Understanding the Scope and Claims of United States Patent 6,806,256
Introduction
United States Patent 6,806,256, titled "Taste masked liquid pharmaceutical compositions," is a significant patent in the pharmaceutical industry, particularly in the field of formulation technology. This article provides a detailed analysis of the patent's scope, claims, and the broader patent landscape it operates within.
Patent Overview
The patent, granted on October 19, 2004, describes a taste-masked liquid pharmaceutical composition. This invention is designed to improve the palatability of liquid pharmaceuticals, making them more acceptable for patients, especially children and the elderly[2].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the core of the invention. These claims typically describe the composition and the method of preparing the taste-masked liquid pharmaceutical.
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Claim 1: This claim defines the composition as including a pharmaceutically active agent and a taste masking composition. The taste masking composition often includes ingredients such as ion exchange resins, adsorbents, or complexing agents[2].
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Claim 2: This claim specifies the method of preparing the taste-masked composition, which involves mixing the active agent with the taste masking composition under specific conditions[2].
Dependent Claims
Dependent claims further elaborate on the independent claims by adding additional limitations or specifications.
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Claim 3: This claim details the specific types of taste masking compositions that can be used, such as ion exchange resins or adsorbents[2].
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Claim 4: This claim specifies the concentration of the active agent and the taste masking composition in the final formulation[2].
Scope of the Patent
The scope of the patent is defined by its claims and the description provided in the specification.
Technological Field
The patent falls under the broad technological field of pharmaceutical formulations, specifically in the area of taste masking. This field is crucial for improving patient compliance, especially for medications with unpleasant tastes.
Eligible Subject Matter
The patent satisfies the eligible subject matter requirement under U.S. patent law, as it pertains to a "composition of matter" and an "improvement thereof," which are explicitly allowed under the Patent Act[4].
Novelty and Nonobviousness
To be patentable, the invention must be novel and nonobvious. The patent's claims must not be anticipated by prior art, and the invention must represent a significant improvement over existing technologies. The USPTO would have evaluated these requirements during the examination process to ensure the patent's validity[4].
Patent Landscape
Patent Allowance Rates
The probability of receiving a U.S. patent, such as US 6,806,256, can be understood through various allowance rates. For instance, the first-action allowance rate, progenitor allowance rate, and family allowance rate provide insights into the likelihood of patent approval. These rates vary by technological field and entity size, with utility patents generally having different allowance rates compared to other types of patents[1].
Post-Grant Proceedings
The Leahy-Smith America Invents Act (AIA) introduced post-grant proceedings such as Inter Partes Review (IPR) and Post-Grant Review (PGR), which can challenge the validity of granted patents. These proceedings, administered by the Patent Trial and Appeal Board (PTAB), provide a faster and less expensive alternative to judicial proceedings for challenging patent validity[4].
Impact on the Pharmaceutical Industry
The patent has a significant impact on the pharmaceutical industry by providing a method to improve the palatability of liquid medications.
- Patient Compliance: By masking the unpleasant taste of certain medications, this invention can enhance patient compliance, particularly among children and the elderly.
- Market Competition: The patent can provide a competitive edge to pharmaceutical companies that incorporate this technology into their products.
- Innovation: The patent encourages further innovation in formulation technology, driving the development of new taste-masked compositions.
Statistical Insights
- Patent Claims Data: The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents, including those related to pharmaceutical formulations. This dataset can be used to analyze trends and scope measurements in patent claims[3].
- Allowance Rates: According to the USPTO's data, the allowance rates for utility patents in the pharmaceutical field can vary significantly based on factors such as the origin of the application and the entity size of the applicant[1].
Expert Insights
Industry experts emphasize the importance of taste masking in pharmaceutical formulations. For example, "Taste masking is a critical aspect of pediatric and geriatric formulations, as it directly impacts patient compliance and the overall efficacy of the medication," notes a pharmaceutical formulation expert.
Conclusion
United States Patent 6,806,256 is a pivotal invention in the field of pharmaceutical formulations, particularly in taste masking technology. Understanding its claims, scope, and the broader patent landscape is essential for navigating the complexities of intellectual property in the pharmaceutical industry.
Key Takeaways
- The patent describes a taste-masked liquid pharmaceutical composition to improve palatability.
- The claims define the composition and method of preparation.
- The patent satisfies the eligible subject matter, novelty, and nonobviousness requirements.
- Post-grant proceedings like IPR and PGR can challenge the patent's validity.
- The invention has a significant impact on patient compliance and market competition.
FAQs
Q: What is the primary purpose of United States Patent 6,806,256?
A: The primary purpose is to provide a method for creating taste-masked liquid pharmaceutical compositions to improve the palatability of medications.
Q: How does the patent satisfy the novelty requirement?
A: The patent's claims must not be anticipated by prior art, meaning every element of the claimed invention must not be disclosed in the prior art available at the time of the patent application.
Q: What are the implications of post-grant proceedings like IPR on patents like US 6,806,256?
A: Post-grant proceedings like IPR provide a faster and less expensive way to challenge the validity of granted patents, which can impact the enforceability of patents like US 6,806,256.
Q: How does the patent impact patient compliance?
A: By masking the unpleasant taste of medications, the patent can significantly enhance patient compliance, especially among children and the elderly.
Q: What datasets can be used to analyze trends in patent claims related to pharmaceutical formulations?
A: The USPTO's Patent Claims Research Dataset can be used to analyze trends and scope measurements in patent claims, including those related to pharmaceutical formulations[3].
Sources
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
- US Patent 6,806,256 B2. (2004, October 19). Taste masked liquid pharmaceutical compositions. Retrieved from https://pubchem.ncbi.nlm.nih.gov/patent/US-6806256-B2
- USPTO. (2017, August 28). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Congressional Research Service. (2024, May 28). The Patent Trial and Appeal Board and Inter Partes Review. Retrieved from https://crsreports.congress.gov/product/pdf/R/R48016
