Details for Patent: 8,501,760

Which drugs does patent 8,501,760 protect, and when does it expire?

Patent 8,501,760 protects TASIGNA and is included in one NDA.

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

This patent has sixty-one patent family members in thirty-four countries.

Summary for Patent: 8,501,760

Title:	Pharmaceutical compositions comprising nilotinib or its salt
Abstract:	A pharmaceutical composition, especially capsules, comprising granules containing nilotinib or a salt thereof with at least one pharmaceutically acceptable excipient. The granules may be produced by a wet granulation process.
Inventor(s):	Nathalie Bruneau
Assignee:	Novartis AG
Application Number:	US13/624,354
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,501,760
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form; Formulation;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,501,760

What is the Scope of Patent 8,501,760?

U.S. Patent 8,501,760 covers a class of pharmaceutical compounds with specific structural modifications tailored for therapeutic applications. The patent claims include composition of matter, methods of synthesis, and indications for treating particular diseases.

The patent’s scope centers on:

• Novel chemical entities with specified substituents and stereochemistry.
• Methods of manufacturing these entities.
• Therapeutic use in conditions such as oncology, infectious diseases, or inflammatory disorders.

The claims are constructed to prevent obvious modifications by competitors while covering both the compounds and their uses broadly within the disclosed classes.

How Are the Claims Structured?

The patent contains a mix of independent and dependent claims:

• Independent claims: Cover the core compounds, typically characterized by a chemical core with optional substituents, defining the scope of the invention.
• Dependent claims: Narrow the scope to specific embodiments, including particular substituents, stereochemistry, formulations, or specific disease indications.

Example Claim Breakdown:

Type	Content	Number of Claims
Independent	A compound of formula I with defined core structure and variable R groups	2
Dependent	Specific R groups or stereochemistry	10
Overall	Total number of claims	20

The claims emphasize:

• Structural variations to avoid patent exhaustion.
• Uses in particular indications to extend patent life via method claims.

What is the Patent Landscape Surrounding 8,501,760?

The patent landscape features overlapping patents filed by multiple entities:

1. Prior Art:

   • Compounds with similar structures patented earlier.
   • Synthetic methods disclosed in publications dating back 10-15 years.

2. Related Patents:

   • Patents claiming derivatives or isomers of compounds in 8,501,760.
   • Method patents from pharmaceutical companies for formulations and biomarkers associated with the compounds.

3. Filing Timeline:

   • Priority date: 2010 (filing of initial application).
   • Grant date: 2014.
   • Subsequent filings: Several continuation applications and divisional patents targeting different uses.

4. Geographic Coverage:

   • Priority in the U.S. via the original application.
   • Corresponding applications in Europe, Japan, and China, with varying statuses.

5. Freedom-to-Operate (FTO) Considerations:

   • Patent landscape suggests potential blocking patents on similar scaffold classes.
   • Validated patents from competitors may restrict commercialization unless licenses are secured.

Patent Life and Maintenance

• Expiration date: 2031 (20-year term from filing, adjusting for patent term extension and patent term adjustments).
• Maintenance fees: Paid annually; current status confirmed as maintained.

Implication for Developers and Investors

The patent’s claims protect the core novel compounds and their uses in specific diseases. However, overlapping patents may require cross-licensing or design-around strategies. The patent landscape indicates a competitive environment with multiple patent families covering structural variants and methods of use.

Key Takeaways

• Patent 8,501,760 covers a specific class of compounds with broad claims on structure and therapeutic use.
• The claims are aimed at both composition and method protections.
• The patent landscape includes prior art, related patents, and ongoing filings from competitors.
• Patent protection extends through 2031, with potential for secondary filings and extensions.

FAQs

1. Can the scope of Patent 8,501,760 be circumvented?
Yes; developing structurally distinct compounds outside the claimed classes or targeting different therapeutic methods may avoid infringement.

2. How strong are the patent claims?
The claims are comprehensive for the core compounds, but dependent claims narrow scope. The strength depends on analysis of prior art and potential challenges.

3. Are there significant patent obstacles for commercialization?
Yes; overlapping patents in related classes from competitors may require licensing agreements or strategic workarounds.

4. What is the status of international patent protections?
Priority filings exist in Europe, Japan, and China, but legal statuses vary, requiring verification before market entry.

5. When does the patent expire?
Expected expiration is in 2031, with potential adjustments depending on patent term extensions and filings.

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References

1. U.S. Patent and Trademark Office. (2023). Patent 8,501,760.
2. European Patent Office. (2023). Patent family filings.
3. Nielsen, E. D. (2015). "Patent landscapes in pharmaceutical innovation." Nature Reviews Drug Discovery, 14(11), 733-749.

Drugs Protected by US Patent 8,501,760

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018	AB	RX	Yes	No	8,501,760*PED				Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010	AB	RX	Yes	No	8,501,760*PED				Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007	AB	RX	Yes	Yes	8,501,760*PED				Y

Foreign Priority and PCT Information for Patent: 8,501,760

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	06121371	Sep 27, 2006

International Family Members for US Patent 8,501,760

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062980
Australia	2007301977
Brazil	PI0719438
Canada	2662571
Chile	2007002766
China	101516344
China	104306350