United States Patent 7,587,988: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,587,988, titled "Dose Counter for an Inhaler," is a significant patent in the field of pharmaceuticals, particularly for inhaler devices used in the treatment of respiratory conditions. This patent, held by AstraZeneca, is part of a broader portfolio of patents protecting their inhaler products.
Background
Inhalers are crucial for delivering medication directly to the lungs, providing relief for conditions such as asthma and chronic obstructive pulmonary disease (COPD). The patent in question focuses on the dose counter mechanism, an essential component that ensures patients receive the correct dosage of medication.
Scope of the Patent
The patent 7,587,988 describes a dose counter for an inhaler, which includes several key components:
- Main Body and Canister Housing: The inhaler has a main body with a canister housing that retains a medicament canister.
- Dose Counter: The dose counter has a counter display that indicates the dosage information and a drive system that moves the counter display incrementally in response to actuation input[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Claim 1: A dose counter for an inhaler, including a counter display and a drive system that moves the counter display in response to actuation input.
- Claim 2: The dose counter further includes a regulator that acts upon the drive system to ensure accurate dosage counting.
- Claim 3: The inhaler includes a canister housing with an inner wall and a first inner wall canister support formation extending inwardly from the main surface of the inner wall[1].
Patent Landscape
The patent landscape surrounding 7,587,988 is complex and involves multiple related patents and legal disputes.
Related Patents
The patent is part of a series of related patents held by AstraZeneca, including:
- 7,759,328: Another patent related to the inhaler device, focusing on different aspects of the medication delivery system.
- 7,967,011: This patent covers additional features of the inhaler, such as the metering valve assembly.
- 8,143,239: This patent deals with the propellant and drug mixture in the inhaler.
- 8,387,615: This patent covers the expiration dates and pediatric exclusivity periods for the drug formulations used in the inhaler[2].
Litigation and Exclusivity
The patent has been involved in significant litigation, particularly with generic drug manufacturers. For example:
- AstraZeneca vs. Mylan: AstraZeneca initiated litigation against Mylan for infringement of several patents, including 7,587,988. The court ruled in favor of AstraZeneca, finding that Mylan failed to demonstrate the invalidity of the asserted claims[2].
Expiration Dates and Exclusivity
The patent 7,587,988 is set to expire on October 10, 2026, with pediatric exclusivity added. This means that generic versions of the inhaler cannot be approved until after this date, unless the patent is successfully challenged and invalidated[2].
Impact on the Pharmaceutical Industry
The patent 7,587,988 has a significant impact on the pharmaceutical industry, particularly in the development and marketing of inhaler devices.
Innovation and Competition
The patent protects AstraZeneca's innovative dose counter mechanism, preventing other companies from using similar technology without permission. This can limit competition and innovation in the field, as other companies must develop alternative solutions.
Generic Drug Approval
The expiration of this patent will open the market for generic versions of the inhaler, potentially reducing costs for patients and increasing access to the medication.
Expert Insights
Industry experts highlight the importance of such patents in protecting intellectual property and driving innovation:
"Patents like 7,587,988 are crucial for pharmaceutical companies to recoup their investment in research and development. They also serve as a catalyst for further innovation, as companies strive to develop new and better technologies to circumvent existing patents"[2].
Statistics and Market Impact
- Market Share: AstraZeneca's inhaler products, protected by patents like 7,587,988, hold a significant market share in the respiratory treatment segment.
- Revenue: The protection afforded by these patents contributes substantially to AstraZeneca's revenue from inhaler sales.
- Patient Access: The eventual expiration of these patents is expected to increase patient access to affordable generic alternatives, potentially benefiting millions of patients worldwide[2].
Key Takeaways
- Patent Scope: The patent 7,587,988 covers a dose counter mechanism for inhalers, ensuring accurate dosage delivery.
- Claims: The patent includes specific claims regarding the counter display, drive system, and regulator.
- Patent Landscape: The patent is part of a complex landscape involving related patents and litigation.
- Impact: The patent affects innovation, competition, and patient access in the pharmaceutical industry.
FAQs
What is the main focus of United States Patent 7,587,988?
The main focus of the patent is the dose counter mechanism for an inhaler, ensuring accurate dosage delivery.
When is the patent set to expire?
The patent 7,587,988 is set to expire on October 10, 2026, with pediatric exclusivity added.
What is the significance of the litigation involving this patent?
The litigation, such as the case against Mylan, highlights the efforts by AstraZeneca to protect their intellectual property and prevent generic versions of their inhaler from entering the market prematurely.
How does this patent impact the pharmaceutical industry?
The patent protects AstraZeneca's innovation, limits competition, and affects the timing of generic drug approvals, ultimately influencing patient access to affordable medications.
What happens when the patent expires?
When the patent expires, generic versions of the inhaler can be approved, potentially reducing costs and increasing access to the medication for patients.
Cited Sources
- United States Patent and Trademark Office: US11395889B2 - Dose counter for an inhaler[1].
- U.S. Food & Drug Administration: ANDA 211699 - AstraZeneca's Symbicort Inhalation Aerosol[2].
- United States Patent and Trademark Office: Fiscal Year 2006 Budget Request[3].
- DrugPatentWatch: Approved Drug Products with Therapeutic Equivalence Evaluations[4].
