Understanding the Scope and Claims of United States Patent 10,829,465
Introduction
The United States Patent 10,829,465, hereafter referred to as the '465 patent, is a significant patent in the pharmaceutical industry, particularly related to the drug tasimelteon. This patent is part of a broader landscape of intellectual property protections surrounding tasimelteon, a medication used for treating sleep disorders. Here, we will delve into the details of this patent, its claims, and the broader patent landscape.
Background on Tasimelteon
Tasimelteon is an oral medication indicated for the treatment of non-24 hour sleep-wake disorder in adult patients and for the treatment of nighttime sleep disturbances in patients with Smith-Magenis Syndrome[4].
Patent Overview
The '465 patent, titled "Process for preparing a batch of highly purified, pharmaceutical grade tasimelteon," is focused on the manufacturing process of tasimelteon. Here are the key aspects:
Patent Number and Expiration
The patent number is 10,829,465, and it is estimated to expire on February 12, 2035[4][5].
Claims
The patent claims are centered around a specific process for preparing highly purified, pharmaceutical-grade tasimelteon. Here are some key claims:
- Manufacturing Process: The patent describes a detailed process for synthesizing tasimelteon under Good Manufacturing Practice (GMP) conditions. This includes steps for purification and analysis to ensure the drug meets pharmaceutical standards[2].
- Purity and Quality: The claims emphasize the importance of achieving high purity levels, which is crucial for pharmaceutical applications. The process ensures that the final product meets stringent quality control criteria[2].
Independent Claims
Independent claims are critical in defining the scope of the patent. For the '465 patent, these claims typically include:
- The method of synthesizing tasimelteon.
- The steps involved in purifying the compound.
- The analytical methods used to ensure the purity and quality of the final product[2].
Patent Scope
The scope of the '465 patent is defined by its claims and the specific process it describes.
Independent Claim Length and Count
Research on patent scope often uses metrics such as independent claim length (ICL) and independent claim count (ICC) to measure the breadth and clarity of patent claims. While specific data on ICL and ICC for the '465 patent is not provided here, these metrics are generally used to assess the complexity and scope of patents. Narrower claims, as indicated by shorter ICL and lower ICC, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Examination Process
The examination process for the '465 patent would have involved a thorough review to ensure that the claims are clear, novel, and non-obvious. The process tends to narrow the scope of patent claims, especially during longer examination periods, to ensure that the patent meets the required standards[3].
Litigation and Enforcement
The '465 patent is part of a larger set of patents related to tasimelteon that have been involved in litigation. For instance, litigation was initiated against Teva Pharmaceuticals USA Inc. for infringement of several patents, including those related to tasimelteon, within the statutory 45-day period[1].
Broader Patent Landscape
The '465 patent is one of many patents protecting tasimelteon. Here are some key points about the broader landscape:
Multiple Patents
There are several patents related to tasimelteon, including those covering different aspects of the drug such as its use, formulation, and manufacturing process. These include patents like US9060995, US9549913, US9539234, and others[4].
Expiration Dates
The expiration dates of these patents vary, with some expiring in 2033 and others in 2035. This staggered expiration ensures ongoing protection for the drug over several years[4].
Generic Entry
The expiration of these patents will pave the way for generic versions of tasimelteon. However, the specific process patented in the '465 patent may remain protected until its expiration in 2035, potentially delaying generic entry for this particular manufacturing process[5].
Industry Impact
The '465 patent and the broader patent landscape around tasimelteon have significant implications for the pharmaceutical industry.
Innovation and Competition
Patents like the '465 patent encourage innovation by providing a period of exclusivity for the patent holder. However, they also create barriers to entry for generic manufacturers, which can impact competition and drug prices[3].
Licensing and Litigation
The complexity of the patent landscape around tasimelteon can lead to increased licensing and litigation costs. This can be a challenge for companies looking to enter the market with generic versions of the drug[3].
Key Takeaways
- Manufacturing Process: The '465 patent is focused on a specific process for preparing highly purified, pharmaceutical-grade tasimelteon.
- Patent Scope: The scope is defined by the independent claims, which emphasize the purity and quality of the final product.
- Litigation and Enforcement: The patent is part of a larger set of patents involved in litigation to protect the intellectual property rights of tasimelteon.
- Broader Landscape: The '465 patent is one of many protecting tasimelteon, with varying expiration dates and implications for generic entry.
FAQs
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What is the primary focus of the '465 patent?
The primary focus of the '465 patent is the process for preparing highly purified, pharmaceutical-grade tasimelteon.
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When is the '465 patent estimated to expire?
The '465 patent is estimated to expire on February 12, 2035.
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What are the implications of the '465 patent for generic manufacturers?
The '465 patent may delay generic entry for tasimelteon manufactured using the specific process described in the patent.
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How does the patent landscape around tasimelteon impact innovation and competition?
The patent landscape encourages innovation by providing exclusivity but also creates barriers to entry for generic manufacturers, affecting competition and drug prices.
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What metrics are used to measure the scope of patent claims?
Metrics such as independent claim length (ICL) and independent claim count (ICC) are used to measure the scope and clarity of patent claims.
Sources
- FDA Letter: Tasimelteon Capsules - accessdata.fda.gov
- Unified Patents Portal: US-10829465-B2 - Unified Patents Portal
- Hoover Institution: Patent Claims and Patent Scope - Hoover Institution
- DrugBank: Tasimelteon: Uses, Interactions, Mechanism of Action - DrugBank
- Drug Patent Watch: Pharmaceutical drugs covered by patent 10,829,465 - Drug Patent Watch
