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Last Updated: December 22, 2024

Details for Patent: 10,722,471


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Summary for Patent: 10,722,471
Title:Galenic formulations of organic compounds
Abstract:The present invention relates to a solid unit oral dosage form comprising sacubitril and valsartan in a 1:1 molar ratio, preferably in the form of the so-called angiotensin receptor neprilysin inhibitor (ARNI) LCZ696, which is a complex salt hydrate of sacubitril, valsartan, and sodium ions, appropriate for use in pediatrics or other patients where low and individual dosing is required or who encounter problems with swallowing e.g. as a result of a disease or because of age, to the manufacture of said solid dosage form and to invention embodiments relating to therapy using said dosage form.
Inventor(s):Winzenburg Gesine, Trueby Bernd, Chen Fabian, Ayalasomayajula Surya Prakash, Bush Christopher, Berkhin Masha
Assignee:Novartis AG
Application Number:US16074579
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,722,471: A Detailed Analysis

Introduction

Patents are a cornerstone of innovation, providing protection for inventors and encouraging the development of new technologies. However, the patent landscape can be complex, especially when it comes to the scope and claims of individual patents. This article will delve into the specifics of United States Patent 10,722,471, exploring its scope, claims, and the broader patent landscape it operates within.

Background on Patent 10,722,471

United States Patent 10,722,471, while not explicitly detailed in the provided sources, can be analyzed through the lens of general patent principles and the current state of patent law.

Patent Scope and Claims

Definition and Importance

Patent scope and claims are critical components of any patent. The scope defines the boundaries of what is protected, while the claims specify the exact inventions or innovations covered by the patent[3].

Metrics for Measuring Patent Scope

Research has identified simple metrics to measure patent scope, such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For instance, narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Impact of Examination Process

The examination process tends to narrow the scope of patent claims, both in terms of claim length and claim count. This narrowing is more significant when the duration of examination is longer, indicating that the patent office scrutinizes claims rigorously to ensure they are specific and valid[3].

Claims Analysis

Independent and Dependent Claims

Patent claims are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The clarity and specificity of these claims are crucial for determining the patent's scope and enforceability[3].

Practical Applications and Technological Improvements

For a patent to be eligible, its claims must integrate abstract ideas into practical applications. This means the claims should specify how the invention is used in a way that provides concrete benefits or solves specific problems in the relevant field. For example, in AI-related inventions, specifying the use of separated audio components in a real-time speech recognition system to enhance accuracy demonstrates a practical application that transforms the abstract idea into patent-eligible subject matter[4].

Patent Landscape and Current Issues

Patent Thickets and Terminal Disclaimers

In the pharmaceutical and biotech industries, the practice of obtaining numerous patents, often referred to as "patent thickets," can create significant barriers for generic and biosimilar drug manufacturers. These thickets, which include many terminally disclaimed patents, drive up costs and reduce the efficiency of patent litigation. The USPTO has proposed rules to address this issue by linking the enforceability of terminally disclaimed patents, thereby discouraging the accumulation of questionable patents[1].

Impact on Generic and Biosimilar Drugs

The accumulation of large numbers of patents, particularly those that are terminally disclaimed, can delay the market entry of generic and biosimilar drugs. This practice leads to uncertainty regarding exclusivity dates and results in higher numbers of patent settlements, which can be costly and time-consuming for generic and biosimilar applicants[1].

USPTO Guidance and Updates

AI Patent Eligibility

Recent updates from the USPTO, such as the 2024 guidance on AI patent eligibility, provide clarity on how to determine the patent eligibility of AI-related inventions. These updates emphasize the importance of integrating judicial exceptions into practical applications and highlight the role of human contribution in AI-assisted inventions[4].

Practical Applications in AI Patents

For AI patents to be eligible, they must specify real-world applications that provide tangible benefits. For example, a claim that uses separated audio components in a speech recognition system to improve voice command accuracy in hands-free environments is considered patent-eligible because it adds a practical application that transforms the abstract idea into a concrete technological improvement[4].

Case Studies and Examples

IMBRUVICA Patents

The drug IMBRUVICA, manufactured by Johnson and Johnson, is a prime example of the issue with patent thickets. Out of 41 patents listed for IMBRUVICA, 31 are terminally disclaimed, indicating that 75% of the remaining patents are duplicative. This practice creates significant barriers for generic and biosimilar entry into the market[1].

Industry Expert Insights

Industry experts emphasize the need for high-quality, valid patents that do not rely on duplicative or questionable secondary patents. The USPTO's proposed rules aim to rebalance the system by encouraging brands to obtain innovative, high-quality patents with patentably distinct claims, rather than amassing large numbers of questionable patents[1].

Statistics and Empirical Data

Empirical data shows that the institution rate of inter partes and post grant review petitions for Bio/Pharma patents is high, indicating that many patents are of questionable quality. For instance, in fiscal year 2024, 65% of such petitions were instituted, highlighting the need for stricter patent quality standards[1].

Key Takeaways

  • Patent Scope and Claims: The scope and claims of a patent are crucial for defining what is protected and must be specific and valid.
  • Practical Applications: Patents must integrate abstract ideas into practical applications to be eligible.
  • Patent Thickets: The accumulation of numerous patents, especially in the pharmaceutical industry, can create barriers for generic and biosimilar drugs.
  • USPTO Updates: Recent guidance updates clarify the eligibility of AI-related inventions and emphasize the importance of practical applications.
  • Industry Impact: High-quality patents are essential for encouraging innovation and reducing litigation costs.

FAQs

What is the significance of patent scope and claims in a patent?

Patent scope and claims define the boundaries of what is protected by the patent, ensuring that the invention is clearly and specifically described.

How do patent thickets affect the pharmaceutical industry?

Patent thickets, particularly those involving terminally disclaimed patents, drive up costs and reduce the efficiency of patent litigation, delaying the market entry of generic and biosimilar drugs.

What are the key points of the USPTO's 2024 guidance on AI patents?

The guidance emphasizes integrating judicial exceptions into practical applications, ensuring that AI-assisted inventions are evaluated on equal footing with other technologies, and highlighting the role of human contribution in these inventions.

Why are practical applications important for patent eligibility?

Practical applications transform abstract ideas into concrete technological improvements, making the claims patent-eligible by providing tangible benefits and solving specific problems in the relevant field.

How do recent USPTO updates impact the patent landscape?

Recent updates aim to clarify and refine the process for determining patent eligibility, particularly for AI-related inventions, and to discourage the accumulation of questionable patents by linking the enforceability of terminally disclaimed patents.

Sources

  1. Letterhead DC Office - Regulations.gov: "Our patents reflect important innovative and inventive steps..."
  2. Unified Patents Portal: "US-20190083406-A1 - Unified Patents Portal"
  3. SSRN: "Patent Claims and Patent Scope"
  4. Mintz: "Understanding the 2024 USPTO Guidance Update on AI Patent"
  5. Unified Patents Portal: "RU-2018130601-A | Unified Patents - Unified Patents Portal"

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Drugs Protected by US Patent 10,722,471

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis ENTRESTO SPRINKLE sacubitril; valsartan CAPSULE, PELLETS;ORAL 218591-001 Apr 12, 2024 RX Yes No 10,722,471 ⤷  Subscribe Y TREATMENT OF HEART FAILURE WITH ORAL PELLETS ⤷  Subscribe
Novartis ENTRESTO SPRINKLE sacubitril; valsartan CAPSULE, PELLETS;ORAL 218591-002 Apr 12, 2024 RX Yes Yes 10,722,471 ⤷  Subscribe Y TREATMENT OF HEART FAILURE WITH ORAL PELLETS ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 10,722,471

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2017215530 ⤷  Subscribe
Australia 2019280026 ⤷  Subscribe
Canada 3010778 ⤷  Subscribe
China 108601741 ⤷  Subscribe
European Patent Office 3411018 ⤷  Subscribe
European Patent Office 3411021 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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