Understanding the Scope and Claims of United States Patent 11,980,623
Introduction
United States Patent 11,980,623, titled "Solid dosage formulations of an orexin receptor antagonist," is a crucial patent in the pharmaceutical industry, particularly for the drug Belsomra, which is owned by Merck Sharp and Dohme Corp. This patent is one of several that protect the drug's active ingredient and formulation.
Patent Overview
The patent with the number US11980623 is focused on the solid dosage formulations of an orexin receptor antagonist, specifically suvorexant, which is the active ingredient in Belsomra. This drug is used to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance[1].
Claims and Scope
Active Ingredient Protection
The patent claims cover the specific formulations of suvorexant, ensuring that only the patent owner can produce and market products using these formulations until the patent expires. The claims are detailed and specify the composition, dosage, and mode of administration (e.g., oral tablets or capsules)[1].
Independent Claims
The patent includes independent claims that define the scope of the invention. These claims are critical as they outline what is novel and non-obvious about the invention. For example, the claims might specify the exact chemical composition, the process of manufacturing the solid dosage form, and any unique characteristics of the formulation that enhance its efficacy or stability[2].
Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can indicate the breadth and clarity of the patent. Narrower claims with fewer words and fewer independent claims often result in a higher probability of grant and a shorter examination process. However, the specifics of US11980623 would need to be analyzed to determine how these metrics apply[3].
Expiration and Generic Launch
The patent US11980623 is set to expire on May 29, 2033, which is also the estimated generic launch date for Belsomra. This date can be influenced by various legal activities such as the payment of maintenance fees, term extensions, or amendments to the patent claims. Tracking these activities is essential for understanding the potential timeline for generic entry[1].
Exclusivity Information
While the patent itself provides protection until 2033, Belsomra also had exclusivity protections that have since expired. The New Chemical Entity (NCE) exclusivity expired on August 13, 2019, and another exclusivity (M-253) expired on January 29, 2023. These exclusivities, although expired, were additional barriers to generic competition during their term[1].
Family Patents and Global Protection
Belsomra's protection is not limited to the United States; it is protected by a family of patents in multiple countries. Understanding the global patent landscape is crucial for strategizing market entry, as it helps identify markets with weaker patent protection that could be ideal for generic entry[1].
Recent Legal Activities
The patent has undergone several legal activities that are tracked to ensure the latest developments are accounted for. These include payments of maintenance fees, notices of final determination, and recordation of patent grants. These activities can affect the patent's expiry date and the timing of generic launch[1].
Impact on Innovation and Competition
The scope and claims of US11980623 influence innovation and competition in the pharmaceutical industry. Broad and clear claims can provide strong protection, but overly broad claims can lead to increased litigation and licensing costs, potentially stifling innovation. The examination process tends to narrow the scope of patent claims, ensuring that only novel and non-obvious inventions are protected[3].
Key Takeaways
- Patent Protection: US11980623 protects the solid dosage formulations of suvorexant, the active ingredient in Belsomra.
- Expiration Date: The patent is set to expire on May 29, 2033, marking the potential generic launch date.
- Claims and Scope: The patent includes detailed claims on the composition and formulation of the drug.
- Global Landscape: Belsomra is protected by a family of patents globally, affecting market entry strategies.
- Legal Activities: Ongoing legal activities can impact the patent's expiry date and generic launch.
FAQs
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What is the active ingredient protected by US11980623?
The active ingredient protected by US11980623 is suvorexant, an orexin receptor antagonist used in the drug Belsomra.
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When is the patent US11980623 set to expire?
The patent US11980623 is set to expire on May 29, 2033.
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What are the implications of the patent's expiration for generic drugs?
The expiration of the patent allows for the potential launch of generic versions of Belsomra, increasing competition and potentially reducing costs for consumers.
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How do exclusivity protections affect the market entry of generics?
Exclusivity protections, although expired for Belsomra, would have prevented generic competition during their term, providing the original drug with a market monopoly.
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Why is tracking legal activities on the patent important?
Tracking legal activities helps in understanding any changes to the patent's expiry date and the potential timing for generic entry, which is crucial for market strategy and planning.
