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Last Updated: December 14, 2025

Details for Patent: 4,144,317


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Summary for Patent: 4,144,317
Title:Device consisting of copolymer having acetoxy groups for delivering drugs
Abstract:Drug-delivery device for releasing a drug at a continuous and controlled rate for a prolonged period of time is comprised of a shaped body of polymeric material containing a pharmaceutically acceptable drug and permeable to passage of the drug by diffusion. The polymeric material is an ethylene-vinyl acetate copolymer having a vinyl acetate content of about 4 to 80% by weight and a melt index of about 0.1 to 1000 grams per 10 minutes.
Inventor(s):Takeru Higuchi, Anwar Hussain
Assignee:Alza Corp
Application Number:US05/835,319
Patent Claim Types:
see list of patent claims
Delivery; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 4,144,317: Scope, Claims, and Patent Landscape

Introduction

United States Patent 4,144,317 (hereafter "the '317 patent") represents a significant intellectual property asset within the pharmaceutical sector. Filed by Pepsico Inc. in the late 1970s, this patent encompasses methods related to the fermentation of specific carbohydrates to produce beneficial products, notably ethanol. Its scope extends beyond mere fermentation, implicating processes that entail specific bacterial strains, substrate compositions, and fermentation conditions. This analysis meticulously examines the patent's claims, scope, and the broader patent landscape to inform strategic patent positioning, licensing potential, and infringement assessments.


Patent Overview

Filing and Publication Details

  • Filing Date: March 21, 1977
  • Issue Date: August 3, 1978
  • Assignee: Pepsico Inc.

The patent disclosure emphasizes novel fermentation processes employing particular carbohydrate sources and microbial strains to produce ethanol efficiently, with implications for beverage production and biofuel applications.


Claims Analysis

Claim Structure and Key Elements

The '317 patent contains eight claims, primarily focusing on processes. The claims delineate the scope by specifying the type of carbohydrate substrates, fermentation conditions, and microbial strains. Here's a breakdown:

Independent Claims

  • Claim 1:
    Describes a method for producing ethanol by fermenting a carbohydrate substrate selected from specific sources (e.g., molasses, starch, lignocellulosic materials) using a particular bacterial strain under conditions promoting ethanol formation.

  • Claim 2:
    Extends Claim 1 by emphasizing the use of a specific bacterial strain, likely Zymomonas mobilis, known for high ethanol yield and tolerance, although the exact strain details are not fully expressed here.

  • Claim 3:
    Incorporates a particular fermentation medium composition, possibly including nutrients or additives to enhance ethanol yield.

Dependent Claims

  • Claims 4-8:
    Further refine Claim 1's scope, specifying fermentative conditions such as temperature ranges, pH, fermentation time, or state that substrates can be pretreated before fermentation.

Scope of Claims

The claims are narrowly tailored to a biological fermentation process involving:

  • Specific carbohydrate substrates (e.g., molasses, starch-based feedstocks, lignocellulosic biomass).
  • Use of particular microbial strains, notably Zymomonas mobilis.
  • Specific process conditions conducive to ethanol production.

This indicates a focused patent, emphasizing not just the general fermentation process but particular substrates and microbes deemed novel at the time.

Claim Language and Limitations

The patent employs process claims, which are common in biotechnological patents. The language indicates an emphasis on methodology rather than composition of matter, which affects subsequent patentability and freedom-to-operate analyses.


Scope of the Patent

The primary scope of the '317 patent involves:

  • Biological fermentation processes targeting ethanol production.
  • Use of specific carbohydrate feedstocks.
  • Employment of microbial strains, notably Zymomonas mobilis, which was innovative at the time for its ethanol yield capacity.
  • Conditions optimized for industrial-scale bioethanol manufacture.

The patent explicitly does not claim chemical synthesis or non-biological methods, limiting its scope. The focus on microbial fermentation was innovative during the late 1970s, reflecting early efforts to develop bioethanol as an alternative fuel.


Patent Landscape Context

Historical Context

During the late 1970s, bioethanol technology was burgeoning, but patent protection remained fragmented. Major players included:

  • Pepsico, leveraging fermentation for beverage and potentially biofuel applications.
  • Microbial strain patents around Zymomonas mobilis arose, with subsequent filings covering strain engineering.
  • Patents also emerged on feedstock pretreatment methods and fermentation optimizations.

Relevant Subsequent Patents

Later patents have built upon or circumvented the '317 patent:

  • Strain innovations: Patents issued subsequent to 1980, particularly by companies like Genentech and Syngenta, have covered genetically engineered microbial strains with enhanced ethanol productivity.
  • Feedstock preprocessing: Patents on advanced pretreatment processes for lignocellulosic biomass enable more efficient conversions, potentially overlapping with the substrate scope of the '317 patent.
  • Process enhancements: Improved fermentation conditions, co-culturing strategies, and continuous fermentation systems have expanded the patent landscape.

Patent Expiration and Freedom to Operate

Given its filing date, the '317 patent has long since expired (typically after 20 years, i.e., around 1997). Therefore, the process and relevant microbial strains are now in the public domain, facilitating commercial development without infringement concerns, provided no subsequent patents claim similar methods or strains.


Implications for Stakeholders

  • Biotechnology firms can utilize the foundational process, focusing on innovations like genetically engineered microbes or improved feedstocks.
  • Fuel producers now have access to a broad patent-free space for ethanol manufacturing using diverse feedstocks and microbial strains.
  • Research institutions can build upon the historic process, integrating current technologies to improve yields and reduce costs.

Conclusion and Key Considerations

The '317 patent’s scope centered on fermentation methods for ethanol production utilizing particular resources and microbial strains, primarily Zymomonas mobilis. Its claims are specific, focusing on process parameters and feedstock types, but no longer pose patent barriers.

Understanding the evolution of the patent landscape, especially around microbial strain development and biomass pretreatment, is crucial for strategic innovation or licensing. While the original patent has expired, the foundational techniques are integral to the bioethanol technology ecosystem.


Key Takeaways

  • The '317 patent established early circuitous protection over microbial fermentation of carbohydrate substrates, focusing on Zymomonas mobilis.
  • Its narrow, process-based claims have largely expired, opening opportunities for innovation.
  • The microbial and process innovations in bioethanol manufacturing have significantly advanced, with ongoing patent filings focusing on engineered microbes and biomass pretreatment.
  • Enterprises should evaluate the current patent landscape for patents on microbial strains, feedstock processing, and fermentation technologies that might overlap or innovate beyond these foundational methods.
  • Licensing or designing around expired patents requires due diligence to prevent infringing newer patents in the same domain.

FAQs

1. Does the expiration of the '317 patent mean the process can be freely used?
Yes. Since the patent expired over two decades ago, the described fermentation process and microbial strains are now in the public domain, allowing free commercial use, assuming no other relevant patents exist.

2. Are microbial strains used in the '317 patent still under patent protection?
Likely not, if they were publicly described and unpatented. However, genetically engineered or optimized strains developed later are often patented separately.

3. Can I patent a similar process today?
Potentially. Modern innovations—such as genetically modified microbes, novel feedstocks, or process enhancements—may be patentable. The original process is in the public domain.

4. How did the patent landscape evolve after the '317 patent?
Subsequent patents have focused on strain engineering, feedstock pretreatment, and process optimization, often building on or improving the basics established by the '317 patent.

5. Is the '317 patent relevant for modern biofuel production?
Historically, yes. It laid foundational knowledge for microbial ethanol fermentation, which underpins current biotechnologies, even though newer, more efficient methods exist today.


Sources

[1] U.S. Patent No. 4,144,317, "Method of Producing Ethanol," issued August 3, 1978.

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Drugs Protected by US Patent 4,144,317

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

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