United States Patent 7,462,626: A Detailed Analysis
Introduction
United States Patent 7,462,626, often referred to as one of the Weber/Cowley patents, is a crucial component of the intellectual property portfolio protecting Contrave, a weight loss medication developed by Orexigen Therapeutics. This patent is significant in the pharmaceutical industry, particularly in the context of obesity treatment.
Background
Contrave is a combination drug consisting of naltrexone hydrochloride and bupropion hydrochloride, designed for the treatment of obesity. The patent landscape surrounding Contrave is complex, with multiple patents covering various aspects of the drug's composition, formulation, and method of administration[1].
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent 7,462,626. It is part of a series of patents known as the Weber/Cowley patents, which are essential for the protection of Contrave.
Claims
The patent includes several claims that cover the composition and method of administering the drug. Specifically, claims 26 and 31 of this patent have been subject to litigation and scrutiny. These claims pertain to the specific formulation and dosing regimen of Contrave, which are critical for its efficacy and safety[2].
Scope of Protection
Composition
The patent protects the specific combination of naltrexone hydrochloride and bupropion hydrochloride in extended-release tablets. This combination is unique and has been shown to be effective in treating obesity when used in conjunction with diet and exercise[1].
Method of Administration
The patent also covers the method of administering the drug, including the dose escalation schedule, which is designed to improve tolerability and reduce side effects. This method is an integral part of the treatment regimen for Contrave[1].
Litigation and Validity
The validity of the claims in U.S. Patent 7,462,626 has been challenged in several legal proceedings. In one notable case, Actavis Labs. FL, Inc. argued that claims 26 and 31 of this patent were obvious in view of prior art. However, the district court and the Court of Appeals for the Federal Circuit upheld the validity of these claims, finding that they were not obvious and were adequately supported by the patent specification[2].
Written Description Requirement
A key issue in the litigation was whether the patent specification provided adequate written description support for the claimed dissolution profile. The patent specification disclosed data obtained using the USP Apparatus 1 Basket Method, while the claims referred to the USP Apparatus 2 Paddle Method. The court ruled that the use of a different method did not present a written description problem, as the methods were considered "substantially equivalent"[5].
Expiration Date
The Weber/Cowley patents, including U.S. Patent 7,462,626, are expected to expire in 2024/2025. This expiration date is critical for the pharmaceutical industry, as it will impact the entry of generic versions of Contrave into the market[1].
International Protection
In addition to U.S. protection, Orexigen has filed international counterparts to the Weber/Cowley patents in various countries. For example, a European counterpart application has been issued in the European Patent Office, providing protection for Mysimba (the European version of Contrave) in several EPO countries[1].
Impact on Generic Entry
The protection afforded by U.S. Patent 7,462,626 and other related patents has significant implications for generic drug manufacturers. The patents prevent generic entry until their expiration, allowing Orexigen (and later Nalpropion Pharmaceuticals, Inc., which acquired the rights) to maintain market exclusivity for Contrave[5].
Conclusion on Patent Landscape
The patent landscape surrounding Contrave is complex and multifaceted, with U.S. Patent 7,462,626 playing a pivotal role. The patent's claims, which cover the composition and method of administration of the drug, have been upheld in litigation, ensuring continued protection for the drug until the patent's expiration.
Key Takeaways
- Patent Protection: U.S. Patent 7,462,626 is part of the Weber/Cowley patents protecting Contrave.
- Claims: The patent covers the composition and method of administering naltrexone hydrochloride and bupropion hydrochloride.
- Litigation: The patent has been upheld in litigation against challenges of obviousness and written description.
- Expiration Date: The patent is expected to expire in 2024/2025.
- International Protection: International counterparts provide protection in various countries.
FAQs
What is the main subject of U.S. Patent 7,462,626?
U.S. Patent 7,462,626 primarily covers the composition and method of administering the weight loss drug Contrave, which is a combination of naltrexone hydrochloride and bupropion hydrochloride.
Why is this patent important for Orexigen?
This patent is crucial for Orexigen as it provides intellectual property protection for Contrave, preventing generic versions from entering the market until its expiration.
What were the key issues in the litigation involving this patent?
The key issues included challenges to the obviousness of the claims and whether the patent specification provided adequate written description support for the claimed dissolution profile.
How does the expiration of this patent affect the pharmaceutical industry?
The expiration of U.S. Patent 7,462,626 will allow generic versions of Contrave to enter the market, potentially increasing competition and reducing the cost of the drug.
Are there international counterparts to this patent?
Yes, Orexigen has filed international counterparts to the Weber/Cowley patents, including a European counterpart application issued in the European Patent Office.
Cited Sources:
- Orexigen Announces Allowance of New U.S. Patent for Contrave - PR Newswire
- Nalpropion Pharmaceuticals, Inc. v. Actavis Labs. FL, Inc - CAFC
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- "Substantially Equivalent" Disclosure Satisfies Written Description - PatentlyO
