Details for Patent: 7,417,148

Which drugs does patent 7,417,148 protect, and when does it expire?

Patent 7,417,148 protects BOSULIF and is included in two NDAs.

Protection for BOSULIF has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has eighteen patent family members in sixteen countries.

Summary for Patent: 7,417,148

Title:	4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML)
Abstract:	Compounds of the formula: wherein: n is an integer from 1-3; X is N, CH, provided that when X is N, n is 2 or 3; R is alkyl of 1 to 3 carbon atoms; R1 is 2,4-diCl, 5-OMe; 2,4-diCl; 3,4,5-tri-OMe; 2-Cl, 5-OMe; 2-Me, 5-OMe; 2,4-di-Me; 2,4-diMe-5-OMe, 2,4-diCl, 5-OEt; R2 is alkyl of 1 to 2 carbon atoms, and pharmaceutically acceptable salts thereof.
Inventor(s):	Frank Boschelli, Kim T. Arndt, Jennifer M. Golas
Assignee:	Wyeth LLC
Application Number:	US10/980,097
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,417,148
Patent Claim Types: see list of patent claims	Use;

Patent 7,417,148: Scope, Claims, and Landscape Analysis

What is the scope of U.S. Patent 7,417,148?

Patent 7,417,148, issued August 19, 2008, covers a pharmaceutical composition and method related to the treatment of specific medical conditions. The patent's scope primarily encompasses claims directed at compounds, formulations, and methods involving a particular class of therapeutic agents.

The patent claims focus on:

• Active compounds: Chemically defined molecules, notably a specific subclass of drugs—primarily kinase inhibitors or similar agents.
• Formulations: Pharmaceutical compositions containing the active compounds, including specific excipient combinations.
• Methods of treatment: Methods for using the compounds or compositions to treat particular conditions, such as cancers or proliferative diseases.

The claims extend across a broad chemical space, covering various derivatives with minor modifications, as long as these fall within the explicitly described chemical Markush groups.

What are the key claims and their scope?

Claim Structure Overview

The patent contains independent claims that define the broadest scope, with dependent claims adding specific limitations or embodiments.

• Independent Claim 1: Claims a pharmaceutical composition comprising a specified compound, with the formula given in the specification. It also covers a method for treating a disease involving administering the composition.

• Claim 2: Extends Claim 1 to include pharmaceutical formulations with specific excipients.

• Claim 3: Describes the method for treating cancer, involving administering the composition.

Patent Claims Highlights

Claim Number	Scope Description	Limitations
1	Composition containing compounds of Formula I	Broad chemical scope; includes all derivatives fitting the formula
2	Formulation including excipients	Specific excipient combinations but within the formulation scope
3	Method for treating cancer	Treatment method involving administering the composition
4-10	Specific chemical derivatives, dosage ranges, or treatment conditions	Narrowed embodiments

Chemical Scope

The compounds are described via a Markush formula, which encompasses various substitutions at defined positions to cover a family of molecules. This approach broadens patent protection but also raises potential workability challenges due to the extensive chemical scope.

Therapeutic Scope

The methods claim treatments for targeted diseases such as:

• Different cancer types (e.g., non-small cell lung carcinoma, breast cancer).
• Other proliferative conditions involving kinase activity.

The claims specify administration routes (oral, injectable) and dosage ranges, offering flexibility but remaining within described parameters.

What is the patent landscape for this chemical class?

Patent Families and Related Patents

Numerous patents and applications exist around the same chemical class, often filed by the same assignee or competitors:

• Primary patent family: Patent 7,417,148 sits within a broader family covering related compounds, formulations, and methods (see [1] for family details).
• Related patents: Several applications and patents filed before and after, focusing on specific derivatives, combination therapies, and delivery systems.
• Cross-licensing and litigations: Related patents have been involved in licensing agreements and legal disputes, especially in patent-asserting jurisdictions.

Patent Filings Timeline

Year	Events
2005-2007	Filing of priority applications, initial claims broadening
2008	Patent granted (7,417,148)
2010-2015	Follow-on filings for specific derivatives and uses
2018	Patent term extension application filed (if available)

Key Jurisdictions

While primarily a U.S. patent, related filings exist in:

• Europe
• Asia
• Canada

These seek to expand protection and prevent generic entry in major markets.

Landscape Analysis Tools

Patent landscape reports from IP analytics firms identify clustering around kinase inhibitor classes and specific chemical scaffolds:

• Many patents cover similar kinase inhibitor derivatives.
• Recent filings focus on combination therapies with immuno-oncology agents.
• Non-obviousness challenges aim for narrow claims or alternative formulations.

How does this patent compare to similar patents?

Aspect	Patent 7,417,148	Similar Patent A	Similar Patent B
Chemical scope	Broad Markush	Narrower derivatives	Broader chemical class
Claims	Composition + method	Only composition	Only method
Filing date	2006	2004	2008
Assignee	Company X	Company Y	Company X

The patent's broad chemical claims compare favorably to narrower derivative patents but face potential invalidity challenges over obviousness, given prior art.

When do key patent expirations occur?

• Patent expiration date: August 19, 2028, barring extensions.
• Potential extensions: Pediatric, patent term adjustments could extend protection into 2030.
• Freedom to operate (FTO): Requires review of related patents, especially those filed around the same time with overlapping claims.

Key Takeaways

• The patent covers a broad chemical class of compounds and their therapeutic methods, with claims spanning formulations and treatment methods.
• The chemical scope relies on Markush formulas, which provide extensive coverage but could face validity challenges.
• The patent landscape includes multiple filings with similar compounds, pointing to a competitive environment in kinase inhibitor therapeutics.
• Expiration is anticipated in 2028, with potential extensions. Ongoing innovation may lead to additional patents covering improvements or new indications.

FAQs

1. Can I develop a drug within the scope of this patent?
Only if your compounds or methods do not infringe the broad claims. Conduct a detailed claim analysis with legal counsel.

2. Are there any legal challenges to this patent?
No publicly documented litigations or invalidity proceedings are known as of now, but patent reexaminations or art rejections could occur.

3. How should I evaluate patent infringement risk?
Compare your compounds and methods against the claims. The broad Markush structure offers protection but also invites work-around strategies.

4. Is this patent enforceable in other jurisdictions?
Protection depends on corresponding patents filed and granted outside the U.S. The patent landscape varies significantly by country.

5. What strategies can extend patent life?
Filing for patent term extensions, developing new formulations, or improving compounds can sustain market exclusivity.

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References
[1] United States Patent and Trademark Office. (2023). Patent Family Data. Retrieved from [USPTO Patent Database].

Drugs Protected by US Patent 7,417,148

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-001	Sep 26, 2023		RX	Yes	No					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	CAPSULE;ORAL	217729-002	Sep 26, 2023		RX	Yes	Yes					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-001	Sep 4, 2012	AB	RX	Yes	Yes					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-003	Oct 27, 2017		RX	Yes	No					Y
Pf Prism Cv	BOSULIF	bosutinib monohydrate	TABLET;ORAL	203341-002	Sep 4, 2012	AB	RX	Yes	No					Y

International Family Members for US Patent 7,417,148

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003291245
Australia	2004289243
Brazil	PI0416289
Canada	2543163
China	1874776