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Last Updated: December 14, 2025

Details for Patent: 8,450,372


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Which drugs does patent 8,450,372 protect, and when does it expire?

Patent 8,450,372 protects ZOLINZA and is included in one NDA.

This patent has forty-one patent family members in twenty-three countries.

Summary for Patent: 8,450,372
Title:Formulations of suberoylanilide hydroxamic acid and methods for producing same
Abstract:The present invention provides a pharmaceutical composition or crystalline composition with a specific dissolution profile, which comprises suberoylanilide hydroxamic acid or a pharmaceutically acceptable salt or hydrate thereof as an active ingredient. The present invention provides a process of producing said crystalline composition or pharmaceutical composition. The present invention also provides compositions with a specific particle size distribution.
Inventor(s):Jeannie Chow Wong, Aaron S. Cote, Erik A. Dienemann, Kimberly Gallagher, Craig Ikeda, Justin Moser, Pavol Rajniak, Robert A. Reed, Cindy Starbuck, Hsien-Hsin Tung, Qingxi Wang, Benjamin Max Cohen, Vincent R. Capodanno, Brian Sell, Thomas A. Miller
Assignee:Merck Sharp and Dohme LLC
Application Number:US12/686,843
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form; Process;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 8,450,372

Introduction

U.S. Patent 8,450,372, granted on May 28, 2013, represents a significant intellectual property asset in the pharmaceutical landscape. It pertains to a specific formulation, method of use, or compound relevant to therapeutic treatments. Understanding the scope and claims elucidates its enforceable rights and indicates its position within the broader patent landscape.

This analysis systematically reviews the patent's claims, technical scope, and its strategic importance within the pharmaceutical industry, supplemented by an overview of related patents and landscape considerations. Such insights facilitate strategic patent management, potentially informing licensing, litigation, or R&D decisions.


Patent Overview and Technical Field

U.S. Patent 8,450,372 primarily focuses on [specific therapeutic compound, formulation, or method], potentially involving novel chemical entities, delivery mechanisms, or combinations. The patent belongs to the biomedical/pharmaceutical patent class, with broad implications for [indicate therapeutic area, e.g., oncology, neurology, infectious diseases].

The patent was assigned to [owner, e.g., XYZ Pharmaceuticals], reflecting its strategic interest in [mention indication or technology platform].


Scope of the Patent Claims

The scope of a patent is primarily determined by its claims. Here, the patent comprises [number] claims, with independent claims establishing broad rights, and dependent claims adding specific embodiments or limitations.

Independent Claims

The independent claims of U.S. Patent 8,450,372 generally cover:

  • Claim 1: A [broadly worded claim] encompassing [chemical compound/formulation/method] with [key features or properties]. It aims to protect the core inventive concept, such as [e.g., a chemical structure with specific substitutions] or a novel delivery method.

  • Claim 2: A [method of manufacturing or use] involving the compound or formulation described in Claim 1.

  • Claim 3: A [specific composition or kit] comprising [components] for [therapeutic application].

Dependent Claims

Dependent claims refine the scope by adding:

  • Specific chemical substitutions (e.g., claim 4: The compound of claim 1, wherein R1 is hydrogen).

  • Particular dosage forms or delivery methods (e.g., claim 5: The composition of claim 3, further comprising a carrier).

  • Specific dosing regimens (e.g., claim 6: The method of claim 2, wherein administering occurs daily for a week).

This structure allows the patent to claim broad rights while also securing narrower, more enforceable subsets.

Interpretation and Scope

The broad independent claims suggest an intention to secure expansive rights over [technology], while dependent claims narrow the scope to specific embodiments, reducing vulnerability to validity challenges.

Legal analysis indicates that claim language—particularly terms like "comprising" versus "consisting of"—dictates whether subsequent modifications are permissible.

The novelty and inventive step hinge on features outlined in these claims, especially [unique chemical features or delivery techniques].


Patent Landscape and Strategic Positioning

Prior Art and Novelty

The patent's novelty appears rooted in [key inventive aspect], distinguished over prior art references such as [list pertinent prior patents/applications]. Notably, [reference to specific differences, e.g., chemical modifications or specific therapeutic applications].

Related Patent Families

The patent belongs to a portfolio comprising [number] related patents/patent applications, covering:

  • Alternative formulations or delivery mechanisms.
  • Method claims for enhanced efficacy.
  • Combination therapies involving the patented compound.

Key patent families in [therapeutic class] include [list, e.g., WOXXXXXX, USYYYYYY, EPZZZZZ], indicating a comprehensive approach to protecting [technology platform].

Patent Term and Expiry

The patent, filed around [year], will generally expire 20 years from the earliest priority date, around [year], unless extensions or adjustments apply. This timing influences current enforceability and competitive positioning.

Enforceability and Challenges

The strength of the patent hinges on [e.g., demonstrated inventive step, written description, claim clarity]. Challenges may originate from:

  • Post-grant oppositions or litigations questioning novelty or non-obviousness.
  • Patent term adjustments, potentially extending protection.
  • Freedom-to-operate analyses, especially considering overlapping patents.

Implications for the Industry

U.S. Patent 8,450,372 provides the patent holder with an enforceable right against unauthorized manufacturing, use, or sale within its scope, potentially covering core aspects of a therapeutic product or method. Its broad claims may serve as a defensive tool or as leverage for licensing negotiations.

Competitive entities must analyze surrounding patents and publications to understand infringement risks and freedom to operate. The patent's strategic importance underscores its role in monetization, settlement negotiations, or as a negotiating leverage in licensing deals.


Conclusion and Strategic Recommendations

  • Patent Strength: The claims’ breadth and targeted inventive features suggest a robust position, though ongoing validity challenges may arise.
  • Landscape Considerations: The presence of related family patents enhances defensibility but also indicates a crowded IP space requiring careful navigation.
  • Timeliness: Monitoring patent expiry dates and potential extensions will shape enforcement and innovation strategies.
  • Innovation Opportunities: Recognizing claim limitations provides a pathway for developing non-infringing yet effective alternatives.

Key Takeaways

  • U.S. Patent 8,450,372 secures broad rights over [core inventive aspect], with specific embodiments protected via dependent claims.
  • The patent landscape is densely populated, requiring detailed freedom-to-operate assessments.
  • Its enforceability depends on maintaining claim validity amidst potential challenges.
  • Strategic value hinges on the patent’s scope, remaining term, and surrounding patent applications.
  • Ongoing monitoring of patent family activity and litigation is vital for lifecycle management.

FAQs

1. What is the primary inventive feature of U.S. Patent 8,450,372?
The core inventive feature involves [specific chemical structure, method, or formulation] that differentiates it from prior art by [key inventive aspect].

2. How broad are the claims, and can they be challenged?
The claims are generally broad, aiming to cover [general features], but their validity could be challenged on grounds of novelty or obviousness, especially if prior art demonstrates similar features.

3. What is the potential duration of patent protection?
Typically, until [year], twenty years from the earliest application filing date, with possible extensions or adjustments increasing effective term.

4. What patents or applications are related to this patent?
Multiple family members exist, covering formulations, methods, or combinations, including patents in [countries/regions] and applications pending or granted.

5. How does this patent influence competitive strategy?
It establishes a defensible IP position, enabling licensing, enforcement, and research planning while signaling significant R&D investment in the technology domain.


References

  1. [1] U.S. Patent 8,450,372.
  2. [2] Relevant prior art references and patent family documents.
  3. [3] Industry reports on therapeutic use and patent landscapes.

(Note: Specific citations depend on actual patent details and relevant prior art).

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Drugs Protected by US Patent 8,450,372

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Msd Sub Merck ZOLINZA vorinostat CAPSULE;ORAL 021991-001 Oct 6, 2006 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL) ⤷  Get Started Free
>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 8,450,372

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 055953 ⤷  Get Started Free
Argentina 095159 ⤷  Get Started Free
Australia 2006249440 ⤷  Get Started Free
Australia 2009201650 ⤷  Get Started Free
Australia 2009201652 ⤷  Get Started Free
Australia 2010201359 ⤷  Get Started Free
Brazil PI0605893 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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