United States Patent 7,807,715: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,807,715, assigned to UCB Pharma GmbH, is a significant patent in the pharmaceutical industry, particularly related to the drug fesoterodine. This patent covers various aspects of pharmaceutical compositions and formulations, which are crucial for the stability and efficacy of fesoterodine.
Patent Overview
Inventors and Assignees
The patent was invented by Mika Hans-Jürgen, Arth Christoph, Komenda Michael, and Bicane Fatima, and is assigned to UCB Pharma GmbH[2].
Patent Expiration Date
The patent is set to expire on June 7, 2027, marking the end of the exclusive rights granted to UCB Pharma GmbH for the protected inventions[2].
Claims and Scope
Primary Claims
The patent primarily claims pharmaceutical compositions comprising fesoterodine, which is a drug used for the treatment of overactive bladder. The claims include specific formulations that enhance the stability and efficacy of fesoterodine.
Stabilizers Against Hydrolysis
One of the key claims involves the use of stabilizers against hydrolysis, which are preferably sugars such as mannitol, maltitol, or lactose. These stabilizers prevent the degradation of fesoterodine, ensuring the drug remains effective over its shelf life[5].
Formulation Details
The patent describes detailed formulations, including the use of diluents, binders, drug stabilizers, disintegrants, glidants, lubricants, release rate modifiers, and preservatives. These components are crucial for maintaining the drug's stability and ensuring its proper release in the body[4].
Patent Landscape
Related Patents
The patent landscape around fesoterodine includes several related patents that cover different aspects of the drug's formulation and use. For example, patents like US 9,629,805 B2 focus on the stabilization of moisture-sensitive drugs, including fesoterodine, using various excipients[4].
Competitor Activity
Other pharmaceutical companies, such as Accord Healthcare Inc. and Sandoz, have been involved in patent infringement disputes related to fesoterodine. These companies have filed Abbreviated New Drug Applications (ANDAs) and have challenged the validity and enforceability of UCB Pharma's patents[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by the patent, 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. It ensures that all claims are analyzed concurrently, providing a comprehensive view of the intellectual property protection[3].
Claim Charts
Interactive claim charts generated by software like ClaimScape® can be used to review patent coverage with technical experts. These charts help determine whether specific scope concepts are applicable to target products or methods, highlighting areas where claim coverage may be lacking[3].
Legal and Regulatory Aspects
Patent Validity and Infringement
The validity of the patent has been challenged by several defendants in court cases. The court must determine whether the asserted claims are invalid due to obviousness, anticipation, or indefiniteness. The patent holder must demonstrate that the invention was not obvious to a person of ordinary skill in the art at the time of its creation[1].
FDA Exclusivity
In addition to patent protection, fesoterodine may also be protected by FDA exclusivity periods, which can run concurrently with or independently of patent protection. These exclusivity periods grant the manufacturer sole marketing rights for a specified period[2].
Industry Impact
Generic Competition
The expiration of the patent on June 7, 2027, will open the market to generic competition. Companies like Accord Healthcare Inc. and Sandoz have already filed ANDAs, indicating their readiness to enter the market once the patent expires[2].
Innovation and Development
The patent landscape around fesoterodine encourages continuous innovation. New formulations and stabilization methods, as described in related patents, contribute to the development of more stable and effective pharmaceutical compositions[4].
Expert Insights
Quote from Industry Experts
"Patent analytics is crucial for understanding the complex landscape of pharmaceutical patents. It helps in identifying not just the current protection but also future opportunities and gaps," says a patent analyst at Schwegman Lundberg & Woessner.
Statistics and Examples
Patent Expiration and Generic Entry
For example, the expiration of the patent for fesoterodine is expected to lead to a significant increase in generic entries into the market. According to industry reports, generic drugs can reduce the cost of treatment by up to 80% compared to branded drugs.
Market Impact
The market for overactive bladder treatments is substantial, with millions of patients worldwide. The entry of generic fesoterodine is expected to expand access to this treatment, benefiting both patients and healthcare systems.
Key Takeaways
- Patent Scope: The patent covers specific pharmaceutical compositions of fesoterodine, including stabilizers against hydrolysis.
- Expiration Date: The patent expires on June 7, 2027.
- Related Patents: Several related patents cover different aspects of fesoterodine formulations.
- Legal Challenges: The patent has faced challenges regarding its validity and enforceability.
- Industry Impact: The expiration will lead to generic competition, expanding access to the drug.
Frequently Asked Questions (FAQs)
1. What is the primary claim of the United States Patent 7,807,715?
The primary claim involves pharmaceutical compositions comprising fesoterodine with stabilizers against hydrolysis, such as sugars like mannitol, maltitol, or lactose.
2. When does the patent expire?
The patent is set to expire on June 7, 2027.
3. What is the significance of the stabilizers mentioned in the patent?
The stabilizers prevent the degradation of fesoterodine, ensuring the drug remains effective over its shelf life.
4. How does the patent landscape around fesoterodine look?
The landscape includes several related patents and ongoing legal disputes over patent validity and infringement.
5. What impact will the patent expiration have on the market?
The expiration will open the market to generic competition, potentially reducing treatment costs and expanding access to fesoterodine.
Cited Sources:
- District of Delaware, Plaintiffs - Pfizer Inc. and UCB Pharma GmbH.
- Drugs.com, Generic Toviaz Availability.
- Schwegman Lundberg & Woessner, Patent Analytics.
- United States Patent and Trademark Office, Patent No.: US 9,629,805 B2.
- World Intellectual Property Organization, Extended release pharmaceutical compositions of fesoterodine.
