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Last Updated: January 7, 2025

Patent: 8,791,070


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Summary for Patent: 8,791,070
Title:Glycopegylated factor IX
Abstract:Conjugates between Factor IX and PEG moieties. are disclosed in the present application. The conjugates are linked via a glycosyl linking group interposed between and covalently attached to the peptide and the modifying group. Conjugates are formed from glycosylated peptides by the action of a glycosyltransferase. The glycosyltransferase ligates a modified sugar moiety onto a glycosyl residue on the peptide. Also provided are methods for preparing the conjugates, methods for treating various disease conditions with the conjugates, and pharmaceutical formulations including the conjugates.
Inventor(s):DeFrees Shawn, Bayer Robert J., Bowe Caryn, Paneerselvam Krishnasamy
Assignee:Novo Nordisk A/S
Application Number:US14052442
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 8,791,070

Introduction

Understanding the nuances of a specific patent, such as United States Patent 8,791,070, involves a detailed analysis of its claims, the broader patent landscape, and the regulatory environment in which it was granted. This article will delve into these aspects, providing insights into the patent's validity, the challenges it might face, and the implications for similar patents.

Understanding the Patent

To begin, it is crucial to understand the subject matter of the patent in question. However, since the specific details of U.S. Patent 8,791,070 are not provided, we will use general principles to analyze its claims and the surrounding patent landscape.

Claims Analysis

Claim Structure and Scope

Patent claims are the heart of any patent, defining the scope of the invention and what is protected. A thorough analysis of the claims involves examining their clarity, specificity, and breadth. Claims that are too broad may be challenged for lack of novelty or non-obviousness, while overly narrow claims may not provide sufficient protection[2].

Patentability Requirements

For a patent to be granted, the invention must meet the requirements of novelty, non-obviousness, and utility. The claims must be directed to eligible subject matter, avoiding laws of nature, natural phenomena, and abstract ideas unless they contain an inventive concept that transforms the nature of the claim[2].

The Patent Landscape

Technology Field

The technology field in which the patent is classified can significantly impact its validity and enforcement. For instance, fields like "Drugs and Medical Instruments" and "Computers and Communications" have seen a decrease in patent allowance rates over time, indicating stricter examination standards[1].

Prior Art and Citation Dynamics

The presence of prior art and the citation dynamics of the patent can indicate its novelty and impact. Patents with high forward citation counts are generally considered more valuable and influential in their field[3].

Regulatory Environment

Leahy-Smith America Invents Act (AIA)

The AIA introduced significant changes to U.S. patent law, including the creation of the Patent Trial and Appeal Board (PTAB) and procedures like inter partes review (IPR) and post-grant review (PGR). These mechanisms allow for more efficient and cost-effective challenges to patent validity compared to federal court litigation[2].

PTAB and IPR/PGR

PTAB procedures are often preferred by entities accused of patent infringement due to their faster and less expensive nature, as well as the lower burden of proof required to invalidate patents. This can pose a significant challenge to the validity of patents, including U.S. Patent 8,791,070, if it is subject to such reviews[2].

Economic and Litigation Implications

Patent Values and Litigation Costs

The economic value of a patent is influenced by its renewal choices, citation dynamics, and the overall technology landscape. High-value patents are more likely to be litigated, and the costs associated with patent litigation can be substantial. The USPTO's Patent Litigation Docket Report Data provides insights into these costs and the frequency of litigation in various technology fields[3].

Impact of Patent Trolls

The AIA aimed to reduce litigation by "patent trolls" by providing mechanisms to weed out poor-quality patents. However, critics argue that PTAB has made it too easy to challenge patents, creating uncertainty and potentially stifling innovation[2].

Challenges and Validity

Continuation Procedures

The use of continuation procedures, such as Requests for Continued Examination (RCEs), can extend the prosecution process but also increase the chances of patent allowance. However, these procedures can also complicate the patent landscape by creating multiple related applications[1].

Examination Pendency and Backlog

The average pendency times for patent applications and the backlog of unexamined applications can affect the timing and likelihood of patent grant. Efficient management of these factors by the USPTO is crucial for maintaining a predictable and reliable IP protection system[4].

Case Studies and Industry Insights

Industry Expert Opinions

Industry experts often highlight the importance of patent quality and the need for a balanced IP system. For example, the Center for Strategic and International Studies (CSIS) suggests that strengthening the IP system involves initiatives such as improving patent quality and reducing unwarranted litigation costs[5].

Statistical Insights

Studies have shown that only about 55.8% of patent applications are granted without using continuation procedures. This rate has decreased over time, particularly in certain technology fields. Such statistics provide context for the challenges faced by patent applicants and the rigor of the examination process[1].

Key Takeaways

  • Claims Clarity and Scope: The specificity and breadth of patent claims are critical for determining the scope of protection and potential challenges.
  • Regulatory Environment: The AIA and PTAB procedures significantly impact the validity and enforcement of patents.
  • Economic Implications: Patent values and litigation costs are influenced by various factors, including citation dynamics and the technology landscape.
  • Challenges and Validity: Continuation procedures and examination pendency times can affect the likelihood and timing of patent grant.
  • Industry Insights: Maintaining a balanced IP system involves improving patent quality and reducing litigation costs.

FAQs

Q: What is the average allowance rate for U.S. patent applications? A: The average allowance rate for U.S. patent applications without using continuation procedures is approximately 55.8%[1].

Q: How do PTAB procedures differ from federal court litigation? A: PTAB procedures are generally faster, cheaper, and require a lower burden of proof to invalidate patents compared to federal court litigation[2].

Q: What are the main challenges faced by patent applicants in the current landscape? A: Patent applicants face challenges such as stricter examination standards, the use of continuation procedures, and the potential for PTAB reviews[1][2].

Q: How do patent values relate to citation dynamics and technology fields? A: Patent values are significantly influenced by citation dynamics and the technology field in which the patent is classified. High forward citation counts often indicate higher patent values[3].

Q: What are the implications of the Leahy-Smith America Invents Act for patent litigation? A: The AIA has introduced mechanisms like IPR and PGR, which provide a more efficient and cost-effective way to challenge patent validity, potentially reducing litigation costs and improving patent quality[2].

Sources

  1. Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
  2. Congressional Research Service. (2024). The Patent Trial and Appeal Board and Inter Partes Review. Congressional Research Service Report R48016.
  3. USPTO. (2024). Working papers and book chapters. USPTO Economic Working Papers.
  4. Federal Register. (2024). Trademark Office (USPTO) proposes to set or adjust patent fees. Federal Register/Vol. 89, No. 65.
  5. Center for Strategic and International Studies. (2023). Four Actions to Strengthen the U.S. Intellectual Property System. CSIS Analysis.

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Details for Patent 8,791,070

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 May 31, 2017 8,791,070 2033-10-11
Novo Nordisk Inc. REBINYN coagulation factor ix (recombinant), glycopegylated For Injection 125611 August 11, 2022 8,791,070 2033-10-11
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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