United States Patent 5,211,954: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,211,954, owned by Mallinckrodt Inc., is a significant patent in the pharmaceutical industry, particularly concerning the formulation of the drug temazepam. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The patent, issued to Mallinckrodt Inc., pertains to a low-dose temazepam composition. Temazepam is a benzodiazepine used for the short-term treatment of insomnia. The patent specifically covers formulations containing 6 to 8 milligrams and 7.5 milligrams of crystalline temazepam[2][5].
Claims of the Patent
The claims of U.S. Patent 5,211,954 are crucial in defining the boundaries of the invention. Here are some key points regarding the claims:
- Claim Scope: The claims must be "meaningfully precise" to define the invention's boundaries. The Federal Circuit has emphasized that claims should not be confined to the specific embodiments described in the specification unless the patentee has demonstrated a clear intention to limit the claim scope[2].
- Specific Dosages: The relevant claims specify formulations with "6 to 8 milligrams" and "7.5 milligrams" of crystalline temazepam. These specific dosages are critical in distinguishing the invention from other temazepam formulations[5].
Claim Construction
Claim construction is a critical process in patent litigation, as it determines the scope of the patent's protection. Here are some key aspects:
- Definiteness Requirement: The claims must meet the definiteness requirement under 35 U.S.C. § 112, which means a person of ordinary skill in the art must be able to ascertain a "meaningfully precise claim scope"[2].
- Embodiments vs. Claims: The Federal Circuit has warned against confining claims to the embodiments described in the specification. Claims should be interpreted broadly unless there is a clear intention to limit the scope[2].
Patent Infringement Litigation
The patent has been involved in significant litigation, particularly in the case of Tyco Healthcare Group LP and Mallinckrodt Inc. v. Mutual Pharmaceutical Company, Inc. and United Research Laboratories, Inc. This case arose from Mutual Pharmaceutical's filing of an Abbreviated New Drug Application (ANDA) with the FDA to manufacture and sell temazepam products, which Mallinckrodt and Tyco alleged infringed on their patent[2].
Patent Landscape
Understanding the broader patent landscape is essential for navigating the intellectual property rights surrounding temazepam formulations.
- Global Patent System: The USPTO's Global Dossier service allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This can help in identifying similar patents and potential infringement risks[1].
- International Search: Searching international patent databases, such as those provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), can reveal whether similar patents exist abroad[1].
Public Search Resources
Several resources are available for conducting thorough patent searches:
- Patent Public Search: This tool provides enhanced access to prior art and is a powerful resource for searching U.S. patents and published patent applications[1].
- Patent and Trademark Resource Centers (PTRCs): These centers offer local search resources and training in patent search techniques, which can be invaluable for understanding the patent landscape[1].
Data and Statistics
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, which can be used to analyze trends and scope measurements in patent claims. This dataset includes claim-level and document-level statistics, offering insights into the complexity and breadth of patent claims[3].
Key Takeaways
- Precise Claim Scope: The claims of U.S. Patent 5,211,954 must be interpreted precisely to define the invention's boundaries.
- Specific Dosages: The patent specifically covers formulations with 6 to 8 milligrams and 7.5 milligrams of crystalline temazepam.
- Litigation: The patent has been involved in significant litigation regarding infringement claims.
- Global Landscape: Understanding the global patent system and searching international databases are crucial for navigating IP rights.
- Public Resources: Utilizing public search tools and PTRCs can aid in comprehensive patent searches.
FAQs
What is the main subject of U.S. Patent 5,211,954?
U.S. Patent 5,211,954 pertains to a low-dose temazepam composition, specifically formulations containing 6 to 8 milligrams and 7.5 milligrams of crystalline temazepam.
How are the claims of the patent interpreted?
The claims must be "meaningfully precise" and should not be confined to the specific embodiments described in the specification unless the patentee has demonstrated a clear intention to limit the claim scope.
What is the significance of the definiteness requirement in patent claims?
The definiteness requirement under 35 U.S.C. § 112 ensures that a person of ordinary skill in the art can ascertain a "meaningfully precise claim scope."
How can one search for similar patents internationally?
One can use resources like the Global Dossier service, European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) databases to search for similar patents internationally.
What resources are available for conducting thorough patent searches in the U.S.?
Resources include the Patent Public Search tool, Patent and Trademark Resource Centers (PTRCs), and the USPTO Public Search Facility.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- GovInfo - Case 2:07-cv-01299-SRC-CLW Document 193: https://www.govinfo.gov/content/pkg/USCOURTS-njd-2_07-cv-01299/pdf/USCOURTS-njd-2_07-cv-01299-1.pdf
- USPTO - Patent Claims Research Dataset: 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: https://www.commerce.gov/bureaus-and-offices/uspto
- Finnegan - Last Month at the Federal Circuit Newsletter - July 2011: https://www.finnegan.com/files/upload/Newsletters/Last_Month_at_the_Federal_Circuit/2011/July/FCN_Jul11_10.html
