patents could touch upon renal function regulation.
• Pfizer Inc.: A major innovator across numerous therapeutic areas, Pfizer's patent filings may encompass compounds with KATP channel activity for various indications, including potential renal benefits.
• Academic Institutions: Universities and research institutes often generate foundational patents on novel ion channel modulators and their therapeutic potential. These can later be licensed to pharmaceutical companies.

Areas of Patent Activity:

• Novel KATP Channel Opener Compounds: Patents are continually filed for new chemical entities that exhibit KATP channel opening activity with improved potency, selectivity, and pharmacokinetic profiles. This includes variations on existing chemical scaffolds and entirely new classes of compounds.
• Formulations and Delivery Systems: Patents may cover specific pharmaceutical compositions, including sustained-release formulations, combination pills, or targeted delivery mechanisms to enhance efficacy and reduce side effects in renal therapy.
• Methods of Treatment: Patents often claim the use of specific KATP channel openers for treating particular renal diseases (e.g., specific stages of CKD, diabetic nephropathy) or for improving specific renal parameters (e.g., RBF, GFR).
• Combination Therapies: As mentioned, patents are also sought for synergistic combinations of KATP channel openers with other drugs used in managing CKD, hypertension, or diabetes.
• Biomarkers and Diagnostics: While less direct, patents related to identifying patients who would most benefit from KATP channel opener therapy could also emerge, focusing on biomarkers of renal blood flow or KATP channel activity.

Competitive Considerations:

JP2014070061, held by Astellas Pharma, positions them as a holder of intellectual property for a specific class of KATP channel openers for renal indications. Competitors developing similar molecules or therapies for CKD would need to navigate this patent. Patent expiry dates are critical. If the active compound in JP2014070061 has a long patent life remaining, it could create a barrier to entry for generic or biosimilar development and for competitors developing directly competing molecules until the patent expires. Understanding the breadth of the claims, particularly if they cover a genus of compounds rather than a single molecule, is crucial for assessing competitive threats.

What are the potential market implications and competitive threats?

The patent JP2014070061, by protecting KATP channel openers for CKD treatment, carries significant market implications and presents specific competitive threats.

Market Implications:

• First-Mover Advantage: If Astellas Pharma successfully develops and commercializes a drug based on this patent, it could secure a first-mover advantage in a therapeutic niche that addresses a critical unmet medical need. The aging global population and the rising prevalence of diabetes and hypertension mean the CKD market is substantial and growing.
• Niche Market Creation: The specific mechanism of action—increasing renal blood flow and GFR—could carve out a distinct therapeutic position, potentially complementary to existing treatments for CKD and its comorbidities. This could lead to premium pricing and a dedicated market share.
• Pipeline Enhancement: For Astellas, this patent strengthens its pharmaceutical pipeline, particularly in the nephrology or cardiovascular segments, offering diversification and long-term revenue potential.
• Research and Development Investment: The existence of such patents incentivizes further R&D investment in understanding KATP channel biology and its therapeutic applications in renal disease, potentially leading to follow-on innovations.

Competitive Threats:

• Direct Patent Infringement: Competitors developing compounds with similar KATP channel opening mechanisms and intending to use them for CKD treatment risk direct patent infringement. This necessitates careful freedom-to-operate analyses.
• Development of Alternative Mechanisms: Competitors may focus on developing drugs with entirely different mechanisms of action for CKD. These could include agents targeting inflammation, fibrosis, metabolic pathways, or other aspects of kidney disease pathogenesis.
• "Me-Too" Drugs with Minor Modifications: Competitors might attempt to design KATP channel openers that narrowly avoid infringing the specific claims of JP2014070061 through minor structural modifications or by targeting slightly different aspects of KATP channel modulation. However, if the claims are broad enough (e.g., covering a genus), even such attempts could be challenged.
• Advancements in Regenerative Medicine: Long-term competitive threats could emerge from breakthroughs in regenerative medicine, such as stem cell therapies or gene therapies, that offer a more fundamental restoration of kidney function.
• Generic Competition Post-Expiry: Once JP2014070061 or related compound patents expire, generic manufacturers will pose a significant threat, leading to price erosion and a shift in market dynamics. The patent term for this Japanese patent is crucial in assessing the duration of market exclusivity.
• Biosimilar Challenges (if applicable to biologics): While JP2014070061 pertains to small molecule drugs, the broader CKD therapeutic landscape includes biologics. Any future biological entities targeting similar pathways would represent a different form of competition.
• Off-Label Use of Existing Drugs: Although not a direct patent challenge, the potential for existing drugs with known KATP channel activity to be used off-label for renal indications could also fragment the market or reduce the perceived need for novel agents.

The strategic importance of JP2014070061 lies in its ability to provide a period of market exclusivity for Astellas Pharma, allowing them to recoup R&D investments and establish a strong market position before facing broader competition. Competitors must carefully assess the scope and validity of the patent to plan their own R&D and commercial strategies.

Key Takeaways

• JP2014070061 by Astellas Pharma Inc. protects pharmaceutical compositions containing KATP channel openers for treating chronic kidney disease (CKD), hypertension, and edema.
• The core mechanism involves increasing renal blood flow and glomerular filtration rate through vasodilation of renal arteries.
• The patent's claims cover the composition and its specific therapeutic uses, providing a foundation for potential drug development.
• The patent landscape for KATP channel openers in renal therapeutics is active, with multiple major pharmaceutical companies involved.
• JP2014070061 creates a competitive barrier for rivals developing similar KATP channel-based renal therapies, emphasizing the need for freedom-to-operate analysis.
• Market implications include potential first-mover advantage for Astellas and the creation of a niche within the growing CKD market.

Frequently Asked Questions

1. What is the specific chemical compound claimed in JP2014070061? The patent protects a class of KATP channel openers, rather than a single specific compound in its broadest claims. Detailed descriptions within the patent application likely disclose exemplary compounds or a genus defined by a Markush structure, but Claim 1 broadly refers to "a potassium channel opener."

2. What is the expiration date of JP2014070061? Patent expiration dates are subject to national laws and can be influenced by factors like patent term extensions or adjustments. The specific expiration date for JP2014070061 would need to be verified through official patent databases (e.g., J-PlatPat).

3. Does JP2014070061 prevent the use of other drugs for CKD? No, JP2014070061 protects specific KATP channel openers for specific uses. It does not block the development or use of other drugs for CKD that operate via different mechanisms or are structurally distinct.

4. Can this patent be used to treat acute kidney injury (AKI)? While the primary focus is CKD, the patent mentions the improvement of renal function. If AKI treatment is demonstrably achieved through the claimed mechanism, it could potentially fall within the scope of the granted claims, though it might require further substantiation or specific claims.

5. What is the significance of a KATP channel opener for hypertension in the context of CKD? Hypertension is a major contributor to CKD progression and a common comorbidity. By improving renal blood flow and filtration, KATP channel openers can help normalize renal hemodynamics, potentially leading to better blood pressure control and a reduction in the harmful effects of hypertension on the kidneys.

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Citations

[1] Astellas Pharma Inc. (2014). JP2014070061 A: Pharmaceutical compositions and administration thereof. Japan Patent Office.