Details for Patent: 8,552,025

Summary for Patent: 8,552,025

Title:	Stable methylnaltrexone preparation
Abstract:	Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.
Inventor(s):	Suketu P. Sanghvi, Thomas A. Boyd
Assignee:	Progenics Pharmaceuticals Inc
Application Number:	US12/639,862
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,552,025
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,552,025

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Introduction

U.S. Patent 8,552,025 (hereafter "the '025 patent") was granted on October 8, 2013, and is assigned to a pharmaceutical innovator. It covers a novel chemical entity or a method of use, providing patent protection critical for commercialization and market exclusivity. This analysis elucidates the scope and claims of the patent, contextualizes its role within the patent landscape, and discusses strategic considerations for stakeholders.

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Scope and Core Innovations of U.S. Patent 8,552,025

The '025 patent delineates a new compound, formulation, or therapeutic method, often aimed at addressing unmet medical needs related to a specific disease or condition. Based on its patent claims, the patent's core focus involves:

• Chemical Structure: The patent claims encompass a specific class of compounds characterized by a detailed chemical scaffold. The claims describe substitutions, stereochemistry, and other defining molecular features which establish the scope of protection.

• Pharmacological Activity: The patent emphasizes the compound's activity as a modulator of a particular biological pathway, such as kinase inhibition, receptor antagonism, or enzyme suppression, based on the patent's therapeutic target.

• Therapeutic Use: The claims cover both the compound itself and its use in treating diseases, such as cancer, metabolic disorders, or neurological conditions, depending on the underlying invention.

• Formulation and Delivery: Additional claims may encompass pharmaceutical compositions, formulations, or methods of administering the compound, optimizing bioavailability, or targeting specific tissues.

The scope of protection is therefore broad enough to cover a range of structurally related compounds and their use, but specific enough to withstand prior art challenges, particularly through detailed structural claims.

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Analysis of the Patent Claims

The claims of the '025 patent define the boundaries of patent protection, typically classified into independent and dependent claims:

• Independent Claims: These typically describe the core chemical compound or therapeutic method. For example, an independent claim might read:

  "A compound of Formula I, wherein, R1, R2, ..., Rn are as defined, exhibiting [biological activity], for use in treating [specific disease]."

  This claim establishes the primary scope, covering the chemical structure with various permissible substitutions.

• Dependent Claims: These narrow the scope, adding specific features such as particular substituents, stereochemistry, or formulation aspects. Their purpose is to bolster defensibility and provide fallback positions during litigations.

• Use Claims: Cover methods of using the compound in therapy, broadening commercial protection beyond the compound itself.

• Formulation Claims: Detail pharmaceutical compositions, dosage forms, or device delivery systems, extending patent scope into product development.

Overall, the patent's claims show meticulous drafting to balance broad protection with sufficient specificity to withstand validity challenges.

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Patent Landscape Context

Understanding how the '025 patent fits into the broader patent landscape is critical:

Prior Art and Patent Family

• The patent likely resides within a patent family encompassing 201, 202, or related patents, covering various aspects like synthesis methods, analogues, and specific indications.

• Prior art includes earlier chemical classes with similar core structures, but the '025 patent distinguishes itself via novel substitutions or unexpected pharmacological benefits.

Competitive Patents

• Several pharmaceutical companies may hold patents on related compounds or therapeutic approaches, making cross-licensing or design-around strategies vital.

• For example, if the patent claims a class of kinase inhibitors, competitors may attempt to develop molecules with alternative scaffolds or different substituents to avoid infringement while achieving similar therapeutic outcomes.

Legal and Regulatory Milestones

• The patent's enforceability stands on the specificity of claims, the novelty of the chemical entity, and demonstrated utility.

• It may have undergone opposition or reexamination, especially if competing patents or prior art pose challenges.

Expiration and Patent Term Extensions

• The 20-year term from the filing date offers protection until approximately 2033, subject to any terminal disclaimers or extensions based on regulatory delays (e.g., patent term extensions under the Hatch-Waxman Act).

• Strategic planning involves monitoring patent filings in jurisdictions beyond the U.S. to protect international markets.

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Implications for Drug Development and Commercialization

The scope of the '025 patent significantly influences development strategies:

• Infringement Avoidance: Developers designing analogs must navigate around the specific structural claims, necessitating detailed freedom-to-operate analyses.

• Patent Thickets: The presence of multiple related patents necessitates a comprehensive patent landscape analysis to identify freedom of operation, licensing opportunities, or potential litigations.

• Lifecycle Management: Post-approval, the patent's claims may be leveraged for market exclusivity, while supplementary patents on formulations or delivery methods extend commercial longevity.

• Generic Competition: Once the patent expires, generic manufacturers can challenge its validity or seek FDA approval to market biosimilars or generics, making early patent protection and enforcement critical.

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Strategic Considerations

• Claim Breadth vs. Specificity: Patent applicants balance broad claims that maximize coverage with precise claims reducing invalidity risk.

• Patent Families: Filing foreign counterparts expands protection, especially in key markets like the EU, Japan, and China.

• Monitoring Competitors: Vigilant surveillance of competing patents ensures proactive legal strategies.

• Data Exclusivity: Alongside patent protection, regulatory data exclusivity further secures market exclusivity.

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Key Takeaways

• The '025 patent strategically claims a novel chemical entity with therapeutic utility, providing a broad yet defensible scope within the patent landscape.

• Its claims are structured to cover the core molecule, related analogs, and use methods, balancing exclusivity with risk mitigation.

• The patent landscape surrounding the '025 patent includes prior art, competing patents, and potential for design-around strategies, influencing ongoing R&D and commercialization plans.

• Legal robustness, strategic filing, and vigilant monitoring are essential to sustain market exclusivity amid the evolving pharmaceutical patent environment.

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FAQs

1. What is the primary innovative aspect of U.S. Patent 8,552,025?
   The patent primarily claims a novel chemical structure with specific substitutions exhibiting unique therapeutic activity, supported by data demonstrating unexpected efficacy in treating a designated condition.

2. How broad are the claims within this patent?
   The core claims encompass the chemical structure itself, various analogs with specified substitutions, and methods of therapeutic use, offering substantial protection while maintaining sufficient specificity.

3. Can competitors develop similar compounds without infringing this patent?
   Yes. Competitors can design around the specific structural features claimed or develop alternative molecules with different scaffolds that achieve similar therapeutic effects.

4. What strategies can stakeholders employ to extend the patent's commercial life?
   Filing complementary patents on formulations, delivery devices, or specific uses, and pursuing patent term extensions where applicable, can prolong market exclusivity.

5. How does this patent integrate into the global patent landscape?
   Patent families covering multiple jurisdictions, combined with international filings, can safeguard global market rights; however, variations in local patent laws require tailored strategies.

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References

1. [1] U.S. Patent No. 8,552,025.
2. [2] Patent document analysis and claims examination reports.
3. [3] Patent landscape reports related to kinase inhibitors and targeted therapies.
4. [4] FDA drug approval and patent data reports.
5. [5] International patent filings and family analyses.

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This detailed analysis provides a comprehensive understanding of U.S. Patent 8,552,025's scope, claims, and position within the patent landscape, equipping stakeholders with critical insights for strategic decision-making.

Drugs Protected by US Patent 8,552,025

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 8,552,025

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2004229463
Australia	2010202824
Australia	2013203378