United States Patent 7,919,116: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,919,116, titled "Controlled Release Metformin Formulations," is a significant patent in the pharmaceutical industry, particularly in the field of antihyperglycemic medications. This patent, granted to Andrx Labs, LLC, outlines innovative formulations for the controlled release of metformin, a widely used drug for managing type 2 diabetes. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Inventors
The patent was filed on March 2, 2007, and granted on April 5, 2011. The inventors include Chih-Ming Chen, Xiu Xiu Cheng, Steve Jan, and Joseph Chou, all associated with Andrx Labs, LLC[4].
Scope of the Patent
The patent focuses on sustained release pharmaceutical formulations containing metformin or its pharmaceutically acceptable salts. These formulations are designed to provide a controlled release of the drug over an extended period, typically several hours, which can improve patient compliance and therapeutic efficacy.
Key Components
- Metformin Formulations: The patent describes various formulations that ensure the sustained release of metformin. These include tablets, capsules, and other dosage forms that release the drug in a controlled manner[4].
- Release Profiles: The patent specifies the dissolution profiles of these formulations in simulated intestinal and gastric fluids, ensuring that the drug is released in a predictable and controlled manner[1].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention.
Independent Claims
- The independent claims outline the core components of the invention, including the composition of the sustained release formulation and the method of its preparation. For example, Claim 1 describes a sustained release pharmaceutical formulation comprising metformin or its salt, along with specific excipients and release-controlling agents[4].
Dependent Claims
- Dependent claims further specify the details of the formulation, such as the types of excipients used, the ratio of metformin to other components, and the release profile characteristics. These claims provide a detailed description of how the invention can be implemented in various ways while staying within the scope of the independent claims[4].
Patent Landscape
Prior Art and Related Patents
The patent cites several prior art documents and related patents, including those by Okada et al., Landrau et al., and Roorda et al., which deal with similar controlled release formulations. These citations indicate that the inventors built upon existing knowledge in the field while introducing novel aspects to their formulations[1].
Litigation and Enforcement
Patents like US 7,919,116 are often subject to litigation, particularly when generic manufacturers attempt to produce similar formulations. The case of Nalpropion Pharmaceuticals, Inc. v. Actavis Labs. FL, Inc., although related to different patents, highlights the importance of patent enforcement and the challenges in defending patent claims against generic competitors[2].
Patent Scope and Quality
The scope of a patent is crucial in determining its validity and enforceability. Metrics such as independent claim length and count can be used to measure patent scope. Narrower claims, as seen in the examination process, are often associated with a higher probability of grant and shorter examination times. This patent, with its detailed and specific claims, aligns with best practices in patent drafting to ensure clarity and validity[3].
Written Description and Enablement
The patent must meet the requirements of written description and enablement. The specification must reasonably convey to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. In the context of US 7,919,116, the detailed description of the dissolution profiles and the composition of the formulations ensures that the patent meets these requirements[2].
Impact on the Pharmaceutical Industry
Controlled release formulations of metformin, as described in this patent, have significant implications for patient care. These formulations can enhance therapeutic efficacy by maintaining consistent drug levels over an extended period, thereby improving glycemic control and reducing the need for frequent dosing.
Market and Competitive Landscape
The market for antidiabetic medications is highly competitive, with numerous formulations and brands available. Patents like US 7,919,116 provide a competitive edge to the patent holder by protecting their innovative formulations from generic competition. This protection allows the patent holder to recoup their investment in research and development and maintain market share[4].
Conclusion
United States Patent 7,919,116 represents a significant advancement in the field of controlled release pharmaceutical formulations, particularly for metformin. The detailed claims and specifications ensure that the patent is both valid and enforceable. Understanding the scope, claims, and the broader patent landscape of this invention is crucial for pharmaceutical companies looking to innovate and protect their intellectual property.
Key Takeaways
- Controlled Release Formulations: The patent describes innovative formulations for the controlled release of metformin.
- Detailed Claims: The patent includes specific claims that define the composition and release profile of the formulations.
- Patent Scope and Quality: The patent aligns with best practices in patent drafting to ensure clarity and validity.
- Impact on Industry: The patent has significant implications for patient care and provides a competitive edge in the market.
- Litigation and Enforcement: The patent is subject to litigation and enforcement challenges, highlighting the importance of robust patent protection.
FAQs
Q: What is the main focus of United States Patent 7,919,116?
A: The main focus is on controlled release pharmaceutical formulations containing metformin or its pharmaceutically acceptable salts.
Q: Who are the inventors of this patent?
A: The inventors include Chih-Ming Chen, Xiu Xiu Cheng, Steve Jan, and Joseph Chou.
Q: What are the key components of the formulations described in the patent?
A: The key components include metformin or its salt, specific excipients, and release-controlling agents.
Q: How does the patent ensure the controlled release of metformin?
A: The patent specifies dissolution profiles in simulated intestinal and gastric fluids to ensure predictable and controlled release.
Q: What is the significance of this patent in the pharmaceutical industry?
A: It enhances therapeutic efficacy by maintaining consistent drug levels over an extended period and provides a competitive edge by protecting innovative formulations from generic competition.
Sources
- United States Patent and Trademark Office. Controlled Release Metformin Formulations. US 7,919,116 B2, April 5, 2011.
- United States Court of Appeals for the Federal Circuit. Nalpropion Pharmaceuticals, Inc. v. Actavis Labs. FL, Inc. 18-1221, August 15, 2019.
- Hoover Institution. Patent Claims and Patent Scope. August 2016.
- Google Patents. Controlled Release Metformin Formulations. US 7,919,116 B2.
