Understanding the Scope and Claims of United States Patent 7,465,462
Introduction
United States Patent 7,465,462, titled "Multiparticulate controlled release selective serotonin reuptake inhibitor formulations," is a crucial patent associated with Luvox CR, a drug used for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults. This patent, owned by Jazz Pharmaceuticals Inc., has significant implications for the pharmaceutical industry, particularly in the context of generic drug development and market entry.
Patent Overview
The patent was issued on December 16, 2008, and it primarily focuses on the formulation and method of use of Luvox CR, which incorporates Elan's SODAS (Spheroidal Oral Drug Absorption System) technology. This technology enables the controlled release of the active ingredient, fluvoxamine maleate, ensuring a once-daily dosing regimen[2].
Patent Claims
The patent claims are centered around the multiparticulate controlled release formulations of selective serotonin reuptake inhibitors (SSRIs). Here are the key aspects of the claims:
- Formulation: The patent describes a specific formulation that uses SODAS technology to achieve a controlled release profile. This formulation is designed to improve patient compliance by reducing the frequency of dosing[2].
- Method of Use: The patent also claims a method of using the formulation for the treatment of SAD and OCD. This method involves administering the controlled release formulation once daily[2].
Patent Scope
The scope of the patent is defined by its claims, which are critical in determining the breadth of protection. Here are some metrics and considerations:
- Independent Claim Length and Count: Research suggests that the scope of a patent can be measured by the length and count of its independent claims. Narrower claims with fewer words and fewer independent claims generally indicate a more focused and possibly stronger patent[3].
- Patent Maintenance and Examination: The patent's scope can also be influenced by the maintenance and examination process. For example, the examination process may narrow the scope of the patent claims, making them more specific and less broad[3].
Patent Expiration and Generic Launch
The patent expired on May 10, 2020, marking the end of the exclusive period for Jazz Pharmaceuticals Inc. to market Luvox CR. This expiration date is crucial for generic drug manufacturers, as it allows them to seek FDA approval for generic versions of the drug.
- Generic Launch Date: The generic launch date for Luvox CR was estimated to be May 10, 2020, based on the expiration of the last outstanding patent. However, this date could be influenced by legal activities such as patent term extensions or amendments to the patent claims[1].
Paragraph IV Certification
Generic drug manufacturers can seek FDA approval before the patent expiration by filing a Paragraph IV certification. This certification states that the patent is invalid, unenforceable, or will not be infringed by the generic product.
- Litigation: Filing a Paragraph IV certification can lead to litigation. For example, Anchen Pharmaceuticals Inc. filed a Paragraph IV certification for their ANDA, which resulted in litigation against Jazz Pharmaceuticals Inc. and Elan Pharma International Limited[4].
Recent Legal Activities
The patent has undergone several legal activities that are important for understanding its current status:
- Patent Expiry: The patent expired on May 10, 2020, which was confirmed by subsequent legal activities such as the "Expire Patent Critical" notice on January 18, 2021[1].
- Maintenance Fee Reminder: There were reminders for maintenance fees, which are essential for keeping the patent in force until its expiration[1].
International Patent Landscape
While the focus here is on the U.S. patent, it is important to note that Luvox CR is protected by patents in multiple countries. Understanding the global patent landscape is crucial for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[1].
Impact on Generic Drug Development
The expiration of this patent has significant implications for generic drug development:
- Market Entry: The expiration allows generic manufacturers to enter the market, potentially reducing the cost of the drug and increasing accessibility for patients.
- Competition: Increased competition from generic versions can drive innovation and improve the quality of drug formulations[1][4].
FDA Approval Process
For generic manufacturers, the FDA approval process involves several steps, including the submission of an Abbreviated New Drug Application (ANDA) and compliance with FDA regulations.
- ANDA Submission: The ANDA must include a Paragraph IV certification if the generic drug is to be launched before the patent expiration. The FDA reviews this application to ensure the generic product is therapeutically equivalent to the branded drug[4].
Labeling and Specifications
Generic manufacturers must also comply with labeling and specification requirements. For example, Anchen Pharmaceuticals Inc. had to revise their labeling to match changes in the Reference Listed Drug (RLD) labeling, which delayed their tentative approval[4].
Key Takeaways
- Patent Expiration: The patent expired on May 10, 2020, allowing for generic versions of Luvox CR.
- Paragraph IV Certification: Generic manufacturers can seek FDA approval before patent expiration by filing a Paragraph IV certification.
- Global Patent Landscape: Understanding international patent protection is crucial for market entry strategies.
- FDA Approval: Generic manufacturers must comply with FDA regulations, including ANDA submissions and labeling requirements.
FAQs
Q: What is the primary focus of United States Patent 7,465,462?
A: The patent focuses on the formulation and method of use of Luvox CR, incorporating Elan's SODAS technology for controlled release of fluvoxamine maleate.
Q: When did the patent expire?
A: The patent expired on May 10, 2020.
Q: How can generic manufacturers launch their products before the patent expiration?
A: Generic manufacturers can launch their products before the patent expiration by filing a Paragraph IV certification stating that the patent is invalid, unenforceable, or will not be infringed.
Q: What is the significance of the FDA Orange Book in this context?
A: The FDA Orange Book lists approved drug products and their associated patents, facilitating the legal requirement for generic drug applicants to include an appropriate certification to each such patent as part of their ANDA.
Q: What are the implications of the patent expiration for the pharmaceutical market?
A: The patent expiration allows generic manufacturers to enter the market, potentially reducing drug costs and increasing patient accessibility, while also driving competition and innovation.
Cited Sources
- Pharsight: Luvox Cr patent expiration - Pharsight
- Medindia: Jazz Pharmaceuticals Announces Issuance of Key Patent for Once-A-Day LUVOX CR
- Hoover Institution: Patent Claims and Patent Scope
- FDA: Fluvoxamine Maleate Extended-release Capsules, 100 mg and 150 mg[4].
