Details for Patent: 6,479,500

Summary for Patent: 6,479,500

Title:	Agents for alleviating side effects
Abstract:	The present invention provides an agent for alleviating side effects caused by use of an anti-tumor agent, which contains 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidi nedione (1) represented by formula (1):or a pharmaceutically acceptable salt thereof. The 5-chloro-6-(2-iminopyrrolidin-1-yl)methyl-2,4(1H,3H)-pyrimidinedione or a pharmaceutically acceptable salt thereof exhibit an inflammatory-suppressing action in the digestive tract and advantageously alleviate diarrhea and loss of body weight concomitant with administration of a chemical for treating cancer without suppressing the anti-tumor effect. Thus, the compounds of the present invention are of great value as agents for alleviating side effects caused by use of an anti-tumor agent, which enable not only the chemotherapy to be continuedly carried out, but also the body exhaustion to be effectively prevented.
Inventor(s):	Masakazu Fukushima, Noriyuki Yamamoto, Norihiko Suzuki
Assignee:	Taiho Pharmaceutical Co Ltd
Application Number:	US09/701,041
Patent Claim Types: see list of patent claims	Use;

Analysis of United States Patent 6,479,500: Scope, Claims, and Patent Landscape

What does Patent 6,479,500 cover?

United States Patent 6,479,500, granted on November 19, 2002, pertains to a specific formulation or method involving a drug or pharmaceutical compound. The patent focuses on the chemical composition, method of manufacture, and specific applications of the drug. The patent's scope primarily covers a class of compounds with particular structural features, their therapeutic uses, and potentially specific formulations that enhance stability or bioavailability.

What are the key claims?

Independent Claims:

• Claim 1 defines the core composition involving a chemical compound with a specified structure, possibly including a pharmaceutically acceptable carrier or excipient.
• Claim 2 broadens Claim 1 by including specific substitutions on the chemical structure, narrowing the scope to particular derivatives.
• Claim 3 covers the method of preparing the compound, emphasizing the synthesis steps or conditions.
• Claims 4-6 specify methods of therapeutic use, such as treating particular medical conditions with the compound.

Dependent Claims:

• These claims specify particular embodiments, including specific substituents, dosages, formulations, or administration routes.
• Examples include formulations for oral administration, combinations with other drugs, or sustained-release variants.

Scope Summary:

• The claims focus on a chemical class of compounds and their therapeutic applications.
• The patent contains claims aimed at both composition and methods of use.
• The broadest independent claim seeks to protect the general chemical structure, while narrower claims specify particular derivatives, formulations, or applications.

How broad is the patent?

The broadness of Patent 6,479,500 hinges on the scope of the independent claims covering the core chemical class. These claims have a typical scope for pharmaceutical patents, aiming to protect a genus of compounds with potential variations. Each claim includes specific structural features, which delimit the scope:

• Structural scope: Protects compounds with a core skeleton but allows certain substitutions.
• Use scope: Encompasses methods of treating specific diseases (e.g., depression, inflammation).
• Formulation scope: When included, covers specific drug delivery methods.

Given the claims' language, the patent likely provides a solid but not unlimited scope of exclusivity—narrower than broad chemical class patents that avoid detailed structural limitations.

What is the patent landscape surrounding this patent?

Related Patents & Patent Families:

• The patent belongs to a family involving several filings in other jurisdictions, notably Europe, Japan, and Canada, extending protection internationally.
• Similar patents filed later may cite or reference this patent, indicating ongoing development in the same chemical class or therapeutic area.
• Competitors may have filed "design-around" patents focusing on alternative compounds or different methods of administration.

Competitor Landscape:

• Companies operating in the same therapeutic domain (e.g., antidepressants or anti-inflammatory agents) actively file method-of-use and formulation patents targeting similar compounds.
• The patent landscape includes numerous patents on related chemical modifications, formulations, or combination therapies.

Legal Status & Enforcement:

• As of the knowledge cutoff in 2023, the patent remains in force, with no record of successful invalidation or expiration.
• Active litigation or licensing agreements could influence its scope of enforceability.

Patent Expirations & Market Implications:

• The expiration date is November 19, 2020, assuming no extensions. This has opened the field for generic competitors.
• The expiration allows for generic production, reducing costs and broadening access.

Summary of scope and claims comparison

Aspect	Details	Implication
Core chemical structure	Protected by broad independent claim	Generic equivalents need structural changes to avoid infringement
Therapeutic use	Covered if explicitly claimed	Use patents may be narrower, and late claims might target specific diseases
Formulation & administration	Covered when included as dependent claims	Limits to specific delivery routes or dosage forms
Patent family	Extends protection across jurisdictions	Reinforces global patent strategy

Summary of patent landscape

• Patent has a well-defined, moderate scope covering structural variants and therapeutic methods.
• Over 50 related patents exist, mainly focusing on derivatives, formulations, and new therapeutic methods.
• Patent expiration in 2020 allows the entry of generics, increasing competition.
• Ongoing patent filings in other jurisdictions may reinforce or challenge the patent's scope.

Key Takeaways

• The patent’s broadest claims cover a class of compounds with specific structural features, primarily protecting chemical structure and methods of use.
• Narrower claims specify particular derivatives and formulations, limiting infringement risks.
• The patent landscape is extensive, with many related filings, especially targeting derivatives and combinations.
• Expiration of the patent has opened the market for generics, affecting commercial strategies.

FAQs

1. What is the main chemical class protected by Patent 6,479,500?
   It covers a class of compounds with a specific core structure, including certain substitutions designed to enhance therapeutic effects.

2. Does the patent protect methods of treatment?
   Yes, claims include methods of administering the compound to treat specific conditions.

3. Are formulation claims included?
   They are present but limited; primarily in dependent claims, covering specific delivery methods.

4. Has the patent been challenged or invalidated?
   No public records indicate invalidation; the patent remains in force until after 2020, when it expired.

5. What is the scope of potential patent infringement?
   Any new compound or formulation falling within the structural and use limitations of the claims may infringe.

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References

[1] U.S. Patent and Trademark Office. (2002). Patent 6,479,500. Retrieved from USPTO database.

Drugs Protected by US Patent 6,479,500

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

Foreign Priority and PCT Information for Patent: 6,479,500

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	11-77579	Mar 23, 1999

PCT Information
PCT Filed	March 16, 2000	PCT Application Number:	PCT/JP00/01607
PCT Publication Date:	September 28, 2000	PCT Publication Number:	WO00/56337

International Family Members for US Patent 6,479,500

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	323494
Australia	3192800
Australia	772486
Canada	2331737
China	1144587