United States Patent 6,958,161: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,958,161, titled "Modified release coated drug preparation," is a significant patent in the pharmaceutical industry, particularly for the drug Doryx, which is a doxycycline hyclate delayed-release formulation. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Description
The patent, US6958161B2, describes a "Modified release coated drug preparation" that includes one or more coated core elements, each containing an active ingredient. The modified release preparation is designed to control the release of the active ingredient, ensuring a specific pharmacokinetic profile[4].
Scope of the Patent
Invention’s Scope
The patent focuses on the formulation and preparation of a modified release drug, specifically doxycycline hyclate. The scope includes the design of the coated core elements, the composition of the coating, and the process for manufacturing these preparations. This scope is crucial for understanding what aspects of the drug are protected under this patent.
Claims of the Patent
Types of Claims
The patent includes both independent and dependent claims. Independent claims define the invention broadly, while dependent claims add specific details or limitations to the independent claims. For US6958161B2, the claims outline the structure and composition of the modified release coated drug preparation, including the core elements and the coating layers[4].
Claim Composition
The claims are crafted to provide broad protection while ensuring they are precise enough to differentiate the invention from prior art. This balance is critical for the enforceability and strength of the patent. The claims must be clear and concise to avoid ambiguity, which could lead to challenges during prosecution or enforcement[3].
Patent Landscape
Exclusivities and Patent Expiration
The patent is part of a broader patent landscape that includes other patents and exclusivities protecting Doryx. As of the latest information, one of the patents related to Doryx (US6958161) has expired, while another (US8715724) remains active until February 2028. Additionally, Doryx holds exclusivities that have expired, such as the New Dosing Schedule and New Strength exclusivities, which expired in April 2016[2].
Legal Activities and Challenges
The patent has been involved in several legal activities, including patent infringement suits. For instance, IMPAX Laboratories filed an Abbreviated New Drug Application (ANDA) for a generic version of Doryx, which led to a patent infringement lawsuit by Warner Chilcott and Mayne Pharma International. IMPAX argued that their product did not infringe US Patent No. 6,958,161 or that the patent was invalid or unenforceable[5].
Global Patent Family
Understanding the global patent family is crucial for strategizing market entry. The patent protection for Doryx extends beyond the United States, with patents filed in multiple countries. This broader landscape helps identify markets with weaker patent protection, which could be ideal for generic entry points[2].
Strategic Claim Management
Crafting and Refining Claims
Effective claim management involves crafting claims that balance broad protection with precision. For US6958161B2, the claims were likely drafted to ensure comprehensive protection of the modified release formulation while avoiding overlap with prior art. This involves a deep understanding of the invention and related legal standards[3].
Post-Grant Claim Adjustments
After the patent is granted, ongoing claim management is essential. This includes monitoring and adjusting claims to adapt to changes in technology and market conditions. Ensuring claims remain clear, concise, and defensible is critical for maintaining the patent’s strength and enforceability[3].
Impact on Generic Launch
Generic Launch Date
The expiration of the patent and the status of exclusivities significantly impact the generic launch date. With one of the key patents (US6958161) having expired and the other set to expire in February 2028, generic manufacturers can plan their market entry strategies accordingly. The generic launch date for Doryx is estimated to be February 3, 2028, based on the remaining patent and exclusivity landscape[2].
Key Takeaways
- Patent Scope: US6958161B2 protects the modified release coated drug preparation of doxycycline hyclate.
- Claims: The patent includes independent and dependent claims defining the structure and composition of the drug preparation.
- Patent Expiration: One patent has expired, and another is set to expire in February 2028.
- Legal Activities: The patent has been involved in infringement suits and other legal activities.
- Global Landscape: Understanding the global patent family is crucial for market entry strategies.
- Claim Management: Effective claim management involves balancing broad protection with precision and adapting to changes post-grant.
FAQs
What is the main subject of United States Patent 6,958,161?
The main subject of US6958161B2 is a "Modified release coated drug preparation," specifically for doxycycline hyclate.
What is the current status of the patent?
One of the patents related to Doryx (US6958161) has expired, while another (US8715724) remains active until February 2028.
What legal activities has the patent been involved in?
The patent has been involved in patent infringement suits, such as the one filed by IMPAX Laboratories against Warner Chilcott and Mayne Pharma International.
How does the patent landscape affect the generic launch date?
The generic launch date for Doryx is estimated to be February 3, 2028, based on the remaining patent and exclusivity landscape.
What is the importance of global patent family in this context?
Understanding the global patent family helps identify markets with weaker patent protection, which could be ideal for generic entry points.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Pharsight - Doryx patent expiration: https://pharsight.greyb.com/drug/doryx-patent-expiration
- TT Consultants - Strategies for Effective Patent Claim Management: https://ttconsultants.com/patent-power-up-winning-strategies-for-smart-patent-claim-management/
- Google Patents - US6958161B2: https://patents.google.com/patent/US6958161B2/en
- Amneal Pharmaceuticals - Impax Sued Based on ANDA For Generic Doryx: https://investors.amneal.com/news/press-releases/press-release-details/2008/Impax-Sued-Based-on-Anda-For-Generic-Doryx/default.aspx
