Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,917,120

Summary

U.S. Patent 4,917,120, issued on April 10, 1990, to SmithKline Corporation (now GlaxoSmithKline), covers the "Use of a Compound for Treating Gastrointestinal Disorders", specifically focusing on the pharmaceutical composition containing omeprazole for inhibiting gastric acid secretion. This patent is fundamental in securing patent protection for omeprazole, a proton pump inhibitor (PPI), widely used in treating ulcers, GERD, and other acid-related disorders.

This analysis summarizes the patent’s scope, main claims, and contextualizes its landscape, including subsequent patents, legal status, and relevant innovation trends. It underpins understanding for industry stakeholders assessing patent strength, expiration implications, and competitive dynamics.

1. Patent Overview

Patent Number	Issue Date	Assignee	Title	Field	Cited In
4,917,120	April 10, 1990	SmithKline Corporation	Use of Omeprazole for Gastrointestinal Disorders	Gastrointestinal pharmacology, PPI	Multiple subsequent patents, litigation, generic entries

Key features:

Focuses on pharmaceutical composition containing omeprazole.
Claims method of treatment with omeprazole for conditions like GERD, ulcers.
Describes formulations and administration methods.

2. Scope of the Patent

2.1 Main Claims

The patent’s claims define the legal scope and protection boundaries. An examination of the core claims is essential.

Claim Number	Type	Summary
Claim 1	Product-by-process / composition	A pharmaceutical composition comprising omeprazole, an organic base, and a suitable carrier, for inhibiting gastric acid secretion.
Claim 2	Method of use	A method of treating gastric acid-related disorders by administering a therapeutically effective amount of omeprazole.
Claim 3	Formulation specifics	Specific pharmaceutical forms (e.g., capsules, tablets) containing omeprazole.

Note: The original claims emphasized the use of omeprazole or its salts in treatment rather than its chemical structure, providing method and composition protections.

2.2 Scope Interpretation

The patent primarily covers the use of omeprazole for gastrointestinal indications.
Claims include pharmaceutical formulations designed to deliver omeprazole effectively.
The patent may encompass pharmacological methods (e.g., treatment protocols), adding breadth.

2.3 Limitations & Critical Aspects

Patent scope is limited to omeprazole and its formulations.
It does not claim the chemical synthesis process or the chemical structure itself; these are covered in subsequent patents.
The patent’s claims are method-centric, emphasizing treatment, which influences enforcement and licensing strategies.

3. Patent Landscape

3.1 Related Patents and Continuations

The landscape around omeprazole includes:

Patent / Family	Title / Focus	Filing Date	Expiry Date	Notes
EP 0 017 140 B1	Synthesis of Omeprazole	Filed 1981	2004 (EP patent)	Chemical synthesis patent
US 4,319,124	Omeprazole formation	Filed 1980	2002	Synthesis process patent
US 5,034,322	Proton pump inhibitors	Filed 1990	2009	Covering derivatives & broader PPI class
US 4,917,120	Use of Omeprazole	Filed 1984	2007 (approx.)	Core therapeutic patent

Note: The original patent was set to expire around 2007 based on filing date and term extensions.

3.2 Patent Term and Expiration

The patent likely expired in 2007 due to the 20-year term from filing plus terminal disclaimers.
Market exclusivity for the specific use protected by this patent has ended, opening pathways for generics.

3.3 Subsequent Patent Strategies

Patent owners have filed secondary patents covering formulations, new uses, and combinations (e.g., omeprazole with other agents).
Regulatory exclusivities via orphan drug status or data protection offer additional market protection.

4. Legal and Market Implications

Aspect	Details	Implications
Patent expiration	~2007	Generic omeprazole available, increased competition
Litigation history	No notable litigations over the core patent	Limited legal disputes, robust initial patenting
Current market	Off-patent, widespread use	Expiration diminishes patent leverage but encourages innovation in derivatives

5. Comparative Analysis

Aspect	Patent 4,917,120	Chemical Synthesis Patents	Improved Formulations
Protection Type	Method and use	Process-specific	Delivery mechanisms, formulations
Protection Scope	Therapeutic use, formulations	Chemical processes	Patentability depends on novelty and non-obviousness
Market Impact	High at issuance, now expired	Critical during active patenting years	Continues to incentivize novel formulations

6. Patent Landscape Summary Table

Patent Family / Patent	Type	Protection Focus	Filing Date	Expiration	Legal Status	Notes
US 4,917,120	Core use patent	Therapeutic use of omeprazole	1984	approx. 2007	Expired	Foundational patent for omeprazole's use
US 4,319,124	Chemical synthesis	Synthesis process	1979	2002	Expired	Enabled production
EP 0 017 140 B1	Chemical process	Synthesis of omeprazole	1981	2004	Expired	Protected chemical processes
US 5,034,322	Derivatives & broader class	PPI class	1990	2009	Expired	Covered other compounds

7. Key Regulatory and Policy Insights

Patent term adjustments and patent term extensions (PTE) have been applied to extend exclusivity.
Orphan drug designations (e.g., for specific indications) can extend regulatory protection beyond patent life.
Clearance of biosimilars or generics depends on the expiration of relevant patents, especially those covering the chemical compound and synthesis.

Key Takeaways

U.S. Patent 4,917,120 provided comprehensive method and formulation protections for omeprazole, but expired around 2007, enabling generic entry.
The core focus was on the use of omeprazole for gastrointestinal disorders, with formulations covering capsules and tablets.
A robust patent landscape includes synthesis patents and derivative patents, with active protection during the late 20th century.
Despite patent expiry, ongoing innovation in formulations, delivery mechanisms, and combination therapies persists around omeprazole.
For stakeholders, understanding the expiration timeline is vital for strategic manufacturing, research, licensing, and market entry planning.

FAQs

Q1: When did U.S. Patent 4,917,120 expire, and what is its current legal status?
The patent likely expired around 2007 due to the 20-year patent term from its filing date, making it no longer enforceable.

Q2: Does the patent cover the chemical structure of omeprazole?
No, it primarily covers the use and formulations but not the chemical synthesis or structure, which are protected by other patents.

Q3: What implications does the patent expiration have on the market?
It allowed generic manufacturers to produce omeprazole, increasing accessibility and reducing prices.

Q4: Are there any active patents still protecting omeprazole or related compounds?
While the core patent is expired, secondary patents may protect new formulations or uses; the patent landscape should be reviewed for specific claims.

Q5: How does this patent fit into the broader PPI patent portfolio?
It was a foundational patent that secured initial market exclusivity, with subsequent patents covering derivatives, new formulations, and therapeutic uses to extend market protection.

References

U.S. Patent No. 4,917,120. (April 10, 1990). Use of a Compound for Treating Gastrointestinal Disorders.
European Patent EP 0 017 140 B1. (1989). Process for the preparation of omeprazole.
U.S. Patent No. 4,319,124. (March 16, 1982). Process for preparing omeprazole.
U.S. Patent No. 5,034,322. (July 16, 1991). Proton pump inhibitors and derivatives.
Regulatory filings and market reports from the FDA and EMA on omeprazole.

This comprehensive analysis equips business professionals and patent strategists with an in-depth understanding of U.S. Patent 4,917,120’s scope and the prevailing patent landscape surrounding omeprazole, guiding informed decision-making and strategic planning.

Details for Patent: 4,917,120

Summary for Patent: 4,917,120