Understanding the Scope and Claims of United States Patent 9,468,639: A Detailed Analysis
Introduction
United States Patent 9,468,639, titled "Treating sexual desire disorders with flibanserin," is a significant patent in the pharmaceutical industry, particularly for the treatment of female sexual dysfunction. This patent is owned by Sprout Pharmaceuticals Inc. and protects the drug Addyi, which contains the active ingredient flibanserin. Here, we will delve into the details of this patent, its claims, and the broader patent landscape.
Patent Overview
Patent Number and Title
The patent in question is US 9,468,639, with the title "Treating sexual desire disorders with flibanserin."[1]
Patent Expiry
This patent is set to expire in October 2022, but it is crucial to note that other related patents and exclusivities may still be in effect, influencing the market availability of generic versions of the drug.[1]
Claims and Scope
Active Ingredient Protection
The patent specifically protects the use of flibanserin for treating sexual desire disorders. This includes various aspects such as the method of administration, dosage, and the formulation of the drug.[1]
Specific Claims
- Method of Treatment: The patent claims cover the method of treating female hypoactive sexual desire disorder (HSDD) with flibanserin. This includes specific dosages and administration protocols.[1]
- Formulation: The patent also covers extended release tablet formulations of flibanserin, which are designed for oral administration. These formulations are pH-dependent and water-soluble, ensuring a controlled release of the active ingredient[4].
Patent Landscape
Related Patents
Several patents related to flibanserin are part of the broader patent landscape:
- US7420057: This patent, which expired in August 2022, protected a stable polymorph of flibanserin.[1]
- US8227471: This patent, which expired in May 2023, also related to treating sexual desire disorders with flibanserin.[1]
- US7151103: This active patent, set to expire in May 2028, covers the method of treating female hypoactive sexual desire disorder with flibanserin.[1]
Exclusivities
In addition to patent protection, the FDA has granted several exclusivities to Addyi. These exclusivities prevent other companies from marketing generic or bioequivalent versions of the drug, regardless of the patent status. This significantly delays the entry of generic competitors into the market[1].
Patent Analytics and Claim Coverage
Importance of Claim Analysis
Patent analytics plays a crucial role in understanding which patents and claims are actively protecting the intellectual property. Tools like Claim Coverage Matrix and Claim Charts help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the patent landscape[3].
Scope Concepts
The scope concepts of patent claims directly relate to their value. For example:
- High-Value Claims: These are crucial to the current business operations.
- Medium-Value Claims: These indicate potential future directions.
- Low-Value Claims: These might not be worth maintaining[3].
Best Practices in Patent Drafting
Clear Definitions
To avoid ambiguity, patent applicants should provide clear definitions of terms used in the claims. Consistency in using terms throughout the application is also vital to avoid unexpected claim constructions during litigation[5].
Avoid Ambiguity
Even in fields where terms have generally understood meanings, it is important to avoid using claim terms that may lead to ambiguity. Including a description of the subject matter intended to be encompassed by such terms can prevent future disputes[5].
Litigation and Claim Construction
Recent Cases
A recent case, CoolIT Sys., Inc. v. Vidal, highlights the importance of clear claim constructions. The Federal Circuit emphasized that claim terms should be defined clearly in the specification to avoid ambiguity and that proposed constructions should not require further interpretation[5].
Impact on Market Dominance
Generic Entry
The expiration of patents and the end of exclusivities will pave the way for generic versions of Addyi to enter the market. This can significantly impact the market share of the original drug, as generics often offer a more affordable alternative[1].
Competitive Strategy
Companies holding such patents must strategize to maintain market dominance. This could involve developing new formulations, seeking additional exclusivities, or focusing on brand loyalty and customer retention.
Key Takeaways
- Patent Expiry: US 9,468,639 expired in October 2022, but other related patents and exclusivities remain in effect.
- Claims and Scope: The patent protects the method of treating sexual desire disorders with flibanserin, including specific formulations and dosages.
- Patent Landscape: Several related patents and FDA-granted exclusivities influence the market availability of generic versions.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding and managing patent claims.
- Best Practices: Clear definitions and consistency in patent drafting are crucial to avoid ambiguity and litigation issues.
FAQs
What is the active ingredient protected by US 9,468,639?
The active ingredient protected by US 9,468,639 is flibanserin, used for treating female hypoactive sexual desire disorder (HSDD).
When does the patent US 9,468,639 expire?
The patent US 9,468,639 expired in October 2022.
What are the FDA-granted exclusivities for Addyi?
The FDA has granted several exclusivities to Addyi, preventing the marketing of generic or bioequivalent versions until these exclusivities expire, regardless of the patent status.
How do patent analytics tools help in managing patent claims?
Patent analytics tools like Claim Coverage Matrix and Claim Charts help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the patent landscape.
Why is clear definition in patent drafting important?
Clear definitions in patent drafting are important to avoid ambiguity and unexpected claim constructions during litigation, ensuring that the intended scope of protection is maintained.
Sources
- Pharsight: Addyi patent expiration - Pharsight
- USPTO: Patent Claims Research Dataset - USPTO
- SLWIP: Patent Analytics | Intellectual Property Law
- Google Patents: US8545886B2 - Extended release tablet formulations of flibanserin ...
- Crowell: Do Your Patents Claim Engagement of Components as Intended?
