United States Patent 5,829,434: A Detailed Analysis
Overview of the Patent
U.S. Patent No. 5,829,434, titled "Inhaler for Powdered Medications," was assigned to Schering Corporation, now part of Merck Sharp and Dohme LLC. The patent was approved on March 30, 2005, for the commercial use and sale of ASMANEX® TWISTHALER®, a cap-activated inhalation-driven multi-dose dry powder inhaler containing mometasone furoate and anhydrous lactose[1].
Scope of the Patent
The patent covers a specific type of inhaler designed for delivering powdered medications. Here are the key aspects of its scope:
Product Description
The patented device is a cap-activated inhalation-driven multi-dose dry powder inhaler. It is designed to deliver mometasone furoate, a corticosteroid used for treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)[1].
Mechanism of Action
The inhaler operates by using the patient's inhalation to activate the release of the powdered medication. This mechanism ensures that the medication is delivered directly to the lungs, enhancing its efficacy.
Claims of the Patent
The patent includes several claims that define the specific features and functionalities of the inhaler. Here are some key claims:
Structural Claims
- The patent claims a device with a housing containing a plurality of doses of powdered medication.
- It includes a cap that, when removed, allows the patient to inhale the medication.
- The device has a mechanism to ensure that only one dose is released per inhalation[1].
Functional Claims
- The claims also cover the method of using the inhaler, including the steps of removing the cap, inhaling to activate the release of the medication, and replacing the cap after use.
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around U.S. Patent No. 5,829,434, one would start by defining the scope of the analysis and identifying relevant keywords such as "dry powder inhaler," "mometasone furoate," and "inhalation-driven"[3].
Search and Organize Patents
Using patent databases, one would search for patents related to these keywords and organize them based on factors like filing date, assignee, and technology subcategories. This would help in identifying similar patents and understanding the evolution of the technology[3].
Identify Trends and Key Players
The analysis would reveal trends in patent filings related to inhalation devices and identify key players in the field. For instance, companies like Schering Corporation (now part of Merck) and other pharmaceutical companies would be significant contributors to this technology domain[3].
Analyze Citations and Evolution
By studying how patents reference each other, one can understand the impact and development of the technology. This would include analyzing citations to and from U.S. Patent No. 5,829,434 to see how it fits into the broader landscape of inhaler technology[3].
Regulatory and Legal Considerations
Patent Term Extension
The patent was subject to an application for patent term extension under 35 U.S.C. § 156, which allows for the extension of a patent term due to regulatory review periods. However, the application was denied because the active ingredient, mometasone furoate, had been previously approved under § 505 of the Federal Food, Drug, and Cosmetic Act (FFDCA) for other products like ELOCON® and NASONEX®[1].
Eligibility Criteria
For a patent to be eligible for term extension under § 156, the product must be the first permitted commercial marketing or use of the product under the relevant provision of law. Since mometasone furoate was already approved for other products, U.S. Patent No. 5,829,434 did not meet this criterion[1].
Competitive Landscape
Key Players
The competitive landscape includes other pharmaceutical companies and medical device manufacturers that produce inhalation devices. Companies like GlaxoSmithKline, AstraZeneca, and Teva Pharmaceuticals are significant players in this market.
Technological Trends
The trend in inhaler technology is towards more user-friendly, efficient, and precise delivery systems. There is a focus on developing devices that are easier to use, especially for patients with respiratory conditions, and that provide better control over medication dosing.
Insights for Strategic Decisions
Innovation and R&D
A patent landscape analysis provides insights into ongoing innovations and future trends. This can guide research and development strategies, helping companies to focus on areas that are less crowded and more likely to result in novel and patentable inventions.
Legal Vulnerabilities
Understanding the patent landscape also helps in identifying potential legal vulnerabilities. By analyzing the claims and scope of existing patents, companies can avoid infringement and develop strategies to protect their own intellectual property.
Key Takeaways
- U.S. Patent No. 5,829,434 covers a specific type of dry powder inhaler for delivering mometasone furoate.
- The patent was denied extension under 35 U.S.C. § 156 due to prior approvals of the active ingredient.
- The patent landscape analysis is crucial for understanding trends, key players, and potential legal vulnerabilities in the field of inhaler technology.
- Insights from the analysis can guide strategic decisions in innovation, R&D, and intellectual property protection.
Frequently Asked Questions (FAQs)
What is the main product covered by U.S. Patent No. 5,829,434?
The main product is ASMANEX® TWISTHALER®, a cap-activated inhalation-driven multi-dose dry powder inhaler containing mometasone furoate and anhydrous lactose.
Why was the patent term extension application denied?
The application was denied because the active ingredient, mometasone furoate, had been previously approved under § 505 of the FFDCA for other products, making it not the first permitted commercial marketing or use of the product.
What are the key steps in performing a patent landscape analysis?
The key steps include defining the scope and keywords, searching and organizing patents, identifying trends and key players, analyzing citations and evolution, and generating insights for strategic decisions.
How does the patent landscape analysis help in strategic decision-making?
It provides insights into ongoing innovations, trends, and key players, helping companies to focus their R&D efforts, avoid legal vulnerabilities, and protect their intellectual property.
What are some of the trends in inhaler technology?
The trends include developing more user-friendly, efficient, and precise delivery systems, with a focus on easier use and better control over medication dosing.
Cited Sources:
- United States Patent and Trademark Office, "NOTICE OF FINAL DETERMINATION - U.S. Patent No. 5,829,434"[1].
- CAFC, "CONTOUR IP HOLDING LLC v. GOPRO, INC."[2].
- Goldstein Patent Law, "How to Do Patent Landscape Analysis"[3].
- USPTO, "Search for patents"[4].
- Unified Patents Portal, "US-5829434-A - Inhaler for Powdered Medications"[5].
