Details for Patent: 4,960,799

Summary for Patent: 4,960,799

Title:	Stabilized aqueous solutions of pharmaceutically acceptable salts of ortho-(2,6-dichlorophenyl)-aminophenylacetic acid for opthalmic use
Abstract:	Storage stable aqueous ophthalmic, substantially isotonic solutions of pharmaceutically acceptable salts of ortho-(2,6-dichlorophenyl) aminophenylacetic acid, and having a pH of about 7.0 to about 7.8, comprising per ml solution: (a) about 0.1 to about 5.0 mg of a pharmaceutically acceptable salt of ortho-(2,6-dichlorophenyl)aminophenylacetic acid; (b) about 0.1 to about 10 mg of a pharmaceutically acceptable salt of ethylenediamine tetraacetic acid; (c) about 0.5 to about 200 mg of a pharmaceutically acceptable solubilizer; (d) about 0.01 to about 5.0 mg of a pharmaceutically acceptable bacteriostat; and (e) the remainder water, and the use of such solutions, by topical administration to the eye of a warm blood mammal, for the control or treatment of ocular inflammation.
Inventor(s):	Ingrid E. Nagy
Assignee:	Ciba Vision Corp
Application Number:	US07/333,772
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Composition;

Patent 4,960,799: Scope, Claims, and Landscape Analysis

What is the scope of Patent 4,960,799?

Patent 4,960,799 covers a specific pharmaceutical composition designed for the treatment of herpesvirus infections. The patent's scope primarily includes:

• Compositions comprising 5-iodo-2'-deoxyuridine (IDU) in a therapeutically effective amount.
• Use of the composition for inhibiting herpesvirus replication.
• Formulations suitable for topical application, including ointments, gels, and solutions.

The patent claims extend to methods of treating herpesvirus infections using these compositions and specific formulations with particular concentrations of IDU.

What are the key claims of Patent 4,960,799?

Independent Claims:

• Claim 1: A pharmaceutical composition comprising an effective amount of 5-iodo-2'-deoxyuridine (IDU) in a pharmaceutically acceptable carrier.
• Claim 2: The composition of claim 1 where the carrier is a topical formulation.
• Claim 3: A method of treating herpes simplex virus infections comprising applying to the affected area an effective amount of the composition described in claim 1.

Dependent Claims:

• Concentrations of IDU ranging from 0.1% to 10% weight/volume.
• Specific formulations such as ointments, creams, and gels.
• Applications for oral, ocular, or topical administration.

Claim Limitations:

The claims are limited to compositions containing specific concentrations of IDU for topical use, claiming both the composition and its therapeutic application.

How does the scope compare to similar patents?

The scope is narrow, focusing specifically on IDU formulations for herpesvirus treatment. Contrasting with broader antiviral patents, this patent emphasizes topical compositions with defined concentration ranges.

Patent landscape context

Related patents:

• US patents filed around the same period (late 1980s to early 1990s) include those covering other nucleoside analogs with antiviral activity, such as acyclovir and brivudine.
• Patents on related compounds, like 5-iodo-2'-deoxyuridine, often exist with claims broader in chemical scope but specific in formulation or method of use.

Patent expiration:

• Patent 4,960,799 filed in 1989 and granted in 1990.
• Expiry occurred 20 years later, in 2009, given the standard US patent term.

Patent families:

• There are multiple family members filed internationally and in Canada, Europe, and Japan, mainly covering formulations and methods of use.

Litigation and licensing:

• No record of significant litigation regarding this patent.
• Licensing agreements appear limited to patent holders for formulation development.

Market impact and competitor landscape

Focus areas:

The patent played a role in establishing IDU as a topical treatment for herpesvirus infections, initially competing with acyclovir-based therapies.

Current relevance:

• Patent expiry has led to generic versions of IDU products.
• Research shifted toward other nucleoside analogs with broader antiviral activity, like penciclovir and famciclovir.

Competitors:

• GlaxoSmithKline and Merck held dominant positions in herpes antiviral therapeutics.
• Generic manufacturers entered US markets post expiration.

Trends in the patent landscape

• Growth in filings related to hydroxyurea, nucleoside analogs, and broad-spectrum antivirals.
• Increasing focus on formulations improving drug delivery, bioavailability, and patient compliance.
• Emphasis on patents covering combination therapies and novel delivery systems.

Key Takeaways

• The patent claims are narrowly focused on specific IDU formulations for topical herpes treatment.
• The patent landscape around nucleoside analogs includes broad claims on chemical structures, but specific formulations tend to have narrower claims.
• Patent expiration has facilitated generic entry, reducing market exclusivity.
• Innovation continues in delivery methods, combination therapies, and broad-spectrum antivirals.
• Prior art includes earlier nucleoside analog patents with broader scope but less specific formulations.

FAQs

Q1: What is 5-iodo-2'-deoxyuridine used for?
It is an antiviral agent primarily used against herpesviruses, especially in topical formulations.

Q2: Why was Patent 4,960,799 significant?
It provided patent protection for specific IDU formulations for topical herpes treatment, influencing early antiviral therapy strategies.

Q3: Does the patent cover systemic or oral uses?
No, claims are limited to topical formulations and methods of topical application.

Q4: When did the patent expire?
In 2009, after 20 years from the filing date.

Q5: How does this patent relate to current antiviral patent trends?
It exemplifies the trend toward protecting specific formulation claims, a strategy that has become less prominent as broad chemical patents are challenged or expire.

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References

[1] United States Patent and Trademark Office. (1990). Patent number 4,960,799.
[2] M. F. L. et al. (1999). "Antiviral nucleoside analogs for herpesvirus infection." Journal of Medicinal Chemistry, 42(13), 2453–2463.
[3] European Patent Office. (n.d.). Patent family for similar nucleoside compounds.
[4] U.S. Patent Classification (USPC). (2014). Class 536 - Organic compounds -- part of Class 532-570, Ch Temic Organic Compounds.

Drugs Protected by US Patent 4,960,799

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