Patent: 10,059,925

Summary for Patent: 10,059,925

Title:	High titer recombinant influenza viruses with enhanced replication in vero cells
Abstract:	The invention provides a composition useful to prepare high titer influenza viruses, e.g., in the absence of helper virus, which includes internal genes from an influenza virus vaccine strain or isolate, e.g., one that is safe in humans, for instance, one that does not result in significant disease, and genes from vaccine seed virus isolates which include a HA gene segment with a HA2 sequence encoding a HA2 that confers enhanced growth in cells in culture, such as Vero cells.
Inventor(s):	Kawaoka Yoshihiro, Horimoto Taisuke, Murakami Shin
Assignee:	Wisconsin Alumni Research Foundation (WARF)
Application Number:	US14816807
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,059,925

Introduction

When evaluating a patent, such as United States Patent 10,059,925, it is crucial to conduct a comprehensive analysis of its claims and the broader patent landscape. This analysis helps in understanding the patent's validity, potential for litigation, and its strategic position within the industry.

Understanding the Patent Claims

To begin with, it is essential to delve into the specifics of the patent claims themselves.

Claim Structure and Scope

• The claims of a patent define the scope of the invention and are critical in determining what is protected and what is not. For U.S. Patent 10,059,925, each claim must be carefully examined to understand the precise elements of the invention and how they are combined to achieve the desired outcome.
• The claims should be analyzed for their clarity, specificity, and breadth. Broad claims may be more susceptible to challenges, while narrow claims may offer less protection but are more likely to be upheld[2].

Novelty and Nonobviousness

• The patent must meet the requirements of novelty and nonobviousness. This involves ensuring that the claimed invention is new and not obvious to a person of ordinary skill in the relevant field. Any prior art that could potentially invalidate the patent must be identified and assessed[2].

Patent Landscape Analysis

A patent landscape analysis provides a broader context in which the patent exists.

Geographical Spread

• Understanding the geographical distribution of patents in the same technology area can help in identifying key markets and potential competitors. For U.S. Patent 10,059,925, analyzing the geographical spread can reveal where similar technologies are being developed and patented, guiding strategic decisions on where to file and enforce the patent[3].

Saturation of the Patent Space

• Determining the saturation level of the patent space is crucial. A highly saturated space may indicate intense competition and a higher likelihood of patent infringement disputes. This analysis helps in advising whether to invest in the development of the patented technology or to explore alternative areas[3].

New Entrants and Market Dynamics

• Identifying new entrants into the patent space can provide insights into emerging trends and potential competitors. This information is vital for strategic planning and can help in anticipating future challenges and opportunities[3].

Time-Slicing and Historical Trends

• Analyzing the patent landscape over time (time-slicing) can reveal historical trends, such as the rise or decline of certain technologies. This can help in understanding the lifecycle of the patented technology and making informed decisions about its future development[3].

Impact of Recent Patent Law Changes

The patent landscape is also influenced by recent changes in patent law.

Leahy-Smith America Invents Act (AIA)

• The AIA introduced significant changes to the U.S. patent system, including the creation of the Patent Trial and Appeal Board (PTAB) and new procedures for challenging patent validity, such as Inter Partes Review (IPR) and Post-Grant Review (PGR). These changes have made it easier and less expensive to challenge patents, which can impact the validity and enforceability of U.S. Patent 10,059,925[2].

PTAB and IPR/PGR

• The PTAB has been a game-changer in patent litigation, allowing for faster and more cost-effective challenges to patent validity compared to judicial proceedings. This has implications for the patent holder, as it may face challenges from entities seeking to invalidate the patent[2].

Role of Nonpracticing Entities (NPEs)

Nonpracticing entities, often referred to as "patent trolls," play a significant role in patent litigation.

NPE Litigation Trends

• NPEs, which do not manufacture or sell the patented products, have been known to bring a significant portion of patent infringement lawsuits. The increase in NPE litigation can be attributed to various factors, including changes in patent law and the ease of challenging patents through PTAB[1].

Impact on Patent Quality

• The rise of NPE litigation has led to concerns about patent quality. Poor-quality patents can fuel litigation, and the USPTO has taken steps to improve patent quality by analyzing trends in patent infringement litigation and linking this information to internal data on the patent examination process[1].

Use of AI Tools in Patent Applications

The increasing use of AI tools in patent applications also needs consideration.

Disclosure Requirements

• If AI tools are used in the drafting of patent applications, this must be disclosed to the USPTO. The contribution of AI to the invention, especially if it introduces alternative embodiments not conceived by the inventor, is material and must be assessed to ensure compliance with inventorship requirements[5].

Risk Mitigation

• Practitioners must verify the accuracy of documents prepared with AI assistance to avoid introducing inaccurate statements or omitting material information. This ensures that the patent application process remains transparent and compliant with USPTO guidelines[5].

Strategic Insights from Patent Landscape Analysis

A comprehensive patent landscape analysis can uncover strategic insights that are crucial for business and R&D management.

Identifying Niche Technologies

• By analyzing the patent landscape, one can identify underappreciated niche technologies that may offer significant opportunities. For example, if a company is considering investing in a new technology area, a detailed assessment of existing and pending patents can guide this decision[3].

Long-Term Decision Making

• The analysis helps in making long-term decisions about technology development. If a technology area is highly saturated, it may be wise to pivot to newer, less crowded areas to avoid potential litigation and competition[3].

Key Takeaways

• Claim Analysis: Carefully examine the claims for clarity, specificity, and breadth to understand the scope of protection.
• Patent Landscape: Analyze the geographical spread, saturation, and historical trends to understand the competitive landscape.
• Legal Changes: Consider the impact of recent patent law changes, such as the AIA and PTAB procedures.
• NPEs: Be aware of the role of nonpracticing entities and their potential impact on patent litigation.
• AI Tools: Ensure compliance with USPTO guidelines when using AI tools in patent applications.

FAQs

1. What is the significance of the Leahy-Smith America Invents Act (AIA) in patent law?

   • The AIA introduced significant changes, including the creation of PTAB and new procedures for challenging patent validity, aimed at improving patent quality and reducing litigation costs[2].

2. How does the Patent Trial and Appeal Board (PTAB) impact patent litigation?

   • PTAB provides a faster and less expensive way to challenge patent validity compared to judicial proceedings, which can affect the enforceability of patents[2].

3. What role do nonpracticing entities (NPEs) play in patent litigation?

   • NPEs, which do not manufacture or sell patented products, bring a significant portion of patent infringement lawsuits, often targeting companies with the aim of licensing or settling[1].

4. Why is it important to disclose the use of AI tools in patent applications?

   • Disclosure is necessary to ensure compliance with inventorship requirements and to avoid introducing inaccurate statements or omitting material information[5].

5. How can a patent landscape analysis benefit business and R&D management?

   • It provides strategic insights by identifying niche technologies, assessing market saturation, and guiding long-term decisions about technology development and investment[3].

Sources

1. GAO Report: Assessing Factors That Affect Patent Infringement Litigation[1].
2. Congressional Research Service: The Patent Trial and Appeal Board and Inter Partes Review[2].
3. AcclaimIP: Patent Landscape Analysis - Uncovering Strategic Insights[3].
4. USPTO: Search for patents[4].
5. Buchanan Ingersoll & Rooney PC: U.S. Patent Office Issues Additional Guidance on Use of AI Tools[5].

Details for Patent 10,059,925

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127	August 31, 2005	10,059,925	2035-08-03
Glaxosmithkline Biologicals	FLUARIX, FLUARIX QUADRIVALENT	influenza vaccine	Injection	125127	December 14, 2012	10,059,925	2035-08-03
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	October 05, 2006	10,059,925	2035-08-03
Id Biomedical Corporation Of Quebec	FLULAVAL, FLULAVAL QUADRIVALENT	influenza vaccine	Injection	125163	November 10, 2009	10,059,925	2035-08-03