United States Patent 8,246,980: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,246,980, titled "Transdermal delivery system," is a significant patent in the pharmaceutical industry, particularly in the field of transdermal drug delivery systems. This patent, assigned to UCB, Inc., is part of a broader portfolio related to the drug Neupro, which contains rotigotine, a dopamine agonist used for the treatment of Parkinson's disease and restless legs syndrome.
Background
To understand the context of this patent, it is essential to know the background of Neupro and the challenges associated with its formulation. Neupro is a transdermal patch that delivers rotigotine through the skin. The original formulation of Neupro faced issues with crystallization, which affected its stability and efficacy. This led to the development of new formulations and patents, including the one in question.
Scope of the Patent
Claims
The patent 8,246,980 claims a transdermal delivery system (TDS) designed for amine functional drugs, such as rotigotine. The key claims include:
- A TDS comprising a matrix with microreservoirs containing the drug and a self-adhesive layer[4].
- The system is designed to provide a high steady state flux rate of the drug over the TDS/skin interface, ensuring consistent and effective drug delivery.
Invention Details
The invention focuses on improving the delivery of amine functional drugs through the skin. It involves a matrix system with microreservoirs that contain the drug, which is then released steadily over time. This design enhances the stability and efficacy of the drug delivery, addressing issues such as crystallization and inconsistent drug release rates.
Claims Analysis
Claim 1: Transdermal Delivery System
Claim 1 defines the TDS as comprising a matrix with microreservoirs containing the amine functional drug and a self-adhesive layer. This claim sets the foundation for the invention, highlighting the unique structure of the delivery system.
Claim 2: Matrix Composition
Claim 2 specifies the composition of the matrix, including the materials and the structure of the microreservoirs. This claim is crucial as it details how the drug is encapsulated and released.
Claim 3: Self-Adhesive Layer
Claim 3 describes the self-adhesive layer, which is essential for ensuring the patch adheres to the skin and maintains contact for the duration of the treatment.
Patent Landscape
Related Patents
The patent 8,246,980 is part of a larger family of patents related to Neupro and its formulations. Other relevant patents include:
- U.S. Patent No. 6,699,498
- U.S. Patent No. 6,884,434 (Muller '434)
- U.S. Patent No. 7,413,747 (Muller '747)
- U.S. Patent No. 10,130,589 ('589 Patent)[1].
Litigation and Settlements
These patents have been involved in various litigation cases, particularly against generic manufacturers. For example, UCB, Inc. has sued Actavis Laboratories, Inc. for infringement of the '434 Patent and the '589 Patent, resulting in injunctions preventing the FDA from approving Actavis's ANDA (Abbreviated New Drug Application) for a generic version of Neupro[5].
Prior Art and Obviousness
The validity of the '589 Patent, which is closely related to the '980 Patent, has been challenged on grounds of obviousness and anticipation. UCB has argued that the prior art, such as the Tang reference, does not teach the specific ratio of rotigotine to PVP (polyvinylpyrrolidone) claimed in the '589 Patent, making it nonobvious over the prior art[1].
Industry Impact
The '980 Patent and related patents have significant implications for the pharmaceutical industry, particularly in the development of transdermal drug delivery systems. These patents protect the intellectual property of UCB, Inc. and prevent generic manufacturers from producing similar formulations without authorization.
Expiry and Exclusivity
The '980 Patent, along with other related patents, contributes to the exclusivity period for Neupro. While some of the earlier patents like the '434 Patent have expired or are nearing expiry, the '980 Patent and the '589 Patent continue to provide exclusivity until their respective expiry dates, ensuring UCB maintains market dominance for Neupro[5].
Conclusion
The United States Patent 8,246,980 is a critical component of UCB's intellectual property portfolio related to Neupro. It addresses specific challenges in transdermal drug delivery and provides a unique solution through its matrix and microreservoir design. Understanding the scope, claims, and patent landscape of this invention is essential for navigating the complex world of pharmaceutical patents and litigation.
Key Takeaways
- The '980 Patent claims a transdermal delivery system with a matrix and microreservoirs for amine functional drugs.
- The invention is designed to improve the stability and efficacy of drug delivery.
- The patent is part of a broader portfolio related to Neupro and has been involved in significant litigation.
- The validity of related patents has been challenged on grounds of obviousness and anticipation.
- The patent continues to provide exclusivity for UCB, Inc. in the market.
FAQs
What is the main claim of the '980 Patent?
The main claim of the '980 Patent is for a transdermal delivery system comprising a matrix with microreservoirs containing the drug and a self-adhesive layer.
How does the '980 Patent improve drug delivery?
The '980 Patent improves drug delivery by providing a steady state flux rate of the drug over the TDS/skin interface, ensuring consistent and effective drug release.
What is the significance of the microreservoirs in the '980 Patent?
The microreservoirs in the '980 Patent encapsulate the drug, allowing for controlled and steady release, which enhances the stability and efficacy of the drug delivery.
Is the '980 Patent involved in any litigation?
Yes, the '980 Patent, along with related patents, has been involved in litigation against generic manufacturers to protect UCB's intellectual property rights.
When does the '980 Patent expire?
The '980 Patent expires on its specified date, although the exact date is not provided in the sources, it is part of the broader exclusivity period protected by UCB's patent portfolio.
Cited Sources:
- UCB, Inc. v. Actavis Labs. UT, Inc. - Casetext
- ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP
- Glossary - USPTO
- US8246980B2 - Transdermal delivery system - Google Patents
- UCB, Inc. v. Actavis Labs. UT, Inc. - Federal Cases - Case Law - Vlex
