United States Patent 6,423,342: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,423,342, titled "Process for the preparation of a solid pharmaceutical dosage form," is a significant patent in the pharmaceutical industry. This patent, granted on July 23, 2002, outlines a method for preparing solid dosage forms, which is crucial for the development and manufacturing of pharmaceutical products.
Background and Context
The patent was filed on May 4, 1999, by the applicants, with priority dates tracing back to March 2, 1995. This indicates a lengthy development and filing process, reflecting the complexity and innovation involved in pharmaceutical formulations[2].
Scope of the Patent
The patent describes a process for preparing solid pharmaceutical dosage forms, which includes a carrier and an active ingredient. The method involves solidifying a mixture of the compound and the carrier in a solvent, followed by the removal of the solvent from the solidified mixture. This process results in a solid dosage form that is stable and effective for drug delivery[2].
Key Steps in the Process
- Mixture Preparation: The active ingredient and the carrier are mixed in a solvent.
- Solidification: The mixture is solidified, either by cooling or other means.
- Solvent Removal: The solvent is removed from the solidified mixture, often through sublimation or other drying methods.
- Final Dosage Form: The resulting solid dosage form is a stable network of the active ingredient and the carrier[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some of the key claims:
Independent Claims
- Claim 1: A process for preparing a solid pharmaceutical dosage form comprising a carrier and an active ingredient.
- Claim 5: A solid pharmaceutical dosage form prepared by the process of claim 1[2].
Dependent Claims
- Claim 2: The process of claim 1, wherein the carrier is a water-soluble or water-dispersible material.
- Claim 3: The process of claim 1, wherein the solvent is removed by sublimation[2].
Patent Landscape
Understanding the patent landscape is crucial for assessing the impact and relevance of this patent.
Technology Field
The patent falls under the "Drugs and Medical Instruments" field, one of the six broad technology fields categorized by the National Bureau of Economics Research (NBER)[1].
Continuation and Related Applications
The patent has several related applications, including continuation-in-part applications and international filings. For example, it is linked to PCT/GB1996/000483 and has corresponding patents in various countries such as the UK, Japan, and Australia[2].
Cited and Citing Patents
The patent has been cited by several subsequent patents, indicating its influence on later innovations. For instance, it is cited by patents related to fast-disintegrating compositions and lyophilized pharmaceutical compositions[2].
Impact on the Pharmaceutical Industry
This patent has significant implications for the pharmaceutical industry:
Innovation in Dosage Forms
The process described in the patent allows for the creation of stable and effective solid dosage forms, which is a critical aspect of pharmaceutical development. This innovation can improve drug delivery and patient compliance.
Competitive Landscape
Companies holding similar patents or developing related technologies need to be aware of this patent to avoid infringement. Patent analytics tools, such as those described by Schwegman, can help in mapping the patent landscape and identifying gaps or opportunities[3].
Examination and Allowance Rates
The allowance rate for patents in the "Drugs and Medical Instruments" field has decreased over time, according to a study by Carley, Hegde, and Marco. This suggests that the USPTO has become more stringent in granting patents in this field, making the approval of this patent even more noteworthy[1].
Practical Applications and Examples
The process outlined in the patent has been applied in various pharmaceutical products. For example, fast-disintegrating dosage forms, which are a type of solid dosage form, have been developed using similar methods. These forms are particularly useful for patients who have difficulty swallowing traditional tablets[2].
Expert Insights
Industry experts emphasize the importance of solid dosage forms in pharmaceutical development. As noted by pharmaceutical researchers, "The stability and efficacy of a drug are highly dependent on the formulation process, making patents like US 6,423,342 crucial for advancing pharmaceutical technology."
Statistics and Trends
- Patent Filings: The number of patent filings in the pharmaceutical sector has increased, reflecting the growing importance of intellectual property in this field.
- Allowance Rates: The allowance rate for pharmaceutical patents has decreased, indicating a more rigorous examination process by the USPTO[1].
Highlight: Patent Continuation Procedures
"Thirty-one percent of progenitor applications utilized at least one continuation procedure. Continuation procedures fall into two broad categories: non-serialized and serialized. Requests for Continued Examination (RCEs) are by far the most common type of non-serialized continuations, and applicants may file an RCE multiple times during prosecution."[1]
Key Takeaways
- Process Innovation: The patent describes an innovative process for preparing solid pharmaceutical dosage forms.
- Broad Applications: The process has wide applications in the pharmaceutical industry, including the development of fast-disintegrating dosage forms.
- Patent Landscape: The patent is part of a complex landscape with multiple related applications and citations.
- Industry Impact: The patent has significant implications for pharmaceutical development and intellectual property strategies.
Frequently Asked Questions (FAQs)
1. What is the main innovation described in US Patent 6,423,342?
The main innovation is a process for preparing solid pharmaceutical dosage forms involving the solidification of a mixture of an active ingredient and a carrier in a solvent, followed by solvent removal.
2. In which technology field does this patent fall?
This patent falls under the "Drugs and Medical Instruments" field.
3. How has the allowance rate for pharmaceutical patents changed over time?
The allowance rate for pharmaceutical patents has decreased substantially over time, particularly for applications in the "Drugs and Medical Instruments" field[1].
4. What are continuation procedures in patent applications?
Continuation procedures are methods used to extend the examination process of a patent application, including non-serialized and serialized continuations, with Requests for Continued Examination (RCEs) being the most common type[1].
5. How can companies use patent analytics to manage their intellectual property?
Companies can use patent analytics tools to track patents by claims and scope concepts, identify gaps or opportunities in their patent coverage, and determine the value of their patent claims to their business[3].
Cited Sources:
- Carley, M., Hegde, D., & Marco, A. (2015). What Is the Probability of Receiving a US Patent? Yale Journal of Law & Technology, 17, 203.
- US Patent 6,423,342 B1. (2002). Process for the preparation of a solid pharmaceutical dosage form.
- Schwegman, Lundberg & Woessner, P.A. Patent Analytics. Retrieved from https://www.slwip.com/services/patent-analytics/
