United States Patent 7,410,957: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,410,957, titled "Method of treatment using bisphosphonic acid," is a significant patent in the pharmaceutical sector, particularly in the treatment of bone-related disorders. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Invention Description
The patent describes a pharmaceutical composition and method of treatment using bisphosphonic acids or their pharmaceutically acceptable salts. The composition includes a bisphosphonic acid, such as ibandronic acid, and various excipients. The method involves administering an effective amount of these bisphosphonic acids to treat, reduce, or prevent disorders characterized by pathologically increased bone resorption[4].
Publication and Legal Status
The patent was published on October 18, 2005, and has since expired due to fee-related issues. The legal status indicates that the patent is no longer in force, but its contents remain relevant for understanding the state of the art in this field[4].
Scope of the Patent
Claims
The patent includes 20 claims that define the scope of the invention. These claims can be broadly categorized into two main areas:
- Composition Claims: These claims describe the pharmaceutical composition, including the bisphosphonic acid or its salt, and the various excipients such as lactose, polyvinylpyrrolidone, and microcrystalline cellulose[4].
- Method Claims: These claims outline the method of treating bone resorption disorders by administering the bisphosphonic acid composition to a mammal[4].
Dependent and Independent Claims
The patent includes both dependent and independent claims. Independent claims define the invention broadly, while dependent claims narrow down the scope by adding specific limitations. For example, Claim 1 is an independent claim that describes the pharmaceutical composition, while subsequent claims depend on this initial claim and add further details such as the specific excipients and their proportions[4].
Patent Claims Analysis
Claim Structure
The claims are structured to provide a clear and detailed description of the invention. They follow a logical sequence, starting with broad independent claims and then narrowing down to more specific dependent claims. This structure helps in defining the boundaries of the invention and what constitutes infringement.
Claim Scope
The scope of the claims is critical in determining the patent's coverage. For instance, Claim 1 covers a broad range of bisphosphonic acids and their salts, while subsequent claims specify the types of excipients and their formulations. This ensures that the patent protects not just the core invention but also various embodiments and applications of the invention[4].
Patent Landscape
Related Patents and Prior Art
The patent landscape surrounding US 7,410,957 includes several related patents and prior art references. For example, the patent cites U.S. Pat. Nos. 6,143,326 and 6,294,196, which describe similar pharmaceutical compositions and methods of treatment using bisphosphonic acids[4].
Global Dossier and International Patent Offices
To understand the global patent landscape, tools like the Global Dossier can be used. This service provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices (USPTO, EPO, JPO, KIPO, and CNIPA). This helps in identifying similar patents and applications filed in other jurisdictions[1].
Competitor Patents
Competitors in the pharmaceutical industry, such as Hoffmann-La Roche Inc., have filed similar patents and engaged in litigation related to bisphosphonic acid compositions. For instance, the '196, '938, and '957 patents were involved in a lawsuit related to the manufacture and sale of ibandronate sodium tablets, highlighting the competitive nature of this patent space[2].
Search and Analysis Tools
USPTO Resources
The USPTO provides several resources for searching and analyzing patents, including the Patent Public Search tool, which replaced legacy search tools like PubEast and PubWest. This tool offers enhanced access to prior art and is crucial for conducting thorough patent searches[1].
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset is another valuable resource. It contains 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 helps in analyzing patent scope and trends in the pharmaceutical sector[3].
Litigation and Enforcement
Paragraph IV Certifications
The patent was involved in litigation related to paragraph IV certifications under the Hatch-Waxman Act. This type of certification is made by generic drug manufacturers asserting that the patent is invalid, unenforceable, or will not be infringed by their product. The litigation involving the '196, '938, and '957 patents is a prime example of how patent disputes can arise in this field[2].
Office Actions and Patent Assignments
Tools like the Patent Examination Data System (PEDS) and the Patent Assignment Search website can provide insights into office actions and changes in ownership related to the patent. These resources are essential for understanding the patent's history and any legal challenges it faced[1].
Key Takeaways
- Patent Scope: The patent covers a broad range of bisphosphonic acid compositions and methods of treatment, with specific claims detailing the types of excipients and formulations.
- Related Patents: The patent landscape includes several related patents and prior art references, highlighting the competitive nature of the pharmaceutical industry.
- Global Patent Landscape: Tools like the Global Dossier and international patent office databases are crucial for understanding the global patent landscape.
- Litigation: The patent was involved in significant litigation related to paragraph IV certifications and patent infringement.
FAQs
What is the main subject of US Patent 7,410,957?
The main subject of US Patent 7,410,957 is a pharmaceutical composition and method of treatment using bisphosphonic acids or their pharmaceutically acceptable salts.
What are the key claims of the patent?
The key claims include composition claims describing the pharmaceutical composition and method claims outlining the treatment of bone resorption disorders.
Is the patent still in force?
No, the patent has expired due to fee-related issues.
What tools can be used to analyze the patent landscape?
Tools such as the USPTO's Patent Public Search, Global Dossier, and the Patent Claims Research Dataset can be used to analyze the patent landscape.
Was the patent involved in any litigation?
Yes, the patent was involved in litigation related to paragraph IV certifications under the Hatch-Waxman Act.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- FDA - ANDA 078998: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078998Orig1s000OtherActionLtrs.pdf
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US7410957B2: https://patents.google.com/patent/US7410957B2/en
