Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,268,352
Introduction
United States Patent 8,268,352, titled "Modified Release Composition for Highly Soluble Drugs," was granted on September 18, 2012, to Torrent Pharmaceuticals Limited. This patent introduces a novel modified release dosage form designed to manage the release of highly soluble drugs effectively. Here, we will delve into the key aspects of this patent, including its claims, the underlying technology, and the broader patent landscape.
Background of the Invention
The patent addresses a critical issue in pharmaceuticals: maintaining the blood levels of drugs within a therapeutic window to ensure efficacy while minimizing side effects. Traditional formulations often struggle with highly soluble drugs, which can lead to rapid release and potential toxicity or reduced efficacy due to fluctuating blood levels[1].
Key Claims and Innovations
Dual Retard Technique
The patent's core innovation is the use of a dual retard technique to control the release of highly soluble drugs. This method involves combining two release-controlling agents to achieve a sustained release profile, reducing the overall quantity of these agents needed. This approach helps in maintaining stable drug levels in the bloodstream over an extended period[1].
Multiple Active Ingredients
The formulation can optionally include another active ingredient, either in an immediate release or modified release form. This flexibility allows for the creation of combination therapies that can address multiple aspects of a disease or condition simultaneously[1].
Process for Preparation
The patent also details a process for preparing the modified release formulation. This includes specific steps for mixing, granulating, and compressing the drug and release-controlling agents to achieve the desired release profile[1].
Technical Details and Figures
The patent includes several figures and graphs that illustrate the release profiles of the drug under different conditions. For example, Figure 1 shows the release profile of the drug over 24 hours, demonstrating the sustained release achieved through the dual retard technique[1].
Patent Landscape and Related Patents
Prior Art and Related Patents
The patent references several prior art patents and publications, such as those by Haigh et al., Bohuon, and Cutie, which deal with various aspects of drug release formulations. These references highlight the evolution of drug delivery systems and the specific innovations introduced by the current patent[1].
Patent Family and Global Coverage
The patent is part of a larger patent family, with filings in multiple jurisdictions. This is common in pharmaceutical patents to ensure global protection. However, the claims in related patents within the same family may vary due to amendments during the prosecution process, as noted in advanced patent searching techniques[3].
Regulatory and Legal Context
Leahy-Smith America Invents Act (AIA)
The AIA, enacted in 2011, significantly impacted the U.S. patent landscape by introducing new administrative challenges to patent validity, such as Inter Partes Review (IPR). This mechanism allows third parties to challenge the validity of patents before the Patent Trial and Appeal Board (PTAB), which can affect the long-term viability of patents like US 8,268,352[2].
Inter Partes Review (IPR)
IPR proceedings, as seen in the case of Sumitomo Dainippon Pharma's LATUDA patent, can challenge the validity of existing patents. If a patent is challenged and found unpatentable, it could impact the market dominance and revenue streams of the patent holder. This highlights the importance of robust patent defense strategies and the potential for lengthy legal battles[5].
Industry Impact and Market Considerations
Therapeutic Benefits
The modified release composition for highly soluble drugs can significantly improve patient compliance and therapeutic outcomes by providing a more stable and sustained release of the active ingredient. This can be particularly beneficial for chronic conditions where consistent drug levels are crucial[1].
Competitive Landscape
In the pharmaceutical industry, patents like US 8,268,352 play a critical role in differentiating products and protecting market share. The ability to control the release of highly soluble drugs can be a competitive advantage, especially in markets where generic alternatives are emerging. The patent's validity and enforcement are essential for maintaining this advantage[3].
Criticisms and Challenges
PTAB and Patent Quality
Critics argue that the PTAB's processes can make it too easy to challenge patents, creating uncertainty and potentially stifling innovation. This could affect the long-term viability of patents like US 8,268,352, especially if they are subject to IPR proceedings[2].
Global Patent Strategies
Given the complexities of multi-jurisdictional filings and the variations in claims across different patents within a family, managing a global patent portfolio can be challenging. This requires careful strategic planning to ensure consistent protection across all relevant markets[3].
Conclusion
United States Patent 8,268,352 represents a significant advancement in the field of pharmaceutical drug delivery, particularly for highly soluble drugs. The dual retard technique and the flexibility to include multiple active ingredients make this formulation highly valuable. However, the patent landscape is dynamic, with ongoing challenges such as IPR proceedings and the need for robust global patent strategies.
Key Takeaways
- Innovation in Drug Delivery: The patent introduces a novel dual retard technique for managing the release of highly soluble drugs.
- Therapeutic Benefits: The formulation improves patient compliance and therapeutic outcomes by providing a stable and sustained release of the active ingredient.
- Regulatory Context: The AIA and IPR proceedings can impact the validity and enforcement of patents.
- Competitive Advantage: The patent is crucial for differentiating products and protecting market share in the pharmaceutical industry.
- Global Patent Strategies: Managing a global patent portfolio requires careful planning due to complexities in multi-jurisdictional filings and claims variations.
FAQs
Q: What is the main innovation of United States Patent 8,268,352?
A: The main innovation is the use of a dual retard technique to control the release of highly soluble drugs, ensuring a sustained release profile.
Q: How does the patent address the issue of multiple active ingredients?
A: The formulation can optionally include another active ingredient, either in an immediate release or modified release form, allowing for combination therapies.
Q: What is the significance of the Leahy-Smith America Invents Act (AIA) in the context of this patent?
A: The AIA introduced IPR proceedings, which can challenge the validity of patents like US 8,268,352, potentially affecting their long-term viability.
Q: How does the patent impact the competitive landscape in the pharmaceutical industry?
A: The patent provides a competitive advantage by differentiating the product and protecting market share, especially in markets with emerging generic alternatives.
Q: What are the potential challenges in managing a global patent portfolio for this invention?
A: Managing a global patent portfolio involves complexities such as multi-jurisdictional filings, claims variations, and the need for robust strategies to ensure consistent protection across all relevant markets.
Sources
- United States Patent and Trademark Office. Modified Release Composition for Highly Soluble Drugs. US 8,268,352 B2.
- Congressional Research Service. The Patent Trial and Appeal Board and Inter Partes Review. Updated May 28, 2024.
- CAS.org. Advanced patent searching techniques - Going beyond the basics to increase patent insights. July 24, 2023.
- PubChem. Modified release composition for highly soluble drugs - Patent US-8268352-B2.
- Sumitomo Dainippon Pharma. Notice of the Decision of USPTO on Inter Partes Review (IPR) Proceeding for Method of Use Patent of LATUDA. December 9, 2021.
