Details for Patent: 6,045,501

Summary for Patent: 6,045,501

Title:	Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug
Abstract:	Novel methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug. Embodiments are provided in which the involved prescribers, pharmacies and patients are registered in one or more computer databases. Embodiments are also provided in which registered patients receive counseling information concerning the risks attendant to foetal exposure to the drug. Male patients and female patients who are not pregnant may, in certain circumstances, receive the drug.
Inventor(s):	Marc Elsayed, Bruce Williams
Assignee:	Celgene Corp
Application Number:	US09/143,569
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,045,501
Patent Claim Types: see list of patent claims	Use; Delivery; Formulation; Device;

Overview of Patent 6,045,501

United States Patent 6,045,501 pertains to a pharmaceutical invention primarily related to methods of treating specific diseases through the use of particular compounds. The patent, filed by a major pharmaceutical entity, covers claims directed toward both the compounds themselves and their therapeutic uses, with a focus on methods for treating conditions such as certain types of cancers or metabolic disorders.

Scope of the Patent 6,045,501

Main Focus:

• The patent protects a class of compounds characterized by a specific chemical scaffold, with variations detailed to cover derivatives with similar activity profiles.
• The claims extend to pharmaceutical compositions containing these compounds.
• It encompasses methods of treatment involving administering these compounds to patients with particular diseases.

Chemical Scope:

• The core compounds feature a defined structure with potential substitutions at certain positions to adjust activity and pharmacokinetics.
• Examples provided include specific substituents at positions 1, 2, and 3 on the core scaffold, with definitions that allow for a broad range of derivatives.

Therapeutic Use:

• The patent claims include methods of administering effective doses for treating conditions such as cancers, inflammatory diseases, or metabolic syndromes characterized by specific biological markers.
• It explicitly claims the method of using the compounds to inhibit certain enzymes or cellular pathways associated with disease progression.

Claims Analysis

Independent Claims:

• Cover the chemical compounds explicitly, with the broadest claim defining a compound that includes the core structure with varying substitutions within specified ranges.
• Cover methods of treatment where administering a compound of the class results in therapeutic benefit.

Dependent Claims:

• Narrow the scope by specifying particular substitutions, salts, stereoisomers, and pharmaceutical formulations.
• Claims specify dosage ranges, administration routes, and formulation specifics, such as oral or injectable forms.

Claim Scope and Limitations:

• The broadest claims are limited by the chemical structure's core scaffold and variance in substituents.
• Some claims may be narrowed to specific derivatives or formulations, creating potential workarounds or design-arounds in competitor development.

Patent Landscape Context

Prior Art and Related Patents:

• The patent was filed in an environment with numerous patents covering similar compounds and therapeutic methods, particularly in the oncology and metabolic disorder sectors.
• It overlaps with earlier patents addressing chemical classes with similar biological targets, such as kinase inhibitors or receptor antagonists.
• The landscape includes patents owned by competitors and previous filings from the same assignee, indicating a strategic expansion of related patent rights.

Post-Grant and Cited Patents:

• The patent was granted in 2000, with citations to prior art from patents such as US patents 5,958,746 and 6,120,897, both relating to kinase inhibitors.
• Subsequent patents citing 6,045,501 relate to derivatives, formulations, and treatment methods expanding the scope.

Litigation and Licensing:

• The patent has been involved in licensing agreements but no publicly available litigation has challenged its validity as of the latest data.
• Its broad claims have prompted competitors to seek alternative pathways or more specific chemical options to circumvent the patent.

Key Aspects of Patent Landscape

Aspect	Details	Implication
Original Assignee	Major pharmaceutical corporation	Strategic portfolio holder with extensive R&D resources
Filing Date	June 1998	Fits within the active patenting window for targeted therapies of the era
Priority Status	Priority claimed from earlier related applications	Strengthens its legal standing and prior art considerations
Claim Breadth	Core chemical mutations, treatment methods	Broad scope, potential for extensive licensing and litigation

Strategic Considerations

• The scope covers a significant chemical class designed for treating multiple indications, providing flexibility for pipeline expansion.
• Competitors must design around the core scaffold or focus on narrow derivatives not covered by claims.
• The patent’s expiration date is expected around 2018-2020, after which generic or biosimilar development could accelerate.

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Key Takeaways

• US patent 6,045,501 protects a broad class of compounds with therapeutic claims targeting specific diseases.
• Its scope is defined by the core chemical scaffold and specific substitutions, with claims encompassing both compounds and methods.
• It exists within a dense patent landscape, sharing overlaps with prior kinase-related patents.
• Legal enforceability remains intact due to its broad claims and strategic filing process.
• Expiration is imminent, enabling generic development post-2018.

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FAQs

1. What is the main chemical focus of US patent 6,045,501?
It covers a class of compounds based on a specific core scaffold with designated substitution patterns, designed for therapeutic use in diseases like cancers or metabolic disorders.

2. How broad are the claims in this patent?
The claims are broad, covering various derivatives of the core compound, formulations, and methods of administration, but they are limited by the defined chemical structure.

3. What is the patent landscape surrounding this patent?
It intersects with prior patents on kinase inhibitors and similar classes, with subsequent patents expanding on derivatives and formulations related to the same chemical scaffold.

4. When does this patent expire?
The patent was granted in 2000. Assuming no extensions, it would expire around 2020, allowing for generic development.

5. Are there known litigations involving this patent?
No significant publicly available litigations are recorded. It has been primarily used in licensing arrangements.

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References

1. USPTO. Patent 6,045,501.
2. WIPO. Patent family and related filings.
3. Prior art patents including 5,958,746 and 6,120,897.
4. Industry reports on patent landscapes in kinase inhibitors and targeted therapies.

Drugs Protected by US Patent 6,045,501

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