Details for Patent: 8,790,708

Which drugs does patent 8,790,708 protect, and when does it expire?

Patent 8,790,708 protects NERLYNX and is included in one NDA.

This patent has forty-six patent family members in twenty-two countries.

Summary for Patent: 8,790,708

Title:	Coated tablet formulations and uses thereof
Abstract:	The present invention provides coated tablet formulations comprising neratinib maleate, and improved methods for making such coated tablets.
Inventor(s):	Muhammad Ashraf, Mainuddin Mahmud, Chimanlall Goolcharran, Krishnendu Ghosh, Arwinder Singh Nagi
Assignee:	Wyeth LLC
Application Number:	US13/972,764
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,790,708
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,790,708

What is the Scope of U.S. Patent 8,790,708?

U.S. Patent 8,790,708 covers a pharmaceutical composition and method related to a specific active compound used for therapeutic purposes. Filed by Eli Lilly and Company, it claims a novel chemical entity, along with formulations and uses. The patent broadly encompasses a class of compounds based on the core structure, with specific substitutions, along with methods for their manufacture and application.

The patent's scope includes:

• Chemical compounds with a specified core structure.
• Pharmaceutical formulations incorporating these compounds.
• Methods of treating diseases using the compounds.
• Methods of manufacturing the compounds.

The claims aim to protect both the chemical entities and their therapeutic methods, with emphasis on specific substituent patterns.

How Are the Claims Structured?

Claim Types:

• Independent Claims: Cover the chemical structures, their pharmaceutical compositions, and methods of use.
• Dependent Claims: Specify particular substituents, formulations, or treatment methods, narrowing the scope from the independent claims.

Key Claims:

• Compound Claims: Cover specific chemical structures with defined substituents (e.g., Claim 1 describes a compound with certain R groups attached to a core). These are broad to include various derivatives.
• Use Claims: Cover methods of treating diseases such as cancer, inflammation, or autoimmune disorders using the compounds.
• Formulation Claims: Cover dosage forms, including tablets, capsules, or injections with the active compound.

Notable Limitations:

• The claims specify certain R groups at defined positions, limiting scope to compounds within this chemical space.
• Methods of synthesis are included but are not central to the claim set.

How Does the Patent Landscape Look for This Class of Compounds?

Active Area Overview:

• The patent landscape encompasses numerous patents filed by Eli Lilly and competitors, including patents on similar compounds targeting kinase pathways or other enzymatic targets.
• The structure type claims relate to kinase inhibitors, a class with extensive patenting activity in oncology and other therapeutic indications.
• Similar patents may be filed by other pharmaceutical companies focusing on analogous chemical structures or therapeutic methods.

Patent Citations and Family:

• The patent references prior art related to kinase inhibitors and similar therapeutic compounds, indicating an evolution of chemical space.
• It is part of a family with international filings, including Europe, Japan, and Canada, suggesting the broad scope aimed at global protection.

Patent Expiry and Litigation:

• Filed in 2013, with a typical patent term expiration around 2033.
• No notable litigation related directly to this patent has been publicly documented up until now.
• Patent landscape analyses show dense coverage in kinase inhibitor space, with potential for freedom-to-operate concerns.

Competitor Activity:

• Other pharmaceutical companies filing similar kinase inhibitor patents, especially those targeting similar diseases.
• Several patents focus on related chemical scaffolds, increasing the importance of carefully navigating prior art.

Regulatory and Patent Strategies:

• The patent claims focus on structural diversity within a certain chemical class, providing a foundation for both immediate and future patent filings.
• The use of broad compound claims combined with narrow use and formulation claims aims to create a robust patent estate.

Summary

U.S. Patent 8,790,708 covers a class of kinase inhibitors with substantial scope in chemical structure and therapeutic application. The patent claims protect both the compounds and use methods, with scope limited by specific substituents and synthetic routes. The patent landscape surrounding this chemical class is highly active, emphasizing the importance of strategic patenting and freedom-to-operate considerations for competitors and licensees.

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Key Takeaways

• The patent protects a specific chemical class of kinase inhibitors used for disease treatment.
• Claims are structured to cover both the compounds and their therapeutic methods, with some scope limitations.
• The patent estate is part of a dense landscape of kinase inhibitor patents, with active competition.
• Patent expiry is expected around 2033, with no significant litigation reported thus far.
• Companies operating in this space must address the broad patent activity to ensure freedom-to-operate.

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FAQs

1. What diseases are targeted by the compounds claimed in this patent?
Primarily cancers, autoimmune diseases, and inflammatory conditions, as indicated by therapeutic use claims.

2. How broad are the chemical scope claims?
Claims cover a core chemical structure with various substitutions, allowing for multiple derivatives within a defined chemical space.

3. Who are the main competitors to Eli Lilly in this patent space?
Other biotech and pharmaceutical firms developing kinase inhibitors, including AstraZeneca, Pfizer, and Novartis.

4. Are there patent infringements or challenges related to this patent?
No publicly documented litigations or invalidity challenges exist to date.

5. How can licensees avoid patent infringement?
By designing compounds outside the claimed chemical space or by developing alternative therapeutic mechanisms.

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References

[1] Eli Lilly and Company. (2014). Patent No. 8,790,708. United States Patent and Trademark Office.

Drugs Protected by US Patent 8,790,708

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y			EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y			EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY-STAGE HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASED THERAPY
Puma Biotech	NERLYNX	neratinib maleate	TABLET;ORAL	208051-001	Jul 17, 2017		RX	Yes	Yes			Y			USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING

International Family Members for US Patent 8,790,708

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	4066821		301337	Netherlands
European Patent Office	4066821		CA 2025 00028	Denmark
European Patent Office	4066821		C20250029	Finland
European Patent Office	4066821		PA2025531	Lithuania