United States Patent 8,216,604: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 8,216,604, titled "Method of managing or treating pain," is associated with the drug Lazanda, which is an intranasal formulation of fentanyl. This patent is crucial for understanding the intellectual property protection surrounding Lazanda, particularly in the context of pain management.
Patent Description
The patent describes a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof. It outlines an aqueous solution that includes fentanyl, which is designed for nasal administration to manage or treat pain, particularly in cases of acute or breakthrough pain[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Composition Claims: These claims specify the components of the aqueous solution, including fentanyl, pectin, and other excipients that facilitate the intranasal delivery of the drug[4].
- Method Claims: These claims describe the method of managing or treating pain using the intranasal fentanyl composition. This includes the administration process and the therapeutic effects achieved[4].
- Device Claims: Although not the primary focus, some claims may also relate to the intranasal spray device used for delivering the pharmaceutical composition[4].
Mechanism of Action
The patent is based on the mechanism of action of fentanyl, which is a potent opioid analgesic. Fentanyl acts as an agonist at the mu-type and delta-type opioid receptors, providing rapid and effective pain relief[1].
Patent Expiration and Status
The patent US8216604B2 has expired due to fee-related issues. The expiration date was October 2024, marking the end of its exclusive protection period[2][4].
Patent Landscape
Active and Expired Patents
As of the latest updates, several patents related to Lazanda have expired, including US8216604B2. Other patents, such as US9731869, remain active until January 2032. The expiration of these patents will impact the generic launch of similar drugs[2].
Exclusivities
The FDA has granted several exclusivities to Lazanda, which delay the generic launch even after the patents have expired. These exclusivities are critical in maintaining market exclusivity for the original drug[2].
Oppositions and Legal Activities
Lazanda has faced oppositions in the European Patent Office, such as the one filed by Generics [UK] Limited in 2014. These oppositions and ongoing legal activities can affect the patent's validity and the timing of generic entries[2].
Impact on Generic Launch
The expiration of the patent US8216604B2 and other related patents, along with the exclusivities granted by the FDA, will influence the timing of the generic launch of Lazanda. The estimated generic launch date is January 26, 2032, based on the active patents and exclusivities[2].
Broader Patent Scope
Understanding the full scope of patent protection for Lazanda involves looking at its family patents across multiple countries. This broader landscape helps in identifying markets with weaker patent protection, which could be ideal for generic entry points[2].
Metrics for Measuring Patent Scope
Research on patent scope often uses metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of patent claims, which can influence the patent's validity and the ease of generic entry[3].
Conclusion on Patent Scope and Claims
The patent US8216604B2 is a significant component of the intellectual property protection for Lazanda. Its expiration, along with other patent and exclusivity considerations, will shape the market dynamics for fentanyl-based pain management drugs. Understanding the scope and claims of this patent, as well as the broader patent landscape, is essential for strategizing market entry and innovation in the pharmaceutical industry.
Key Takeaways
- Patent Description: The patent describes an intranasal fentanyl composition for pain management.
- Claims: The patent includes claims related to the composition, method of administration, and therapeutic effects.
- Expiration: The patent has expired due to fee-related issues.
- Exclusivities: FDA-granted exclusivities delay the generic launch.
- Broader Landscape: Understanding family patents and exclusivities is crucial for market strategy.
- Metrics for Scope: Independent claim length and count are used to assess patent scope.
FAQs
What is the primary use of the drug described in US Patent 8,216,604?
The primary use is for the intranasal delivery of fentanyl to manage or treat pain, particularly acute or breakthrough pain.
What is the mechanism of action of fentanyl?
Fentanyl acts as an agonist at the mu-type and delta-type opioid receptors, providing rapid and effective pain relief.
Why has the patent US8216604B2 expired?
The patent has expired due to fee-related issues.
What impact do FDA exclusivities have on the generic launch of Lazanda?
FDA exclusivities delay the generic launch of Lazanda even after the patents have expired.
How can understanding the broader patent landscape help in market strategy?
Understanding the broader patent landscape helps in identifying markets with weaker patent protection, which could be ideal for generic entry points.
Sources
- DrugBank Online - Fentanyl: Uses, Interactions, Mechanism of Action
- Pharsight - Lazanda patent expiration
- SSRN - Patent Claims and Patent Scope
- Google Patents - US8216604B2 - Method of managing or treating pain
