United States Patent 6,217,909: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,217,909, owned by J. Rettenmaier Sohne GMBH + Co. KG (JRS) and exclusively licensed to Somaxon Pharmaceuticals, Inc., is a critical component of the intellectual property portfolio protecting Somaxon's FDA-approved drug, Silenor®. This patent is part of a broader landscape of patents related to low-dose oral doxepin formulations used for treating insomnia.
Background of the Patent
The patent in question, U.S. Patent No. 6,217,909, is one of the several patents listed in the Orange Book for Silenor®, a doxepin hydrochloride drug product approved for the treatment of insomnia[1][4].
Scope of the Patent
Invention Overview
The patent generally relates to low-dose oral doxepin pharmaceutical formulations and their use in promoting sleep. It covers specific formulations and methods for preparing these low-dose doxepin tablets, which are designed to minimize side effects while maintaining efficacy in treating insomnia[4].
Claims
The patent includes 20 claims that define the scope of the invention. These claims are divided into various categories, including:
- Composition Claims: These claims describe the specific formulation of the low-dose doxepin tablets, including the active ingredient and excipients.
- Method Claims: These claims outline the methods for preparing the formulations.
- Use Claims: These claims specify the therapeutic use of the formulations, particularly in promoting sleep and treating insomnia[4].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to doxepin formulations. Other relevant patents include U.S. Patent Nos. 5,585,115; 5,725,884; 5,866,166; 5,948,438; and 6,103,219, all of which are also listed in the Orange Book for Silenor®[1].
Expiration Dates
Understanding the expiration dates of these patents is crucial for managing the intellectual property landscape. For instance, the 047 patent, which is related but not the focus here, was due to expire on March 26, 2013, while the229 patent was due to expire on February 17, 2020[1].
Generic Entry and Litigation
The filing of Abbreviated New Drug Applications (ANDAs) by generic manufacturers like Par Pharmaceutical Inc. has led to litigation over patent infringement. Par's ANDA included paragraph IV certifications challenging the validity and enforceability of the patents, including the `229 patent and the unasserted patents like the one in question[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To effectively manage and analyze the patent landscape, companies use tools like a Claim Coverage Matrix. This matrix helps in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and potential future design opportunities[3].
Claim Charts
Interactive claim charts generated by software like ClaimScape® are useful for reviewing patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, ensuring that the patent claims are aligned with the company's current and future technological directions[3].
Jurisdiction and Litigation
Court Jurisdiction
The court has jurisdiction over patent infringement cases under 28 U.S.C. §§ 1331 and 1338(a). This jurisdiction is crucial for resolving disputes related to the validity and infringement of patents like U.S. Patent No. 6,217,909[1].
Covenants Not to Sue
In the context of litigation, Somaxon and JRS provided covenants not to sue Par Pharmaceutical Inc. for the unasserted patents, including the one in question. This move was part of a strategy to manage the litigation landscape and focus on the most critical patents[1].
Industry Impact
Market Exclusivity
The patent landscape around Silenor® affects market exclusivity. Generic manufacturers like Actavis and Mylan, who filed ANDAs on the same day, are entitled to share the 180-day exclusivity period, which prohibits other generic manufacturers from entering the market during this period[1].
Competitive Advantage
Maintaining a robust patent portfolio, including U.S. Patent No. 6,217,909, is essential for Somaxon to retain its competitive advantage in the market. This portfolio helps in protecting the company's intellectual property and ensuring that generic versions of Silenor® do not enter the market prematurely[1].
Expert Insights
Patent Strategy
Industry experts emphasize the importance of a well-managed patent strategy. "A Claim Coverage Matrix and interactive claim charts are powerful tools for ensuring that your patents cover the technology you intend to protect," notes a patent analyst. "This approach helps in identifying gaps and opportunities, which is crucial for maintaining a competitive edge in the pharmaceutical industry"[3].
Statistics and Examples
Patent Expiration and Generic Entry
For instance, the expiration of key patents can significantly impact the market. When the `047 patent expired in 2013, it opened up opportunities for generic manufacturers to enter the market, highlighting the importance of managing patent expiration dates strategically[1].
Litigation Costs
Litigation over patent infringement can be costly. Somaxon's litigation with Par Pharmaceutical Inc. and other generic manufacturers underscores the financial and strategic importance of robust patent protection[1].
Key Takeaways
- Patent Scope and Claims: U.S. Patent No. 6,217,909 covers low-dose oral doxepin formulations and their use in treating insomnia.
- Patent Landscape: The patent is part of a larger family of patents protecting Silenor®, including other related patents listed in the Orange Book.
- Litigation and Jurisdiction: The patent has been involved in litigation over generic entry, with Somaxon and JRS managing the litigation landscape through covenants not to sue.
- Industry Impact: The patent portfolio around Silenor® affects market exclusivity and competitive advantage.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing and analyzing the patent landscape.
FAQs
What is the main subject of U.S. Patent No. 6,217,909?
The main subject of U.S. Patent No. 6,217,909 is low-dose oral doxepin pharmaceutical formulations and their use in promoting sleep and treating insomnia.
Who owns U.S. Patent No. 6,217,909?
U.S. Patent No. 6,217,909 is owned by J. Rettenmaier Sohne GMBH + Co. KG (JRS) and is exclusively licensed to Somaxon Pharmaceuticals, Inc.
What is the significance of the Orange Book in relation to this patent?
The Orange Book lists approved drug products with therapeutic equivalence evaluations, and U.S. Patent No. 6,217,909 is one of the patents listed for Somaxon's drug product, Silenor®.
How does the expiration of this patent affect the market?
The expiration of this patent, along with other related patents, can open up the market for generic versions of Silenor®, potentially reducing Somaxon's market share and revenue.
What tools are used to manage and analyze the patent landscape?
Tools such as a Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® are used to manage and analyze the patent landscape, ensuring that the patent claims are aligned with the company's technological directions.
Cited Sources:
- Somaxon Pharmaceuticals, Inc. v. Par Pharmaceutical - Casetext
- Pharmaceutical drugs covered by patent 6,217,909 - Drug Patent Watch
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
- United States Patent 11,096,920 B2 - Google Patents
