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Last Updated: December 27, 2024

Patent: 5,814,605


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Summary for Patent: 5,814,605
Title: Therapeutic uses of keratinocyte growth factor
Abstract:Based on extensive in vivo studies in animals, it has now been discovered that KGF stimulates proliferation, growth and differentiation in various cells of epithelial tissue, besides keratinocytes. This better understanding of the biological effects of KGF in vivo enables the use of this polypeptide as a therapeutic agent, suitably formulated in a pharmaceutical composition, for the specific treatment of disease states and medical conditions afflicting tissues and organs such as the dermal adnexae, the liver, the lung, and the gastrointestinal tract.
Inventor(s): Pierce; Glenn Francis (Rancho Santa Fe, CA), Housley; Regina Mae (Thousand Oaks, CA), Morris; Charles Frederick (Newbury Park, CA)
Assignee: Amgen Inc. (Thousand Oaks, CA)
Application Number:08/484,065
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 5,814,605

Introduction

United States Patent 5,814,605, like any other patent, is a complex document that requires a thorough analysis to understand its claims, validity, and position within the broader patent landscape. This article will delve into the key aspects of this patent, including its claims, the legal framework governing it, potential challenges, and the current state of patent law in the United States.

Understanding the Patent Claims

To analyze the patent, it is crucial to start with the claims themselves. Patent claims define the scope of the invention and are the basis for determining infringement and validity. Here are some key points to consider:

Claim Structure

  • The claims of a patent are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

Claim Interpretation

  • The interpretation of patent claims is a critical step in understanding the patent's scope. This involves analyzing the language of the claims, the specification, and the prosecution history of the patent[3].

Legal Framework: America Invents Act (AIA)

The America Invents Act (AIA) of 2011 significantly altered the U.S. patent landscape. Here’s how it impacts the analysis of patent claims:

Post-Grant Review and Inter Partes Review

  • The AIA introduced new procedures for challenging patents, including Inter Partes Review (IPR) and Post-Grant Review (PGR). These procedures allow for the challenge of patent validity before the Patent Trial and Appeal Board (PTAB)[2].

Impact on Patent Litigation

  • The AIA aimed to improve patent quality and reduce unwarranted litigation costs. However, critics argue that PTAB has made it too easy to challenge patents, creating uncertainty and stifling innovation[2].

Obviousness-Type Double Patenting (ODP)

ODP is a doctrine that prevents the granting of multiple patents for the same invention or for inventions that are not patentably distinct from each other.

Case Law and Statutory Language

  • The Federal Circuit has ruled that ODP analysis must be performed on patents that have overlapping subject matter, even if they are part of the same patent family[1].

Practical Implications

  • For patents like U.S. Patent 5,814,605, ensuring that there is no ODP issue is crucial. This involves analyzing the patent's claims in relation to other patents in the same family or those that claim priority from the same application[1].

Patent Trial and Appeal Board (PTAB)

PTAB plays a significant role in the post-grant review process of patents.

Institution Rates and Challenges

  • PTAB's institution rates for IPR and PGR petitions have been increasing, indicating a higher likelihood of challenges to patent validity. This trend suggests that patents are more frequently being scrutinized for their validity[5].

Criticisms and Controversies

  • PTAB has been criticized for making it too easy to challenge patents, leading to uncertainty in patent rights. This criticism is particularly relevant for patents that are challenged multiple times through different procedures[2].

Patent Litigation Trends

Recent trends in patent litigation can provide insights into the challenges and opportunities facing patent holders.

Rise in NPE Filings

  • Non-Practicing Entities (NPEs) continue to play a significant role in patent litigation. The increase in NPE filings indicates a higher risk for patent holders to face litigation challenges[5].

Reexamination Requests

  • The number of reexamination requests has also increased, with a significant portion of these requests overlapping with district court litigation and PTAB challenges. This indicates a multi-pronged approach by challengers to invalidate patents[5].

Eligible Subject Matter and Patentability

The eligibility of subject matter is a critical aspect of patent law.

Alice/Mayo Test

  • The Alice/Mayo test is used to determine whether patent claims are directed to ineligible subject matter, such as laws of nature, natural phenomena, or abstract ideas. If the claims are directed to such subject matter, they must contain an "inventive concept" to be patentable[2].

Practical Application

  • For U.S. Patent 5,814,605, ensuring that the claims pass the Alice/Mayo test is essential. This involves demonstrating that the invention is more than just an abstract idea or a natural phenomenon[2].

International and National Patent Landscape

The global patent landscape can influence the validity and enforceability of U.S. patents.

Provisional Patents and Priority

  • Provisional patents, often used to quickly protect an invention, can impact the priority and validity of subsequent utility patents. Ensuring that all necessary information is included in these provisional patents is crucial[4].

Cross-Border Challenges

  • Patents that are part of international patent families face additional challenges, including variations in patent laws and procedures across different jurisdictions[4].

Key Takeaways

  • Claims Analysis: Thoroughly analyze the claims to understand the scope of the invention.
  • AIA Procedures: Be aware of the post-grant review procedures under the AIA and their potential impact on patent validity.
  • ODP: Ensure that the patent does not violate the doctrine of obviousness-type double patenting.
  • PTAB Challenges: Anticipate potential challenges from PTAB and the increasing trend of patent litigation.
  • Eligible Subject Matter: Ensure that the patent claims are directed to eligible subject matter and contain an "inventive concept" if necessary.

FAQs

What is the significance of the America Invents Act (AIA) in patent law?

The AIA introduced new procedures for challenging patents, such as Inter Partes Review (IPR) and Post-Grant Review (PGR), aimed at improving patent quality and reducing litigation costs[2].

How does the Patent Trial and Appeal Board (PTAB) impact patent validity?

PTAB can invalidate patent claims through IPR and PGR procedures, which has led to increased scrutiny of patent validity and criticism for creating uncertainty in patent rights[2].

What is the Alice/Mayo test, and why is it important?

The Alice/Mayo test is used to determine if patent claims are directed to ineligible subject matter. It requires that claims contain an "inventive concept" to be patentable, ensuring that patents are not granted for abstract ideas or natural phenomena[2].

How do provisional patents affect the priority and validity of subsequent utility patents?

Provisional patents can impact the priority of subsequent utility patents. Ensuring all necessary information is included in these provisional patents is crucial to maintain the validity and priority of the subsequent patents[4].

What are the current trends in patent litigation, and how do they affect patent holders?

Current trends show an increase in NPE filings and reexamination requests, indicating a higher risk for patent holders to face litigation challenges. This necessitates a proactive approach to defending patent validity[5].

Sources

  1. In re Cellect - United States Court of Appeals for the Federal Circuit. (2023, August 28). IN RE: CELLECT, LLC.
  2. The Patent Trial and Appeal Board and Inter Partes Review - Congressional Research Service. (2023, June 29).
  3. Chisum on Patents - LexisNexis Store.
  4. Invention, Knowledge Transfer, and Innovation - National Science Foundation. (2022, March 8).
  5. Q3 in Review: US NPE Upswing Continues as UPC Comes Further into Focus - RPX Corporation. (2024, October 8).

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Details for Patent 5,814,605

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Swedish Orphan Biovitrum Ab (publ) KEPIVANCE palifermin For Injection 125103 December 15, 2004 ⤷  Subscribe 2015-09-29
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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