Patent: 11,028,448

Summary for Patent: 11,028,448

Title:	Methods of identifying risk of vascular endothelial growth factor (VEGF) pathway inhibitor-induced hypertension
Abstract:	The disclosure relates to methods of identifying subjects at risk of developing bevacizumab-induced toxicities such as proteinuria and/or hypertension involving measuring nucleic acid or gene mutations in a sample obtained from the subject.
Inventor(s):	Innocenti Federico, Quintanilha Julia, Lin Danyu, Owzar Kouros, Wang Jin
Application Number:	US16932002
Patent Claims:	see list of patent claims

Analyzing the Claims and Patent Landscape of United States Patent 11,028,448

Introduction

When analyzing a patent, such as United States Patent 11,028,448, it is crucial to delve into several key aspects, including the determination of inventorship, the claims of the patent, the patent landscape, and the potential challenges and validations processes. Here is a comprehensive analysis of these elements.

Determining Inventorship

Inventorship is a critical aspect of patent law, as it determines who has the right to the patent. In the United States, inventorship is defined by the conception of the idea and the reduction of that idea to practice. The conception step is paramount, requiring the identification of each person who conceived the idea or ideas represented by the patent claims[1].

• Conception: This is the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention. It must be complete and include every feature of the subject matter claimed in the patent.
• Reduction to Practice: While important, this step does not confer inventorship unless it involves more than ordinary skill in the field.

Analyzing the Claims

The claims of a patent define the scope of the invention and are crucial for determining what is protected.

• Claim Construction: The first step in analyzing the claims is to construe them to determine the subject matter for which patent protection is sought. This involves understanding the scope and meaning of each claim[2].
• Claim Types: Patents can have various types of claims, including independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.
• Claim Validity: The validity of the claims can be challenged through various mechanisms, such as inter partes review (IPR) and post-grant review (PGR), which are administrative challenges heard by the Patent Trial and Appeal Board (PTAB)[2].

Patent Landscape Analysis

Understanding the broader patent landscape is essential for assessing the strength and potential of a patent.

• Prior Art Search: Conducting a prior art search helps determine whether an invention is novel and non-obvious. This involves identifying existing technologies or innovations that may affect the validity or patentability of the new invention[3].
• Patent Family Analysis: Analyzing patent families helps determine the geographical coverage of a patent and whether it has been filed in multiple countries. This can indicate the global reach and potential value of the patent[3].
• Citation Analysis: Examining patent citations can provide insights into how a patent relates to prior and subsequent innovations, gauging its importance within a technological field[3].

Challenges to Patent Validity

Patents can face challenges to their validity through various legal and administrative processes.

• Inter Partes Review (IPR) and Post-Grant Review (PGR): These are administrative challenges to the validity of patents, heard by PTAB. These processes are often faster and less expensive than federal court litigation and use a lower standard of proof to invalidate patents[2].
• Federal Court Litigation: Patents can also be challenged in federal court, where the standard of proof to demonstrate invalidity is higher (clear and convincing evidence). This process is typically more time-consuming and expensive[2].

Patent Assertion Entities (PAEs)

PAEs, often referred to as "patent trolls," can significantly impact the patent landscape by asserting patents against various entities.

• Business Models: PAEs operate under two main business models: Portfolio PAEs, which negotiate licenses for large portfolios without necessarily suing, and Litigation PAEs, which often precede licenses with patent infringement suits[4].
• Impact on Patent Landscape: PAEs can affect the patent landscape by asserting patents across various industries, including those unrelated to the original field of the patent. This can lead to significant legal and financial burdens on the accused infringers[4].

Valuation and Strategic Use of Patents

Patents are valuable intellectual property assets that can be used strategically.

• Valuation of Intellectual Property: Patent analysis helps companies and inventors assess the value of their intellectual property portfolios, which is crucial for licensing, mergers and acquisitions, and negotiations with investors or partners[3].
• R&D Strategy: Analyzing patents in a particular field can help organizations refine their R&D strategies by identifying white spaces or areas with fewer patents, indicating potential opportunities for innovation[3].

Legal and Regulatory Compliance

Ensuring compliance with legal and regulatory requirements is vital for maintaining the validity and enforceability of a patent.

• Correct Inventorship: Proper determination of inventorship is crucial. Errors in inventorship can lead to the patent being invalid and unenforceable if there is deceptive intent[1].
• Prior Art Compliance: Conducting thorough prior art searches is essential to ensure that the invention is novel and non-obvious, which is a requirement for patentability[3].

Technology Transfer and Commercialization

Patent analysis facilitates the identification of technologies with commercial potential, aiding in the transfer of knowledge and technologies from research settings to the marketplace.

• Identifying Commercial Potential: By analyzing patents, universities, research institutions, and companies can identify technologies that have the potential to be commercialized[3].
• Market Insights: Patent analysis provides insights into the size and dynamics of a particular market, helping businesses understand the competitive landscape and barriers to entry[3].

Key Takeaways

• Inventorship: Accurate determination of inventorship is critical for the validity of a patent.
• Claim Analysis: Understanding the claims of a patent is essential for determining the scope of protection.
• Patent Landscape: Analyzing the broader patent landscape helps in assessing the strength and potential of a patent.
• Challenges to Validity: Patents can face challenges through IPR, PGR, and federal court litigation.
• Strategic Use: Patents can be used strategically for valuation, R&D, and technology transfer.

FAQs

Q: What is the significance of determining the correct inventors for a patent? A: Correct inventorship is crucial because it ensures the patent's validity and enforceability. Incorrect inventorship, especially with deceptive intent, can render the patent invalid and unenforceable[1].

Q: How do inter partes review (IPR) and post-grant review (PGR) differ from federal court litigation? A: IPR and PGR are administrative challenges heard by PTAB, which are generally faster, less expensive, and use a lower standard of proof compared to federal court litigation[2].

Q: What role do Patent Assertion Entities (PAEs) play in the patent landscape? A: PAEs assert patents against various entities, often using two business models: Portfolio PAEs and Litigation PAEs. They can significantly impact the patent landscape by asserting patents across different industries[4].

Q: Why is prior art search important in the patent application process? A: Prior art search is essential to determine whether an invention is novel and non-obvious, which are requirements for patentability[3].

Q: How can patent analysis aid in technology transfer and commercialization? A: Patent analysis helps identify technologies with commercial potential, facilitating the transfer of knowledge and technologies from research settings to the marketplace[3].

Sources

1. Determining Inventorship for US Patent Applications - Oregon State University[1]
2. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service[2]
3. Patent Analysis - Evalueserve[3]
4. Patent Assertion Entity Activity: An FTC Study - Federal Trade Commission[4]

Details for Patent 11,028,448

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	June 04, 1986	11,028,448	2040-07-17
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		11,028,448	2040-07-17
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	Injection	103132		11,028,448	2040-07-17