Understanding the Scope and Claims of United States Patent 6,294,196
Introduction
United States Patent 6,294,196, hereafter referred to as the '196 patent, is a significant patent in the pharmaceutical industry, particularly related to the drug ibandronate sodium, the active ingredient in Boniva tablets. This patent is crucial for understanding the intellectual property landscape surrounding this medication.
Patent Overview
The '196 patent was granted on September 25, 2001, and it expired on October 7, 2019. It is one of the patents listed in the FDA's "Orange Book" for the drug product Boniva, which is used for the treatment of osteoporosis[2].
Claims and Scope
The '196 patent covers specific aspects of ibandronate sodium, including its composition, methods of preparation, and uses. Here are some key points about the claims and scope:
Composition
The patent describes the chemical composition of ibandronate sodium and its various forms, including salts and solvates. For instance, another patent related to ibandronate sodium discusses the propylene glycol solvate of ibandronate sodium, highlighting the importance of specific chemical formulations[4].
Methods of Preparation
The patent includes detailed methods for preparing ibandronate sodium. These methods are critical for ensuring the quality and efficacy of the drug. The preparation processes often involve complex chemical reactions and purification steps.
Uses
The '196 patent specifies the therapeutic uses of ibandronate sodium, primarily focusing on its application in treating bone diseases such as osteoporosis. The drug's mechanism of action and its benefits in preventing bone fractures are well-documented within the patent claims.
Patent Landscape
To understand the broader patent landscape surrounding the '196 patent, it is essential to look at related patents and the global intellectual property environment.
Related Patents
Other patents related to ibandronate sodium include U.S. Patent Numbers 4,927,814, 7,192,938, and 7,410,957. These patents cover various aspects of the drug, such as different formulations, manufacturing processes, and additional therapeutic uses. For example, the '938 and '957 patents also expired in 2023, marking the end of a significant period of patent protection for Boniva[2].
Global Intellectual Property Environment
The '196 patent is part of a global network of patents related to ibandronate sodium. For instance, the Canadian Patents Database lists a patent application (CA 2570949) for ibandronate sodium propylene glycol solvate, which, although deemed abandoned, illustrates the international scope of patent filings for this drug[4].
Litigation and Regulatory Environment
The '196 patent has been involved in significant litigation, particularly in the context of generic drug approvals.
Generic Drug Approvals
When generic drug manufacturers, such as Orchid Healthcare, filed Abbreviated New Drug Applications (ANDAs) for ibandronate sodium, they included paragraph IV certifications stating that the '196 patent, among others, was invalid, unenforceable, or would not be infringed by their manufacture, use, or sale of the generic drug. This led to litigation, as seen in the case of Hoffmann-La Roche Inc. v. Orchid Chemical & Pharmaceuticals Ltd.[2][5].
Regulatory Impact
The FDA's approval process for generic versions of Boniva was significantly influenced by the '196 patent. The FDA's tentative approval of ANDAs was contingent upon the resolution of patent disputes, highlighting the critical role patents play in the regulatory environment[2].
Search and Analysis Tools
For professionals conducting patent searches related to the '196 patent, several tools and resources are available:
USPTO Resources
The USPTO provides the Patent Public Search tool, which replaced legacy search tools like PubEast and PubWest. This tool offers enhanced access to prior art and is essential for conducting thorough patent searches[1].
Global Dossier
The Global Dossier service allows users to access file histories of related applications from participating IP Offices, including the IP5 Offices. This service is valuable for understanding the global patent family and citation data related to the '196 patent[1].
International Patent Databases
Databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) offer access to international patent collections and machine translations, which can be crucial for a comprehensive patent search[1].
Key Takeaways
- Patent Claims and Scope: The '196 patent covers specific compositions, methods of preparation, and therapeutic uses of ibandronate sodium.
- Related Patents: Other patents like the '814, '938, and '957 patents are part of the broader patent landscape for Boniva.
- Litigation and Regulation: The '196 patent has been involved in significant litigation related to generic drug approvals and has impacted the FDA's regulatory decisions.
- Search Tools: Utilizing resources like the USPTO's Patent Public Search, Global Dossier, and international patent databases is essential for thorough patent searches.
FAQs
Q: What is the expiration date of the '196 patent?
A: The '196 patent expired on October 7, 2019.
Q: What is the main therapeutic use of ibandronate sodium covered by the '196 patent?
A: The main therapeutic use is the treatment of osteoporosis.
Q: Which regulatory agency is involved in the approval process of generic versions of Boniva?
A: The FDA is involved in the approval process.
Q: What is the significance of paragraph IV certifications in ANDAs related to the '196 patent?
A: Paragraph IV certifications state that the patent is invalid, unenforceable, or will not be infringed by the generic drug manufacturer.
Q: How can one access prior art and global patent family information related to the '196 patent?
A: Tools like the USPTO's Patent Public Search and the Global Dossier service can be used to access prior art and global patent family information.
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
- Canadian Patents Database - Patent 2570949 Summary: https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2570949/summary.html
- Patent Docs - Biotech/Pharma Docket: https://www.patentdocs.org/2010/10/biotechpharma-docket-1.html
