Analyzing the Scope and Claims of United States Patent 9,265,784
Introduction
United States Patent 9,265,784, titled "Trastuzumab-DM1: building a chemotherapy free road in the treatment of human epidermal growth factor receptor 2-positive breast cancer," is a significant patent in the field of oncology. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignees
The patent was invented by Isakoff and Baselga and assigned to Genentech, Inc., a leading biotechnology company. This assignment indicates that the patent is part of Genentech's intellectual property portfolio, which is crucial for their research and development in cancer treatments[5].
Patent Publication and Grant
The patent was granted on January 30, 2014. Understanding the publication and grant dates is essential for determining the patent's validity period and any potential prior art that may have influenced the invention.
Scope of the Patent
Background and Motivation
The patent addresses the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer, a subtype of breast cancer that is aggressive and often requires targeted therapies. The invention aims to provide a chemotherapy-free treatment option using Trastuzumab-DM1, an antibody-drug conjugate (ADC)[5].
Technical Details
Trastuzumab-DM1 combines the monoclonal antibody Trastuzumab with the cytotoxic agent DM1. This ADC targets HER2-positive cancer cells, delivering the cytotoxic agent directly to the cancer cells while minimizing damage to healthy cells. The patent describes the composition, method of preparation, and the therapeutic uses of Trastuzumab-DM1[5].
Claims Analysis
Independent and Dependent Claims
The patent includes a set of independent and dependent claims that define the scope of the invention. Independent claims typically outline the broadest aspects of the invention, while dependent claims narrow down the scope by adding additional limitations.
- Independent Claims: These claims define the core aspects of the invention, such as the composition of Trastuzumab-DM1, its method of preparation, and its use in treating HER2-positive breast cancer.
- Dependent Claims: These claims build upon the independent claims by adding specific details, such as the dosage regimen, the type of linker used between the antibody and the cytotoxic agent, and the specific patient populations that can be treated[5].
Claim Construction
Claim construction is crucial for understanding the patent's scope. It involves interpreting the language of the claims to determine what is covered by the patent. For example, the claims might specify the particular linker chemistry used in the ADC, which could impact the patent's enforceability against similar but distinct ADCs[5].
Patent Landscape
Prior Art and Related Patents
To understand the patent landscape, it is essential to identify prior art and related patents. The USPTO's Patent Public Search tool and the Common Citation Document (CCD) application can be used to find prior art cited by various patent offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and SIPO)[1].
- Historical Patents: Historical patents related to antibody-drug conjugates and HER2-targeting therapies can provide context on how the field has evolved. Resources like the NYPL Libguides and the Hathi Trust offer access to historical patent documents[4].
Competing Patents and Litigation
The patent landscape also includes competing patents and potential litigation. Companies like Roche and other biotech firms may have similar patents in the field of ADCs. The Patent Claims Research Dataset by the USPTO can provide insights into claim-level statistics and document-level statistics, helping to identify potential overlaps or conflicts[3].
Global Dossier and International Implications
Global Patent Family
The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This is crucial for understanding the global reach of the patent and any international filings or grants[1].
Office Actions and Citations
The Global Dossier also provides Office Action Indicators and citation data, which can help in identifying any challenges or citations during the patent prosecution process. This information is vital for assessing the patent's strength and potential for enforcement in different jurisdictions[1].
Economic and Research Implications
Patent Claims Research Dataset
The Patent Claims Research Dataset by the USPTO offers detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. This dataset can be used to analyze trends in patent scope and claims in the biotechnology sector, providing insights into the economic impact of such patents[3].
Economic Impact
Patents like US 9,265,784 have significant economic implications. They can influence the development of new treatments, impact market competition, and affect healthcare costs. The economic working papers by the USPTO, such as "Patent Claims and Patent Scope," provide valuable insights into these economic aspects[3].
Conclusion
United States Patent 9,265,784 represents a critical advancement in the treatment of HER2-positive breast cancer. Understanding its scope, claims, and the broader patent landscape is essential for researchers, legal professionals, and business strategists.
Key Takeaways
- Invention Details: The patent describes Trastuzumab-DM1, an antibody-drug conjugate for treating HER2-positive breast cancer.
- Claims Analysis: Independent and dependent claims define the patent's scope, including composition, preparation, and therapeutic use.
- Patent Landscape: Prior art, related patents, and global dossier information are crucial for understanding the patent's position and potential conflicts.
- Economic Implications: The patent has significant economic and research implications, influencing healthcare and market competition.
FAQs
Q1: What is the main invention described in US Patent 9,265,784?
The main invention is Trastuzumab-DM1, an antibody-drug conjugate for treating HER2-positive breast cancer.
Q2: Who are the inventors and assignees of the patent?
The inventors are Isakoff and Baselga, and the assignee is Genentech, Inc.
Q3: How can one search for prior art related to this patent?
One can use the USPTO's Patent Public Search tool and the Common Citation Document (CCD) application to find prior art cited by various patent offices.
Q4: What is the significance of the Global Dossier in this context?
The Global Dossier provides access to the patent family for a specific application, including related applications filed at participating IP Offices, along with citation data and office actions.
Q5: Where can one find detailed information on claims from U.S. patents?
The Patent Claims Research Dataset by the USPTO offers detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014.
Sources
- USPTO - Search for patents
- ACUS - U.S. Patent Small Claims Court
- USPTO - Patent Claims Research Dataset
- NYPL Libguides - How to Search for an Historical U.S. Patent
- US Patent 9,265,784 - Trastuzumab-DM1
