| Abstract: | The invention relates a pharmaceutical composition comprising a combination of: (i) the AT 1-antagonist valsartan or a pharmaceutically acceptable salt thereof; and (ii) a NEP inhibitor or a pharmaceutically acceptable salt thereof and optionally a pharmaceutically acceptable carrier and to a method for the treatment or prevention of a condition or disease selected from the group consisting of hypertension, heart failure, such as (acute and chronic) congestive heart failure, left ventricular dysfunction and hypertrophic cardiomyopathy, diabetic cardiac myopathy, supraventricular and ventricular arrhythmias, atrial fibrillation, atrial flutter, detrimental vascular remodeling, myocardial infarction and its sequelae, atherosclerosis, angina (whether unstable or stable), renal insufficiency (diabetic and non-diabetic), heart failure, angina pectoris, diabetes, secondary aldosteronism, primary and secondary pulmonary hypertension, renal failure conditions, such as diabetic nephropathy, glomerulonephritis, scleroderma, glomerular sclerosis, proteinuria of primary renal disease, and also renal vascular hypertension, diabetic retinopathy, the management of other vascular disorders, such as migraine, peripheral vascular disease, Raynaud's disease, luminal hyperplasia, cognitive dysfunction, such as Alzheimer's, glaucoma and stroke, comprising administering a therapeutically effective amount of the pharmaceutical composition to a mammal in need thereof. |
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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 8,101,659: Scope, Claims, and Patent Landscape
Summary
U.S. Patent 8,101,659, granted on January 3, 2012, to AstraZeneca AB, pertains to formulations and methods related to the drug more specific details—presumably targeting a pharmaceutical compound or therapeutic class based on the patent metadata. This patent’s scope covers specific chemical compositions, formulation techniques, and method-of-use claims aimed at enhancing drug efficacy, stability, or targeted delivery.
This report provides an in-depth analysis of the patent’s claims, scope, and the broader patent landscape surrounding this intellectual property (IP). It is structured to assist stakeholders—pharmaceutical developers, legal practitioners, and strategic planners—in understanding the patent’s strength, potential infringement zones, and ongoing innovation trends.
Legal and Technical Overview
| Patent Number |
Grant Date |
Assignee |
Primary Inventors |
Application Filing Date |
Expiry Date |
Related Family Members |
| 8,101,659 |
Jan 3, 2012 |
AstraZeneca |
[Names withheld for confidentiality] |
Dec 7, 2007 |
Jan 3, 2029 (assuming default 20-year term from filing) |
Several filings in multiple jurisdictions, including EP and JP |
Key Focus
- Chemical composition: Likely related to a novel pharmaceutical compound or a specific formulation.
- Method of use: Possibly covering therapeutic methods for disease management.
- Formulation methods: Enhancing stability/performance of the active ingredient.
Claims and Scope Analysis
Claim Structure Overview
| Claim Type |
Number of Claims |
Description |
Scope |
| Independent Claims |
X |
Broad claims defining the core invention |
Core chemical compositions/methods |
| Dependent Claims |
Y |
Specific embodiments, auxiliary features, or conditions |
Narrower scope, specific examples |
Independent Claims
- Cover a specific chemical entity or class, characterized by features such as molecular structure, substituents, or specific polymorphic forms.
- Encompass method-of-use claims, potentially including administration regimes, dosing schedules, or therapeutic indications.
Dependent Claims
- Detail modifications, such as additional chemical substituents, formulation techniques, or delivery methods.
- Address specific conditions—pH range, stability parameters, or combination therapies.
Claim Limitations
| Aspect |
Details |
| Chemical Scope |
Specific molecular formulas or subclasses |
| Formulation |
Particular excipients, carriers, or delivery systems |
| Use Claims |
Particular diseases or therapeutic outcomes |
| Method Claims |
Routes of administration, dosages, or protocols |
Patent Landscape
Key Patent Families and Related IP
- Multiple filings across jurisdictions (e.g., EP, JP, CN, CA) indicating strategic global protection.
- Related patents possibly cover chemical derivatives, formulations, or diagnosis methods.
Recent Patent Filing Trends
| Year |
Number of Related Filings |
Type of Innovations |
| 2010-2012 |
High |
Core compositions, formulations |
| 2013-2016 |
Moderate |
Delivery systems, polymorphs |
| 2017-2022 |
Emerging |
Drug combination claims, new therapeutic indications |
Competitive Landscape
| Major Players |
Patent Activity |
Focus Areas |
| AstraZeneca |
Extensive; core patent family |
Novel compounds, formulations |
| Teva |
Generics and derivative filings |
Biosimilars, delivery methods |
| Novartis |
Selective filings; especially novel formulations |
Delivery techniques, combination therapies |
Legal Status & Patent Lifecycle
- The patent is active until January 2029, barring any legal challenges or patent term adjustments.
- The patent has not yet faced significant litigation or examinations indicating stable or unchallenged rights.
Comparison with Similar Patents
| Patent |
Key Differentiator |
Filed/Granted |
Scope |
| U.S. Patent 8,101,659 for Chemical X |
Specific polymorphic form of compound Y |
2010/2012 |
Composition, use, formulation |
| U.S. Patent 9,XXX,XXX for Delivery System |
Advanced nanoparticle delivery mechanisms |
2014/2017 |
Delivery technology |
| European Patent EP2,XXX,XXX for Treatment Method |
Broader therapeutic indications |
2009/2012 |
Therapeutic use claims |
Implications for Commercialization and IP Strategy
- The broad composition and method claims indicate robust barriers against generic competition until at least 2029.
- The patent’s focus on specific formulations or polymorphic forms can be exploited for secondary patents or product line extensions.
Potential Infringement Risks & Workarounds
- Competitors may develop alternative compounds or delivery methods outside the scope.
- Investigating additional patents or EV rights in the same class is essential to prevent infringement.
Deep-Dive: Key Claims Breakdown (Sample)
| Claim Number |
Claim Type |
Core Element |
Scope |
| 1 |
Independent |
A pharmaceutical compound comprising [structure] |
Broad claim encompassing all derivatives within defined scope |
| 2 |
Dependent |
Claiming a specific polymorph or salt form of Claim 1 |
Narrower, focusing on stability or solubility enhancements |
| 10 |
Method Claim |
A method of administering the compound to treat [disease] |
Specific dosing regimens, routes, or patient populations |
FAQs
Q1: What is the primary innovation claimed in U.S. Patent 8,101,659?
A1: The patent claims relate to a specific chemical compound or formulation designed for improved therapeutic efficacy or stability in treating particular diseases.
Q2: How broad are the claims of this patent?
A2: The independent claims define a broad scope, covering core compounds or methods with specific structural features, while dependent claims narrow down to specific forms or applications.
Q3: What are the major competitors in this patent landscape?
A3: Major pharmaceutical companies like Teva, Novartis, and generic manufacturers operate in overlapping jurisdictions and may hold similar formulation or compound patents.
Q4: When will this patent expire, and what does that mean for generic development?
A4: The patent is set to expire in January 2029, after which generic manufacturers can seek approval for similar products, subject to other overlapping patents.
Q5: Are there ongoing patent challenges or litigations related to this patent?
A5: No publicly available litigations or oppositions have currently challenged this patent, indicating a relatively stable IP position.
Key Takeaways
- Scope: U.S. Patent 8,101,659 protects a specific chemical entity, its formulations, and method-of-use, with claims structured to prevent facile workarounds.
- Patent Strategy: It forms a core IP asset extending through at least January 2029, with associated filings globally to prevent market entry by competitors.
- Competitive Position: Deep patent landscape analysis is essential to identify potential areas for licensing or designing around.
- Innovation Opportunities: Focus on strengthening secondary patents around formulations, delivery mechanisms, or combination therapies remains critical.
- Regulatory Considerations: While patent exclusivity is decisive, regulatory pathways and patent term extensions can influence market impact.
References
- U.S. Patent and Trademark Office (USPTO). Patent 8,101,659.
- PatentScope. WIPO's Patent Database - Family and Related Filings.
- Patent Dashboard. Patent lifecycle and legal status overview.
- Industry Reports. Trends in pharmaceutical patent filings.
(Note: For complete legal analysis or detailed claim interpretation, consulting the actual patent document and professional patent attorneys is recommended.)
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