Detailed Analysis of the Scope and Claims of United States Patent 8,148,401
Introduction
United States Patent 8,148,401, titled "Benzimidazole Derivatives," was issued on April 3, 2012, and is assigned to Pfizer Inc. This patent is crucial in the field of pharmaceuticals, particularly in the treatment of abnormal cell growth, such as cancer.
Background of the Invention
The patent relates to novel benzimidazole derivatives that are useful in treating abnormal cell growth in mammals, especially humans. These compounds are part of a broader class of molecules involved in various biological processes, including those mediated by Hedgehog (Hh) proteins, which play significant roles in embryonic development and postnatal tissue maintenance[1].
Scope of the Patent
Claims and Compounds
The patent includes 17 claims that describe the benzimidazole derivatives, their pharmaceutical compositions, and methods for their use. The compounds are defined by a specific formula (Formula I) and can be substituted with various groups such as halo, hydroxy, —CN, —(C-C)alkyl, and others. The claims also cover pharmaceutically acceptable salts of these compounds[1].
Specific Embodiments
The patent details specific embodiments where the compound of Formula I or its pharmaceutically acceptable salt has R selected from the group consisting of hydrogen and —(C-C)alkyl. In one embodiment, R is specifically hydrogen, highlighting the versatility and specificity of the compounds covered[1].
Pharmaceutical Compositions
The patent describes pharmaceutical compositions containing the benzimidazole derivatives. These compositions can be formulated in various ways, including oral forms such as tablets and capsules, and are intended for the treatment of abnormal cell growth in humans[4].
Patent Claims Analysis
Independent Claim Length and Count
The scope of the patent can be analyzed using metrics such as independent claim length and count. Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. This indicates that the claims in US 8,148,401, being specific and well-defined, likely underwent a rigorous examination process to ensure their validity and scope[3].
Claim Language and Scope
The claim language is critical in defining the patent scope. The use of specific chemical structures and substitution patterns in the claims helps to delineate the boundaries of the invention, preventing overly broad interpretations that could lead to patent disputes. This precision is essential for maintaining patent quality and ensuring that the invention is clearly distinguishable from prior art[3].
Patent Landscape
Related Patents and Exclusivities
The benzimidazole derivatives covered by US 8,148,401 are part of a larger patent portfolio related to Daurismo, a drug owned by Pfizer Inc. Other patents, such as US 10,414,748 and US 8,431,597, also protect various aspects of Daurismo, including crystalline forms and other benzimidazole derivatives. These patents, along with FDA-granted exclusivities, delay the generic launch of Daurismo until April 13, 2036[4][5].
Patent Expiration Dates
The patent US 8,148,401 is set to expire on January 30, 2031. However, the overall protection for Daurismo extends until April 13, 2036, due to other patents and exclusivities. This extended protection period is crucial for Pfizer Inc. to maintain market exclusivity for Daurismo[4][5].
Legal and Regulatory Activities
Recent legal activities, such as transactions for FDA Determination of Regulatory Review Period and post-issue communications, indicate ongoing efforts to maintain and possibly extend the patent life. These activities are essential for tracking the latest developments in the patent process and understanding how they might affect the generic launch date of Daurismo[4].
Industry Impact
The benzimidazole derivatives and their associated patents have significant implications for the pharmaceutical industry. These compounds represent a class of therapeutic agents with potential in treating cancer and other diseases characterized by abnormal cell growth. The patent protection ensures that Pfizer Inc. can continue to invest in research and development without immediate generic competition, which is vital for innovation in the pharmaceutical sector[1].
Ethical and Regulatory Considerations
The integrity of the patent process is crucial, as highlighted by the USPTO's actions against fraudulent use of signatures. Ensuring that all patent applications and proceedings are conducted with honesty and transparency is essential for maintaining trust in the system and protecting legitimate inventions[2].
Key Takeaways
- Specific Claims: The patent includes specific claims defining benzimidazole derivatives and their pharmaceutical compositions.
- Pharmaceutical Use: The compounds are intended for treating abnormal cell growth, particularly cancer.
- Patent Scope: The scope is defined by independent claim length and count, ensuring clarity and validity.
- Related Patents: Part of a larger patent portfolio protecting Daurismo.
- Exclusivities: FDA-granted exclusivities extend market protection until April 13, 2036.
- Patent Expiration: US 8,148,401 expires on January 30, 2031.
- Legal Activities: Ongoing legal activities impact the patent life and generic launch date.
FAQs
What is the primary use of the benzimidazole derivatives described in US 8,148,401?
The primary use is in the treatment of abnormal cell growth, such as cancer, in mammals, especially humans.
Who is the assignee of US 8,148,401?
The assignee is Pfizer Inc.
What is the expiration date of US 8,148,401?
The patent is set to expire on January 30, 2031.
How do FDA exclusivities affect the generic launch of Daurismo?
FDA exclusivities granted to Daurismo delay the generic launch until April 13, 2036, regardless of the patent status.
What metrics are used to analyze the scope of patent claims?
Metrics such as independent claim length and count are used to analyze the scope and validity of patent claims.
Sources
- United States Patent and Trademark Office. Benzimidazole Derivatives. US008148401B2. April 3, 2012.
- United States Patent and Trademark Office. USPTO terminates patent application proceedings for fraudulent use of signature. October 2, 2024.
- Hoover Institution. Patent Claims and Patent Scope. August 18, 2024.
- Pharsight - GreyB. Daurismo patent expiration. 2024.
- Drugs.com. Generic Daurismo Availability. November 6, 2024.
