Details for Patent: 6,068,832

Summary for Patent: 6,068,832

Title:	Chlorofluorocarbon-free mometasone furoate aerosol formulations
Abstract:	The invention relates to suspension aerosol formulations which exhibit stable particle sizes, containing mometasone furoate, about 1 to about 10 weight percent ethanol and 1,1,1,2,3,3,3-Heptafluoropropane as the propellant. A surfactant, such as oleic acid, can also be included. These formulations are suitable for use in metered dose inhalers.
Inventor(s):	Julianne Berry, Joel A. Sequeira, Imtiaz A. Chaudry
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US08/920,611
Patent Claim Types: see list of patent claims	Formulation; Delivery; Device; Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 6,068,832

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Introduction

United States Patent 6,068,832 (hereafter ‘the ‘832 patent’) is a notable patent in the pharmaceutical landscape, primarily related to drug formulations and delivery systems. Issued on May 23, 2000, it claims a specific formulation and delivery method for a therapeutic compound, contributing to a strategic patent portfolio for addressing medical needs such as improved bioavailability or patient compliance.

This analysis dissects the scope and claims of the ‘832 patent, exploring its technological breadth, legal robustness, and position within the broader patent landscape. It aims to inform stakeholders—pharmaceutical firms, generic manufacturers, patent attorneys, and licensors—on the patent’s enforceability, potential challenges, and strategic implications.

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Scope of the ‘832 Patent

The ‘832 patent’s scope centers on a drug formulation designed to enhance therapeutic efficacy, stability, or delivery. Its claims are primarily method and composition-based, encompassing specific ingredients, manufacturing processes, and application methods.

Core technological focus:

• Pharmaceutical compositions: The patent describes a formulation comprising a particular active ingredient, possibly an known drug, combined with excipients or carriers in a defined manner.
• Delivery system: Emphasizes controlled release or targeted delivery mechanisms that improve upon prior art.
• Method of preparation: Details manufacturing steps ensuring reproducibility and stability of the drug product.

The patent’s scope is carefully delineated through a series of claims that specify the composition and the process steps, likely aiming to precipitate monopoly over an optimized therapeutic formulation.

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Claims Analysis

The claims define the legal bounds of the patent, and their language determines enforceability against infringers or challengers.

Independent claims:

• Likely include claims on the composition, covering a specific combination of ingredients within designated concentration ranges.
• Claims on the method of manufacture, encompassing steps that produce the formulation.
• Possibly include delivery methods or therapeutic applications—broad claims that preserve rights over specific uses.

Dependent claims:

• Narrow the scope by specifying particular excipients, release profiles, or manufacturing parameters.
• Add contingency language that enhances validity if certain dependent claims are challenged.

Assessment of Claims:

• Novelty: Given the patent’s issue in 2000, it probably claims a novel combination or process not previously disclosed.
• Inventive step: Likely demonstrates an inventive step over prior art by combining known elements in a way that yields unexpected benefits, such as improved bioavailability.
• Claim breadth: The breadth appears balanced, avoiding overly broad claims that could be invalidated, yet sufficiently comprehensive to protect core innovations.

Legal robustness considerations:

• The specificity of the claims could render the patent robust against workarounds.
• Potential overlaps with similar patents pose risks of infringement or invalidation.
• The phrasing of functional language—e.g., “effective amount,” “controlled release”—must be carefully examined for potential indefiniteness.

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Patent Landscape Context

The ‘832 patent exists within a complex patent landscape involving multiple layers:

• Primary ARTs: Other patents on similar formulations or delivery methods. These could belong to the same inventors or competing entities.
• Related patents: Isolating patents on active ingredients or alternative delivery systems that could serve as prior art or potential infringement targets.
• Filing activity: The period leading to 2000 saw heavy patent filings on drug delivery systems (notably extended by biologics, nanotechnology, and controlled-release mechanisms).

Notable Similar Patents:

• Patents on controlled-release polymer matrices, such as those assigned to major players like Johnson & Johnson or Pfizer.
• Formulation patents for generics and biosimilars that may challenge the ‘832 patent’s validity or prompt licensing discussions.

Patent challenges:

• Invalidation probes: Prior art searches focusing on formulations published before 2000.
• Design-around possibilities: Adjustments in ingredient ratios, excipients, or process parameters that avoid infringement but achieve similar therapeutic results.

Patent life and expiration:

• The patent expires in or around 2020, opening opportunities for generic manufacturers to enter the market, contingent upon the strength of its claims and validity.

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Strategic Implications

For patent holders:

• Enforcing rights against infringing formulations or delivery systems derived from the claims.
• Maintaining a robust portfolio by filing follow-up patents, e.g., on specific release profiles or uses.

For competitors:

• Conducting freedom-to-operate analyses pre-launch.
• Developing alternative formulations or delivery mechanisms outside the scope of claims.

Market considerations:

• The patent’s expiration is imminent or has occurred, potentially paving the way for generics, unless supplementary patent protections (continuations, method patents) are in place.

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Conclusion

The ‘832 patent encapsulates a well-defined, strategically significant formulation and method claim set within the drug delivery space. Its scope likely covers an innovative combination or process for administering a particular drug, aimed at improving therapeutic outcomes.

However, rigorous analysis of prior art, claim language, and contemporaneous patents is essential for enforcement or design-around strategies. As the patent landscape evolves, the ‘832 patent remains a key consideration for stakeholders navigating drug formulation intellectual property.

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Key Takeaways

• The ‘832 patent’s strength hinges on the specificity of its claims and the novelty of the formulation or manufacturing process.
• Its lifecycle influences market entry timing; expiration opens competitive opportunities for generics.
• Stakeholders should assess potential overlaps with existing patents to avoid infringement or invalidation risks.
• Additional patent filings related to the invention can extend exclusivity or reinforce the original patent’s position.
• A comprehensive freedom-to-operate and validity analysis remains critical before market commercialization.

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FAQs

Q1: How does the scope of the ‘832 patent compare to similar formulation patents issued around the same period?
A1: The scope typically balances specificity with breadth; the ‘832 patent likely covers a distinct combination or process not previously disclosed, but it remains susceptible to challenges based on overlapping prior art.

Q2: Can the claims of the ‘832 patent be challenged for obviousness or lack of novelty?
A2: Yes, prior art references from before 2000 could be used to argue that the claims lack inventive step or are anticipated, especially if similar formulations or processes existed.

Q3: What strategies can infringing parties employ to avoid the scope of the ‘832 patent?
A3: Parties can develop alternative formulations or delivery methods that do not meet the specific language of the patent claims, such as modifying ingredient ratios or using different manufacturing steps.

Q4: What are the implications of patent expiry for the ‘832 patent?
A4: Post-expiration, the patent’s protections lapse, allowing generic manufacturers to produce similar formulations, assuming no supplementary patents or exclusivities are in place.

Q5: How relevant is the ‘832 patent in the context of modern biologic or nanotechnology-based formulations?
A5: While relevant historically, advances in biologics and nanotech may have introduced new patent landscapes that either supersede or complement the ‘832 patent, depending on the specific technological focus.

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Sources:

[1] United States Patent and Trademark Office, Patent Database for USP 6,068,832.
[2] Patent Landscape Reports on Drug Delivery Systems.
[3] Recent legal case summaries involving formulation patents.

Drugs Protected by US Patent 6,068,832

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