United States Patent 5,681,590: A Detailed Analysis
Overview of the Patent
United States Patent 5,681,590, titled "Dry Mix Formulation for Bisphosphonic Acids," was issued on December 15, 1998, to inventors Simon R. Bechard, Kenneth A. Kramer, and Ashok V. Katdare. This patent is associated with Merck & Co., Inc., and it pertains to novel pharmaceutical compositions and processes for manufacturing bisphosphonic acids and their salts, which are useful in treating various bone diseases.
Scope of the Patent
The scope of the patent encompasses the formulation, composition, and method of manufacturing bisphosphonic acids, specifically alendronate sodium, which is used in the treatment of diseases such as osteoporosis, Paget’s disease, malignant hypercalcemia, and metastatic bone disease. The patent describes a dry mix formulation that improves the stability and efficacy of these pharmaceuticals[5].
Claims of the Patent
The patent includes several claims that define the invention:
- Composition Claims: These claims describe the specific formulation of the dry mix, including the active ingredients (bisphosphonic acids) and excipients.
- Method Claims: These claims outline the process for preparing the dry mix formulation, including the steps involved in mixing, granulating, and compressing the ingredients.
- Use Claims: These claims specify the therapeutic uses of the formulation, such as the treatment and prevention of bone diseases[5].
Patent Landscape Analysis
To understand the position of this patent within the broader patent landscape, several key steps are involved:
Define Scope and Keywords
The analysis begins by defining the technology field, which in this case is pharmaceutical formulations of bisphosphonic acids. Key terms such as "bisphosphonic acids," "alendronate sodium," "dry mix formulation," and "bone disease treatment" are identified[3].
Search and Organize Patents
Using databases like the USPTO's Patent Public Search, PATENTSCOPE, and other international patent databases, relevant patents are searched and organized. This includes patents filed by Merck and other competitors in the field. The patents are organized by factors such as filing date, assignee, and classification schemes like the Cooperative Patent Classification (CPC)[1][4].
Identify Trends and Key Players
The analysis reveals trends in patent filings related to bisphosphonic acids and identifies key players in the industry. Merck, as the assignee of the '590 patent, is a significant player. Other companies and research institutions involved in similar technologies are also identified[3].
Analyze Citations and Evolution
The citations and references within the '590 patent and related patents are studied to understand the impact and development of the technology. This includes analyzing how patents reference each other and the evolution of the technology over time[3].
Generate Insights for Decisions
The analysis translates into practical guidance for strategic decisions. For example, it helps in evaluating the competitive landscape, identifying potential legal vulnerabilities, and assessing the strength of the patent portfolio. This information is crucial for making informed decisions about further research, development, and potential litigation[3].
Competitive Landscape
The competitive landscape in the field of bisphosphonic acids is highly competitive, with several pharmaceutical companies holding patents related to these compounds. The '590 patent, along with other patents held by Merck, forms a significant part of this landscape. Companies like Apotex, which have filed Abbreviated New Drug Applications (ANDAs) for generic versions of Merck's drugs, also play a crucial role in this landscape[2][5].
Legal and Regulatory Aspects
The '590 patent has been involved in several legal disputes, particularly in the context of ANDA filings by generic drug manufacturers. For instance, Apotex filed an ANDA with the FDA, which led to litigation with Merck over the validity and infringement of the '590 patent among others. Understanding these legal aspects is crucial for navigating the patent landscape[2][5].
Expiration and Exclusivity
The '590 patent expired on December 2, 2012, but Merck benefited from an additional six months of regulatory exclusivity beyond the patent term. This extended exclusivity period is significant in maintaining market dominance and preventing generic competition[2].
International Patent Family
The '590 patent is part of an international patent family, with corresponding patents filed in various countries. Using tools like the Global Dossier and PATENTSCOPE, one can access the file histories and citation data for these related applications, providing a comprehensive view of the global patent landscape[1][4].
Impact on Innovation
The '590 patent has contributed significantly to the innovation in the field of bisphosphonic acids. It has set a standard for dry mix formulations and has influenced subsequent research and development in this area. The patent landscape analysis reveals how this patent has impacted the technological trends and key players in the industry[3].
Key Takeaways
- The '590 patent is a critical component of Merck's patent portfolio related to bisphosphonic acids.
- It has been involved in significant legal disputes, particularly with generic drug manufacturers.
- The patent landscape analysis provides valuable insights into the competitive landscape, technological trends, and key players.
- The expiration of the patent and the extended regulatory exclusivity period have implications for market competition.
- The international patent family of the '590 patent highlights its global significance.
FAQs
What is the main subject of United States Patent 5,681,590?
The main subject of the patent is a dry mix formulation for bisphosphonic acids, specifically alendronate sodium, used in treating bone diseases.
Who are the inventors of the '590 patent?
The inventors are Simon R. Bechard, Kenneth A. Kramer, and Ashok V. Katdare.
What is the significance of the '590 patent in the pharmaceutical industry?
The patent is significant for its contribution to the development of stable and effective dry mix formulations of bisphosphonic acids, which are crucial in treating various bone diseases.
What legal disputes has the '590 patent been involved in?
The patent has been involved in disputes related to ANDA filings by generic drug manufacturers, such as Apotex, which led to litigation over patent validity and infringement.
When did the '590 patent expire?
The '590 patent expired on December 2, 2012, with an additional six months of regulatory exclusivity.
Cited Sources:
- USPTO - Search for patents - USPTO https://www.uspto.gov/patents/search
- United States Court of Appeals for the Federal Circuit - Merck & Co., Inc. v. Apotex, Inc. http://cafc.uscourts.gov/opinions-orders/07-1362.pdf
- Goldstein Patent Law - How to Do Patent Landscape Analysis https://www.goldsteinpatentlaw.com/how-to-patent-landscape-analysis/
- Clemson University Libraries - Research and Course Guides: Patent Searching, Advanced: Overview https://clemson.libguides.com/advanced_patent_searching
- United States District Court for the District - Merck & Co., Inc. v. Apotex, Inc. https://insight.rpxcorp.com/litigation_documents/2326908
