United States Patent 8,623,411: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,623,411, assigned to Veloxis Pharmaceuticals A/S, is a significant patent in the field of pharmaceuticals, particularly concerning the formulation and delivery of tacrolimus, a crucial immunosuppressive drug used in transplant patients. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Tacrolimus
Tacrolimus is a potent immunosuppressive agent widely used to prevent the rejection of transplanted organs. However, its stability and bioavailability have been challenges in its formulation and administration[2].
Patent Overview
Inventors and Assignee
The patent was invented by Per Holm, among others, and assigned to Veloxis Pharmaceuticals A/S. It was issued on January 7, 2014[1].
Patent Claims
The patent claims revolve around a stable pharmaceutical composition comprising a solid dispersion of tacrolimus in a vehicle. This composition includes a stabilizing agent that maintains a pH below 7, thereby preventing or reducing the formation of major degradation products of tacrolimus, such as 8-epitacrolimus[2].
Scope of the Invention
Stable Pharmaceutical Composition
The invention focuses on creating a stable formulation of tacrolimus that enhances its shelf life and bioavailability. The solid dispersion of tacrolimus in a vehicle, along with a stabilizing agent, ensures that the drug remains effective over time[2].
pH Control
The stabilizing agent is crucial in maintaining a pH below 7, which is essential for preventing the degradation of tacrolimus. This pH control is a key aspect of the patent, as it directly impacts the stability and efficacy of the drug[2].
Claims Analysis
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims specify the composition, the role of the stabilizing agent, and the conditions under which the formulation is prepared and stored[1].
Dependent Claims
Dependent claims further elaborate on the independent claims by specifying additional details such as the type of stabilizing agents, the vehicle used, and the method of preparation. These claims provide a comprehensive coverage of the invention, ensuring that various aspects of the formulation are protected[1].
Patent Landscape
Related Patents
The patent landscape for tacrolimus formulations is complex, with multiple patents filed by Veloxis Pharmaceuticals A/S and other entities. Patents such as US 7,994,214 and US 12,083,103 also relate to tacrolimus formulations and have different expiration dates, with some expiring as early as August 30, 2024, and others extending until May 30, 2028[2].
Competing Formulations
Other companies have also developed formulations of tacrolimus, each with their own set of patents and claims. For instance, the generic version of Envarsus XR, a tacrolimus formulation, has its own patent landscape that intersects with the claims of US 8,623,411[2].
Patent Expiration and Exclusivity
Patent Expiration Dates
The patent US 8,623,411 has expired, but its impact on the current patent landscape is still significant. Other related patents, such as those mentioned above, have later expiration dates, which continue to influence the market[2].
Drug Exclusivity
In addition to patent protection, drug exclusivity granted by the FDA can provide additional market protection. This exclusivity can run concurrently with patent protection and can extend from 180 days to seven years, depending on the circumstances[2].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by US 8,623,411 and related patents, a Claim Coverage Matrix can be used. This tool categorizes patents by claims and scope concepts, helping to identify gaps or opportunities in the patent landscape[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review patent coverage and determine whether specific scope concepts are applicable to target products or methods. This approach is particularly useful for identifying areas where claim coverage is lacking and highlighting future design opportunities[3].
Global Patent System and Search Tools
Global Dossier
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family for a specific application and related citation data. This service is invaluable for navigating the global patent landscape[4].
Patent Public Search
The Patent Public Search tool and other resources like the USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) are essential for conducting thorough patent searches. These tools help in identifying prior art and understanding the broader patent landscape[4].
Impact on Pharmaceutical Industry
Stability and Bioavailability
The invention described in US 8,623,411 has significantly improved the stability and bioavailability of tacrolimus, making it a more reliable option for transplant patients. This advancement has set a new standard in the formulation of immunosuppressive drugs[2].
Market Competition
The expiration of this patent and the presence of other related patents have created a competitive landscape in the market for tacrolimus formulations. Generic versions and alternative formulations are now more feasible, which can lead to increased market competition and potentially lower prices for patients[2].
Key Takeaways
- Stable Formulation: The patent describes a stable pharmaceutical composition of tacrolimus with improved shelf life and bioavailability.
- pH Control: The use of a stabilizing agent to maintain a pH below 7 is crucial for preventing drug degradation.
- Patent Landscape: The patent is part of a complex landscape with multiple related patents and competing formulations.
- Expiration and Exclusivity: The patent has expired, but related patents continue to influence the market, and drug exclusivity can provide additional protection.
- Global Patent System: Tools like Global Dossier and Patent Public Search are essential for navigating the global patent landscape.
Frequently Asked Questions (FAQs)
What is the main innovation of US 8,623,411?
The main innovation is the creation of a stable pharmaceutical composition of tacrolimus using a solid dispersion in a vehicle with a stabilizing agent to maintain a pH below 7.
Why is pH control important in this patent?
pH control is crucial because it prevents the degradation of tacrolimus, specifically the formation of 8-epitacrolimus, thereby ensuring the drug's stability and efficacy.
What is the current status of the patent?
The patent US 8,623,411 has expired, but its impact on the patent landscape and the pharmaceutical industry remains significant.
How does this patent affect the market for tacrolimus formulations?
The expiration of this patent, along with the presence of other related patents, has created a competitive market for tacrolimus formulations, potentially leading to more generic versions and lower prices.
What tools are available for analyzing the patent landscape?
Tools such as Claim Coverage Matrix, Claim Charts, Global Dossier, and Patent Public Search are available for analyzing the patent landscape and identifying gaps or opportunities.
Cited Sources:
- United States Patent and Trademark Office, "United States Patent 11,110,081 B2," September 7, 2021.
- Drugs.com, "Generic Envarsus XR Availability," November 6, 2024.
- Schwegman Lundberg & Woessner, "Patent Analytics," accessed December 21, 2024.
- United States Patent and Trademark Office, "Search for patents," October 18, 2018.
