United States Patent 11,166,960: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,166,960, hereafter referred to as the '960 patent, is a critical component in the intellectual property portfolio of Supernus Pharmaceuticals, Inc., particularly in relation to their product Oxtellar XR®, which contains the anticonvulsant drug oxcarbazepine. This patent is central to ongoing litigation involving Supernus and Apotex Inc., highlighting its significance in the pharmaceutical industry.
Background on Oxcarbazepine
Oxcarbazepine is an anticonvulsant medication used to treat epilepsy by inhibiting abnormal electrical activity in the brain[1].
Patent Overview
Patent Number and Status
The '960 patent is one of several patents listed in the FDA's Orange Book as covering Oxtellar XR®, a formulation of oxcarbazepine. This patent is active and has been the subject of recent litigation[2][5].
Claims and Scope
Infringement Allegations
The '960 patent is at the heart of a patent infringement lawsuit filed by Supernus against Apotex Inc. and Apotex Corp. Supernus alleges that Apotex's Abbreviated New Drug Application (ANDA) for a generic version of Oxtellar XR® infringes on this patent, among others[2][5].
Specific Claims
The patent covers specific formulations and methods related to the delivery of oxcarbazepine. This includes modified-release preparations designed to provide controlled release profiles, such as immediate release (IR), delayed release (DR), and extended release (XR) formulations. These formulations are crucial for maintaining therapeutic efficacy while minimizing side effects[4].
Patent Landscape
Related Patents
The '960 patent is part of a larger portfolio of patents related to oxcarbazepine formulations. Other patents in this portfolio include U.S. Patent Nos. 7,722,898, 7,910,131, 8,617,600, 8,821,930, 9,119,791, 9,351,975, 9,370,525, 9,855,278, and 10,220,042. These patents collectively protect various aspects of Oxtellar XR®, including its formulation, manufacturing process, and therapeutic uses[2][5].
Litigation History
Supernus has been actively defending these patents against generic manufacturers. The litigation involves two main actions: the first asserting the earlier patents and the second specifically asserting the '960 patent. These actions aim to prevent Apotex from marketing a generic version of Oxtellar XR® before the expiration of these patents[2][5].
Formulation and Delivery
Modified Release Preparations
The '960 patent details modified-release preparations containing oxcarbazepine and its derivatives. These preparations can include minipellets, granules, or tablets with unique release profiles. The patent also describes multi-layer tablets where each layer releases the active compound at different rates, allowing for a combination of IR, DR, and XR formulations[4].
Excipients and Solubility Enhancers
The patent specifies the use of various excipients and solubility enhancers to modify the release profile of oxcarbazepine. These include surface active agents, complexing agents, and pH-modifying agents such as citric acid and sodium hydroxide. These components are crucial for ensuring the drug's stability and efficacy[4].
Industry and Market Impact
Competitive Landscape
The '960 patent, along with other related patents, plays a significant role in protecting Supernus's market share for Oxtellar XR®. Generic competition is a major threat to branded pharmaceuticals, and these patents help Supernus maintain its exclusivity and revenue stream[2][5].
Research and Development
The patent landscape around oxcarbazepine reflects the ongoing research and development in the field of anticonvulsant medications. The high cost and complexity of clinical trials make patent protection essential for recouping investment and driving innovation[3].
Legal and Regulatory Context
Patent Reform Act
The 2011 Patent Reform Act, which shifted the U.S. patent system from "first-to-invent" to "first-to-file," has significant implications for patent applications and litigation. This change affects how prior art is considered and modifies the application process, making it more critical for companies to file patents promptly[3].
FDA Regulations
The '960 patent is subject to FDA regulations, particularly those related to ANDA submissions and paragraph IV certifications. Apotex's ANDA submission with paragraph IV certifications challenges the validity of the '960 patent, leading to the ongoing litigation[2][5].
Key Players and Organisations
Supernus Pharmaceuticals, Inc.
Supernus is the primary holder of the '960 patent and is actively involved in defending it against generic manufacturers. The company's principal place of business is in Rockville, Maryland[2].
Apotex Inc. and Apotex Corp.
Apotex is the defendant in the patent infringement lawsuit, seeking to market a generic version of Oxtellar XR®. Apotex operates primarily out of Florida and is engaged in the development, manufacturing, and distribution of generic pharmaceuticals[2].
Conclusion and Future Implications
The '960 patent is a pivotal asset in the intellectual property strategy of Supernus Pharmaceuticals, Inc., particularly in the context of Oxtellar XR®. The ongoing litigation highlights the importance of patent protection in the pharmaceutical industry and the complexities involved in defending these rights.
Key Takeaways
- The '960 patent covers specific formulations and delivery methods for oxcarbazepine.
- It is part of a larger portfolio of patents protecting Oxtellar XR®.
- Supernus is actively defending this patent against generic manufacturers like Apotex.
- The patent landscape is influenced by regulatory changes such as the 2011 Patent Reform Act.
- The use of modified-release preparations and various excipients is crucial for the therapeutic efficacy of oxcarbazepine.
Frequently Asked Questions (FAQs)
What is the primary use of oxcarbazepine?
Oxcarbazepine is primarily used as an anticonvulsant to reduce the incidence of seizures in epilepsy by inhibiting abnormal electrical activity in the brain[1].
What does the '960 patent specifically cover?
The '960 patent covers modified-release preparations containing oxcarbazepine and its derivatives, including specific formulations and delivery methods such as immediate release, delayed release, and extended release[4].
Why is the '960 patent important for Supernus Pharmaceuticals?
The '960 patent is crucial for Supernus Pharmaceuticals as it protects their product Oxtellar XR® from generic competition, helping to maintain market exclusivity and revenue[2][5].
What is the current status of the litigation involving the '960 patent?
The litigation is ongoing, with Supernus Pharmaceuticals asserting that Apotex's ANDA submission infringes on the '960 patent, among others. The case is being heard in the United States District Court for the District of New Jersey[2][5].
How does the 2011 Patent Reform Act impact patent applications like the '960 patent?
The 2011 Patent Reform Act changed the U.S. patent system from "first-to-invent" to "first-to-file," affecting how prior art is considered and modifying the application process. This change emphasizes the importance of timely patent filings[3].
Cited Sources:
- DrugBank - Oxcarbazepine: Uses, Interactions, Mechanism of Action.
- Insight.rpxcorp.com - Complaint against Apotex Inc. and Apotex Corp.
- Biorxiv.org - A novel approach to understand patents from the drug discovery perspective.
- Google Patents - Modified release preparations containing oxcarbazepine and derivatives thereof.
- Justia.com - Settlement Agreement between Supernus Pharmaceuticals, Inc. and Apotex Inc.
