United States Patent 7,977,488: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,977,488, assigned to Takeda Pharmaceutical Company Limited, is a significant patent in the pharmaceutical industry, particularly for its implications in drug development and intellectual property protection. This patent, related to the compound vonoprazan, is crucial for understanding the patent landscape, scope, and claims associated with this innovative drug.
Background of the Patent
The patent, titled "1-Heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-)aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors," was granted on July 12, 2011. It was filed on August 29, 2006, as part of the international patent application PCT/JP2006/317408[4].
Inventors and Assignee
The inventors listed on the patent are Masahiro Kajino, Atsushi Hasuoka, and Haruyuki Nishida, all from Osaka, Japan. The assignee is Takeda Pharmaceutical Company Limited, a major pharmaceutical company based in Osaka, Japan[4].
Patent Scope and Claims
Chemical Composition
The patent describes a compound represented by a specific formula, which includes a monocyclic nitrogen-containing heterocyclic group optionally condensed with a benzene ring or a heterocycle. The compound is designed to inhibit acid secretion and is part of a broader class of 1-H-pyrrole derivatives[4].
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims are structured to cover various aspects of the compound, including its chemical structure, synthesis methods, and therapeutic applications. The claims are detailed and specific, ensuring broad protection for the patented compound while avoiding overly broad claims that could be challenged for lack of clarity or validity[3].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims define the core invention, while dependent claims further specify and narrow down the scope of the invention. For example, Claim 1 describes the general formula of the compound, while subsequent claims detail specific substitutions and modifications to the core structure[4].
Patent Term and Exclusivity
Patent Term Extension
The patent term for U.S. Patent 7,977,488 has been extended due to the regulatory review period associated with the drug's approval. The FDA determined a regulatory review period of 971 days, which includes 727 days for the testing phase and 244 days for the approval phase. This led to a patent term extension application seeking 599 days of extension[1].
Exclusivity Periods
In addition to patent protection, the drug may also benefit from exclusivity periods granted by the FDA. These periods can run concurrently with the patent term and provide additional market protection, ranging from 180 days to seven years depending on the circumstances of the exclusivity grant[2].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 7,977,488 includes other related patents, such as Patent 9,186,411, which covers a pharmaceutical composition and a stabilizing method for a pharmaceutically active ingredient. These patents are part of a broader intellectual property strategy to protect various aspects of the drug and its formulations[2].
Competitive Environment
The pharmaceutical industry is highly competitive, and patents like U.S. Patent 7,977,488 play a critical role in protecting innovation. The patent scope and claims are designed to prevent competitors from developing similar compounds, thereby maintaining a competitive edge for Takeda Pharmaceutical Company Limited.
Impact on Drug Development
Innovation Incentives
Patents like U.S. Patent 7,977,488 provide significant incentives for innovation by protecting the intellectual property rights of the inventors and the company. This protection allows for substantial investment in research and development, knowing that the returns on investment will be safeguarded by patent law[3].
Regulatory Approval
The regulatory review process, which includes the testing and approval phases, is crucial for determining the patent term extension. This process ensures that the drug meets safety and efficacy standards before it is marketed, further validating the importance of the patented compound[1].
Patent Expiration and Generic Availability
Patent Expiration Date
The patent is set to expire on August 11, 2028, considering the extension granted due to the regulatory review period. After this date, generic versions of the drug may become available, subject to FDA approval and compliance with other regulatory requirements[2].
Generic Competition
The expiration of the patent will open the market to generic competition, which can significantly impact the pricing and market share of the original drug. However, the exclusivity periods and other intellectual property protections may still provide some level of market protection even after the patent expires.
Key Takeaways
- Patent Scope and Claims: U.S. Patent 7,977,488 covers specific 1-H-pyrrole derivatives designed to inhibit acid secretion, with detailed claims protecting the chemical structure and therapeutic applications.
- Patent Term Extension: The patent term has been extended by 599 days due to the regulatory review period associated with the drug's approval.
- Exclusivity Periods: Additional market protection is provided through FDA-granted exclusivity periods.
- Patent Landscape: The patent is part of a broader intellectual property strategy, including related patents that protect various aspects of the drug.
- Impact on Drug Development: The patent provides incentives for innovation and protects significant investments in research and development.
- Patent Expiration and Generic Availability: The patent will expire on August 11, 2028, after which generic versions may become available.
FAQs
What is the main compound protected by U.S. Patent 7,977,488?
The main compound protected is a 1-H-pyrrole derivative designed to inhibit acid secretion, specifically vonoprazan.
Who are the inventors and assignee of U.S. Patent 7,977,488?
The inventors are Masahiro Kajino, Atsushi Hasuoka, and Haruyuki Nishida, and the assignee is Takeda Pharmaceutical Company Limited.
What is the significance of the regulatory review period for this patent?
The regulatory review period, which includes the testing and approval phases, is crucial for determining the patent term extension, providing an additional 599 days of protection.
When is the patent set to expire?
The patent is set to expire on August 11, 2028.
What happens after the patent expires?
After the patent expires, generic versions of the drug may become available, subject to FDA approval and compliance with other regulatory requirements.
Cited Sources
- Federal Register/Vol. 89, No. 176/Wednesday, September 11, 2024
- Generic Voquezna Availability - Drugs.com
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- US7977488.pdf - googleapis.com
- Patent Term Extension Application for VOQUEZNA (vonoprazan tablets, amoxicillin capsules), Patent No. 7,977,488
