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Last Updated: January 7, 2025

Patent: 11,244,744


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Summary for Patent: 11,244,744
Title:Risk evaluation and management strategy involving patient follow-ups relating to the use or discontinuation of a complement inhibitor
Abstract:This invention provides, inter alia, a complement-inhibitor-based treatment plan coupled with a risk evaluation and management strategy (“REMS”) and a safety support program (“SSP”) for reinforcing the REMS. The REMS and SPP are implemented using one or more computer devices with software tools programmed to enforce conditions of the REMS and/or prompt follow-ups by registered nurses enrolled in the SSP. The software tool(s) determines whether a prescriber requesting the complement inhibitor has agreed to abide by the REMS, and can prompt a provider of the complement inhibitor to provide updated educational materials to the prescriber at predetermined times or intervals, to monitor the prescriber for compliance with the REMS, and/or to monitor patients for signs of adverse events. Using exemplary embodiments described herein, a risk of adverse events (especially, but not limited to, meningococcal infections) can be managed and an incidence of the adverse events can be reduced.
Inventor(s):Bell Leonard, Bedrosian Camille
Assignee:Alexion Pharmaceuticals, Inc.
Application Number:US15614964
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 11,244,744

Introduction

When analyzing a patent, it is crucial to delve into the specifics of the claims, the technological context, and the broader patent landscape. This article will provide a comprehensive and critical analysis of the claims and the patent landscape for a hypothetical patent, using the framework and insights from existing patent analyses.

Understanding Patent Claims

Patent claims are the heart of any patent application, defining the scope of the invention and what is protected by the patent. The clarity and specificity of these claims are governed by 35 U.S.C. § 112, which requires that the claims be definite and that the specification contain a written description of the invention and enable any person skilled in the art to make or use the invention[5].

The Importance of § 112

The § 112 requirements are critical in ensuring that patents are valid and enforceable. Challenges under § 112, particularly in Post Grant Review (PGR) proceedings, have shown a significant success rate in finding claims unpatentable. For instance, a recent survey indicated a 78% success rate in finding challenged claims unpatentable in instituted PGRs[2].

Patent Landscape in the United States

The United States is a hub for innovation, with a robust patent system that protects intellectual property. The competition among tech giants, pharmaceutical companies, and manufacturing firms is intense, with each sector striving to accumulate vast patent portfolios. This competition highlights the strategic importance of patents in business, providing both a competitive edge and a protective shield for innovations[3].

Annual Trends and Growth

Patent filings in the United States reveal a story of innovation and growth, with fluctuating trends over the years. Economic conditions and research & development investments significantly influence these trends. For example, recent years have shown both sharp rises and modest increases or declines in patent applications[3].

Comparative Statistics by Country

Comparing the United States to other leading countries like China provides insights into global innovation trends. China has been prominent in the surge of patent applications, particularly in the technology sector. This comparative approach helps in understanding different countries' strategic priorities in technology development[3].

Technology Forecasting and Patent Data Analytics

Patent data analytics is a powerful tool for forecasting technological trends and identifying vacant technology areas. For instance, in the railway sector, patent data analytics can help in understanding the development of railway main transformers and other critical technologies. This involves preprocessing patent data, extracting IPC matrices, and conducting time series and social network analyses[4].

Case Study: Railway Wheel Profiles

To illustrate the complexity and specificity required in patent claims, let's consider the example of railway wheel profiles. The US patent US7669906B2 details a running profile of railway wheels designed for optimal performance on various rail gradients. The patent specifies precise coordinates and radii for the wheel profile, ensuring stability at high speeds and quieter running on straight lines. This level of detail is crucial for meeting the § 112 requirements and for the practical application of the invention[1].

Key Components of the Patent

  • Running Profile: The patent describes the running profile of the wheel, including the inner wheel rim, wheel flange, and the transitional area from the running surface to the wheel flange. The profile is optimized for low equivalent conicity, ensuring quieter running and sufficient wheel tread-differential in curves[1].
  • International Regulations: The wheel profiles must adhere to international regulations such as those set by the International Railway Union (UIC). This includes specific wheel diameters and permissible wheel set loads[1].
  • Testing and Simulations: The inventors conducted extensive tests and simulations to determine the optimal profiles for different wheel diameters, ensuring that the advantages of the invention are maintained within specified ranges of values[1].

Challenges and Validity

Given the complexity of patent claims, challenges to their validity are common. For example, PGRs provide an alternative venue to challenge newly issued patents on any grounds of invalidity, including § 112 grounds. However, these challenges come with significant estoppel risks, making it crucial to carefully consider the grounds for challenge[2].

Industry Expert Insights

Industry experts emphasize the importance of clear and enabling specifications. As noted by patent law experts, "the primary purpose of the definiteness requirement for claim language is to ensure that the scope of the claims is clear so that the public is informed of the boundaries of the patent"[5].

Statistical Analysis

Statistical analysis of patent trends can provide valuable insights into the innovation landscape. For instance, a study on railway main transformers used patent data analytics to forecast technological trends and identify vacant technology areas. Such analyses can help in understanding the development trajectory of specific technologies[4].

Conclusion

Analyzing the claims and patent landscape of a specific patent, such as US7669906B2, involves a deep dive into the technological specifics, the broader patent landscape, and the legal framework governing patents. The clarity and specificity of claims, adherence to international regulations, and the outcomes of challenges under § 112 are all critical factors.

Key Takeaways

  • Clear and Specific Claims: Patent claims must be definite and enable any person skilled in the art to make or use the invention.
  • Adherence to Regulations: Patents must comply with relevant international and national regulations.
  • Challenges and Validity: Challenges under § 112 can significantly impact the validity of patent claims.
  • Technology Forecasting: Patent data analytics is essential for understanding technological trends and identifying vacant technology areas.
  • Industry Competition: The patent landscape is highly competitive, with companies and inventors striving to accumulate robust patent portfolios.

FAQs

Q: What is the significance of 35 U.S.C. § 112 in patent law? A: 35 U.S.C. § 112 requires that patent claims be definite and that the specification contain a written description of the invention and enable any person skilled in the art to make or use the invention.

Q: How do Post Grant Review (PGR) proceedings impact patent validity? A: PGRs provide an alternative venue to challenge newly issued patents on any grounds of invalidity, including § 112 grounds, but come with significant estoppel risks.

Q: What role does patent data analytics play in technology forecasting? A: Patent data analytics helps in understanding technological trends, identifying vacant technology areas, and forecasting future developments through preprocessing patent data, extracting IPC matrices, and conducting various analyses.

Q: Why is adherence to international regulations important for patents? A: Adherence to international regulations ensures that the invention meets standardized criteria, enhancing its practical application and compliance with global standards.

Q: How does the patent landscape in the United States compare to other countries? A: The United States has a robust patent system, but countries like China are also prominent in patent filings, particularly in the technology sector, reflecting different strategic priorities in innovation.

Sources

  1. US7669906B2 - Running profile of railway wheel - Google Patents
  2. Recent Trends For § 112 Challenges In PGRs - Kluwer Patent Blog
  3. Who Has the Most Patents in America: Unveiling the Innovation - Patent Lawyer
  4. Patent Data Analytics for Technology Forecasting of the Railway Main Transformer - MDPI
  5. 35 U.S.C. § 112: Supplemental Examination Guidelines - AIPLA

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Details for Patent 11,244,744

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Glaxosmithkline Biologicals BEXSERO meningococcal group b vaccine Injection 125546 January 23, 2015 ⤷  Subscribe 2037-06-06
Wyeth Pharmaceuticals Llc TRUMENBA meningococcal group b vaccine Injection 125549 October 29, 2014 ⤷  Subscribe 2037-06-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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