Patent: 10,004,745

Summary for Patent: 10,004,745

Title:	Use of inhibitors of Bruton\'S tyrosine kinase (Btk)
Abstract:	Disclosed herein are methods for treating a cancer comprising: a. administering a Btk inhibitor to a subject sufficient to result in an increase or appearance in the blood of a subpopulation of lymphocytes defined by immunophenotyping; b. determining the expression profile of one or more biomarkers from one or more subpopulation of lymphocytes; and c. administering a second agent based on the determined expression profile.
Inventor(s):	Buggy; Joseph J. (Mountain View, CA), Elias; Laurence (Berkeley, CA), Fyfe; Gwen (San Francisco, CA), Hedrick; Eric (Summit, NJ), Loury; David J. (San Jose, CA), Mody; Tarak D. (Sunnyvale, CA)
Assignee:	Pharmacyclics LLC (Sunnyvale, CA)
Application Number:	15/066,600
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 10,004,745

Introduction

When analyzing a patent, particularly one as complex as United States Patent 10,004,745, it is crucial to delve into the claims, the broader patent landscape, and the implications of these elements on innovation and competition. This analysis will cover the key aspects of the patent, the context within which it exists, and the strategic insights it provides.

Understanding the Patent Claims

Patent claims are the heart of any patent, defining the scope of the invention and what is protected under the patent. For a patent like 10,004,745, the claims must be carefully examined to understand the specific innovations and how they differentiate from prior art.

Claim Structure and Scope

• Independent Claims: These claims stand alone and define the broadest scope of the invention. They are crucial for understanding the core innovation.
• Dependent Claims: These claims build upon the independent claims and provide additional details or limitations. They help in narrowing down the scope and can be used to defend against infringement claims[3].

Claim Analysis

To analyze the claims of 10,004,745, one must identify the key elements, such as the subject matter, the novel features, and how these claims interact with existing patents in the field. This involves a detailed review of the claim language, the specifications, and any drawings or diagrams provided.

Patent Landscape Analysis

A comprehensive patent landscape analysis is essential for understanding the position of 10,004,745 within its technological field.

Geographical Spread

• Global Patent Filings: Analyzing where the patent has been filed globally can provide insights into the strategic priorities of the patent holder. This includes identifying regions where the technology is most valuable or where competition is highest[3].

Saturation of the Patent Space

• Competitor Activity: Assessing the number of patents and patent applications in the same technological area helps in understanding the level of competition and saturation. This can guide decisions on whether to invest further in this space or to pivot to less crowded areas[3].

New Entrants and Market Dynamics

• Emerging Players: Identifying new entrants into the patent space can indicate shifts in market dynamics and potential future competitors. This is crucial for strategic planning and maintaining a competitive edge[3].

Time-Slicing and Historical Trends

• Evolution of Technology: Analyzing the patent landscape over time (time-slicing) reveals how the technology has evolved, which areas are becoming more or less prominent, and why. This helps in predicting future trends and making informed decisions about research and development[3].

Impact on Innovation and Competition

Patent Thickets and Terminal Disclaimers

• Pharmaceutical Sector: In the pharmaceutical industry, the practice of obtaining multiple patents (patent thickets) and using terminal disclaimers can significantly impact competition. The USPTO has proposed rules to address this issue by linking the enforceability of terminally disclaimed patents, thereby reducing the incentive to accumulate weak secondary patents[1].

Quality of Patents

• USPTO Metrics: The USPTO has introduced various metrics to measure patent quality, including the Composite Quality Metric and the Enhanced Patent Quality Initiative. These metrics help in ensuring that patents are of high quality, valid, and not used to unfairly delay generic or biosimilar market entry[2].

Strategic Insights

Navigating Highly Saturated Patent Spaces

• Alternative Technologies: In highly saturated patent spaces, it is often challenging to secure claims. A comprehensive patent landscape analysis can help identify alternative technologies or niche areas that may offer better opportunities for innovation and patent protection[3].

Decision-Making for R&D and Business

• Long-Term Planning: The insights from a patent landscape analysis are critical for long-term decisions in research and development. It helps business and R&D management decide whether to continue investing in a particular technology area or to pivot to newer, less crowded spaces[3].

Case Study: Pharmaceutical Patents

Example of IMBRUVICA

• The drug IMBRUVICA, manufactured by Johnson and Johnson, illustrates the issue of patent thickets. With 41 patents listed, 75% of which are terminally disclaimed, this example highlights the complexity and potential barriers to generic and biosimilar entry caused by such practices[1].

Debunking False Narratives

USPTO Study on Drug Patents

• A recent USPTO study debunked false narratives about pharmaceutical patents, showing that none of the 25 high-value innovative medicines studied enjoyed more than 18 total years of exclusivity. This study underscores the importance of accurate data in policy discussions and the role of patents in fostering innovation rather than hindering competition[5].

Key Takeaways

• Patent Claims: Carefully analyzing the claims of a patent is crucial for understanding the scope of protection and differentiating the invention from prior art.
• Patent Landscape: A comprehensive landscape analysis provides strategic insights into the geographical spread, saturation, and dynamics of the patent space.
• Innovation and Competition: High-quality patents and balanced regulatory practices are essential for fostering innovation while ensuring timely market entry for generic and biosimilar drugs.
• Strategic Decision-Making: Insights from patent landscape analysis are vital for long-term R&D and business decisions, helping to navigate highly saturated patent spaces and identify niche opportunities.

FAQs

1. What is the purpose of a patent landscape analysis?

   • A patent landscape analysis helps attorneys, portfolio managers, and other stakeholders provide strategic advice by analyzing the geographical spread, saturation, and dynamics of a technology patent area.

2. How do terminal disclaimers impact the pharmaceutical industry?

   • Terminal disclaimers can be used to delay generic and biosimilar market entry by creating patent thickets. The USPTO’s proposed rules aim to reduce this practice by linking the enforceability of terminally disclaimed patents.

3. What are the USPTO’s new patent quality metrics?

   • The USPTO introduced new metrics focusing on excellence in work products, measuring patent quality, and customer service. These metrics include clarity review items and transactional data to improve the consistency and transparency of patent examination quality.

4. Why is it important to analyze the geographical spread of patents?

   • Analyzing the geographical spread helps in understanding where the technology is most valuable and where competition is highest, guiding decisions on where to file patents and allocate resources.

5. How does the USPTO study on drug patents impact policy discussions?

   • The USPTO study debunks false narratives about pharmaceutical patents, showing that patents do not extend exclusivity beyond statutory limits. This study supports the role of patents in fostering innovation and corrects misrepresentations that have influenced legislative and regulatory proposals.

Sources

1. Letterhead DC Office - Regulations.gov

   • "Our patents reflect important innovative and inventive steps that the United States Patent and Trademark Office agreed merit protection."
   • [PDF] Letterhead DC Office - Regulations.gov

2. Quality, Quantity and Comments: USPTO's New Patent Quality Metrics

   • "The 2017 Proposed Changes include a single standardized review that replaces the review-specific forms used in the Composite Quality Metric."
   • https://www.klgates.com/Quality-Quantity-and-Comments-USPTOs-New-Patent-Quality-Metrics-03-29-2016

3. Patent Landscape Analysis - Uncovering Strategic Insights

   • "Patent landscape analysis enables attorneys, portfolio managers, and others tasked with making critical IP-related decisions to provide more strategic advice."
   • https://www.acclaimip.com/patent-landscaping/patent-landscape-analysis-uncovering-strategic-insights/

4. United States Patent - googleapis.com

   • "Mutational analysis of the IKBa gene in activated B cell-like diffuse large B-cell lymphoma,"
   • [PDF] United States Patent - googleapis.com

5. Debunked: USPTO Findings Should End False Pharma Patent Narratives

   • "The USPTO study clearly debunks false narratives that resulted in legislative and regulatory proposals harmful to innovation."
   • https://ipwatchdog.com/2024/10/28/debunked-uspto-findings-end-false-pharma-patent-narratives/id=182568/

Details for Patent 10,004,745

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	RITUXAN	rituximab	Injection	103705	November 26, 1997		2030-06-03
Genentech, Inc.	RITUXAN HYCELA	rituximab and hyaluronidase human	Injection	761064	June 22, 2017		2030-06-03