Details for Patent: 8,067,472

Summary for Patent: 8,067,472

Title:	Methods of treating Hodgkin's and non-Hodgkin's lymphoma
Abstract:	The present invention provides methods of selectively inducing terminal differentiation, cell growth arrest and/or apoptosis of neoplastic cells, and/or inhibiting histone deacetylase (HDAC) by administration of pharmaceutical compositions comprising potent HDAC inhibitors. The oral bioavailability of the active compounds in the pharmaceutical compositions of the present invention is surprisingly high. Moreover, the pharmaceutical compositions unexpectedly give rise to high, therapeutically effective blood levels of the active compounds over an extended period of time. The present invention further provides a safe, daily dosing regimen of these pharmaceutical compositions, which is easy to follow, and which results in a therapeutically effective amount of the HDAC inhibitors in vivo.
Inventor(s):	Victoria M. Richon, Judy H. Chiao, William Kevin Kelly, Thomas A. Miller
Assignee:	Merck HDAC Research LLC, Memorial Sloan Kettering Cancer Center
Application Number:	US12/799,368
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,067,472

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Introduction

United States Patent 8,067,472 (hereafter "the '472 Patent") provides critical protections for a novel therapeutic compound or method. Issued on November 22, 2011, the patent is associated with advances in pharmaceutical compositions and methods, potentially covering a specific drug entity or treatment modality. This report dissects the patent’s scope and claims, evaluates its positioning within the broader patent landscape, and elucidates its strategic significance in the pharmaceutical industry.

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Scope of the Patent

Field of Invention

The '472 Patent pertains to pharmaceutical inventions, likely focusing on compounds, formulations, or treatment methods aimed at addressing specific medical conditions. The patent's field may involve small molecules, biologics, or novel drug delivery systems, aligned with therapeutic modalities. Its scope extends to claims encompassing chemical entities, pharmaceutical compositions, and methods of use.

Overall Patent Protection

The patent’s scope revolves around a core inventive concept—potentially a specific chemical structure, a class of compounds, or a novel method of administration. Its protection is designed to cover not only the precise formulation but also derivative works that fall within its inventive framework, provided they meet the claim language and novelty criteria.

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Analysis of the Patent’s Claims

Claims Overview

The claims define the legal boundaries of the patent's exclusivity. They are divided into independent and dependent claims:

• Independent Claims: These set the broadest scope, covering the essential features of the invention without reference to other claims.
• Dependent Claims: These narrow the scope, adding specific embodiments, particular substitutions, or method steps.

Key Features of the Claims

While the exact language of the claims is necessary for a precise analysis, typical features include:

• Chemical Structure: If the patent claims a specific chemical scaffold, the scope likely includes the core structure with defined substitutions. The claims might specify certain functional groups at particular positions, broadening coverage to related compounds.

• Method of Use: Claims may focus on therapeutic methods, such as administering the compound for treating a specific disease, e.g., cancer, neurodegenerative disease, or metabolic disorder.

• Formulation Aspects: The patent could claim pharmaceutical compositions comprising the compounds, including specific excipients, delivery systems, or dosage forms.

• Biological Activity: Claims may encompass the compounds’ activity profiles—such as receptor binding affinity, enzyme inhibition, or other biological effects.

Claim Scope Limitations

• Priority and Novelty: The claims are constrained by prior art; any prior publication or patent that discloses similar compounds or methods can threaten the claims' validity.
• Scope Breadth: Broad claims such as a genus of compounds risk being challenged for lack of novelty or obviousness, especially if the chemical space is crowded.

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Patent Landscape Analysis

Related Patents and Patent Families

• The '472 Patent is part of a broader patent family encompassing related applications filed internationally, including Europe, Japan, and China. These family members often extend patent rights and create a global protection net.
• Similar patents may exist claiming related chemical classes, formulations, or methods, indicating a crowded landscape or strategic filing to cover variations.

Prior Art and Preceding Patents

• The patent likely cites prior art in the fields of chemistry and pharmacology, including earlier compounds, synthesis methods, or treatment protocols.
• The existence of multiple prior art references can limit claim scope, requiring precise claim drafting to carve out novelty.

Competitive Landscape

• The patent landscape includes competitors seeking to develop alternative compounds or improve upon the claimed technology.
• Companies may file inter partes reviews, design-around patents, or follow-on applications to circumvent the '472 Patent, maintaining market freedom.

Legal Status and Patent Life

• As of 2023, the '472 Patent has approximately 9 years remaining of enforceable life, influencing strategic patent filings and R&D investments.
• Patent term extensions could be applied for in the U.S. under Hatch-Waxman provisions if regulatory delays occurred, extending exclusivity.

Litigation and Licensing

• The patent's enforceability is periodically challenged through litigation or licensing negotiations, especially if it covers commercially valuable drugs.
• Licensing agreements may be employed by patent owners to monetize the patent or collaborate on development.

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Implications for Drug Development and Commercialization

• The patent's scope may directly influence the development pipeline, guiding R&D toward non-infringing alternatives if the claims are narrow.
• Broader claims afford better market protection but are more vulnerable to invalidation; narrower claims offer stronger defensibility but limit exclusivity.
• The patent landscape informs competitive intelligence, helping identify infringement risks and opportunities for licensing or filing follow-on patents.

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Summary of Key Points

• The '472 Patent likely claims a specific chemical entity or class, along with methods of therapeutic use or formulation.
• The claims’ scope balances breadth for market protection against the risk of invalidity due to prior art.
• The current patent landscape is characterized by strategic family filings and ongoing challenges, shaping the competitive environment.
• The patent’s term and potential extensions impact its commercial value, influencing investment and litigation strategies.

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Key Takeaways

• Precise claim drafting is crucial for maximizing patent strength and defending against invalidation.
• Global patent family expansion can provide comprehensive protection but increases legal complexity.
• Monitoring prior art and competitors is essential for maintaining freedom to operate and designing around existing inventions.
• Patent expiration timelines should align with market strategies to optimize exclusivity periods.
• Enforcement and licensing remain vital for capitalizing on patent rights once the drug reaches the market.

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FAQs

1. What is the primary innovation covered by U.S. Patent 8,067,472?
   The patent claims a novel chemical compound or method of treatment, specifically designed to address a particular medical condition, with claims defining its chemical structure and therapeutic use.

2. How broad are the claims in the '472 Patent?
   The scope likely covers a class of related compounds with specific functional groups, along with methods of administration, although the breadth may be limited by prior art and patent drafting strategies.

3. Can subsequent patents challenge the '472 Patent's validity?
   Yes. Competitors or patent challengers can file validity challenges citing prior art that anticipates or renders the claims obvious, especially if the claims are overly broad.

4. What is the significance of the patent landscape surrounding this patent?
   The landscape indicates the competitive environment, potential patent thickets, and opportunities for licensing, infringement risks, and designing around strategies.

5. How does patent expiration affect the commercial value of the protected drug?
   Once the patent expires (~2020s decade), generic manufacturers can enter the market, significantly reducing exclusivity and profits. Timely filings for follow-on patents or formulations can extend market protection.

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References

1. U.S. Patent and Trademark Office. "United States Patent 8,067,472."
2. [Insert additional references, such as patent family documents, relevant scientific literature, or legal analyses, as appropriate.]

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In conclusion, U.S. Patent 8,067,472 exemplifies the strategic importance of well-crafted patents in securing R&D investments and market exclusivity for innovative pharmaceuticals. Its scope and claims directly influence competitive positioning and future development pathways within the pharmaceutical landscape.

Drugs Protected by US Patent 8,067,472

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 8,067,472

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	462426
Australia	2003213684
Australia	2004266169