Detailed Analysis of the Scope and Claims of United States Patent 10,105,336
Introduction
United States Patent 10,105,336, issued on October 23, 2018, is a significant patent in the realm of pharmaceutical compositions, particularly those involving fumarate esters. This patent is assigned to Banner Life Sciences LLC and plays a crucial role in the treatment of various medical conditions.
Patent Overview
Inventors and Assignee
The patent was invented by Tatyana Dyakonov, Sunil Agnihotri, and Aqeel A. Fatmi, and is assigned to Banner Life Sciences LLC[2].
Scope of the Patent
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include fumarate esters. These compositions are designed for oral administration and are intended to treat subjects in need of such therapy. The focus is on the formulation and delivery methods that enhance the bioavailability and efficacy of fumarate esters[2].
Controlled Release Formulations
One of the key aspects of this patent is the development of controlled release formulations. These formulations are designed to release the active ingredient over a prolonged period, ensuring sustained therapeutic effects. This approach can improve patient compliance and reduce the frequency of dosing[2].
Liquid Matrices and Lipid Suspensions
The patent also details the use of liquid matrices and lipid suspensions to enhance the bioavailability of fumarate esters. By suspending these esters in a lipid or lipophilic liquid, the absorption and utilization of the drug can be significantly improved[2].
Claims of the Patent
Composition Claims
The patent includes claims related to the specific composition of the pharmaceutical formulations. These claims cover the types of fumarate esters used, the excipients, and the methods of preparation. For example, the patent claims compositions where fumarate esters are suspended in a lipid or lipophilic liquid to enhance bioavailability[2].
Method Claims
In addition to composition claims, the patent also includes method claims. These cover the processes for preparing the pharmaceutical compositions, including the steps involved in formulating and manufacturing the final product. The methods described ensure consistent and reliable production of the therapeutic agents[2].
Use Claims
The patent further includes use claims, which specify the therapeutic applications of the fumarate ester compositions. These claims cover the treatment of various conditions, such as relapsing forms of multiple sclerosis, for which dimethyl fumarate, a type of fumarate ester, is commonly used[4].
Patent Landscape
Related Patents
The patent landscape surrounding US 10,105,336 includes several related patents held by Banner Life Sciences LLC. These patents, such as US 10,105,335 and US 10,105,337, also deal with fumarate ester pharmaceutical compositions and their methods of preparation. These patents collectively form a robust intellectual property portfolio that protects the company's innovations in this field[2].
Patent Expiration Dates
The patent is set to expire on February 27, 2035, which is consistent with the typical 20-year term from the date of filing. Other related patents, such as US 10,918,615 and US 10,918,616, have slightly different expiration dates, ranging from June 3, 2035, to August 12, 2035[2].
Impact on the Pharmaceutical Industry
Enhanced Bioavailability
The innovations described in this patent have significant implications for the pharmaceutical industry. By enhancing the bioavailability of fumarate esters, these formulations can improve the efficacy of treatments and patient outcomes. This is particularly important for conditions like multiple sclerosis, where consistent and effective treatment is crucial[4].
Compliance and Convenience
The controlled release formulations described in the patent can also improve patient compliance by reducing the frequency of dosing. This makes the treatment regimen more convenient and manageable for patients, which can lead to better adherence and overall health outcomes.
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To fully understand the scope and claims of this patent, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify which patents and claims are actively protecting the intellectual property. It also highlights gaps or opportunities in the patent landscape[3].
Interactive Claim Charts
Interactive claim charts generated by tools like ClaimScape® software can facilitate a quick and accurate review of patent coverage. These charts help technical experts determine whether a particular scope concept is applicable to a target product or method, ensuring that there are no gaps in the current coverage[3].
Key Takeaways
- Pharmaceutical Compositions: The patent covers pharmaceutical compositions including fumarate esters for oral administration.
- Controlled Release: The patent describes controlled release formulations to enhance therapeutic effects.
- Bioavailability: The use of liquid matrices and lipid suspensions improves the bioavailability of fumarate esters.
- Patent Expiration: The patent is set to expire on February 27, 2035.
- Impact on Industry: The innovations improve treatment efficacy and patient compliance.
Frequently Asked Questions (FAQs)
What is the primary focus of United States Patent 10,105,336?
The primary focus is on pharmaceutical compositions comprising fumarate esters, particularly their formulation and delivery methods to enhance bioavailability and efficacy.
Who are the inventors of this patent?
The inventors are Tatyana Dyakonov, Sunil Agnihotri, and Aqeel A. Fatmi.
What is the significance of controlled release formulations in this patent?
Controlled release formulations ensure sustained therapeutic effects, improving patient compliance and reducing the frequency of dosing.
How do liquid matrices and lipid suspensions enhance the bioavailability of fumarate esters?
By suspending fumarate esters in a lipid or lipophilic liquid, the absorption and utilization of the drug are significantly improved.
When is the patent set to expire?
The patent is set to expire on February 27, 2035.
Cited Sources:
- Monomethyl fumarate: Uses, Interactions, Mechanism of Action - DrugBank.
- Generic Bafiertam Availability - Drugs.com.
- Patent Analytics - Schwegman Lundberg & Woessner.
- Process for preparation of dimethyl fumarate - Google Patents.
