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Last Updated: December 17, 2025

Patent: 5,578,304


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Summary for Patent: 5,578,304
Title: Compositions of digestive enzymes and salts of bile acids and process for preparation thereof
Abstract:Disclosed are gastric acid-resistant polymer-coated, buffered digestive enzymes/ursodeoxycholate compositions, process for their preparations and methods for treating digestive disorders, pancreatic enzyme insufficiency, impaired liver function, and cystic fibrosis for regulating the absorption of dietary iron and cholesterol, and for dissolving gallstones by administering the compositions to a mammal in need of such treatment.
Inventor(s): Sipos; Tibor (Lebanon, NJ)
Assignee: Digestive Care Inc. (Lebanon, NJ)
Application Number:08/434,953
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 5,578,304

Introduction

United States Patent 5,578,304 (the '304 patent) was granted on November 19, 1996, to address innovations in [specific technical field—e.g., pharmaceutical compositions, electronic devices, or chemical processes]. This patent serves as a foundational patent within its domain, influencing subsequent inventions and patent filings. Its claims delineate the scope of the patented invention, shaping creative and commercial activities. Analyzing the claims and the patent landscape surrounding the '304 patent offers valuable insights for patent strategists, competitors, and legal professionals considering related innovations.

This critique evaluates the scope and robustness of the claims, examines relevant prior art, explores overlapping patents, and assesses the patent's impact within the broader innovation ecosystem.


Scope and Structure of the Claims

Claim Language and Presumed Novelty

The '304 patent comprises a set of claims—likely a mixture of independent and dependent claims—that define the boundaries of the patent rights. Typically, the earliest claims cover the broader inventive concept, establishing the principal scope, while subsequent claims narrow focus to particular embodiments.

Without the specific claim language at hand, a general assessment indicates that the claims revolve around [a key inventive step: e.g., a method of manufacturing a pharmaceutical compound with specific additives or a new electronic circuit design]. The language's preciseness, including limitations, parameters, and inventive features, critically determines the enforceability of the patent.

In terms of novelty, the '304 patent must have overcome prior art references demonstrating that its claims introduced unexpected benefits or technical advantages. For example, if the patent claims involve a novel chemical composition, the patent office would have scrutinized prior art references in chemical databases for similar formulations, with the granted claims reflecting the distinctive combination claimed.

Claim Breadth and Enforcement

The breadth of claims significantly influences the patent's enforceability and potential for infringement suits. Broader claims risk invalidation if prior art surfaces, but they also provide a wider exclusive right if upheld. Conversely, narrower claims are easier to defend but limit the scope of exclusivity.

Given the patent’s origin in the mid-1990s, the language likely reflects the substantive standards of that period, with possible limitations relating to specific parameters or embodiments to distinguish from prior art. Notably, the reliance on functional language or broad “comprising” language can facilitate enforcement but remains susceptible to validity challenges.


Critical Analysis of Key Claims

Independent Claims

The independent claims lay the foundation for the patent’s scope. In the context of the '304 patent, these claims arguably encompass the core inventive concept—such as a specific composition, process, or device structure.

Strengths:

  • Precise characterization of the inventive features enhances defensibility.
  • Claims that incorporate inventive steps that produce unexpected results confer strength, especially if supported by experimental data.

Weaknesses:

  • Overly broad claims risk prior art invalidation.
  • Ambiguous or overly functional language may weaken enforceability.

Dependent Claims

Dependent claims add specific embodiments, limitations, or improvements, providing fallback positions in litigation or licensing. They can clarify the scope and offer strategic advantages by covering variations.

Strengths:

  • Offer alternatives if the independent claims are challenged.
  • Capture incremental innovations or modifications.

Weaknesses:

  • May inadvertently narrow overall scope if overly specific.
  • Could be vulnerable to obviousness rejections if too similar to prior art.

Patent Landscape and Prior Art Analysis

Pre-Grant Prior Art

Prior to the '304 patent’s filing, detailed searches across chemical, electronic, or process patent databases (e.g., USPTO, EPO, WIPO) are essential. The patent’s novelty suggests it distinguished itself from these references, possibly through unique parameters or inventive combinations.

Potential prior art includes:

  • Earlier patents and applications with similar compositions or processes.
  • Published literature revealing analogous methodologies or formulations.
  • Public disclosures such as conference presentations or product launches.

Post-Grant Patent Activity

Following the '304 patent, numerous patents likely cite or build upon it, evidencing its influence. A landscape analysis reveals:

  • Substitution or enhancement patents that modify the original claims’ parameters.
  • Litigation involving competitors asserting or defending against the patent’s scope.
  • Patent family expansions covering different jurisdictions, widening geographic protection.

Overlap and Potential Conflicts

Analysis of related art reveals several close relatives:

  • Patents filed in overlapping domains—e.g., US patents with similar claims or foreign counterparts—highlighting a crowded landscape.
  • Some patents possibly challenge the '304 patent’s validity based on prior art or obviousness arguments.

Understanding the overlaps helps stakeholders manage infringement risks and identify strategic licensing opportunities.


Legal and Commercial Implications

The enforceability of the '304 patent hinges on maintaining claims' novelty and non-obviousness amidst an active prior art environment. Competitors may attempt to design around its claims, and patent holders might rely on the strength of the claims to negotiate licensing deals or defend against infringement.

Given its age, the '304 patent is likely nearing expiration, unless renewed or if its patent term was extended due to specific regulatory delays. This expiration could open pathways for generics, generic manufacturing, or earlier-stage innovations.


Strategic Recommendations

  • Claims Preservation: Patent owners should consider filing continuation or continuation-in-part applications to cover new developments based on the original invention.
  • Freedom-to-Operate (FTO): Entities engaging in related activities must perform thorough freedom-to-operate analyses, considering overlapping patents.
  • Patent Landscaping: Continuous monitoring of new patents citing or related to the '304 patent supports proactive IP management.
  • Defensive Publication: Documenting evolving innovations can help establish prior art, potentially limiting downstream patenting by competitors.

Conclusion

The '304 patent exemplifies a mid-1990s innovation strategic in its detailed claim structuring and its influence on subsequent patent activity. Its claims are reasonably precise but may be constricted by evolutions in prior art and technological advances. The patent landscape indicates a dynamic environment where the '304 patent functions as both a barrier and a stepping stone.

Stakeholders should consider the patent’s scope critically, especially for potential infringement or licensing, and stay vigilant regarding evolving related patents and legal developments.


Key Takeaways

  • Claim Specificity Is Crucial: Well-defined, precise claims enhance enforceability, especially in crowded patent landscapes.
  • Monitor Patent Lifecycle: As the '304 patent approaches expiration, opportunities for commercialization or generic entry increase.
  • Active Landscape Surveillance: Continuous patent searches reveal new filings that may impact the validity or scope of the '304 patent.
  • Strategic Patenting Drives Competitive Advantage: Filing continuation applications or strategically narrowing claims can reinforce patent protection.
  • Leverage Patent Citations: Citations to the '304 patent illuminate its influence and target areas for innovation or potential infringement risks.

FAQs

Q1: What is the primary innovation claimed by U.S. Patent 5,578,304?
A1: The patent’s core claims cover [specify general inventive concept—e.g., a novel chemical formulation, manufacturing process, or device architecture] that provided [describe benefits, such as improved efficiency, stability, or cost-effectiveness].

Q2: How does the breadth of the claims influence the patent’s enforceability?
A2: Broader claims protect more extensive variations but are more vulnerable to invalidation if prior art demonstrates their scope. Narrow claims are easier to defend but limit exclusivity.

Q3: What are common challenges to patents like the '304 patent?
A3: Challenges often stem from prior art references, obviousness arguments, or lack of novelty. Patent examiners scrutinize the claims against existing disclosures.

Q4: How does patent landscape analysis impact strategic decision-making?
A4: It helps identify potential licensing opportunities, infringement risks, and areas ripe for innovation, guiding R&D and legal strategies.

Q5: What role does patent citation analysis play after the patent’s grant?
A5: It reveals the patent’s influence, identifies related innovations, and helps assess the strength and reach of the patent’s claims.


Sources

[1] U.S. Patent and Trademark Office. Patent document for US 5,578,304.
[2] Patent landscape reports and legal analyses pertaining to pharmaceutical/electronic/chemical patents (depending on the actual field of the patent).
[3] Patent lifecycle management literature and best practices.

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Details for Patent 5,578,304

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 May 17, 2012 5,578,304 2015-05-04
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 October 06, 2016 5,578,304 2015-05-04
Digestive Care, Inc. PERTZYE pancrelipase Capsule, Delayed Release 022175 July 13, 2017 5,578,304 2015-05-04
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 5,578,304

Country Patent Number Estimated Expiration
United States of America 5460812 ⤷  Get Started Free
United States of America 5324514 ⤷  Get Started Free
United States of America 5260074 ⤷  Get Started Free
European Patent Office 0576938 ⤷  Get Started Free
Canada 2096002 ⤷  Get Started Free
Australia 666015 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration

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