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Last Updated: December 23, 2024

Patent: 9,511,123


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Summary for Patent: 9,511,123
Title:Combined use of a sulfated glycosaminoglycan and a hyaluronidase for improving the bioavailability of factor VIII
Abstract: The present invention relates to pharmaceutical preparations comprising Factor VIII, a sulfated glycosaminoglycan and a hyaluronidase for the non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders. The invention further relates to the combined use of a Factor VIII, a sulfated glycosaminoglycan and a hyaluronidase for the treatment and prevention of bleeding disorders, and to a method for increasing the bioavailability after non-intravenous administration of Factor VIII by co-administration of a sulfated glycosaminoglycan and a hyaluronidase.
Inventor(s): Zollner; Sabine (Muri, CH), Metzner; Hubert (Marburg, DE)
Assignee: CSL Behring GmbH (Marburg, DE)
Application Number:14/351,502
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Analyzing the Claims and Patent Landscape of United States Patent 9,511,123

Introduction

To conduct a comprehensive and critical analysis of the claims and the patent landscape of United States Patent 9,511,123, it is essential to understand the broader context of patent law, the specific requirements for patent eligibility, and the trends in the relevant technology areas.

Understanding Patent Eligibility

Patent eligibility in the United States is governed by Title 35 of the United States Code, which includes requirements such as novelty (Section 102), non-obviousness (Section 103), and subject matter eligibility (Section 101)[5].

Subject Matter Eligibility

The subject matter eligibility requirement has been a point of contention, particularly since the U.S. Supreme Court's decision in Alice v. CLS Bank in 2014. This decision introduced a two-part test to determine whether a patent application recites patentable subject matter. The test involves determining if the claims are directed to an abstract idea, law of nature, or natural phenomenon, and if they contain an "inventive concept" that transforms the nature of the claim[2][5].

The Patent in Question: U.S. Patent 9,511,123

While the specific details of U.S. Patent 9,511,123 are not provided here, a general analysis can be conducted based on common practices and requirements.

Claims Analysis

  • Conception and Inventorship: The determination of proper inventorship focuses on the conception step, requiring the identification of each person who conceived the idea or ideas of the patent claims. Conception is complete when an idea is sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[4].
  • Claim Scope and Meaning: The first step in analyzing the claims is to determine the scope and meaning of each claim. This involves identifying the subject matter claimed and verifying which individuals conceived each of the claims[4].

Patent Landscape

  • Technology Area: Patents are classified into specific technology areas, which can be aggregated to analyze trends. For example, the USPTO classifies patents into 35 technical fields described by the World Intellectual Property Organization (WIPO) for international comparisons[1].
  • Trends in Patenting: The number of patents granted in specific technology areas can indicate trends and focus areas in innovation. For instance, electrical engineering patents, including those related to computer technology and digital communication, have seen significant increases over the years[1].

Administrative Challenges and Patent Validity

The Leahy-Smith America Invents Act (AIA) of 2011 introduced administrative procedures such as inter partes review (IPR) and post-grant review (PGR) to challenge the validity of patents before the Patent Trial and Appeal Board (PTAB). These procedures are often faster and less expensive than judicial proceedings and require a lower burden of proof to invalidate patents[2].

Impact on Patent Holders

  • Challenges to Patent Validity: The ease of challenging patents through IPR and PGR has led to concerns that the system undermines the U.S. patent system by allowing repeated attacks on the same patent, preventing patent owners from achieving quiet title[5].
  • Enforceability: Even if a court finds patent infringement, obtaining an injunction can be difficult due to the hurdles set by the Supreme Court's decision in eBay Inc. v. MercExchange, L.L.C.[5].

Global and Comparative Trends

  • International Patent Landscape: The WIPO classification system allows for international comparisons of patent trends. This can help in understanding the global context and competitive landscape of the technology area related to U.S. Patent 9,511,123[1][3].

Agrifood Sector Example

For instance, in the Agrifood sector, which includes AgriTech and FoodTech, there has been a significant increase in patents related to sustainable agriculture, precision agriculture, and alternative nutrient sources. This trend indicates a global focus on innovative technologies to ensure food security and sustainability[3].

Strengthening the U.S. Intellectual Property System

Experts recommend several actions to strengthen the U.S. intellectual property system, including clarifying patent eligibility requirements, strengthening patent enforceability, and improving data collection and transparency[5].

Clarifying Patent Eligibility

Legislation such as the Patent Eligibility Restoration Act of 2022 aims to resolve the confusion surrounding Section 101 of the U.S. Code, which has led to uncertainty for innovators and investors[5].

Strengthening Patent Enforceability

Efforts to strengthen patent enforceability include addressing the challenges posed by the PTAB and ensuring that patent holders can effectively enforce their patents without facing repeated and costly challenges[5].

Key Takeaways

  • Patent Eligibility: The eligibility of a patent is crucial and involves satisfying novelty, non-obviousness, and subject matter eligibility requirements.
  • Claims Analysis: Proper inventorship and claim scope are critical in determining the validity and enforceability of a patent.
  • Administrative Challenges: The PTAB and IPR/PGR procedures can significantly impact the validity and enforceability of patents.
  • Global Trends: Understanding global patent trends can provide insights into the competitive landscape and innovation focus areas.
  • Strengthening IP System: Clarifying eligibility requirements and strengthening enforceability are key to maintaining a robust intellectual property system.

FAQs

What are the key requirements for patent eligibility in the United States?

Patent eligibility in the U.S. requires satisfying novelty (Section 102), non-obviousness (Section 103), and subject matter eligibility (Section 101) under the U.S. Code[5].

How does the PTAB impact patent validity?

The PTAB allows for administrative challenges to patent validity through IPR and PGR, which can be faster and less expensive than judicial proceedings but also pose challenges to patent holders by allowing repeated attacks on the same patent[2].

What is the significance of the Alice v. CLS Bank decision?

The Alice v. CLS Bank decision introduced a two-part test to determine whether a patent application recites patentable subject matter, which has been a point of contention and uncertainty for innovators and investors[2][5].

How do global patent trends influence U.S. patent strategies?

Global patent trends, such as those in the Agrifood sector, indicate areas of innovation focus and can influence U.S. patent strategies by highlighting competitive landscapes and emerging technologies[1][3].

What steps are being taken to strengthen the U.S. intellectual property system?

Steps include clarifying patent eligibility requirements, strengthening patent enforceability, and improving data collection and transparency to build a strong, reliable, and predictable IP ecosystem[5].

Cited Sources

  1. National Science Foundation, "Invention: U.S. and Comparative Global Trends," January 15, 2020.
  2. Congressional Research Service, "The Patent Trial and Appeal Board and Inter Partes Review," June 29, 2023.
  3. World Intellectual Property Organization, "Patent Landscape Report - Agrifood," 2023.
  4. Oregon State University, "Determining Inventorship for US Patent Applications," 2023.
  5. Center for Strategic and International Studies, "Four Actions to Strengthen the U.S. Intellectual Property System," August 28, 2023.

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Details for Patent 9,511,123

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 May 05, 2004 9,511,123 2031-10-18
Bausch & Lomb Incorporated VITRASE hyaluronidase Injection 021640 December 02, 2004 9,511,123 2031-10-18
Amphastar Pharmaceuticals, Inc. AMPHADASE hyaluronidase Injection 021665 October 26, 2004 9,511,123 2031-10-18
Akorn, Inc. HYDASE hyaluronidase Injection 021716 October 25, 2005 9,511,123 2031-10-18
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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