United States Patent 9,493,582: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,493,582, titled "Alkylated cyclodextrin compositions and processes for preparing and using the same," is a significant patent in the field of pharmaceuticals and biotechnology. This patent, issued to protect specific compositions and methods related to alkylated cyclodextrins, is crucial for understanding the intellectual property landscape in this domain.
Background and Context
Cyclodextrins are cyclic oligosaccharides that have been widely used in pharmaceutical formulations due to their ability to form inclusion complexes with various guest molecules, enhancing solubility, stability, and bioavailability of drugs. The patent in question focuses on alkylated cyclodextrins, which are modified cyclodextrins with alkyl groups attached, further enhancing their properties[1].
Patent Scope and Claims
The patent 9,493,582 encompasses several key aspects:
Composition Claims
- The patent describes low-chloride alkylated cyclodextrin compositions. These compositions are critical for pharmaceutical applications where the presence of chloride ions could be detrimental.
- The claims include specific chemical structures and methods for synthesizing these alkylated cyclodextrins, ensuring they meet the required standards for pharmaceutical use[1].
Process Claims
- The patent details processes for preparing these alkylated cyclodextrin compositions. This includes methods such as ultra-filtration, diafiltration, and precipitation, which are essential for purifying and stabilizing the final product.
- The processes also cover the use of solvents and other reagents to achieve the desired chemical modifications[1].
Use Claims
- The patent specifies the use of these alkylated cyclodextrin compositions in pharmaceutical formulations. This includes their role as excipients to improve the solubility and stability of active pharmaceutical agents.
- The claims also cover the application of these compositions in various therapeutic areas, although the specific therapeutic uses are not detailed in the patent itself[1].
Enablement and Written Description Requirements
The patent must comply with the enablement and written description requirements under 35 U.S.C. ยง 112(a). This means the patent specification must provide a written description in "such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same." The current jurisprudence, particularly from the Federal Circuit, emphasizes the need for "full scope" enablement, which can be challenging for genus claims involving numerous species[3].
Genus Claims and Their Challenges
Genus claims, which cover a broad class of compounds, are common in pharmaceutical and biotechnology patents. However, these claims face significant challenges under current patent law. The Federal Circuit's rigid stance on genus claims requires the identification of every covered species within the genus, which can be impractical and often leads to the invalidation of such claims due to lack of enablement[3].
Patent Landscape and Expiration
The patent 9,493,582 is part of a broader patent landscape that includes multiple patents protecting various aspects of pharmaceutical compositions and processes. For instance, the patent expiration dates for related patents can significantly impact the market availability of generic versions of drugs that utilize these compositions.
- The patent 9,493,582 itself is set to expire on February 27, 2033, as indicated in related documents[2].
Competitive and Regulatory Implications
The protection offered by this patent is crucial for the innovator companies to maintain their market position. Once the patent expires, generic versions of the drug can enter the market, potentially reducing the innovator's market share.
- The regulatory environment, including FDA approvals and bioequivalence determinations, also plays a significant role in how these patents are enforced and how generic competitors can enter the market[2][4].
Litigation and Settlements
Patent litigation and settlement agreements are common in the pharmaceutical industry, especially when generic manufacturers seek to enter the market before the expiration of the innovator's patents.
- Settlements often involve agreements where the generic manufacturer is allowed to enter the market at a specified date, usually before the patent expiration, in exchange for dropping their challenges to the patent's validity[5].
Impact on Pharmaceutical and Biotechnology Industries
The scope and claims of this patent, along with the broader patent landscape, significantly impact the pharmaceutical and biotechnology industries. Innovators must balance the need for broad patent protection with the practical limitations imposed by current jurisprudence.
- The rigid requirements for genus claims can make it difficult for innovators to protect their inventions fully, while narrow claims can be easily designed around by competitors[3].
Key Takeaways
- Composition and Process Claims: The patent covers specific alkylated cyclodextrin compositions and their preparation processes.
- Enablement and Written Description: The patent must comply with strict enablement and written description requirements.
- Genus Claims Challenges: Broad genus claims face significant challenges under current patent law.
- Patent Expiration and Landscape: The patent expires on February 27, 2033, and is part of a complex patent landscape.
- Regulatory and Competitive Implications: The patent's protection affects market dynamics and generic competition.
- Litigation and Settlements: Patent litigation and settlements are critical in determining market entry for generic manufacturers.
FAQs
Q: What is the primary focus of United States Patent 9,493,582?
A: The primary focus is on alkylated cyclodextrin compositions and the processes for preparing and using them.
Q: What are the key challenges faced by genus claims in pharmaceutical patents?
A: Genus claims face challenges due to the requirement for "full scope" enablement, which involves identifying every covered species within the genus, a task that can be impractical and often leads to invalidation.
Q: When does the patent 9,493,582 expire?
A: The patent is set to expire on February 27, 2033.
Q: How do patent litigation and settlements impact the pharmaceutical industry?
A: These can determine when generic manufacturers can enter the market, often through agreements that allow early market entry in exchange for dropping patent validity challenges.
Q: What is the significance of enablement and written description requirements in patent law?
A: These requirements ensure that the patent specification provides enough detail for a skilled artisan to make and use the invention, which is crucial for the validity of the patent.
Cited Sources:
- US9493582B2 - Alkylated cyclodextrin compositions and processes for preparing and using the same - Google Patents
- Carfilzomib for Injection - accessdata.fda.gov
- Eviscerating Patent Scope - DigitalCommons@NYLS
- KYPROLIS - Drug Patent Watch
- ANDA Litigation Settlements Summer 2021 - Robins Kaplan
