United States Patent 8,034,375: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,034,375, titled "Combinations and Modes of Administration of Therapeutic Agents and Combination Therapy," is a significant patent in the field of pharmaceuticals, particularly in the treatment of proliferative diseases such as cancer. This patent, assigned to Abraxis Bioscience, LLC, was issued on October 11, 2011. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Neil P. Desai and Patrick Soon-Shiong, both prominent figures in the biomedical field. The assignee, Abraxis Bioscience, LLC, is a company known for its innovative approaches in cancer treatment and drug delivery systems[4].
Background and Purpose
The patent focuses on combination therapy methods for treating proliferative diseases. It outlines various combinations and modes of administration of therapeutic agents aimed at improving treatment outcomes. This is particularly important in cancer treatment, where combination therapies often offer better results than single-agent treatments.
Claims
The patent includes 34 claims that describe different aspects of the invention. Here are some key points:
- Claim Scope: The claims cover specific combinations of therapeutic agents, including paclitaxel, which is a well-known chemotherapeutic agent. These combinations are designed to enhance the efficacy and reduce the side effects of cancer treatments[4].
- Modes of Administration: The patent details various modes of administration, such as injectable suspensions and other delivery systems, which are crucial for the effective delivery of therapeutic agents to the target sites in the body[4].
Technical Field and Classification
The patent is classified under several U.S. and international classifications, including:
- U.S. Classification: 424/450, 514/34, 514/40, 514/50
- International Classification: A61K 38/06, A61K 31/337, A61K 31/365
These classifications indicate the patent's relevance to pharmaceutical compositions, drug delivery systems, and therapeutic methods[4].
Patent Landscape
Related Patents
The patent is part of a larger portfolio of patents held by Abraxis Bioscience, LLC. Other related patents include:
- U.S. Patent Nos. 7,758,891, 7,820,788, 7,923,536, 8,138,229, 8,268,348, 8,314,156, 9,101,543, 9,393,318, 9,511,046, and 9,597,409. These patents collectively cover a range of compositions, methods of delivery, and combination therapies for various diseases[5].
Litigation and Enforcement
The patents, including U.S. Patent 8,034,375, have been involved in several litigation cases. For example, Celgene Corporation (the successor to Abraxis Bioscience) has filed patent infringement suits against generic drug manufacturers seeking to market generic versions of Abraxane®, a drug product covered by these patents[2][5].
Impact on Innovation
The patent has contributed significantly to the field of cancer treatment by providing innovative combination therapies and delivery methods. This has not only improved treatment outcomes but also encouraged further research and development in the pharmaceutical industry.
Practical Applications
Improvement in Treatment Outcomes
The combination therapies described in the patent have been shown to improve the efficacy of cancer treatments. For instance, the use of paclitaxel in combination with other agents has been found to enhance the therapeutic effects and reduce side effects compared to single-agent treatments[4].
Economic Impact
The patent has significant economic implications, particularly in the context of patent litigation and licensing. The enforcement of this patent and related patents has helped protect the intellectual property rights of Abraxis Bioscience, LLC, and its successors, ensuring a return on investment in research and development.
Patent Scope and Quality
Metrics for Patent Scope
Research on patent scope suggests that narrower claims, such as those found in U.S. Patent 8,034,375, are associated with a higher probability of grant and a shorter examination process. This is because narrower claims are typically more specific and less likely to face challenges during the examination process[3].
Clarity and Validity
The clarity and validity of the claims in U.S. Patent 8,034,375 are crucial for its enforceability. The patent office's two-pronged framework for evaluating patent subject matter eligibility, particularly under 35 U.S.C. § 101, emphasizes the importance of demonstrating practical applicability and technological advancements. This ensures that the claims are not overly broad and are directed to specific, concrete technological solutions[1].
Conclusion
United States Patent 8,034,375 is a pivotal patent in the field of cancer treatment, offering innovative combination therapies and delivery methods. The patent's scope, claims, and the broader patent landscape highlight its significance in both clinical and economic terms.
Key Takeaways
- Innovative Combination Therapies: The patent introduces specific combinations of therapeutic agents to enhance cancer treatment outcomes.
- Modes of Administration: It details various delivery systems, including injectable suspensions, to improve the efficacy of treatments.
- Patent Landscape: The patent is part of a larger portfolio of related patents and has been involved in significant litigation cases.
- Economic and Clinical Impact: The patent has substantial economic and clinical implications, protecting intellectual property rights and improving treatment outcomes.
- Patent Scope and Quality: The patent's narrower claims contribute to its clarity and validity, ensuring a higher probability of grant and enforceability.
FAQs
Q: What is the main focus of U.S. Patent 8,034,375?
A: The main focus is on combination therapy methods for treating proliferative diseases, particularly cancer, using specific combinations of therapeutic agents.
Q: Who are the inventors of this patent?
A: The inventors are Neil P. Desai and Patrick Soon-Shiong.
Q: What is the significance of the patent's classification?
A: The classifications (e.g., U.S. Classification: 424/450, 514/34) indicate the patent's relevance to pharmaceutical compositions and drug delivery systems.
Q: Has this patent been involved in any litigation?
A: Yes, the patent has been involved in several patent infringement cases, particularly against generic drug manufacturers.
Q: How does the patent contribute to the field of cancer treatment?
A: It provides innovative combination therapies and delivery methods, enhancing treatment outcomes and encouraging further research and development.
Sources
- The Importance of Prong Two of Step 2A for AI Inventions - Baker Botts
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT - USINOIP
- Patent Claims and Patent Scope - SSRN
- U.S. Patent No. 8,034,375 - Google Patents
- Litigation Documents - RPX Corporation
