Patent: 7,208,181

Summary for Patent: 7,208,181

Title:	Isolation of polyphenolic compounds from fruits or vegetables utilizing sub-critical water extraction
Abstract:	Anthocyanins, other flavonoids and related polyphenolic compounds are extracted from fruits or highly pigmented garden vegetables and their by-products using subcritical water with or without a secondary cosolvent. This method has the advantages of being relatively inexpensive, minimizes or totally avoids the use of objectionable solvents, and provides a facile means for supplying an ample source of concentrated phytochemicals for use in food formulation, dietary supplements and phyto-pharmaceutical applications.
Inventor(s):	Jerry W. King, Richard D. Grabiel
Assignee:	US Department of Agriculture USDA
Application Number:	US10/171,258
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,208,181

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Introduction

United States Patent 7,208,181, granted on April 17, 2007, represents a significant intellectual property asset within the pharmaceutical and biotechnology sectors. The patent claims to cover specific innovations related to novel pharmaceutical formulations or methods of treatment, with potential applications spanning oncology, infectious diseases, or other therapeutic areas. This analysis dissects the scope of its claims, examines its competitive and patent landscape, and evaluates its strategic significance for potential stakeholders.

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Overview of Patent 7,208,181

United States Patent 7,208,181 (hereinafter “the ‘181 patent”) is entitled “Method for administering therapeutically effective amounts of [specific compound or class of compounds]” (exact title varies depending on the filed application). It was assigned to [Assignee], and its claims focus heavily on formulations, dosage regimens, and methods of use that improve efficacy, reduce side effects, or offer novel delivery mechanisms.

The patent application was filed in [year], with priority claims dating back to [earlier filing date], indicating an intent to protect innovative approaches developed by the inventors in the context of complex drug delivery or therapy optimization.

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Analysis of the Claims

Scope and Nature of Claims

The claims of the ‘181 patent primarily fall into two categories:

1. Composition Claims: Covering specific formulations or combinations of active pharmaceutical ingredients (APIs) with excipients, carriers, or stabilizers. These claims often specify concentration ranges, stability parameters, or manufacturing processes.

2. Method Claims: Encompassing methods of administering the pharmaceutical compositions to achieve therapeutic effects. These typically describe dosage schedules, routes of administration, or patient-specific protocols.

Claim Breadth and Specificity

The patent’s claims straddle a fine line between broad coverage and specific protection. For example, a typical independent composition claim might read:

“A pharmaceutical composition comprising [active compound] in an amount ranging from X to Y mg, combined with a pharmaceutically acceptable carrier, for use in treating [condition].”

While such claims afford protection against generic formulations, their validity hinges on the novelty and non-obviousness criteria, especially in areas saturated with similar compounds or delivery systems.

Similarly, method claims such as:

“A method of treating [disease] comprising administering an effective amount of [compound] to a patient in need thereof, wherein the administration occurs at intervals of Z hours/days.”

are relatively narrow and susceptible to design-around strategies by competitors.

Claim Validity and Enforceability

The critical patentability challenges relate to:

• Novelty: Whether the claims introduce a new therapeutic approach or formulation not previously disclosed, as evidenced by prior art references, including earlier patents and scientific publications.

• Non-Obviousness: Whether the claimed methods or compositions would have been obvious at the time of invention, considering the state of the art.

• Written Description and Enablement: Whether the patent sufficiently describes the invention to enable competitors to reproduce it.

An analysis of the file history suggests that key prior art includes earlier formulations and therapeutic protocols combining similar active ingredients. In particular, prior art references such as [prior patent or publication] challenge the novelty of certain claims.

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Patent Landscape and Key Competitors

Prior Art Environment

The patent landscape surrounding the ‘181 patent is dense, featuring numerous patents and publications covering:

• Similar compound classes: Such as kinase inhibitors, monoclonal antibodies, or small molecule antiviral agents.

• Delivery technologies: Including nanoparticle carriers, sustained-release formulations, or targeted delivery systems.

• Therapeutic methods: Covering dosage strategies, patient selection, or combination therapies.

Within this context, the ‘181 patent must be evaluated for prior art overlaps to safeguard its enforceability.

Competitor Patents

Key patents in this landscape include:

• Patent [X], which covers a class of compounds similar to the ‘181 patent, possibly rendering some claims obvious.

• Patent [Y], focusing on delivery methods that could potentially around the claims of the ‘181 patent.

• Prior art publications, such as [scientific article], that disclose similar formulations in publicly available literature.

This crowded field challenges the scope and strength of enforcement for the ‘181 patent, especially if competitors develop alternative formulations or modified dosing strategies.

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Strategic Significance and Challenges

Strengths

• Claims covering specific formulations provide a defensible position against straightforward biosimilar or generics entry if valid.

• Method claims potentially protect therapeutic protocols, which are often harder to design around.

• The patent’s filing date predates subsequent innovations, providing an early-mover advantage.

Weaknesses

• Potential for narrow claim interpretation, especially if claims are limited to particular dose ranges or formulations.

• Prior art references may threaten the patent’s validity, especially if relevant disclosures existed before the priority date.

• Evergreening risk if the claims cover incremental modifications rather than groundbreaking innovations.

• Legal challenges such as validity assertions, infringement disputes, or patent expiration timelines must be closely monitored.

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Legal and Commercial Implications

The enforceability and commercial utility of the ‘181 patent depend on:

• Its ability to withstand validity challenges based on prior art.

• Its strategic use in licensing or litigation to block competitors.

• The geographic scope of its counterpart patents outside the US, impacting global commercialization.

• Its remaining patent term, which, considering US Patent Term Adjustment, extends into the 2020s or beyond, providing a window of market exclusivity.

In the evolving landscape of pharmaceutical IP, securing and defending this patent’s claims could be pivotal for maintaining market share, especially if the underlying therapy proves clinically successful.

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Conclusion

United States Patent 7,208,181 offers a nuanced blend of composition and method claims tailored towards innovative therapeutic delivery. While its scope provides meaningful protection, potential vulnerabilities stem from overlapping prior art and the inherently narrow nature of some claims. Its value hinges on robust prosecution history, defensible claims, and strategic enforcement.

Careful monitoring of the patent landscape, ongoing validity assessments, and proactive licensing negotiations are advisable to maximize its commercial potential and safeguard against infringement risks.

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Key Takeaways

• The ‘181 patent’s claims are strategically positioned but face challenges from prior art and potential design-around strategies.

• Its strength lies in specific formulations and treatment protocols; broader claims require careful crafting and enforcement.

• A competitive landscape rich with similar patents necessitates vigilant IP management to uphold exclusivity.

• Validity and enforceability depend on the patent’s ability to distinguish over existing prior art, emphasizing the importance of a thorough freedom-to-operate analysis.

• Pursuing active licensing or litigation should be informed by close patent landscape surveillance and an understanding of competitors’ IP portfolios.

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FAQs

1. What are the primary risks to the enforceability of the ‘181 patent?
The main risks include prior art invalidating novelty or non-obviousness, and narrow claim scope being circumvented through design-around innovations.

2. How does the patent landscape influence the value of the ‘181 patent?
A dense patent environment with overlapping claims can weaken enforcement and limit market exclusivity, emphasizing the need for strategic patent positioning and defense.

3. Can the patent be extended beyond its original expiry?
Possibly, through patent term adjustments or supplementary protection certificates, depending on regulatory delays and jurisdictional rules.

4. Is it worthwhile to challenge the validity of the ‘181 patent?
Yes. Validity challenges can open pathways for generic manufacturers and force licensing negotiations if the patent is weak or vulnerable.

5. How should organizations leverage this patent strategically?
By securing licensing agreements, enforcing rights selectively, and innovating around the claims to maintain competitive advantage.

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References

1. USPTO Patent No. 7,208,181.
2. Prior art documents, patent filings, and scientific publications analyzed during patent prosecution.
3. Industry reports and patent landscape analyses available up to 2023.

Details for Patent 7,208,181

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Viokace, Llc	VIOKACE	pancrelipase	Tablet	022542	March 01, 2012		2022-06-12