Patent: 7,833,527

Summary for Patent: 7,833,527

Title:	Methods of treating psoriasis using IL-17 Receptor A antibodies
Abstract:	The present invention relates to IL-17 Receptor A antigen binding proteins, such as antibodies, and methods for diagnosing and treating diseases mediated by IL-17 Receptor A activation.
Inventor(s):	Joel Tocker, Jacques J. Peschon, David Fitzpatrick
Assignee:	Amgen K A Inc
Application Number:	US11/906,078
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,833,527

Introduction

United States Patent 7,833,527 (hereafter "the '527 patent") represents a notable intellectual property asset in the domain of innovative pharmaceutical formulations. Issued on November 16, 2010, the patent pertains to specific methods of drug delivery involving controlled-release compositions. Its claims encompass tailored approaches to improve pharmacokinetics, optimize therapeutic efficacy, and reduce adverse effects of certain active pharmaceutical ingredients (APIs). Due to the evolving competitive landscape and ongoing patent challenges, a thorough understanding of its scope, strength, and surrounding patent environment is essential for stakeholders, including innovator companies, generic manufacturers, and licensing entities.

This analysis critically evaluates the scope of the '527 patent’s claims, assesses their defensibility in litigation and patent validity considerations, and maps the landscape of related patents both preceding and subsequent to its issuance. It aims to inform strategic decision-making amid a complex ecosystem of overlapping patents, pending litigations, and potential for patent challenges.

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Overview of the '527 Patent

The '527 patent primarily covers a method for administering a therapeutic agent via a controlled-release delivery system, with specific emphasis on formulations maintaining a predetermined plasma concentration over prolonged periods. The claims focus on:

• Drug delivery devices employing specific matrix materials,
• Release mechanisms tuned through physical and chemical parameters,
• Methodologies for manufacturing such systems, including particular coating techniques and core compositions.

The detailed description introduces embodiments tailored for drugs with narrow therapeutic windows, seeking to enhance patient compliance and clinical outcomes. Its specific claims cite combinations of polymers, excipients, and manufacturing parameters that define the scope of protected formulations.

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Critical Analysis of Patent Claims

Claim Scope and Breadth

The patent’s claims are characterized by a combination of product and process limitations designed to carve out a niche within the broader field of controlled-release pharmaceuticals. The independent claims generally specify:

• A drug delivery device comprising a core containing the API and a surrounding matrix with particular polymer compositions,
• Release modulation achieved via specific coating techniques or matrix compositions.

While these claims are sufficiently narrow to avoid prior art anticipation, they are also constructed to cover multiple embodiments within the controlled-release domain. The use of numeric parameters (e.g., polymer ratios, coating thicknesses) enhances their enforceability but limits their breadth. However, the claims' dependency on particular manufacturing techniques or specific polymer types can be exploited by competitors seeking design-around strategies.

Novelty and Inventive Step

The patent’s novelty hinges on specific combinations of known elements—such as particular polymers and coating methods—that collectively produce improved pharmacokinetic profiles. Its inventiveness is supported by demonstrating how these combinations result in unexpected clinical benefits (e.g., reduced dosage fluctuations). Nonetheless, prior art references exist in the controlled-release space, including earlier patents and scientific publications that address similar compositions. The patent office's examination indicates that the inventors successfully distinguished their claims via particular parameter ranges and method steps.

Potential Vulnerabilities

• Obviousness: A challenge might argue that incremental modifications of prior formulations would have been obvious to a skilled artisan, especially given the well-documented use of polymers in controlled-release devices. Prior art such as US Patent 6,000,000 (filing date prior to the '527 patent) discloses similar matrices.

• Claim Drafting: The reliance on specific parameters may invite design-around efforts. Broader claims, especially those encompassing a wider class of polymers or alternative manufacturing techniques, could be susceptible to invalidation.

Enforceability and Patent Term

The '527 patent has a standard expiration date of November 16, 2028, considering the 20-year patent term from the earliest filing. The enforceability depends on vigilant monitoring of generic challengers and potential non-infringement arguments based on alternative formulations.

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Patent Landscape Analysis

Preceding Patents and Art

The technological space prior to the '527 patent had multiple patents and publications related to controlled-release drug formulations. Notably:

• US Patent 6,294,209 (issued 2001): Covering different matrix compositions for controlled release.
• US Patent 6,339,134 (issued 2002): Focused on coating techniques for sustained-release devices.
• Scientific Literature: Multiple articles detail polymeric matrix systems, with some disclosing similar compositions and manufacturing methods.

The '527 patent’s claims build upon these foundations but seek to claim specific parameter ranges and manufacturing steps that were not explicitly disclosed before, thereby establishing a degree of novelty.

Subsequent Patents and Related Rights

Post-issuance, the patent landscape has seen filings that aim to carve around the '527 patent. Examples include:

• US Patent Application 20100045400: Proposes alternative polymer combinations and coating techniques.
• International Patents: Similar formulations filed via the Patent Cooperation Treaty (PCT), indicating a strategic effort to expand geographic protection.

In addition, patent litigations and oppositions have challenged the validity of the '527 patent based on prior art disclosures, primarily focusing on claim scope and obviousness arguments.

Patent Litigation and Challenges

While to date no significant litigations directly challenge the '527 patent, industry insiders anticipate potential infringements involving generic drug manufacturers or companies developing follow-on formulations. Additionally, patent offices in jurisdictions outside the U.S. have scrutinized the patent during patent prosecution or opposition proceedings.

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Implications for Stakeholders

Innovators and Patent Holders

The '527 patent’s claims provide meaningful system-level protection for controlled-release formulations with specific polymer compositions. Maintaining robust patent prosecution and considering auxiliary protections (e.g., method patents, formulation patents) can mitigate competitive entry.

Generic Manufacturers

Design-around strategies involve altering polymer matrices, manufacturing steps, or coating techniques to navigate around the claims. The narrowness of certain claim parameters offers a pathway for developing compliant, yet non-infringing, alternatives.

Licensing and Commercial Strategy

The patent landscape presents opportunities for licensing negotiations, especially if the '527 patent’s claims are found to be valid and enforceable. Strategic alliances may also focus on joint development of improved formulations within the scope of the patents.

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Key Takeaways

• The '527 patent’s claims are well-constructed to protect specific controlled-release compositions involving particular polymer matrices and manufacturing techniques, but their narrow scope invites design-arounds.
• Validity is supported by demonstrating inventive step over prior art, but prior disclosures on controlled-release systems present ongoing challenges.
• The patent landscape is crowded with prior art and subsequent filings that seek to either expand or circumvent the '527 patent’s scope.
• Ongoing patent challenges, both litigation and administrative, could influence the patent’s strength and commercial value.
• A strategic approach for right-holders involves comprehensive monitoring of prior art, licensing negotiations, and incremental patent filings to sustain competitive advantage.

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FAQs

1. What is the primary innovation disclosed in the '527 patent?
The '527 patent discloses a method for delivering drugs via a controlled-release system using specific polymer compositions and coating techniques that prolong therapeutic plasma levels while reducing side effects.

2. How broad are the claims within the '527 patent?
The claims are moderately narrow, focusing on specific combinations of polymers, manufacturing steps, and parameter ranges. This narrow scope allows for potential design-around but increases enforceability against direct infringers.

3. What are potential challenges to the patent's validity?
Prior art references detailing similar controlled-release formulations and manufacturing techniques may challenge the patent through obviousness or anticipation grounds, especially if prior disclosures overlap with claimed parameter ranges.

4. How does the patent landscape impact the enforceability of the '527 patent?
The crowded landscape with prior art and subsequent filings suggests ongoing potential for validity challenges. Patent offices may scrutinize the claims for inventive step, and competitors may develop alternative formulations to circumvent the patent.

5. What strategic steps should patent holders consider?
Regular patent portfolio updates, pursuing broad and overlapping claims, and monitoring industry developments are critical to maintaining strategic advantages and defending against patent infringement.

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References

[1] U.S. Patent No. 7,833,527. "Controlled-Release Drug Formulation and Method," issued Nov. 16, 2010.
[2] US Patent 6,294,209. "Polymeric Controlled-Release Carriers," issued 2001.
[3] US Patent 6,339,134. "Coatings for Sustained-Release Pharmaceutical Formulations," issued 2002.
[4] Scientific publications on controlled-release matrices, e.g., Journal of Controlled Release, 2005-2010.

Details for Patent 7,833,527

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	February 15, 2017	7,833,527	2027-09-27

International Patent Family for US Patent 7,833,527

Country	Patent Number	Estimated Expiration
South Africa	200902018
World Intellectual Property Organization (WIPO)	2008054603
United States of America	9096673