United States Patent 8,003,819: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,003,819, assigned to Millennium Pharmaceuticals, Inc., is a significant patent in the pharmaceutical industry, particularly for the drug NINLARO (ixazomib). This patent is part of a broader portfolio that protects the intellectual property related to this drug. Here, we will delve into the scope, claims, and the patent landscape surrounding this patent.
Background of NINLARO
NINLARO (ixazomib) is a proteasome inhibitor used in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. The approval of NINLARO by the FDA marked a significant milestone in the treatment of multiple myeloma, and the associated patents play a crucial role in protecting this innovation[4].
Patent Details
Patent Number and Title
- Patent Number: 8,003,819
- Title: This patent is part of a series that includes claims related to the composition, synthesis, and use of ixazomib.
Inventors and Assignees
- Inventors: The inventors listed on the patent are key researchers and scientists from Millennium Pharmaceuticals, Inc.
- Assignees: The patent is assigned to Millennium Pharmaceuticals, Inc., which is now part of Takeda Pharmaceutical Company Limited.
Filing and Issue Dates
- Filing Date: The patent application was filed on a date prior to its issue, with the exact date available through the USPTO database.
- Issue Date: The patent was issued on August 23, 2011[2].
Scope and Claims
Claim Structure
The patent includes multiple claims that cover various aspects of ixazomib, including its composition, methods of synthesis, and therapeutic uses. Here are some key types of claims:
Composition Claims
These claims describe the chemical structure of ixazomib and related compounds. They are crucial for defining the scope of protection for the drug itself.
Method Claims
These claims cover the methods of synthesizing ixazomib, which are important for ensuring that the manufacturing process is protected.
Use Claims
These claims specify the therapeutic uses of ixazomib, including its use in combination with other drugs for treating multiple myeloma.
Claim Coverage Matrix
A Claim Coverage Matrix, as described in patent analytics, would help in understanding which specific claims of the patent are actively protecting the intellectual property related to NINLARO. This matrix categorizes claims by scope concepts, making it easier to identify gaps or opportunities in the patent coverage[3].
Patent Landscape
Related Patents
The patent 8,003,819 is part of a family of patents that include other related patents such as U.S. Patent Nos. 7,442,830, 7,687,662, and 8,859,504. These patents collectively provide a comprehensive protection for ixazomib, covering various aspects from synthesis to therapeutic applications[2][4].
Global Dossier
Using the Global Dossier service provided by the USPTO, one can access the file histories of related applications from participating IP Offices. This service helps in understanding the global patent family for NINLARO, including classification, citation data, and office actions[1].
Patent Term Extension
The patent term for U.S. Patent 8,003,819 was subject to extension due to the regulatory review period by the FDA. The FDA determined the regulatory review period for NINLARO, which included both the testing and approval phases, and this determination was used to calculate the potential patent term extension[4].
Regulatory Review Period
The regulatory review period for NINLARO, as determined by the FDA, was 2,538 days, which included 2,404 days in the testing phase and 134 days in the approval phase. This period was critical in determining the eligibility and extent of the patent term extension[4].
Patent Analytics and Claim Charts
Patent analytics tools, such as those provided by Schwegman, can help in analyzing the claims of U.S. Patent 8,003,819 and related patents. Claim charts generated by these tools can be reviewed by technical experts to determine the applicability of scope concepts to target products or methods, highlighting gaps in coverage and future design opportunities[3].
Public Search and Access
The USPTO's Patent Public Search tool and other resources like the Public Search Facility and Patent and Trademark Resource Centers (PTRCs) provide access to the patent documentation, including U.S. Patent 8,003,819. These resources are essential for conducting thorough patent searches and understanding the patent landscape[1].
Conclusion
Understanding the scope and claims of U.S. Patent 8,003,819 is crucial for navigating the intellectual property landscape related to NINLARO. This patent, along with its related patents, provides comprehensive protection for the drug, ensuring that Millennium Pharmaceuticals, Inc. (now part of Takeda) maintains its competitive edge in the market.
Key Takeaways
- Patent Details: U.S. Patent 8,003,819 covers the composition, synthesis, and therapeutic uses of ixazomib.
- Related Patents: Part of a family including U.S. Patent Nos. 7,442,830, 7,687,662, and 8,859,504.
- Regulatory Review: Subject to FDA regulatory review, with a determined review period of 2,538 days.
- Patent Term Extension: Eligible for patent term extension based on the regulatory review period.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for analyzing and managing the patent portfolio.
FAQs
Q: What is the main subject of U.S. Patent 8,003,819?
A: The main subject of U.S. Patent 8,003,819 is the composition, synthesis, and therapeutic uses of ixazomib (NINLARO).
Q: Who is the assignee of U.S. Patent 8,003,819?
A: The assignee of U.S. Patent 8,003,819 is Millennium Pharmaceuticals, Inc., now part of Takeda Pharmaceutical Company Limited.
Q: How long was the regulatory review period for NINLARO determined by the FDA?
A: The FDA determined the regulatory review period for NINLARO to be 2,538 days, including both the testing and approval phases.
Q: What tools can be used to analyze the claims of U.S. Patent 8,003,819?
A: Tools such as Claim Coverage Matrix and Claim Charts, provided by patent analytics services, can be used to analyze the claims and manage the patent portfolio.
Q: Where can one access the documentation for U.S. Patent 8,003,819?
A: The documentation for U.S. Patent 8,003,819 can be accessed through the USPTO's Patent Public Search tool, the Public Search Facility, and Patent and Trademark Resource Centers (PTRCs).
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- FDA U.S. FOOD & DRUG Re: NINLARO Patent: https://downloads.regulations.gov/FDA-2016-E-2466-0006/attachment_1.pdf
- Patent Analytics | Intellectual Property Law: https://www.slwip.com/services/patent-analytics/
- Federal Register - Determination of Regulatory Review Period: https://public-inspection.federalregister.gov/2018-00994.pdf
- The Honorable Michelle K. Lee Re: NINLARO Patent Nos: https://downloads.regulations.gov/FDA-2016-E-2466-0003/attachment_1.pdf
