Analyzing the Scope and Claims of United States Patent 8,883,836: A Comprehensive Guide
Introduction
Understanding the scope and claims of a patent is crucial for inventors, researchers, and businesses to navigate the complex landscape of intellectual property. This article will delve into the details of United States Patent 8,883,836, focusing on its claims, scope, and the broader patent landscape.
Overview of the Patent
Patent Number and Title
United States Patent 8,883,836, titled "Novel solid forms of bendamustine hydrochloride and methods of their preparation and use," was granted to Cephalon, Inc., now a part of Teva Pharmaceuticals[2].
Background
Bendamustine hydrochloride is a chemotherapeutic agent used in the treatment of certain cancers, such as chronic lymphocytic leukemia and non-Hodgkin lymphoma. The patent describes novel solid forms of this compound, which are critical for its stability, efficacy, and manufacturing process.
Claims of the Patent
Independent and Dependent Claims
The patent includes a series of independent and dependent claims that define the scope of the invention. Independent claims stand alone and define the broadest scope of the invention, while dependent claims build upon the independent claims and provide more specific details.
- Independent Claims: These claims describe the novel solid forms of bendamustine hydrochloride, including specific polymorphic forms, and methods for their preparation and use.
- Dependent Claims: These claims further specify the conditions under which the solid forms are prepared, such as particular solvents, temperatures, and crystallization methods[5].
Claim Construction
Claim construction is the process of interpreting the meaning of the claims. It is essential for determining the scope of the patent and identifying potential infringement. The claims in this patent are constructed to cover both the composition of matter (the novel solid forms) and the methods of preparing and using these forms.
Scope of the Patent
Composition of Matter
The patent covers specific solid forms of bendamustine hydrochloride, including polymorphic forms that are stable and suitable for pharmaceutical use. This includes crystalline forms that have been characterized by various analytical techniques such as X-ray powder diffraction (XRPD) and differential scanning calorimetry (DSC)[5].
Methods of Preparation and Use
The scope also includes methods for preparing these solid forms, such as crystallization from specific solvents, and methods for their use in pharmaceutical compositions. These methods are crucial for ensuring the consistency and efficacy of the drug product.
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to bendamustine hydrochloride. Other patents in this family include U.S. Patent Nos. 8,436,190, 8,445,524, 8,609,863, 8,669,279, 8,791,270, 8,895,756, 9,533,955, and 9,572,887, all of which are listed in the FDA's Orange Book in connection with Treanda® and Bendeka®[2].
International Patent Filings
To understand the global scope, it is important to look at international patent filings. The World Intellectual Property Organization (WIPO) and other international patent offices provide databases such as PATENTSCOPE, which allows for full-text searching of international patent applications and granted patents[4].
Search Tools and Resources
USPTO Patent Public Search
The USPTO's Patent Public Search tool is a powerful resource for searching prior art and understanding the patent landscape. It provides enhanced access to prior art and allows users to search multiple databases simultaneously[1].
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, including the IP5 Offices. This is useful for seeing the patent family for a specific application and accessing dossier, classification, and citation data[1].
Cooperative Patent Classification (CPC)
The CPC database is another valuable resource for finding relevant classification schemes. It allows for more precise searching and helps in identifying similar patents and technologies[4].
Legal and Regulatory Implications
Hatch-Waxman Act
The patent is involved in a Hatch-Waxman Act suit, which is a type of litigation that arises when a generic drug manufacturer seeks to market a generic version of a patented drug before the patent expires. The suit involves assertions of infringement and validity of the patents listed in the FDA's Orange Book[2].
Paragraph IV Certification
In such suits, the generic manufacturer often files a Paragraph IV certification, asserting that the patents will not be infringed or are invalid. This certification triggers a lawsuit by the patent holder to protect their rights[2].
Practical Applications and Impact
Pharmaceutical Industry
The novel solid forms of bendamustine hydrochloride described in this patent are crucial for the pharmaceutical industry. They ensure the stability and efficacy of the drug, which is vital for patient safety and treatment outcomes.
Research and Development
Understanding the claims and scope of this patent can guide researchers and developers in creating new formulations or methods that do not infringe on existing patents. This fosters innovation while respecting intellectual property rights.
Key Takeaways
- Claims and Scope: The patent covers specific solid forms of bendamustine hydrochloride and methods for their preparation and use.
- Related Patents: Part of a larger family of patents related to bendamustine hydrochloride.
- International Filings: Important to consider international patent filings and databases.
- Legal Implications: Involved in Hatch-Waxman Act suits and Paragraph IV certifications.
- Practical Applications: Crucial for ensuring the stability and efficacy of bendamustine hydrochloride in pharmaceutical use.
FAQs
Q: What is the main subject of United States Patent 8,883,836?
A: The main subject is novel solid forms of bendamustine hydrochloride and methods for their preparation and use.
Q: How can I search for similar patents?
A: Use the USPTO's Patent Public Search tool, Global Dossier, and Cooperative Patent Classification (CPC) database to search for similar patents.
Q: What is the significance of the Hatch-Waxman Act in relation to this patent?
A: The Hatch-Waxman Act is relevant because the patent is involved in a lawsuit triggered by a generic drug manufacturer's Paragraph IV certification, asserting non-infringement or invalidity of the patent.
Q: How do I determine if a new formulation infringes on this patent?
A: Conduct a thorough analysis of the claims and scope of the patent, and consider consulting with a patent attorney to ensure that your new formulation does not infringe on existing claims.
Q: Where can I find more information on international patent filings related to this patent?
A: Use databases such as PATENTSCOPE provided by WIPO and other international patent offices to find information on international patent filings.
Sources
- USPTO: "Search for patents - USPTO"
- US District Court: "IN THE UNITED STATES DISTRICT COURT FOR THE EASTERN"
- USPTO: "Patent Claims Research Dataset"
- Clemson University: "Research and Course Guides: Patent Searching, Advanced: Overview"
- Unified Patents Portal: "US-8883836-B2 - Unified Patents Portal"
