Understanding the Scope and Claims of United States Patent 7,780,038
Introduction to Patent 7,780,038
United States Patent 7,780,038, titled "Dispensing apparatus with dosage counter," is a critical component in the patent landscape of the drug Qnasl, a nasal spray formulation owned by Teva Branded Pharmaceutical Products R&D Inc. This patent is one of the active patents protecting Qnasl, and it plays a significant role in the drug's exclusivity and generic launch timeline.
Patent Overview
Patent Title and Number
- Patent Number: US7,780,038
- Patent Title: Dispensing apparatus with dosage counter[2].
Issuance and Expiration Dates
- Issuance Date: The patent was issued, but the exact date is not specified in the provided sources. However, it is known to be active.
- Expiration Date: The patent is set to expire on January 24, 2027[2].
Claims and Scope
Key Claims
The patent focuses on a dispensing apparatus equipped with a dosage counter, which is essential for ensuring accurate and controlled delivery of the pharmaceutical formulation. Here are some key aspects of the claims:
- Dispensing Apparatus: The patent describes a device that includes a pressurized aerosol canister, a metering valve, and an actuator. The actuator has a stem block with a receptacle for the valve stem and a sump extending below the receptacle. This setup allows for the precise dispensing of the pharmaceutical formulation[2].
- Dosage Counter: The apparatus includes a dosage counter that tracks the number of doses dispensed. This feature is crucial for patient compliance and safety, ensuring that the correct number of doses is administered.
Scope of Protection
The scope of this patent extends to the specific design and functionality of the dispensing apparatus and the dosage counter. It protects the proprietary technology related to the metering valve, actuator, and the overall mechanism of dispensing the pharmaceutical formulation in metered doses. This scope is limited to the specific claims made in the patent and does not cover broader aspects of the drug formulation itself[2].
Patent Landscape
Active and Expired Patents
Qnasl is protected by multiple patents, with US7,780,038 being one of the two active patents. The other active patent is US10,188,811, which expires on October 21, 2031. There are also three expired patents related to Qnasl, which previously covered aspects such as medicinal aerosol formulations and beclomethasone solution aerosol formulations[1].
International Protection
While US patents provide insights into exclusivity within the United States, Qnasl is also protected by patents in multiple countries. Understanding the full scope of international patent protection is crucial for strategizing market entry and identifying potential generic entry points[1].
Legal Activities and Updates
Recent Legal Activities
The patent has undergone several legal activities, including the payment of maintenance fees. For example, a payment of the maintenance fee for the 12th year was made on February 17, 2022. These activities are critical in maintaining the patent's validity and ensuring it remains active until its expiration date[1].
Oppositions and Litigations
While the provided sources do not detail specific oppositions or litigations related to US7,780,038, it is important to note that Qnasl has faced oppositions in the European Patent Office. Monitoring such legal activities is essential for understanding the patent's strength and potential challenges to its validity[1].
Impact on Generic Launch
Generic Launch Date
The expiration of US7,780,038 on January 24, 2027, will be a significant milestone in the potential generic launch of Qnasl. However, the generic launch date is currently estimated to be October 21, 2031, based on the expiration of the other active patent, US10,188,811. The interplay between these patents and any exclusivity periods granted by the FDA will determine the exact timing of generic entry[1][2].
Conclusion
United States Patent 7,780,038 is a vital component of the patent landscape for Qnasl, protecting the dispensing apparatus and dosage counter of the nasal spray device. Understanding the scope, claims, and legal activities surrounding this patent is crucial for both the patent holder and potential generic manufacturers. The patent's expiration in 2027 will mark an important step towards the eventual generic launch of Qnasl.
Key Takeaways
- Patent Number and Title: US7,780,038 - "Dispensing apparatus with dosage counter"
- Expiration Date: January 24, 2027
- Scope of Protection: Specific design and functionality of the dispensing apparatus and dosage counter
- Legal Activities: Recent maintenance fee payments and potential oppositions in international jurisdictions
- Impact on Generic Launch: Expiration will influence but not solely determine the generic launch date of Qnasl
FAQs
Q: What is the main focus of United States Patent 7,780,038?
A: The patent focuses on a dispensing apparatus with a dosage counter for the precise delivery of pharmaceutical formulations.
Q: When is the patent set to expire?
A: The patent is set to expire on January 24, 2027.
Q: How does this patent impact the generic launch of Qnasl?
A: The expiration of this patent will be a step towards the generic launch, but the actual launch date is influenced by other active patents and exclusivity periods.
Q: Are there any international patent protections for Qnasl?
A: Yes, Qnasl is protected by patents in multiple countries, which is crucial for understanding global market entry strategies.
Q: What are the key components protected by this patent?
A: The patent protects the pressurized aerosol canister, metering valve, actuator, and the dosage counter mechanism.
Sources
- Pharsight: Qnasl patent expiration - Pharsight
- Drugs.com: Generic QNASL Availability - Drugs.com
- SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN
- DrugPatentWatch: approved drug products - DrugPatentWatch
- Unified Patents: US-4563574-A - Hub Odometer | Unified Patents
