Analyzing the Scope and Claims of United States Patent 7,067,555
Introduction
United States Patent 7,067,555, hereafter referred to as US7067555, is a patent that has significant implications in the pharmaceutical industry, particularly concerning the drug sertraline hydrochloride, commonly known by the brand name Zoloft. This patent, now expired, was crucial for the protection of intellectual property related to the formulation and administration of sertraline.
Patent Overview
US7067555 was issued on June 27, 2006, and it pertains to the sertraline oral concentrate formulation. The patent was owned by Viatris (formerly part of Pfizer)[4].
Patent Claims
The claims of a patent are its most critical components, as they define the scope of protection granted by the patent. For US7067555, the claims focus on the specific formulation and mode of administration of sertraline oral concentrate.
Key Claims
- Formulation: The patent claims cover the composition and preparation of sertraline oral concentrate, including the specific ingredients and their proportions.
- Mode of Administration: The claims also specify the method of administering the oral concentrate, which is crucial for ensuring the efficacy and safety of the drug.
- Pediatric Use: There are specific claims related to the pediatric use of the sertraline oral concentrate, indicating that the formulation was designed to be suitable for children[1][4].
Patent Expiration
US7067555 has expired, with the expiration dates being:
- October 11, 2019: For the general claims related to sertraline oral concentrate.
- April 11, 2020: For the pediatric-specific claims related to sertraline oral concentrate[1][4].
Impact of Patent Expiration
The expiration of US7067555 has several implications:
- Generic Competition: With the patent expired, generic versions of sertraline oral concentrate can now be manufactured and marketed by other companies, increasing competition and potentially reducing prices.
- Loss of Exclusivity: Viatris no longer holds exclusive rights to the specific formulation and administration method described in the patent, which can affect their market share and revenue.
Patent Landscape Analysis
Analyzing the patent landscape involves understanding the broader context of related patents and their claims.
Related Patents
Other patents related to sertraline hydrochloride include:
- US6727283: Also pertains to sertraline oral concentrate and has similar expiration dates.
- US5248699: Relates to sertraline polymorph and expired earlier, in August 2012 and February 2013 for general and pediatric claims, respectively[1][4].
Claim Coverage Matrix
To fully understand the patent landscape, a Claim Coverage Matrix can be used. This tool categorizes patents by their claims and scope concepts, helping to identify gaps or opportunities in intellectual property protection. For example, the ClaimScape® software can generate interactive claim charts that help technical experts determine whether a particular scope concept is applicable to a target product or method[3].
Strategic Implications
Understanding the scope and claims of US7067555 and its expiration has strategic implications for pharmaceutical companies:
Competitive Analysis
Companies can analyze the expired patent to understand the formulation and administration methods that were previously protected. This can help in developing new or generic versions of sertraline hydrochloride.
Innovation Opportunities
The expiration of this patent opens up opportunities for innovation. Companies can now explore new formulations or administration methods without infringing on the expired patent claims.
Intellectual Property Management
Effective patent analytics, such as those provided by Claim Coverage Matrix and Claim Charts, are essential for managing intellectual property. These tools help in identifying gaps in current coverage and highlighting future design opportunities[3].
Expert Insights
Industry experts emphasize the importance of thorough patent analysis:
"Patent analytics shows you which patents and claims are actively protecting your intellectual property, and where gaps or opportunities exist," notes an expert from Schwegman, Lundberg & Woessner[3].
Illustrative Statistics
The impact of patent expiration can be significant:
- Generic Market Share: After the expiration of a patent, generic versions can capture up to 80% of the market share within the first year, significantly reducing the revenue of the original patent holder.
- Price Reduction: Generic competition can lead to a price reduction of up to 70% compared to the branded version, making the drug more accessible to a wider population.
Conclusion
The analysis of US7067555 highlights the importance of understanding patent claims, expiration dates, and the broader patent landscape. This knowledge is crucial for pharmaceutical companies to navigate the complex world of intellectual property, identify opportunities for innovation, and manage their portfolios effectively.
Key Takeaways
- Patent Claims: US7067555 covers the formulation and administration of sertraline oral concentrate.
- Patent Expiration: The patent expired in October 2019 and April 2020 for general and pediatric claims, respectively.
- Impact on Competition: Expiration allows for generic competition, reducing prices and increasing accessibility.
- Innovation Opportunities: Companies can now explore new formulations or administration methods without infringing on expired claims.
- Intellectual Property Management: Effective patent analytics is essential for identifying gaps and opportunities in intellectual property protection.
FAQs
Q: What is the significance of US7067555 in the pharmaceutical industry?
A: US7067555 is significant because it protected the formulation and administration method of sertraline oral concentrate, a widely used antidepressant.
Q: When did the patent for US7067555 expire?
A: The patent expired on October 11, 2019, for general claims and April 11, 2020, for pediatric-specific claims.
Q: How does the expiration of US7067555 affect the market?
A: The expiration allows for generic competition, potentially reducing prices and increasing the drug's accessibility.
Q: What tools can be used to analyze the patent landscape?
A: Tools like Claim Coverage Matrix and Claim Charts can be used to analyze the patent landscape and identify gaps or opportunities in intellectual property protection.
Q: Why is it important to understand the claims of a patent?
A: Understanding the claims is crucial because they define the scope of protection granted by the patent, helping companies to avoid infringement and identify innovation opportunities.
Sources
- Pharsight: Zoloft patent expiration.
- DrugPatentWatch: Approved drug products.
- Schwegman, Lundberg & Woessner: Patent Analytics.
- Pharsight: Drug Patents containing Sertraline Hydrochloride.
- Unified Patents: US-7065555-B2 - System and Method Related to Generating and tracking an email campaign.