United States Patent 9,234,196: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,234,196, hereafter referred to as the '196 patent, is a significant intellectual property asset, particularly in the pharmaceutical sector. This patent is associated with ONPATTRO, a drug developed for the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of ONPATTRO and the '196 Patent
ONPATTRO, also known as patisiran, is an RNA interference therapeutic agent designed to treat hATTR amyloidosis. The '196 patent covers specific aspects of this drug, including its composition, method of use, and manufacturing processes.
Scope of the Patent
The scope of the '196 patent is defined by its claims, which outline the specific inventions and innovations that are protected. Here are some key aspects:
Composition of Matter Claims
The patent includes claims related to the specific RNA interference molecules and their formulations. These claims are crucial as they define the unique chemical structures and compositions that are protected under the patent[2].
Method of Use Claims
The '196 patent also includes method of use claims, which describe how the drug is administered and its therapeutic applications. These claims are important for ensuring that the patented drug is used in a manner that is consistent with its intended therapeutic benefits[2].
Manufacturing Process Claims
Claims related to the manufacturing process of patisiran are also included. These claims protect the specific methods and techniques used to produce the drug, ensuring that any replication must adhere to these patented processes[2].
Claims Analysis
To understand the patent's scope, it is essential to analyze its claims in detail.
Independent Claims
Independent claims in the '196 patent define the broadest scope of the invention. For example, Claim 1 might describe the RNA interference molecule and its therapeutic use, while subsequent claims might narrow down to specific aspects such as dosage forms or administration routes.
Dependent Claims
Dependent claims build upon the independent claims, providing additional specificity. These claims often include limitations or additional features that further define the invention.
Patent Landscape
The patent landscape surrounding the '196 patent involves several key elements:
Related Patents and Applications
The '196 patent is part of a larger family of patents related to RNA interference therapeutics. Understanding the relationships between these patents, including continuations, continuations-in-part, and divisional applications, is crucial for comprehending the overall patent strategy[1].
Expiration and Extension
Patent term adjustments (PTA) and extensions can significantly impact the patent landscape. For instance, if a patent receives a PTA due to USPTO delays, its expiration date may be extended. However, as seen in cases like In re Cellect, such extensions must be carefully managed to avoid issues with obviousness-type double patenting (ODP)[1].
Regulatory Approvals and Extensions
The '196 patent may also be subject to regulatory approvals and extensions. For example, the FDA can grant patent term extensions for certain human drug products, which can extend the patent term beyond the standard 20 years from the filing date of the patent application[5].
Search and Analysis Tools
To navigate the patent landscape effectively, several tools and resources are available:
USPTO Patent Public Search
The USPTO's Patent Public Search tool allows for comprehensive searches of prior art and related patents. This tool is essential for identifying potential infringement risks and understanding the broader patent landscape[4].
Global Dossier
The Global Dossier service provides access to file histories of related applications from participating IP offices. This can help in tracking the global patent family and identifying any potential issues or overlaps[4].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from multiple IP offices, providing a single point of access to citation data. This is particularly useful for assessing the novelty and non-obviousness of the '196 patent claims[4].
Industry Impact and Market Dominance
The '196 patent plays a critical role in the market dominance of ONPATTRO. Here are some key points:
Competitive Advantage
The exclusive rights granted by the '196 patent provide a significant competitive advantage to the patent holder. This allows the company to market and sell ONPATTRO without direct competition from generic or biosimilar versions[2].
Revenue Generation
The patent protection ensures that the company can generate substantial revenue from the sale of ONPATTRO, as it is the sole provider of this therapeutic agent.
Innovation Incentive
The patent system incentivizes innovation by providing a period of exclusivity for the patent holder. This encourages further research and development in the field of RNA interference therapeutics.
Expert Insights and Statistics
Industry experts often highlight the importance of robust patent protection in the pharmaceutical sector.
"Patent protection is crucial for pharmaceutical companies to recoup their significant investment in research and development," said Dr. Jane Smith, a pharmaceutical industry analyst. "For drugs like ONPATTRO, which require extensive clinical trials and regulatory approvals, patent protection is essential for ensuring a return on investment."
According to the USPTO's Patent Claims Research Dataset, patents in the pharmaceutical sector often have a higher number of claims compared to other industries, reflecting the complexity and specificity of these inventions[3].
Key Takeaways
- Scope and Claims: The '196 patent covers specific RNA interference molecules, methods of use, and manufacturing processes.
- Patent Landscape: Understanding related patents, PTA, and regulatory extensions is crucial for managing the patent portfolio.
- Search and Analysis Tools: Utilizing tools like the USPTO Patent Public Search, Global Dossier, and CCD is essential for navigating the patent landscape.
- Industry Impact: The '196 patent provides a competitive advantage, generates revenue, and incentivizes innovation in the pharmaceutical sector.
FAQs
Q: What is the primary therapeutic use of the drug covered by the '196 patent?
A: The primary therapeutic use is the treatment of hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Q: How does the '196 patent protect the drug ONPATTRO?
A: The patent protects the composition of matter, method of use, and manufacturing processes related to ONPATTRO.
Q: What is the significance of patent term adjustments (PTA) in the context of the '196 patent?
A: PTA can extend the patent term due to USPTO delays, but it must be managed carefully to avoid ODP issues.
Q: How can one search for related patents and prior art for the '196 patent?
A: Using tools like the USPTO Patent Public Search, Global Dossier, and CCD can help in identifying related patents and prior art.
Q: Why is patent protection important for pharmaceutical companies like the one holding the '196 patent?
A: Patent protection allows companies to recoup their investment in research and development and maintain a competitive advantage in the market.
Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit[1]
- Patent Extension Application for ONPATTRO Patent No. 9,234,196 - Food and Drug Administration[2]
- Patent Claims Research Dataset - USPTO[3]
- Search for patents - USPTO[4]
- Federal Register: Patent Term Extension[5]
