United States Patent 5,334,162: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,334,162, titled "Cartridge Assembly for a Lyophilized Compound Forming a Disposable Portion of an Injection Device," was assigned to Eli Lilly and Co. and has significant implications in the pharmaceutical industry. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Priority Date
The patent was filed on March 15, 1993, and granted on August 2, 1994. This period was marked by advancements in pharmaceutical packaging and delivery systems, highlighting the need for innovative solutions in lyophilization and injection devices[5].
Scope of the Patent
The patent describes a method and apparatus for lyophilizing and sealing an injectable product within a cartridge. The scope includes:
- Lyophilization Process: The method involves lyophilizing a compound within a cartridge, ensuring the product remains stable and effective.
- Cartridge Assembly: The invention details a cartridge assembly designed to be part of a disposable portion of an injection device.
- Sealing Mechanism: The patent includes a sealing mechanism to maintain the integrity of the lyophilized product within the cartridge[2].
Claims of the Patent
The patent claims are crucial as they define the legal boundaries of the invention. Key claims include:
- Method Claims: Claim 1 describes the method of lyophilizing and sealing an injectable product within a cartridge, outlining specific steps and conditions.
- Apparatus Claims: Other claims detail the cartridge assembly and its components, such as the sealing mechanism and the structure of the cartridge[2].
Claim Analysis
To understand the patent's scope, it is essential to analyze the claims:
- Claim 1: This claim is broad and covers the entire process of lyophilizing and sealing the product. It sets the foundation for the other claims.
- Dependent Claims: Subsequent claims are dependent on Claim 1 and provide additional details or variations of the method and apparatus. These claims help to narrow down the scope and provide specificity to the invention[2].
Patent Landscape
The patent landscape around US 5,334,162 involves several key aspects:
- Prior Art: The patent search would involve looking at prior art related to lyophilization, cartridge assemblies, and injection devices. Tools like the USPTO's Patent Public Search and Global Dossier can be used to identify relevant prior art and related applications[1].
- Competitors and Similar Patents: Companies like Pfizer, Merck, and other pharmaceutical giants may have similar patents or be working on related technologies. Analyzing these patents can provide insights into the competitive landscape.
- International Patents: Since pharmaceutical innovations are global, searching international patent databases such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) is crucial to understand the global patent landscape[1].
Impact on the Pharmaceutical Industry
This patent has had a significant impact on the pharmaceutical industry in several ways:
- Improved Drug Stability: The lyophilization method described ensures the stability of injectable products, which is critical for maintaining drug efficacy.
- Innovative Packaging: The cartridge assembly and sealing mechanism have set a standard for disposable injection devices, enhancing patient safety and convenience.
- Compliance and Regulation: The patent's focus on a specific method and apparatus helps in complying with regulatory standards, ensuring that pharmaceutical products meet stringent safety and efficacy requirements[2].
Expiration and Biosimilars
Biologic drug patents, including those related to lyophilization and injection devices, typically expire after 20 years from the filing date. For US 5,334,162, the patent would have expired in 2013, allowing for the development of biosimilars and generic versions of the technology. This expiration opens up opportunities for other companies to develop similar products, potentially leading to increased competition and lower costs for consumers[2].
Legal and Economic Implications
The expiration of this patent has several legal and economic implications:
- Loss of Exclusivity: Eli Lilly and Co. no longer holds exclusive rights to the technology, allowing other companies to enter the market.
- Market Competition: The entry of biosimilars and generic products can increase market competition, potentially driving down prices and improving access to the technology.
- Innovation Incentives: The expiration of patents can also incentivize further innovation as companies seek to improve upon existing technologies to regain market exclusivity[2].
Conclusion
United States Patent 5,334,162 represents a significant innovation in the field of pharmaceutical packaging and delivery systems. Understanding its scope, claims, and the broader patent landscape is crucial for both legal and strategic purposes. As the patent has expired, it has opened up new opportunities for competition and innovation in the pharmaceutical industry.
Key Takeaways
- Patent Scope: The patent covers a method and apparatus for lyophilizing and sealing injectable products within cartridges.
- Claims Analysis: The claims define the legal boundaries of the invention, with Claim 1 being broad and subsequent claims providing specificity.
- Patent Landscape: The landscape involves prior art, competitors, and international patents.
- Industry Impact: The patent has improved drug stability, innovative packaging, and compliance with regulatory standards.
- Expiration and Biosimilars: The patent's expiration has led to increased competition and the development of biosimilars.
FAQs
What is the primary focus of United States Patent 5,334,162?
The primary focus is on a method and apparatus for lyophilizing and sealing an injectable product within a cartridge.
Who was the assignee of this patent?
The assignee was Eli Lilly and Co.
When was the patent filed and granted?
The patent was filed on March 15, 1993, and granted on August 2, 1994.
What are the key claims of this patent?
The key claims include the method of lyophilizing and sealing the product and the apparatus claims detailing the cartridge assembly and sealing mechanism.
What is the significance of the patent's expiration?
The expiration allows for the development of biosimilars and generic versions, increasing market competition and potentially driving down prices.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- DrugPatentWatch - When do biologic drug patents expire and when will biosimilars be available? Retrieved from https://www.drugpatentwatch.com/p/biologics/patent-claims/5334162
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- U.S. Department of Commerce - U.S. Patent and Trademark Office. Retrieved from https://www.commerce.gov/bureaus-and-offices/uspto
- Unified Patents - US-D959694-S1 - Container for Pharmaceuticals. Retrieved from https://portal.unifiedpatents.com/patents/patent/US-D959694-S1
