Understanding the Scope and Claims of United States Patent RE46965: A Detailed Analysis
Introduction
Patent RE46965, issued to Eisai R&D Management Co., Ltd., is a significant patent in the pharmaceutical sector, particularly for the preparation of analogs of Halichondrin B. This patent is crucial for understanding the landscape of macrocyclic compounds and their applications in treating proliferative disorders. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Halichondrin B
Halichondrin B is a naturally occurring compound known for its potent antitumor activity. The development of analogs and intermediates for its synthesis is a critical area of research, given its potential in treating various cancers and other proliferative disorders[4].
Patent Details: RE46965
Inventors and Assignees
The patent RE46965 was invented by Austad Brian, Chase Charles E., Fang Francis G., Calkins Trevor, and Lewis Bryan M., and is assigned to Eisai R&D Management Co., Ltd.[2][4].
Publication and Issue Dates
The patent was issued on July 24, 2018, and is a reissue of an earlier patent, indicating ongoing development and refinement of the original invention[2][4].
Claims and Scope
The patent claims cover macrocyclic compounds, their synthesis, and intermediates used in their preparation. These compounds and their compositions are specifically designed for treating or preventing proliferative disorders. The claims are detailed and include specific chemical formulations, synthesis methods, and the utility of these compounds in medical treatments[4].
Chemical Formulations
The patent describes various chemical compounds, including those with specific functional groups and molecular structures. For example, it includes claims related to compounds with hydroxy groups, ether groups, and other chemical moieties essential for the biological activity of the analogs of Halichondrin B[4].
Synthesis Methods
The patent outlines detailed synthesis methods for these macrocyclic compounds, including reaction conditions, reagents, and intermediate steps. This is crucial for ensuring the reproducibility and efficacy of the compounds[4].
Exclusivity and Patent Expiration
The patent is part of a broader exclusivity framework granted by the FDA. While the patent itself expires on January 8, 2027, there are additional exclusivity periods that can extend the exclusive marketing rights. For instance, pediatric exclusivity can add up to six months to the patent term[2].
Patent Landscape Analysis
Identification of Competitors
Patent landscape analysis helps identify key competitors in the technology sector. For macrocyclic compounds like those covered by RE46965, this involves analyzing patents held by other pharmaceutical companies and research institutions. This analysis can reveal who is actively innovating in this space and potential licensing opportunities[3].
Scope of Patent Landscape Search
To conduct a comprehensive patent landscape analysis, it is essential to define the scope of the search clearly. This includes determining the regions to search, the time frame, and whether to include abandoned patents. For RE46965, the search would focus on patents related to macrocyclic compounds, their synthesis, and medical applications[3].
Patent Search Strategy
Formulating a patent search strategy involves identifying relevant patent and non-patent sources. This could include databases from the USPTO, WIPO, and EPO, as well as technical literature and collaborations with experts in the field. Key terms, patent class codes, and organizations operating in this technical field are crucial for collecting relevant data[3].
Categorization and Analysis
The collected data must be categorized and analyzed by technical and IP expert teams. This involves manual reading of patent documents to classify them based on title, abstract, claims, and full specifications. This step helps in identifying gaps, key inventors, filing year trends, and top filing countries[3].
Legal and Regulatory Considerations
Patent Expiration and Exclusivity
Understanding the patent expiration dates and exclusivity periods is vital for strategic planning. For RE46965, the patent expires on January 8, 2027, but additional exclusivities, such as pediatric exclusivity, can extend this period[2].
Antitrust and Competition Law
In the pharmaceutical sector, patent settlements and exclusivity agreements can raise antitrust concerns. For example, the case of CVS Pharmacy Inc. v. Forest Laboratories Inc. highlights the complexities of reverse payment settlements and the application of the antitrust "rule of reason" to ensure that such agreements do not stifle competition[1].
Market Impact and Strategic Implications
Market Developments
Patent landscape studies reveal significant market developments, such as mergers and acquisitions, in/out-licensing, and litigation activities. For companies like Eisai, understanding these trends is crucial for making informed decisions about R&D investments and licensing strategies[3].
Competitive Advantage
Holding a patent like RE46965 provides a competitive advantage by granting exclusive rights to the patent holder. This can be leveraged to develop new products, enhance existing ones, and negotiate favorable licensing agreements[3].
Key Takeaways
- Patent Scope and Claims: RE46965 covers macrocyclic compounds, their synthesis, and intermediates, with specific claims on chemical formulations and synthesis methods.
- Exclusivity and Expiration: The patent expires on January 8, 2027, with potential extensions due to exclusivity periods.
- Competitor Analysis: Patent landscape analysis helps identify competitors and potential licensing opportunities.
- Legal Considerations: Understanding antitrust laws and regulatory frameworks is essential for navigating the pharmaceutical patent landscape.
- Market Impact: The patent has significant implications for market strategies, including R&D investments and licensing agreements.
FAQs
What is the primary focus of United States Patent RE46965?
The primary focus of RE46965 is on macrocyclic compounds, their synthesis, and intermediates used in the preparation of analogs of Halichondrin B, which are useful for treating or preventing proliferative disorders.
Who are the inventors and assignees of RE46965?
The inventors are Austad Brian, Chase Charles E., Fang Francis G., Calkins Trevor, and Lewis Bryan M., and the assignee is Eisai R&D Management Co., Ltd.
When does the patent RE46965 expire?
The patent RE46965 expires on January 8, 2027.
What is the significance of patent landscape analysis in this context?
Patent landscape analysis helps in identifying competitors, understanding market trends, and making informed decisions about R&D investments and licensing strategies.
How do antitrust laws impact patent settlements in the pharmaceutical sector?
Antitrust laws, such as the Sherman Act and Clayton Act, require that patent settlements, especially those involving reverse payments, be scrutinized to ensure they do not stifle competition. The "rule of reason" is often applied to assess the procompetitive benefits and justifications of such agreements.
Sources
- Patent Litigation: "CVS Pharmacy Inc. v. Forest Laboratories Inc." - Patent Docs.
- Generic Halaven Availability: Drugs.com.
- Navigating Technological Domains with Patent Landscape Analysis: Sagacious Research.
- USRE46965E1 - Intermediates for the preparation of analogs of Halichondrin B: Google Patents.
