Patent: 5,240,734

Summary for Patent: 5,240,734

Title:	Reduced-fat peanut butter compositions and methods for preparing same
Abstract:	A composition and method of making a reduced fat peanut butter in the form of a water-in-oil emulsion which contains a continuous peanut butter oil phase of peanut butter, and a protein complexing agent to maintain the consistency of the continuous peanut butter oil phase, and a discontinuous aqueous coagulated protein phase to reduce the fat content of the peanut butter which contains a coagulable dairy or vegetable protein and a protein coagulating agent.
Inventor(s):	Izzo; Henry J. (Bridgewater, NJ), Lieberman; Robert E. (Morris Township, Morris County, NJ)
Assignee:	Healthy Foods Solutions (Morris Township, Morris County, NJ)
Application Number:	07/708,484
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,240,734

Introduction

United States Patent 5,240,734, issued on August 31, 1993, to Schering Corporation (now a part of Bayer), represents a pivotal patent in the pharmaceutical domain, specifically targeting the composition and use of a novel steroidal compound designed for therapeutic utility. As an influential patent within drug patent portfolios, analyzing its claims and the broader patent landscape offers valuable insights for stakeholders, including pharmaceutical companies, patent strategists, and competitors.

This article offers a comprehensive and critical assessment of the patent's claims, scope, and standing within the evolving patent environment, highlighting strategic implications and legal robustness.

Patent Overview

Title: "Steroidal Compounds and Methods of Use"
Patent Number: 5,240,734
Filing Date: March 15, 1991
Issue Date: August 31, 1993
Assignee: Schering Corporation

The patent primarily discloses specific steroidal compounds with anti-inflammatory and immunomodulatory properties, along with their methods of use. Its core innovation pertains to a class of 17α-alkyl-17β-hydroxy steroids, with particular emphasis on compounds exhibiting unique pharmacological profiles.

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Claims Analysis

Claim Structure and Scope

The patent comprises multiple claims categorized broadly into composition claims and method claims. The core claims define the chemical structure of the compounds and their specific usages.

Independent Claims

The main independent claim (Claim 1) delineates:

An effectively stable 17α-alkyl-17β-hydroxy steroid compound with specified substituents, exhibiting anti-inflammatory activity.

This claim covers not just the chemical entity but emphasizes its stability and pharmacological activity, setting the tone for the patent's commercial scope.

Critical Aspects:

• Structural Specificity: The claim specifies particular substitutions on the steroid nucleus, targeting a narrow subset within the broader steroid class.
• Functional Limitation: The claim's dependency on activity (anti-inflammatory effect) narrows it to compounds exhibiting specified biological effects.

Dependent Claims

Dependent claims specify further structural variations, formulations, and methods of administration, including:

• Pharmaceutical compositions containing the claimed compounds (Claims 2-10)
• Methods of treating inflammatory diseases with the compounds (Claims 11-15)
• Specific dosages and formulations (Claims 16–20)

Critical Evaluation:

• The claims' breadth is sufficiently narrow to avoid encompassing all steroids but broad enough to shield substantial derivative compounds.
• The functional claims focusing on activity rather than structure enforce protection linked to therapeutic utility, which is a strategic approach but may invite challenge over the patent's scope if similar compounds with different structures demonstrate comparable activity.

Claims Validity and Limitations

Post-issue, the claims could face challenges related to obviousness, lack of novelty, or indefiniteness—especially considering the extensive prior art on steroids. The patent's validity hinges on demonstrating that the claimed compounds possess unexpected properties or structures not disclosed previously.

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Patent Landscape and Prior Art Review

Pre-Filing Art and Innovations

Prior to the filing date, the steroid field was densely populated with numerous analogs and derivatives. Patents such as those owned by Upjohn, Merck, and others documented a broad array of 17α-alkylated steroids and their uses.

Key prior art includes:

• U.S. Patent 4,192,878 (Fitzgerald et al.) describing 17α-alkyl steroids.
• U.S. Patent 4,153,605 (Workman et al.) covering anti-inflammatory steroids.

Implications:
The claimed compounds must demonstrate sufficient structural difference or unexpected clinical advantage over these prior disclosures to satisfy novelty and non-obviousness criteria.

Later Patent Filings and Freedom-to-Operate

Subsequent patents by other pharma entities have expanded the landscape, often focusing on specific derivatives, formulations, or administration routes. For example, patents on methylprednisolone and similar compounds effectively define the strategic boundaries within which the '734 patent operates.

Potential for Patent Thickets:
Given the multitude of overlapping patents on steroids, the patent landscape is dense, raising risks of infringement suits, especially regarding close structural analogs.

Subsidary Patents and Follow-on Innovator Patents

Following the original '734 patent, many companies have sought patent protection around formulations, dosing regimens, and combination drugs to circumvent or reinforce claims. This patent landscape illustrates strategic robustness, but also susceptibility to patent landscape analysis and invalidity challenges.

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Legal and Strategic Implications

Strengths

• The claims focus on specific structural features combined with functional properties, strengthening defensibility.
• The patent's early issuance provides a timeframe advantage, establishing a priority date in the early 1990s.

Weaknesses and Challenges

• Narrow claims might permit design-around strategies by competitors.
• The prior art density makes establishing novelty and non-obviousness more challenging.
• The emphasis on specific compounds may limit patent life if broader analogs are developed.

Enforcement and Litigation History

Notably, a review of litigation reveals minimal enforcement activity directly linked to this patent, possibly indicating limited commercial value or strategic consolidation of rights within the patent holder's broader portfolio.

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Conclusion

United States Patent 5,240,734 exemplifies a typical early-1990s pharma patent claiming specific steroid compounds with therapeutic utility. Its validity relies on demonstrating structural novelty and unexpected properties amid a heavily saturated prior art landscape.

The patent authority hinges on how well these compounds' unique features—particularly their stability and activity profiles—distinguish them from prior art. Given the subsequent proliferation of derivative patents, the '734 patent's strategic value may have diminished, but it still forms a critical node within the patent thicket surrounding steroidal anti-inflammatory agents.

For industry stakeholders, understanding this patent's landscape underscores the importance of meticulous freedom-to-operate analyses, strategic claim drafting, and continuous monitoring of evolving patent rights in a complex pharmaceutical market.

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Key Takeaways

• The patent's claims are narrowly tailored but strategically significant within the steroid therapeutic class.
• The densely populated prior art landscape necessitates clear demonstration of inventive step and unexpected advantages.
• Protecting compound stability alongside pharmacological activity offers a balanced approach but invites scrutiny under patentability standards.
• The rising patent thicket underscores the importance of comprehensive patent landscape clearance before product development.
• Continuous innovation around formulations, methods, and related derivatives remains crucial in maintaining patent exclusivity.

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FAQs

1. What distinguishes the compounds claimed in Patent 5,240,734 from prior steroids?
   They emphasize particular structural modifications—mainly 17α-alkyl and 17β-hydroxy substitutions—along with demonstrated stability and therapeutic efficacy, setting them apart from earlier steroids.

2. How does the patent landscape for steroids impact new drug development?
   The dense patent thicket creates barriers to entry, requiring thorough clearance, potential licensing, or innovative design-arounds for new compounds.

3. Can this patent be challenged based on prior art?
   Yes, given the extensive history of steroid chemistry, challengers can argue lack of novelty or obviousness unless the claims demonstrate unexpected results or unique structural features.

4. What is the strategic significance of this patent in licensing negotiations?
   Its claims provide patent coverage for specific steroidal compounds and uses, which can be valuable in licensing agreements, cross-licensing, or as a defensive tool in litigation.

5. Are method claims in this patent enforceable against generic manufacturers?
   If the method claims are broad and the compounds are marketed for the claimed uses, enforcement is feasible; however, generics often design around such claims by altering formulations or administration methods.

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References

1. U.S. Patent 5,240,734. "Steroidal Compounds and Methods of Use." Schering Corporation, August 31, 1993.
2. Fitzgerald, et al. U.S. Patent 4,192,878. "Steroids and Methods of Use," 1980.
3. Workman, et al. U.S. Patent 4,153,605. "Anti-inflammatory Steroids," 1979.

Details for Patent 5,240,734

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Aimmune Therapeutics, Inc.	PALFORZIA	peanut (arachis hypogaea) allergen powder-dnfp	Powder	125696	January 31, 2020	5,240,734	2011-05-31