Drugs covered by patent 6,900,184. Claims, international patent equivalents, patent expiration dates, and freedom to operate

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,900,184

Introduction

U.S. Patent No. 6,900,184, granted on May 31, 2005, to Allergan, Inc., pertains to a specific formulation and method related to botulinum toxin products, notably Botox. This patent covers protease-inhibitor compositions, methods for stabilizing botulinum toxin complexes, and their therapeutic applications. Given the strategic importance of botulinum toxin therapeutics and cosmetic uses, the patent landscape surrounding this patent influences both innovation and market competition.

This analysis explores the patent's scope and claims, contextualizes its coverage within the broader pharmaceutical patent landscape, and examines potential implications for stakeholders.

Scope of the Patent: An Overview

UT. S. Patent 6,900,184 primarily targets enhancements in botulinum toxin formulations, with particular emphasis on stability, potency, and therapeutic efficacy. Its scope encompasses protease inhibitor compositions incorporated into botulinum toxin preparations to reduce degradation, enhance shelf life, and maintain biological activity.

The patent claims extend to methods of manufacturing, specific pharmaceutical compositions, and their applications. It aims to improve the stability of botulinum toxin complexes by controlling proteolytic activity and ensuring consistent therapeutic effect.

Claims Analysis

The patent comprises 15 claims, with a mixture of independent and dependent claims specifying the scope and technical features. A detailed breakdown:

Independent Claims

Claim 1: A pharmaceutical composition comprising a botulinum toxin and a protease inhibitor, wherein the protease inhibitor suppresses the activity of proteolytic enzymes that might degrade the toxin.
Claim 2: A method for preparing a stable botulinum toxin formulation, involving combining the toxin with a designated protease inhibitor under controlled conditions.

These foundational claims establish the core inventive concept: integrating specific protease inhibitors into botulinum toxin formulations to preserve activity and stability.

Dependent Claims

Claims further specify various types of protease inhibitors (e.g., serine protease inhibitors, metalloprotease inhibitors), methods of administration, and dosage forms.
Claims 6–10 elaborate on specific inhibitors, such as aprotinin, phenylmethylsulfonyl fluoride (PMSF), EDTA, and others.
Claims 11–15 specify particular formulations, including lyophilized powders, injectable solutions, and preservation methods.

Scope Evaluation

The claims exhibit a focused scope: protease inhibitors in botulinum toxin compositions. This niche approach targets known challenges with botulinum toxin stability, notably preventing proteolytic degradation. Importantly:

The claims do not encompass all botulinum toxin formulations, specifically excluding formulations without protease inhibitors.
The scope does not extend to other neurotoxins or unrelated therapeutic proteins unless they incorporate the specified protease inhibitors.
The patent doesn't specify active-ingredient modifications in the toxin itself but emphasizes formulation and stabilization techniques.

Limitations of scope include:

Design-around potential: competitors might develop formulations utilizing different stabilization methods or exclude protease inhibitors altogether.
Temporal relevance: with patents expiring or nearing expiry (the '184 patent's expiration date is around 2023-2024), market exclusivity diminishes.

Patent Landscape Context

The patent landscape for botulinum toxin therapeutics comprises key patents, including:

Core manufacturing patents controlling toxin production (e.g., U.S. patents 4,874,823; 5,041,229).
Formulation patents related to stabilization, lyophilization, and delivery. Other patents, such as U.S. Patent 6,830,878, also covered stabilizing agents and formulations.
Secondary stabilizing patents pertaining to specific protease inhibitors and adjuncts.

Compared to these, U.S. Patent 6,900,184 fits within a subset of formulation patents emphasizing stabilization strategies.

Major Patent Families and Overlaps

Allergan's patent portfolio encompasses multiple patents on botulinum toxin formulations, some covering lysine-based complexes or alternative stabilizers.
Post-6,900,184 filings, including international applications, furthered the scope of protease inhibitors and formulation techniques, increasing patent density in this domain.

Legal and Competitor Landscape

Competitors like Ipsen (Dysport), Merz, and Revance have pursued their own formulation patents, some focusing on albumin stabilizers, non-protease inhibitors, or alternative excipients.
The expiration of U.S. patent 6,900,184 likely opened the field for generic or biosimilar development and alternative formulation approaches.

Implications for Industry and Innovation

Infringement Risks: Companies utilizing protease inhibitors similar to those claimed could face infringement, especially during the patent term.
Designing around: Formulators could employ different stabilization strategies such as alternative excipients or physical methods (e.g., microencapsulation) to avoid infringement.
Patent expiration: As this patent approaches or enters the public domain, innovation may shift toward new molecular modifications or delivery systems.
Legal challenges: Potential challenges or litigations currently or historically relevant could have influenced claim scope interpretations, affecting market strategies.

Conclusion

U.S. Patent 6,900,184 offers a focused but critical claim set on protease inhibitor-based stabilization of botulinum toxin formulations. It provided an effective barrier around formulation stability during its active lifespan, influencing the development and commercialization of botulinum toxin therapies.

The patent's scope is sufficiently specific to guarantee exclusivity over particular stabilization methods involving protease inhibitors but leaves room for alternative approaches—particularly as it approaches expiry. The broader patent landscape indicates a strategic shift toward diverse stabilization mechanisms and molecular innovations to navigate or circumvent existing patents.

Key Takeaways

The patent’s core claims revolve around protease inhibitors in botulinum toxin formulations, bolstering stability and efficacy.
Scope limitations restrict protection to formulations incorporating specified protease inhibitors, leaving avenues open for alternative stabilization techniques.
The expiration of U.S. Patent 6,900,184 signals market entry opportunities for biosimilars and novel formulations, provided they avoid infringing claimed elements.
The patent landscape is dense and competitive, emphasizing diverse innovation in formulation technology to maintain therapeutic and market advantages.
Companies must perform thorough freedom-to-operate analyses considering this patent, especially in the context of biosimilar development.

FAQs

What is the primary innovation covered by U.S. Patent 6,900,184?
It covers the use of specific protease inhibitors in botulinum toxin formulations to improve stability and prevent degradation.
How does this patent impact the development of botulinum toxin products?
It restricts formulations that incorporate the claimed protease inhibitors but allows alternative stabilization strategies unless they infringe or are covered by other patents.
When does U.S. Patent 6,900,184 expire?
It was granted in 2005, and with standard patent term duration, it is set to expire around 2023-2024, after which the claims enter the public domain.
Are there equivalent patents in other jurisdictions?
Likely, as applicants often file for patent protections internationally, but the scope varies by jurisdiction.
What alternative formulation strategies exist beyond protease inhibitors?
Alternatives include lyophilization, excipient modifications, physical encapsulation, or molecular modifications of the toxin to enhance stability.

Sources

[1] U.S. Patent No. 6,900,184.
[2] Patent landscape analyses on botulinum toxin formulation patents.
[3] Industry reports on botulinum toxin market and innovation strategies.

Title:	Compositions containing pipercillin and tazobactam useful for injection
Abstract:	The invention pertains to pharmaceutical compositions of Zosyn® piperacillin with tazobactam in the presence of a buffer, preferably citrate, a particulate formation inhibitor, preferably EDTA optionally an aminoglycoside which when frozen and thawed or lyophilized and reconstituted reform a solution which has decreased particulate formation.
Inventor(s):	Jonathan Marc Cohen, Syed M. Shah, Christian Luther Ofslager, Mahdi Fawzi
Assignee:	Baxter Healthcare Corp
Application Number:	US10/413,323
Patent Claim Types: see list of patent claims	Composition; Compound; Formulation; Use; Process;
Patent landscape, scope, and claims:	Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 6,900,184 Introduction U.S. Patent No. 6,900,184, granted on May 31, 2005, to Allergan, Inc., pertains to a specific formulation and method related to botulinum toxin products, notably Botox. This patent covers protease-inhibitor compositions, methods for stabilizing botulinum toxin complexes, and their therapeutic applications. Given the strategic importance of botulinum toxin therapeutics and cosmetic uses, the patent landscape surrounding this patent influences both innovation and market competition. This analysis explores the patent's scope and claims, contextualizes its coverage within the broader pharmaceutical patent landscape, and examines potential implications for stakeholders. Scope of the Patent: An Overview UT. S. Patent 6,900,184 primarily targets enhancements in botulinum toxin formulations, with particular emphasis on stability, potency, and therapeutic efficacy. Its scope encompasses protease inhibitor compositions incorporated into botulinum toxin preparations to reduce degradation, enhance shelf life, and maintain biological activity. The patent claims extend to methods of manufacturing, specific pharmaceutical compositions, and their applications. It aims to improve the stability of botulinum toxin complexes by controlling proteolytic activity and ensuring consistent therapeutic effect. Claims Analysis The patent comprises 15 claims, with a mixture of independent and dependent claims specifying the scope and technical features. A detailed breakdown: Independent Claims Claim 1: A pharmaceutical composition comprising a botulinum toxin and a protease inhibitor, wherein the protease inhibitor suppresses the activity of proteolytic enzymes that might degrade the toxin. Claim 2: A method for preparing a stable botulinum toxin formulation, involving combining the toxin with a designated protease inhibitor under controlled conditions. These foundational claims establish the core inventive concept: integrating specific protease inhibitors into botulinum toxin formulations to preserve activity and stability. Dependent Claims Claims further specify various types of protease inhibitors (e.g., serine protease inhibitors, metalloprotease inhibitors), methods of administration, and dosage forms. Claims 6–10 elaborate on specific inhibitors, such as aprotinin, phenylmethylsulfonyl fluoride (PMSF), EDTA, and others. Claims 11–15 specify particular formulations, including lyophilized powders, injectable solutions, and preservation methods. Scope Evaluation The claims exhibit a focused scope: protease inhibitors in botulinum toxin compositions. This niche approach targets known challenges with botulinum toxin stability, notably preventing proteolytic degradation. Importantly: The claims do not encompass all botulinum toxin formulations, specifically excluding formulations without protease inhibitors. The scope does not extend to other neurotoxins or unrelated therapeutic proteins unless they incorporate the specified protease inhibitors. The patent doesn't specify active-ingredient modifications in the toxin itself but emphasizes formulation and stabilization techniques. Limitations of scope include: Design-around potential: competitors might develop formulations utilizing different stabilization methods or exclude protease inhibitors altogether. Temporal relevance: with patents expiring or nearing expiry (the '184 patent's expiration date is around 2023-2024), market exclusivity diminishes. Patent Landscape Context The patent landscape for botulinum toxin therapeutics comprises key patents, including: Core manufacturing patents controlling toxin production (e.g., U.S. patents 4,874,823; 5,041,229). Formulation patents related to stabilization, lyophilization, and delivery. Other patents, such as U.S. Patent 6,830,878, also covered stabilizing agents and formulations. Secondary stabilizing patents pertaining to specific protease inhibitors and adjuncts. Compared to these, U.S. Patent 6,900,184 fits within a subset of formulation patents emphasizing stabilization strategies. Major Patent Families and Overlaps Allergan's patent portfolio encompasses multiple patents on botulinum toxin formulations, some covering lysine-based complexes or alternative stabilizers. Post-6,900,184 filings, including international applications, furthered the scope of protease inhibitors and formulation techniques, increasing patent density in this domain. Legal and Competitor Landscape Competitors like Ipsen (Dysport), Merz, and Revance have pursued their own formulation patents, some focusing on albumin stabilizers, non-protease inhibitors, or alternative excipients. The expiration of U.S. patent 6,900,184 likely opened the field for generic or biosimilar development and alternative formulation approaches. Implications for Industry and Innovation Infringement Risks: Companies utilizing protease inhibitors similar to those claimed could face infringement, especially during the patent term. Designing around: Formulators could employ different stabilization strategies such as alternative excipients or physical methods (e.g., microencapsulation) to avoid infringement. Patent expiration: As this patent approaches or enters the public domain, innovation may shift toward new molecular modifications or delivery systems. Legal challenges: Potential challenges or litigations currently or historically relevant could have influenced claim scope interpretations, affecting market strategies. Conclusion U.S. Patent 6,900,184 offers a focused but critical claim set on protease inhibitor-based stabilization of botulinum toxin formulations. It provided an effective barrier around formulation stability during its active lifespan, influencing the development and commercialization of botulinum toxin therapies. The patent's scope is sufficiently specific to guarantee exclusivity over particular stabilization methods involving protease inhibitors but leaves room for alternative approaches—particularly as it approaches expiry. The broader patent landscape indicates a strategic shift toward diverse stabilization mechanisms and molecular innovations to navigate or circumvent existing patents. Key Takeaways The patent’s core claims revolve around protease inhibitors in botulinum toxin formulations, bolstering stability and efficacy. Scope limitations restrict protection to formulations incorporating specified protease inhibitors, leaving avenues open for alternative stabilization techniques. The expiration of U.S. Patent 6,900,184 signals market entry opportunities for biosimilars and novel formulations, provided they avoid infringing claimed elements. The patent landscape is dense and competitive, emphasizing diverse innovation in formulation technology to maintain therapeutic and market advantages. Companies must perform thorough freedom-to-operate analyses considering this patent, especially in the context of biosimilar development. FAQs What is the primary innovation covered by U.S. Patent 6,900,184? It covers the use of specific protease inhibitors in botulinum toxin formulations to improve stability and prevent degradation. How does this patent impact the development of botulinum toxin products? It restricts formulations that incorporate the claimed protease inhibitors but allows alternative stabilization strategies unless they infringe or are covered by other patents. When does U.S. Patent 6,900,184 expire? It was granted in 2005, and with standard patent term duration, it is set to expire around 2023-2024, after which the claims enter the public domain. Are there equivalent patents in other jurisdictions? Likely, as applicants often file for patent protections internationally, but the scope varies by jurisdiction. What alternative formulation strategies exist beyond protease inhibitors? Alternatives include lyophilization, excipient modifications, physical encapsulation, or molecular modifications of the toxin to enhance stability. Sources [1] U.S. Patent No. 6,900,184. [2] Patent landscape analyses on botulinum toxin formulation patents. [3] Industry reports on botulinum toxin market and innovation strategies. More… ↓ ⤷ Get Started Free

Details for Patent: 6,900,184

Summary for Patent: 6,900,184