United States Patent 10,898,444: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 10,898,444, titled "Extended Release Multiparticulates of Ranolazine," is a significant patent in the pharmaceutical industry, particularly in the field of controlled release formulations. This patent, assigned to a pharmaceutical company, outlines a novel approach to delivering ranolazine, a drug used primarily for the treatment of chronic angina.
Background of Ranolazine
Ranolazine, first described in U.S. Pat. No. 4,567,264, is a medication used to treat chronic angina. It works by improving blood flow to help the heart work more efficiently[4].
Patent Overview
Publication and Authority
The patent was published under the United States Patent and Trademark Office (USPTO) with the publication number US10898444B2. It falls under the jurisdiction of the United States and is classified under various prior art keywords including "ranolazine," "extended release," "multiparticulate composition," and "phthalate"[1].
Scope of the Patent
Extended Release Multiparticulates
The patent describes an extended release multiparticulate composition comprising a plurality of discrete units. Each discrete unit contains ranolazine or its pharmaceutically acceptable salts, polymorphs, solvates, hydrates, or enantiomers. These units are designed to release the drug over an extended period, enhancing patient compliance and therapeutic efficacy[1].
Composition and Components
The multiparticulate composition includes various components such as:
- Active Ingredient: Ranolazine or its derivatives.
- Polymers: Water-insoluble polymers, copolymers, cellulose acetate, polyvinyl acetate, and polyvinyl alcohol.
- Coating Agents: Phthalates, dibutyl decanedioate, and acetyl tributyl citrate.
- Excipients: Lactose, colloidal silicon dioxide, and magnesium stearate.
- Release Controlling Agents: Lipids and other surface-active agents[1].
Manufacturing Methods
The patent details several manufacturing methods, including:
- Coating Methods: Aqueous film coating using products like Opadry WhiteTM.
- Granulation: Dry granulation, wet granulation, melt granulation, and extrusion spheronization.
- Tablet Formation: Direct compression, double compression, and layering[1][4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover:
- The multiparticulate composition itself.
- The method of manufacturing the composition.
- The specific components and their proportions.
- The extended release profile of the drug[1].
Dependent Claims
Dependent claims further specify the details of the independent claims, including:
- The types of polymers and coating agents used.
- The process of film coating and the materials involved.
- The specific excipients and their roles in the formulation[1].
Patent Landscape
Related Patents
Other patents related to ranolazine formulations include:
- US8901128B2: Describes a novel controlled release pharmaceutical dosage form of ranolazine, including tablets, pellets, beads, and capsules[4].
- Earlier Patents: Such as U.S. Pat. No. 4,567,264, which first described ranolazine and its use in treating cardiovascular diseases[4].
Litigation and Settlements
Patent litigation and settlements are common in the pharmaceutical industry. For example, cases like Mitsubishi Tanabe Pharma Corp. v. Prinston Pharm. Inc. involve disputes over generic versions of patented drugs, highlighting the importance of patent enforcement in protecting intellectual property[2].
Impact on the Pharmaceutical Industry
Innovation and Compliance
This patent encourages innovation in controlled release formulations, which can improve patient outcomes by enhancing drug delivery and compliance. It also sets a standard for compliance with regulatory requirements, ensuring that any generic versions must adhere to the patented formulation and manufacturing processes[1].
Economic Considerations
The patent's extended release formulation can have significant economic implications. By prolonging the release of the drug, it can reduce the frequency of dosing, potentially lowering healthcare costs and improving patient adherence to treatment regimens.
Key Metrics for Patent Scope
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured by metrics such as independent claim length and count. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process, indicating that the claims in this patent are likely well-defined and enforceable[3].
Conclusion
The United States Patent 10,898,444 is a comprehensive patent that details an innovative extended release multiparticulate composition of ranolazine. It covers various aspects of the formulation, manufacturing, and components, providing a robust framework for protecting intellectual property in the pharmaceutical industry.
Key Takeaways
- Extended Release Formulation: The patent describes a multiparticulate composition designed for extended release of ranolazine.
- Components and Manufacturing: It includes detailed descriptions of polymers, coating agents, excipients, and manufacturing methods.
- Claims and Scope: The patent has well-defined independent and dependent claims that specify the invention's scope.
- Impact on Industry: It promotes innovation and compliance in controlled release formulations, with significant economic and therapeutic implications.
- Related Patents and Litigation: The patent is part of a broader landscape of ranolazine-related patents and litigation, highlighting the importance of intellectual property protection.
FAQs
What is the primary purpose of the United States Patent 10,898,444?
The primary purpose is to describe and protect an extended release multiparticulate composition of ranolazine, enhancing its therapeutic efficacy and patient compliance.
What are the key components of the multiparticulate composition?
The composition includes ranolazine or its derivatives, water-insoluble polymers, coating agents like phthalates, and various excipients such as lactose and magnesium stearate.
How is the multiparticulate composition manufactured?
The patent details several manufacturing methods, including dry granulation, wet granulation, melt granulation, and extrusion spheronization, followed by film coating.
What is the significance of the independent claims in the patent?
The independent claims define the scope of the invention, covering the composition, manufacturing method, and specific components, ensuring that the patent is well-defined and enforceable.
How does this patent impact the pharmaceutical industry?
It promotes innovation in controlled release formulations, improves patient outcomes, and sets standards for compliance with regulatory requirements, potentially reducing healthcare costs and improving patient adherence.
Are there related patents and litigation involving ranolazine?
Yes, there are other patents and litigation cases related to ranolazine formulations, such as US8901128B2 and various legal disputes over generic versions of patented drugs.
Sources
- US10898444B2 - Extended release multiparticulates of ranolazine - Google Patents
- ANDA Litigation Settlements - Robins Kaplan LLP Law Firm
- Patent Claims and Patent Scope - SSRN
- US8901128B2 - Pharmaceutical compositions of ranolazine - Google Patents
- Drug Patents containing Ranolazine - Pharsight
