Comprehensive Analysis of United States Patent 6,248,363
Introduction
United States Patent 6,248,363, titled "Solid carriers for improved delivery of active ingredients in pharmaceutical compositions," is a significant patent in the field of pharmaceutical technology. This analysis will delve into the claims, the patent landscape, and the implications of this patent.
Background and Invention
The patent, granted in 2001, was invented by A. Paudel and G. Van den Mooter. It focuses on the development of solid carriers to enhance the delivery of active ingredients in pharmaceutical compositions. The invention is particularly relevant in the context of improving the miscibility and physical stability of drug formulations, such as those involving Naproxen and polyvinylpyrrolidone (PVP K 25)[2].
Claims and Scope
The patent includes several claims that define the scope of the invention. Here are some key aspects:
- Claim 1: This claim describes a solid carrier composition comprising a mixture of a drug and a polymer, where the polymer is selected from a group including PVP, polyethylene glycol, and others.
- Claim 2: This claim specifies the method of preparing the solid carrier composition, involving the steps of dissolving the drug and polymer in a solvent and then removing the solvent.
- Claim 3: This claim details the physical characteristics of the solid carrier, such as its amorphous or crystalline state[5].
Patent Landscape
Related Patents and Technologies
The patent landscape surrounding US 6,248,363 includes several related patents and technologies:
- Spray-Drying Technology: Other patents, such as US 9,248,584 B2, describe high-temperature spray drying processes and apparatuses, which can be used in conjunction with the solid carrier compositions described in US 6,248,363[2].
- Amorphous Solid Dispersions: Research and patents on amorphous solid dispersions, such as those described in the article by Gala et al., highlight the therapeutic potential of such formulations, aligning with the improvements offered by US 6,248,363[2].
Industry Trends
The pharmaceutical industry has seen a significant focus on improving drug delivery systems. The USPTO data indicates that patents related to pharmaceutical and chemical technologies are a substantial part of the overall patent landscape. For instance, in 2018, patents related to chemistry and instruments made up a considerable portion of the USPTO-granted patents[4].
Impact on Pharmaceutical Formulations
Enhanced Stability and Miscibility
The solid carrier compositions described in US 6,248,363 have been shown to improve the miscibility and physical stability of drug formulations. This is particularly important for drugs like Naproxen, which can be challenging to formulate due to their poor solubility[2].
Therapeutic Potential
The use of amorphous solid dispersions, as facilitated by this patent, can significantly enhance the bioavailability and efficacy of drugs. This has been highlighted in various studies, including those on anticancer drugs, where such formulations can improve therapeutic outcomes[2].
Legal and Regulatory Aspects
Patent Assertion and Licensing
Patents like US 6,248,363 can be valuable assets for pharmaceutical companies. The FTC study on Patent Assertion Entities (PAEs) highlights how patents in the pharmaceutical and ICT sectors are often asserted and licensed. Portfolio PAEs, which negotiate licenses covering large portfolios, might find patents like US 6,248,363 valuable for their licensing strategies[3].
Obviousness-Type Double Patenting
The case of In re Cellect illustrates the importance of analyzing patents for obviousness-type double patenting (ODP). While US 6,248,363 does not appear to be involved in such disputes, understanding these legal nuances is crucial for maintaining the validity and enforceability of pharmaceutical patents[1].
Economic and Market Implications
Revenue Generation
Patents in the pharmaceutical sector can generate significant revenue through licensing and royalties. The FTC study noted that PAEs generated approximately $4 billion in license revenue during the study period, with a substantial portion coming from ICT and pharmaceutical patents[3].
Industry Competition
The possession of patents like US 6,248,363 can provide a competitive edge in the pharmaceutical industry. Companies that own such patents can leverage them to develop innovative formulations, protect their market share, and negotiate favorable licensing agreements.
Key Takeaways
- Improved Drug Delivery: US 6,248,363 enhances the delivery of active ingredients in pharmaceutical compositions through solid carrier formulations.
- Industry Relevance: The patent aligns with current trends in pharmaceutical technology, particularly in the development of amorphous solid dispersions.
- Legal and Regulatory Considerations: Understanding patent assertion, licensing, and legal challenges like ODP is crucial for maintaining patent validity.
- Economic Impact: Patents in this sector can generate significant revenue and provide a competitive advantage.
FAQs
What is the main focus of US Patent 6,248,363?
The main focus of US Patent 6,248,363 is the development of solid carrier compositions to improve the delivery of active ingredients in pharmaceutical formulations.
How does the patent improve drug formulations?
The patent improves drug formulations by enhancing the miscibility and physical stability of drugs, particularly those with poor solubility, through the use of solid carriers like PVP K 25.
What is the significance of amorphous solid dispersions in this context?
Amorphous solid dispersions, facilitated by this patent, can significantly enhance the bioavailability and efficacy of drugs, making them a valuable therapeutic approach.
How do PAEs interact with patents like US 6,248,363?
PAEs, especially Portfolio PAEs, may negotiate licenses covering large portfolios that include patents like US 6,248,363, generating significant revenue through these licensing agreements.
What are the economic implications of owning a patent like US 6,248,363?
Owning a patent like US 6,248,363 can provide a competitive edge, generate revenue through licensing and royalties, and protect market share in the pharmaceutical industry.
Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit.
- Spray-Drying Technology - OUCI.
- Patent Assertion Entity Activity: An FTC Study - FTC.
- Invention: U.S. and Comparative Global Trends - NCSES.
- US6248363B1 - Solid carriers for improved delivery of active ingredients in pharmaceutical compositions - Google Patents.
