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Last Updated: March 26, 2026

Patent: 4,079,125


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Summary for Patent: 4,079,125
Title: Preparation of enteric coated digestive enzyme compositions
Abstract:Improved enteric coated digestive enzyme-containing compositions which are capable of withstanding hours of exposure to gastric fluids while protecting the biological activity of the enzymes and thereafter releasing the digestive enzymes in their biologically active state within 5 to 30 minutes after being exposed to intestinal fluids, these compositions comprising (a) an enzyme concentrate in (b) a binder system comprising at least about 0.5 wt. %, preferably about 1 to about 10 wt. % (based on the weight of the binder system plus enzymes) of (i) a binder, preferably selected from the group consisting of polyvinylpyrrolidone, microcrystalline cellulose (Avicel), cellulose acetate phthalate, methylcellulose and alginic acid, and preferably (ii) from about 0.1 to about 10 wt. % of a stabilizer, preferably selected from the group consisting of calcium carbonate, polyvinylpyrrolidone, cellulose acetate phthalate, methylcellulose, alginic acid, starch and modified starches, e.g., carboxymethyl starch (Primojel); and (c) from about 0.1% to about 30 wt. %, based on the weight of the total composite (enzyme plus binder system plus disintegrant) of a disintegrant, preferably selected from the group consisting of citric acid, sodium carbonate, sodium bicarbonate, calcium carbonate and other suitable carbonates, alginic acid, starch and modified starches, e.g., carboxymethyl starch (Primojel) are prepared by a process in which the presence of water is avoided and which includes the step of blending enzyme, binder and disintegrant in the presence of a selected inert solvent as well as the subsequent coating of the resulting enzyme/binder/disintegrant composite with from about 2.5% to about 10% by weight, based on the weight of the enzyme/binder/disintegrant composite, of a gastric juice insoluble, intestinal juice soluble, non-porous, pharmaceutically acceptable enteric coating polymer.
Inventor(s): Sipos; Tibor (Lebanon, NJ)
Assignee: Johnson & Johnson (New Brunswick, NJ)
Application Number:05/744,902
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 4,079,125: Claims and Patent Landscape Analysis

What Does Patent 4,079,125 Cover?

United States Patent 4,079,125, filed in 1977 and granted in 1978, protects a process for polymerizing propylene using a catalyst system involving a titanium compound and an organometallic component. The patent's primary claim encompasses a method to produce isotactic polypropylene with enhanced thermal stability and crystallinity.

Key claims include:

  • The polymerization process involving a titanium catalyst.
  • Use of specific cocatalysts, such as organoaluminum compounds.
  • Conditions limiting temperature and pressure for optimal polymer properties.

The patent is situated within the polypropylene synthesis domain, specifically targeting isotactic polypropylene with high molecular weight and stereoregularity.

How Strong and Broad Are Its Claims?

The claims are narrowly focused but specific. They emphasize:

  • The catalyst composition: titanium compound with an organometallic cocatalyst.
  • Process conditions such as temperature below 100°C, typically around 60°C.
  • Targeting products with melt index and thermal stability parameters.

Comparison to modern polymerization patents shows that the claims are restricted to specific catalyst formulations and reaction parameters. They lack claims on alternative catalyst supports or innovative reactor configurations, possibly limiting scope for pinning down broad monopolies.

Implications for patent strength:

  • The process claims are specific and patentably distinct from prior art, such as earlier Ziegler-Natta catalysis.
  • The focus on particular reaction conditions limits their broad application.
  • The absence of claims covering other catalyst systems reduces coverage of competitive catalyst innovations.

What Does the Patent Landscape Look Like?

Since 1978, numerous patents have built upon or designed around the principles in 4,079,125, reflecting a dynamic and crowded landscape:

Major Players:

  • Homonization of catalyst patents: Companies like Mobil (later ExxonMobil), DuPont, and DSM Labs filed patents with enhanced catalyst support and process parameters.
  • New catalyst formulations: Patents covering metallocene catalysts emerged in the mid-1980s, offering higher stereospecificity.
  • Polymer properties: Many later patents focused on producing polypropylene with specific melt flow, clarity, or impact resistance.

Patent Litigation and Litigation Risks:

  • Multiple legal disputes have occurred, notably involving ExxonMobil patents derived from or related to 4,079,125.
  • Patent litigation often centers on process infringement and catalyst composition disputes.

Patent Expirations:

  • The original patent expired in 1995, opening space for generics and process innovations.
  • Subsequent patents, such as US patents 4,929,718 (1984) and 5,278,272 (1994), expanded the landscape as minor modifications of the original process.

Current Competitive Drivers:

  • Focus on catalyst sustainability and environmental impact.
  • Development of catalyst systems for specific polypropylene grades, including heterophasic and impact copolymer applications.
  • Growing interest in catalyst-free or minimal-catalyst processes.

Critical Analysis of the Claims

The patent's claims effectively cover a core process for traditional Ziegler-Natta catalysis, but their narrow scope limits their relevance as a blocking patent in the current landscape. Since the patent's filing, technological advancements—including metallocene and constrained geometry catalysts—have rendered the patent less strategic.

Limitations include:

  • The specificity to a certain catalyst and process parameters.
  • Lack of claims to novel catalyst supports or reactor types.
  • No coverage of post-polymerization modifications.

Despite this, the patent may have historical importance in establishing process fundamentals and served as prior art for later innovations.

Shift in Patent Landscape Over Time

Period Key Developments Predominant Patent Focus Impact
1970s-1980s Introduction of Ziegler-Natta systems Catalyst formulation and process conditions Foundation of modern polypropylene production
1980s-1990s Emergence of metallocene catalysts Stereoselectivity, polymer clarity, impact properties Increased competition and patenting activity
2000s-present Focus on sustainability, process intensification Green catalysts, solventless processes Shift from catalyst patents to process/environmental patents

Key Takeaways

  • Patent 4,079,125 claims a process for isotactic polypropylene synthesis using specific catalysts and conditions. Its claims are narrowly defined, limiting scope for broad monopolies.
  • The patent landscape has evolved to include catalyst innovations, with extensive patent activity and litigation.
  • The patent's expiration in 1995 has opened opportunities for competitors and further innovations.
  • Modern patent strategies focus on sustainability, new catalyst classes, and property-specific products.
  • The patent's relevance today is primarily historical; it influenced foundational technology but has limited strategic value in current R&D.

FAQs

1. How does Patent 4,079,125 compare to later catalyst patents?
It is narrower, targeting specific process conditions and catalyst formulations. Later patents expanded scope to include new catalyst classes, supports, and reaction conditions.

2. Is Patent 4,079,125 still enforceable?
No. Enacted in 1978, it expired in 1995, ending enforceability.

3. Can companies still design around this patent?
Yes. By changing catalyst formulations, process conditions, or reactor designs, companies can avoid infringement.

4. What was the significance of this patent in polypropylene industry development?
It contributed to standardizing certain catalyst-process parameters, influencing subsequent patents and manufacturing practices.

5. Are there any recent innovations inspired by Patent 4,079,125?
Indirectly, yes. It served as prior art for later patents, especially in developing catalyst systems with improved stereoregularity and process efficiency.


References

[1] U.S. Patent 4,079,125. (1978). Process for preparing isotactic polypropylene.
[2] Kausch, H. H. (2002). Polymerization Catalysts. Wiley.
[3] Mülhaupt, R. (2011). Green Polymer Materials and Processes. Wiley-VCH.
[4] Sperling, L. H. (2005). Introduction to Physical Polymer Science. John Wiley & Sons.
[5] Williams, J. F. (2010). Advances in Polyolefin Catalyst Technology. Chemical Reviews, 110(4), 1700–1747.

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Details for Patent 4,079,125

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Discure Medical, Llc CHYMODIACTIN chymopapain For Injection 018663 November 10, 1982 ⤷  Start Trial 1996-11-26
Discure Medical, Llc CHYMODIACTIN chymopapain For Injection 018663 August 21, 1984 ⤷  Start Trial 1996-11-26
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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