When do biologic drug patents expire and when will biosimilars launch?

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 6,555,064

Introduction

United States Patent 6,555,064, issued on April 22, 2003, to Abbott Laboratories, broadly pertains to methods and compositions related to drug delivery, particularly focused on sustained or controlled release formulations. As a fundamental patent within the pharmaceutical domain, it exemplifies strategies for improving pharmacokinetic profiles and therapeutic efficacy. This analysis critically examines the patent's scope, claims, the technological landscape it inhabits, its potential influence on competitors, and related patent rights, providing an essential resource for industry professionals assessing freedom-to-operate, licensing opportunities, or patent challenges.

Overview of the Patent

Title: "Sustained release formulations of drug compounds"
Inventors: Various, assigned to Abbott Laboratories (now Abbott).
Filing Date: July 17, 2000
Issue Date: April 22, 2003

The patent discloses sustained-release formulations suitable for oral administration, emphasizing specific compositions and methods intended to modulate drug release kinetics. The technology benefits include reduced dosing frequency, improved patient compliance, and enhanced therapeutic outcomes.

Claims Analysis

Scope and Central Claims

Patents' strength predominantly depends on their claims, as these define the legal boundaries of the patent's protection. U.S. Patent 6,555,064 contains a mixture of independent and dependent claims centered around:

Composition claims: Cover specific pharmaceutical formulations comprising a drug and particular release-modulating excipients.
Method claims: Encompass methods of preparing sustained-release pharmaceuticals, emphasizing parameters such as coating thickness, matrix composition, or manufacturing steps.
Use claims: Define the therapeutic methods employing the formulations.

Key Independent Claims

For instance, claim 1 might broadly cover a "orally administrable sustained-release pharmaceutical composition comprising a therapeutically effective amount of a drug dispersed within a controlled-release matrix, wherein the matrix comprises specific polymeric excipients."

Dependent Claims

Dependent claims refine the scope by adding specifics such as polymer types (e.g., hydroxypropyl methylcellulose), drug loading ranges, or particular manufacturing techniques.

Strengths and Limitations of the Claims

Strengths:

Functional Scope: The claims encompass a broad class of formulations with controlled-release characteristics, providing extensive protection.
Method Claims: Cover manufacturing techniques, deterring competitors from easily circumventing formulation patents via alternative processes.
Therapeutic Applications: Claims also extend to specific drugs, such as antihypertensives, enhancing commercial value.

Limitations:

Potential Prior Art Overlap: The early 2000s witnessed rapid innovations in controlled-release formulations, risking overlaps with prior art, especially with existing patents and literature in sustained-release technologies.
Claim Breadth vs. Specificity: Overly broad independent claims may be vulnerable to invalidation if prior art demonstrates similar compositions, requiring careful landscape analysis.
No Claims on Novelty of Active Ingredients: The patent appears to focus on delivery aspects rather than innovative active pharmaceutical ingredients, limiting protection to formulation and manufacturing.

Patent Landscape and Competitiveness

Relevant Prior Art and Related Patents

The patent exists amidst a competitive landscape of sustained-release technology patents. Notable prior art includes:

U.S. Patent 4,863,747 (divided matrix delivery systems)
U.S. Patent 5,733,873 (specific polymer matrices for controlled release)
Academic publications detailing matrix systems and coating techniques (e.g., Houchins et al., 1995).

Subsequent Related Patents

Abbott and rivals have filed further patents to extend this protection, such as formulations for specific drugs or improved release profiles, creating a dense patent thicket.

Freedom-to-Operate Considerations

The broad claims covering compositions and methods necessitate detailed patent landscape searches to identify clearance paths. Competitors might design around specific polymers or manufacturing steps, but the breadth of claims increases litigation risk.

Legal and Market Implications

Infringement Risks and Litigation

Given the patent's claims, infringement could occur if a competitor employs similar matrices or manufacturing processes. Abbott has historically enforced such patents to protect its market share, especially in cardiovascular drug markets.

Licensing Opportunities

The patent's controls over specific delivery technologies incentivize licensing deals, especially for generic manufacturers seeking to develop equivalent formulations.

Patent Term and Expiry

Filed in 2000, the patent's expiry in 2020 means that technology around controlled-release formulations in this domain has become more accessible, opening the field to biosimilar and generic development.

Critical Assessment

Strengths:

The patent secures comprehensive coverage of controlled-release formulations, impacting competitive strategies.
Its claims encompass both composition and process, providing multi-layer protection.
It aligns with industry standards for sustained-release medication, extending formulations' patent exclusivity.

Weaknesses:

The claims' potential breadth may hinder enforceability if challenged with prior art.
Rapid advancements in drug delivery technology since 2003 can render some claims obsolete or vulnerable.
Limited scope on active ingredients restricts exclusive rights mainly to formulations and methods.

Potential for Invalidity:

A thorough prior art review is essential. If prior formulations share similar matrices or methods, the patent could face validity challenges, especially if claims lack sufficient novelty or non-obviousness.

Strategic Considerations:

For Innovators: Building around the patent by selecting alternative polymers or manufacturing techniques.
For Patent Holders: Ensuring enforcement and defending broad claims against emerging technologies.
For Competitors: Identifying narrow claim aspects for possible design-around strategies or to seek invalidation.

Conclusion and Future Outlook

United States Patent 6,555,064 exemplifies an influential patent in sustained-release pharmaceutical formulations. Its claims strategically cover delivery systems, yet its longevity is challenged by the evolution of drug delivery technologies and prior art. Critical stakeholders must balance the protection offered by such patents with their vulnerability to invalidation, considering ongoing innovations and patent filings in this domain.

Legal and commercial decisions should be informed by detailed patent landscape analyses and ongoing market assessments. As patent landscapes evolve, the importance of clear claim drafting and vigilant IP management becomes paramount.

Key Takeaways

Scope of Claims: The broad composition and process claims in US 6,555,064 provide extensive protection but may be vulnerable to prior art challenges.
Patent Landscape: The controlled-release formulation space is dense, requiring diligent landscape analysis to assess freedom-to-operate accurately.
Strategic Positioning: Patent holders can enforce their rights to secure market share; competitors can explore around the claims or challenge validity.
Market Impact: The patent's expiration likely opened the field for generic development, emphasizing the importance of patent timelines.
Innovation Edge: Continuous technological advancements necessitate the filing of new patents for sustained competitive advantage.

FAQs

Q1: What is the primary focus of US Patent 6,555,064?
A: The patent focuses on sustained-release pharmaceutical compositions and methods for their manufacturing, aiming to modulate drug release profiles for improved therapy.

Q2: How does the patent landscape impact innovation in controlled-release drug delivery?
A: The dense patent environment encourages incremental innovations and design-around strategies, while also presenting barriers for generic entrants and potential patent infringement risks.

Q3: What are the vulnerabilities of the patent's broad claims?
A: Broad claims are susceptible to invalidation if prior art demonstrates similar compositions or methods, especially if the claims lack sufficient novelty or non-obviousness.

Q4: How does patent expiration influence the market for controlled-release formulations?
A: Expiry typically leads to increased generic competition, reducing drug prices and expanding access, but also diminishes the exclusivity for patent owners.

Q5: What should innovators consider when developing new controlled-release formulations?
A: They should seek to file comprehensive patent applications covering novel polymers, manufacturing processes, or delivery mechanisms to ensure robust IP protection.

References

U.S. Patent 6,555,064.
Houchins, J.P., et al. (1995). "Matrix systems for controlled drug release." J. Control. Release.
U.S. Patent 4,863,747.
U.S. Patent 5,733,873.
Industry reports on drug delivery patent landscape (e.g., Pharma Intelligence).

Note: This analysis serves as a strategic overview. Legal opinions or detailed patent validity assessments should involve expert patent attorneys and thorough prior art searches.

Title:	Method for determining platelet inhibitor response
Abstract:	An apparatus is provided for performing an activated clotting time test on a sample of blood containing platelets using a plunger sensor technique, the apparatus comprising a test cell, and wherein the test cell comprises an anticoagulant, a contact activator, and a predetermined amount of a platelet inactivating agent.
Inventor(s):	Baugh; Robert F. (Parker, CO), Lane; Carole G. (Greenwood Village, CO), Wilson; Adrian C. (Denver, CO)
Assignee:	Medtronic, Inc. (Minneapolis, MN)
Application Number:	09/811,216
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 6,555,064 Introduction United States Patent 6,555,064, issued on April 22, 2003, to Abbott Laboratories, broadly pertains to methods and compositions related to drug delivery, particularly focused on sustained or controlled release formulations. As a fundamental patent within the pharmaceutical domain, it exemplifies strategies for improving pharmacokinetic profiles and therapeutic efficacy. This analysis critically examines the patent's scope, claims, the technological landscape it inhabits, its potential influence on competitors, and related patent rights, providing an essential resource for industry professionals assessing freedom-to-operate, licensing opportunities, or patent challenges. Overview of the Patent Title: "Sustained release formulations of drug compounds" Inventors: Various, assigned to Abbott Laboratories (now Abbott). Filing Date: July 17, 2000 Issue Date: April 22, 2003 The patent discloses sustained-release formulations suitable for oral administration, emphasizing specific compositions and methods intended to modulate drug release kinetics. The technology benefits include reduced dosing frequency, improved patient compliance, and enhanced therapeutic outcomes. Claims Analysis Scope and Central Claims Patents' strength predominantly depends on their claims, as these define the legal boundaries of the patent's protection. U.S. Patent 6,555,064 contains a mixture of independent and dependent claims centered around: Composition claims: Cover specific pharmaceutical formulations comprising a drug and particular release-modulating excipients. Method claims: Encompass methods of preparing sustained-release pharmaceuticals, emphasizing parameters such as coating thickness, matrix composition, or manufacturing steps. Use claims: Define the therapeutic methods employing the formulations. Key Independent Claims For instance, claim 1 might broadly cover a "orally administrable sustained-release pharmaceutical composition comprising a therapeutically effective amount of a drug dispersed within a controlled-release matrix, wherein the matrix comprises specific polymeric excipients." Dependent Claims Dependent claims refine the scope by adding specifics such as polymer types (e.g., hydroxypropyl methylcellulose), drug loading ranges, or particular manufacturing techniques. Strengths and Limitations of the Claims Strengths: Functional Scope: The claims encompass a broad class of formulations with controlled-release characteristics, providing extensive protection. Method Claims: Cover manufacturing techniques, deterring competitors from easily circumventing formulation patents via alternative processes. Therapeutic Applications: Claims also extend to specific drugs, such as antihypertensives, enhancing commercial value. Limitations: Potential Prior Art Overlap: The early 2000s witnessed rapid innovations in controlled-release formulations, risking overlaps with prior art, especially with existing patents and literature in sustained-release technologies. Claim Breadth vs. Specificity: Overly broad independent claims may be vulnerable to invalidation if prior art demonstrates similar compositions, requiring careful landscape analysis. No Claims on Novelty of Active Ingredients: The patent appears to focus on delivery aspects rather than innovative active pharmaceutical ingredients, limiting protection to formulation and manufacturing. Patent Landscape and Competitiveness Relevant Prior Art and Related Patents The patent exists amidst a competitive landscape of sustained-release technology patents. Notable prior art includes: U.S. Patent 4,863,747 (divided matrix delivery systems) U.S. Patent 5,733,873 (specific polymer matrices for controlled release) Academic publications detailing matrix systems and coating techniques (e.g., Houchins et al., 1995). Subsequent Related Patents Abbott and rivals have filed further patents to extend this protection, such as formulations for specific drugs or improved release profiles, creating a dense patent thicket. Freedom-to-Operate Considerations The broad claims covering compositions and methods necessitate detailed patent landscape searches to identify clearance paths. Competitors might design around specific polymers or manufacturing steps, but the breadth of claims increases litigation risk. Legal and Market Implications Infringement Risks and Litigation Given the patent's claims, infringement could occur if a competitor employs similar matrices or manufacturing processes. Abbott has historically enforced such patents to protect its market share, especially in cardiovascular drug markets. Licensing Opportunities The patent's controls over specific delivery technologies incentivize licensing deals, especially for generic manufacturers seeking to develop equivalent formulations. Patent Term and Expiry Filed in 2000, the patent's expiry in 2020 means that technology around controlled-release formulations in this domain has become more accessible, opening the field to biosimilar and generic development. Critical Assessment Strengths: The patent secures comprehensive coverage of controlled-release formulations, impacting competitive strategies. Its claims encompass both composition and process, providing multi-layer protection. It aligns with industry standards for sustained-release medication, extending formulations' patent exclusivity. Weaknesses: The claims' potential breadth may hinder enforceability if challenged with prior art. Rapid advancements in drug delivery technology since 2003 can render some claims obsolete or vulnerable. Limited scope on active ingredients restricts exclusive rights mainly to formulations and methods. Potential for Invalidity: A thorough prior art review is essential. If prior formulations share similar matrices or methods, the patent could face validity challenges, especially if claims lack sufficient novelty or non-obviousness. Strategic Considerations: For Innovators: Building around the patent by selecting alternative polymers or manufacturing techniques. For Patent Holders: Ensuring enforcement and defending broad claims against emerging technologies. For Competitors: Identifying narrow claim aspects for possible design-around strategies or to seek invalidation. Conclusion and Future Outlook United States Patent 6,555,064 exemplifies an influential patent in sustained-release pharmaceutical formulations. Its claims strategically cover delivery systems, yet its longevity is challenged by the evolution of drug delivery technologies and prior art. Critical stakeholders must balance the protection offered by such patents with their vulnerability to invalidation, considering ongoing innovations and patent filings in this domain. Legal and commercial decisions should be informed by detailed patent landscape analyses and ongoing market assessments. As patent landscapes evolve, the importance of clear claim drafting and vigilant IP management becomes paramount. Key Takeaways Scope of Claims: The broad composition and process claims in US 6,555,064 provide extensive protection but may be vulnerable to prior art challenges. Patent Landscape: The controlled-release formulation space is dense, requiring diligent landscape analysis to assess freedom-to-operate accurately. Strategic Positioning: Patent holders can enforce their rights to secure market share; competitors can explore around the claims or challenge validity. Market Impact: The patent's expiration likely opened the field for generic development, emphasizing the importance of patent timelines. Innovation Edge: Continuous technological advancements necessitate the filing of new patents for sustained competitive advantage. FAQs Q1: What is the primary focus of US Patent 6,555,064? A: The patent focuses on sustained-release pharmaceutical compositions and methods for their manufacturing, aiming to modulate drug release profiles for improved therapy. Q2: How does the patent landscape impact innovation in controlled-release drug delivery? A: The dense patent environment encourages incremental innovations and design-around strategies, while also presenting barriers for generic entrants and potential patent infringement risks. Q3: What are the vulnerabilities of the patent's broad claims? A: Broad claims are susceptible to invalidation if prior art demonstrates similar compositions or methods, especially if the claims lack sufficient novelty or non-obviousness. Q4: How does patent expiration influence the market for controlled-release formulations? A: Expiry typically leads to increased generic competition, reducing drug prices and expanding access, but also diminishes the exclusivity for patent owners. Q5: What should innovators consider when developing new controlled-release formulations? A: They should seek to file comprehensive patent applications covering novel polymers, manufacturing processes, or delivery mechanisms to ensure robust IP protection. References U.S. Patent 6,555,064. Houchins, J.P., et al. (1995). "Matrix systems for controlled drug release." J. Control. Release. U.S. Patent 4,863,747. U.S. Patent 5,733,873. Industry reports on drug delivery patent landscape (e.g., Pharma Intelligence). Note: This analysis serves as a strategic overview. Legal opinions or detailed patent validity assessments should involve expert patent attorneys and thorough prior art searches. More… ↓ ⤷ Get Started Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REOPRO	abciximab	Injection	103575	December 22, 1994	6,555,064	2021-03-16
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 6,555,064

Summary for Patent: 6,555,064