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Last Updated: December 23, 2024

Patent: 7,923,008


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Summary for Patent: 7,923,008
Title:Methods for decreasing osteoclast formation or bone resorption using an antibody to osteoprotegerin binding protein
Abstract: A novel polypeptide, osteoprotegerin binding protein, involved in osteolcast maturation has been identified based upon its affinity for osteoprotegerin. Nucleic acid sequences encoding the polypeptide, or a fragment, analog or derivative thereof, vectors and host cells for production, methods of preparing osteoprotegerin binding protein, and binding assays are also described. Compositions and methods for the treatment of bone diseases such as osteoporosis, bone loss due to arthritis or metastasis, hypercalcemia, and Paget\'s disease are also provided.
Inventor(s): Boyle; William J. (Moorpark, CA)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:11/336,067
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive Analysis of United States Patent 7,923,008: Methods for Decreasing Osteoclast Formation or Bone Resorption

Introduction

United States Patent 7,923,008, titled "Methods for decreasing osteoclast formation or bone resorption using an antibody to osteoprotegerin binding protein," is a patent that addresses a significant medical need in the field of bone health. This analysis will delve into the claims, the patent landscape, and the implications of this patent.

Patent Claims and Scope

The patent claims cover methods for decreasing osteoclast formation or bone resorption using an antibody to osteoprotegerin binding protein. Here are the key aspects of the claims:

  • Claim 1: This claim is broad and encompasses the method of using an antibody to osteoprotegerin binding protein to decrease osteoclast formation or bone resorption.
  • Dependent Claims: These claims narrow down the scope by specifying particular aspects such as the type of antibody, the method of administration, and the specific conditions treated (e.g., osteoporosis, rheumatoid arthritis)[4].

Inventorship and Ownership

Determining proper inventorship is crucial for the validity and enforceability of a patent. For US Patent 7,923,008, the inventors must have conceived the idea of using an antibody to osteoprotegerin binding protein for the specified medical purposes. Inventorship is defined by the conception step, where the formation of a definite and permanent idea of the complete and operative invention is key[1].

Patent Landscape and Prior Art

The patent landscape in the field of bone health and osteoclast regulation is complex and densely populated. Prior art searches are essential to ensure the novelty and non-obviousness of the invention.

  • Prior Art Searches: Conducting thorough prior art searches using patent databases helps identify existing technologies that may affect the validity or patentability of the new invention. This is crucial for ensuring that the methods claimed in US Patent 7,923,008 are not anticipated by prior art[5].
  • Competitor Analysis: Analyzing patents held by competitors in the same field can provide strategic insights. For example, identifying white spaces or areas with fewer patents can indicate potential opportunities for innovation and help in refining R&D strategies[5].

Freedom to Operate (FTO) Analysis

FTO analysis is vital to ensure that the methods described in US Patent 7,923,008 do not infringe on existing patents. This involves assessing whether the product or process may infringe on existing patents, thereby avoiding legal disputes and costly patent infringement litigation.

  • Risk Mitigation: Conducting FTO analysis helps businesses avoid legal risks by ensuring they have the right to manufacture, use, or sell their products without violating someone else's intellectual property rights[5].

Valuation and Strategic Planning

Patents like US Patent 7,923,008 can represent significant assets for a company. Effective patent analysis helps in determining the value of these patents, which is crucial for licensing, mergers and acquisitions, or seeking investment.

  • Market Assessment: Patent analysis provides insights into the size and dynamics of the market, helping businesses understand the competitive landscape and barriers to entry. This can inform decisions about entering new markets or expanding existing ones[5].

Litigation and Enforcement Risks

The patent landscape is also influenced by litigation and enforcement risks. Patent assertion entities (PAEs) often play a significant role in this area.

  • PAE Activity: PAEs, such as Litigation PAEs and Portfolio PAEs, can impact the enforcement and validity of patents. Litigation PAEs, in particular, are known for their aggressive litigation tactics, which can pose significant risks to patent holders[3].

Obviousness-Type Double Patenting (ODP)

The Federal Circuit has emphasized the importance of addressing ODP issues during patent prosecution. This is particularly relevant for patents that claim priority from the same application and receive Patent Term Adjustments (PTA).

  • Terminal Disclaimers: Failing to file terminal disclaimers can result in the invalidation of patents due to ODP concerns. This highlights the need for patent owners to be vigilant and proactive in addressing these issues during prosecution[2].

Technological and Medical Significance

The methods described in US Patent 7,923,008 have significant technological and medical implications. The use of antibodies to osteoprotegerin binding protein represents a novel approach to treating conditions related to bone resorption.

  • Emerging Trends: Analyzing patent data in this field can provide insights into emerging trends and technological advancements. This helps businesses stay competitive and make informed R&D decisions[5].

Competitive Intelligence

Monitoring competitors' patent activities is crucial for maintaining a competitive edge. This includes tracking their patent portfolios and assessing the strength of their intellectual property.

  • Competitor Patent Portfolios: Analyzing competitors' patents can help identify potential threats and develop strategies to protect and expand market share. This competitive intelligence is invaluable for strategic planning and risk mitigation[5].

Regulatory Compliance

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

  • Correct Inventorship: Errors in inventorship, especially those involving deceptive intent, can render a patent unenforceable. Therefore, thorough disclosure and accurate identification of inventors are critical[1].

Key Takeaways

  • Patent Claims and Scope: The patent claims must be carefully drafted to ensure they are novel, non-obvious, and fully supported by the specification.
  • Prior Art and FTO Analysis: Thorough prior art searches and FTO analysis are essential to avoid infringement and ensure the validity of the patent.
  • Valuation and Strategic Planning: Effective patent analysis is crucial for determining the value of the patent and informing strategic business decisions.
  • Litigation and Enforcement Risks: Being aware of PAE activity and addressing ODP concerns during prosecution are vital for maintaining the enforceability of the patent.
  • Technological and Medical Significance: The patent represents a significant advancement in the treatment of bone-related conditions and highlights the importance of staying abreast of emerging trends in the field.

FAQs

Q: What is the primary focus of US Patent 7,923,008?

A: The primary focus is on methods for decreasing osteoclast formation or bone resorption using an antibody to osteoprotegerin binding protein.

Q: Why is prior art searching important for this patent?

A: Prior art searching is crucial to ensure the novelty and non-obviousness of the invention, avoiding potential invalidation due to existing technologies.

Q: How does FTO analysis impact the enforcement of this patent?

A: FTO analysis helps ensure that the methods described do not infringe on existing patents, thereby avoiding legal disputes and costly litigation.

Q: What are the risks associated with PAE activity for this patent?

A: PAE activity, particularly from Litigation PAEs, can pose significant risks through aggressive litigation tactics, which can challenge the validity and enforceability of the patent.

Q: Why is addressing ODP concerns important during patent prosecution?

A: Failing to address ODP concerns and file terminal disclaimers can result in the invalidation of the patent, highlighting the need for proactive measures during prosecution.

Cited Sources

  1. Determination of proper inventorship for US Patent Applications - Oregon State University
  2. Federal Circuit Puts the Onus on Patent Owners to Disclaim Patent - Mintz
  3. Patent Assertion Entity Activity: An FTC Study - FTC
  4. US7923008B2 - Methods for decreasing osteoclast formation or bone resorption - Google Patents
  5. Patent Analysis - Evalueserve

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Details for Patent 7,923,008

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Amgen Inc. PROLIA denosumab Injection 125320 June 01, 2010 7,923,008 2017-04-16
Amgen Inc. XGEVA denosumab Injection 125320 November 18, 2010 7,923,008 2017-04-16
Takeda Pharmaceuticals U.s.a., Inc. NATPARA parathyroid hormone For Injection 125511 January 23, 2015 7,923,008 2017-04-16
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 7,923,008

Country Patent Number Estimated Expiration
South Africa 983189 ⤷  Subscribe
Yugoslavia 50699 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 9846751 ⤷  Subscribe
United States of America 7807795 ⤷  Subscribe
United States of America 7097834 ⤷  Subscribe
United States of America 6316408 ⤷  Subscribe
United States of America 5843678 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration

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