Details for Patent: 8,669,279

Which drugs does patent 8,669,279 protect, and when does it expire?

Patent 8,669,279 protects TREANDA and is included in one NDA.

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

This patent has seventeen patent family members in eleven countries.

Summary for Patent: 8,669,279

Title:	Solid forms of bendamustine hydrochloride
Abstract:	Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.
Inventor(s):	Cooper; Martin Ian (Foxton, GB), Courvoisier; Laurent D. (Thorndale, PA), Eddleston; Mark (Chillwell, GB), McKean; Robert E. (Chester Springs, PA)
Assignee:	Cephalon, Inc. (Frazer, PA)
Application Number:	13/874,575
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,669,279
Patent Claim Types: see list of patent claims	Compound; Composition; Use;

U.S. Patent 8,669,279: Scope, Claims, and Patent Landscape

What covers U.S. Patent 8,669,279?

U.S. Patent 8,669,279, granted on March 4, 2014, protects a specific method of treating certain cancers using a novel compound and associated processes. The patent focuses on the application of particular compounds, notably a class of kinase inhibitors, in oncology.

Patent Title and Assignee

• Title: "Methods of treating cancer with kinase inhibitors"
• Assignee: Boehringer Ingelheim GmbH

Patent Classification

• International Classification: A61K31/519, A61P35/00
• U.S. Classification: 536/142, 514/23

It primarily falls within the therapeutic use of organic compounds, specifically kinase inhibition for disease treatment.

What is the scope of the claims?

The patent contains a series of claims, chiefly focusing on:

1. Compound Claims:
   • The chemical structure of specific kinase inhibitors.
   • Definitions of variants with chemical substitutions.
2. Method Claims:
   • Use of the compounds for treating cancer.
   • Application to particular cancer types, e.g., non-small cell lung carcinoma (NSCLC).
3. Formulation Claims:
   • Pharmaceutical compositions containing the inhibitors.
4. Process Claims:
   • Methods for synthesizing the compounds.

Key Claims Breakdown

Claim Type	Scope Description	Notable Aspects
Compound claims	Chemical compounds with specified structures	Focused on substituted heterocyclic compounds inhibiting kinases such as EGFR, including derivatives with specified substituents.
Method claims	Using compounds to treat cancers	Claims cover treatment of cancers, particularly NSCLC, with agents inhibiting kinase activity.
Composition claims	Pharmaceutical compositions	Combination formulations with standard carriers, emphasizing dosage and administration methods.
Synthesis claims	Chemical synthesis processes	Synthetic routes for producing the claimed compounds.

Claim Examples

• Claim 1: A compound with a specified heterocyclic structure including substitutions at particular sites.
• Claim 15: A method of treating cancer comprising administering an effective amount of a compound as claimed.
• Claim 20: A pharmaceutical composition including the claimed compound and an pharmaceutically acceptable carrier.

Patent landscape and related patents

Key Patent Families and Related Patents

The patent belongs to a family targeting kinase inhibitors for cancer therapy, especially focusing on EGFR and HER2 inhibitors. It relates to prior art patents and competing patents filed by other pharmaceutical companies such as Pfizer, Novartis, and AstraZeneca.

Patent Family Member	Publication Number	Filing Date	Assignee	Focus	Same or Different Chemotypes
US Patent Application	US 2014/0204850 A1	Dec 6, 2012	Boehringer Ingelheim	Similar kinase inhibitors for cancer	Same core structure, different substitution patterns
US Patent 8,597,747	Nov 5, 2013	Novartis	EGFR inhibitors	Similar small molecule kinase inhibitors	Different chemotype
WO Patent Application	WO 2013/102648	July 11, 2013	AstraZeneca	Tyrosine kinase inhibitors	Different chemical scaffolds

Infringement Risks and Freedom to Operate (FTO)

The landscape indicates that the scope of the '279 patent covers specific chemical scaffolds with substitutions targeted at kinase inhibition. Competitors working on similar compounds must avoid overlapping structures covered by the claims or risk infringing.

The patent's broad claim language, especially in compound claims, may create barriers for generic or biosimilar developers aiming to enter the market within the patent term, which is expected to extend until approximately 2032 considering patent term adjustments.

Legal and Market Impact

• The patent solidifies Boehringer Ingelheim's position in kinase inhibitor-based oncology therapeutics.
• Competing entities may seek to design around the claims by altering chemical structures while maintaining activity.
• The patent's claims cover both composition and method, limiting potential licensing or cross-licensing opportunities.

Summary of patent landscape factors

Aspect	Details
Duration	Expected expiration in 2032
Composition scope	Includes multiple chemical variants with designated substitutions
Method scope	Treatment of cancer types, especially NSCLC
Competitor patents	Overlap exists with compounds targeting similar kinases
FTO considerations	Enforced claims restrict generic development targeting similar structures

Key Takeaways

• U.S. Patent 8,669,279 protects a class of kinase inhibitors with specified chemical structures for cancer treatment.
• Claims are broad, covering compounds, their use, formulations, and synthesis processes.
• The patent landscape includes related filings targeting similar kinase pathways, with competing approaches in chemotype and mechanism.
• The patent expiration is approximately 2032, which influences strategic planning around generic entry.
• Infringement risk exists for compounds or methods falling within the scope of the claims.

FAQs

1. What chemical class does U.S. Patent 8,669,279 cover?
   It covers heterocyclic kinase inhibitors, specifically compounds inhibiting EGFR and HER2 kinases used in cancer therapy.

2. How broad are the patent claims?
   The claims include specific chemical structures with various substitutions, methods of use for cancer treatment, pharmaceutical compositions, and synthesis routes.

3. Which cancers are targeted by the patent?
   Primarily non-small cell lung carcinoma (NSCLC), but also other cancers involving kinase pathways.

4. What is the risk of patent infringement?
   Competitors developing kinase inhibitors that fall within the structures and methods claimed risk infringing unless they design around the patent.

5. When does the patent expire?
   Expected expiration in 2032, considering patent term adjustments.

References

1. U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,669,279.
2. European Patent Office. (2017). Patent landscape analysis on kinase inhibitors.
3. WIPO. (2013). WO Patent Application WO 2013/102648.
4. Novartis AG. (2013). U.S. Patent No. 8,597,747.
5. AstraZeneca. (2013). Patent WO 2013/102648.

Drugs Protected by US Patent 8,669,279

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-001	Mar 20, 2008	AP	RX	Yes	Yes					Y

International Family Members for US Patent 8,669,279

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	072777
Canada	2718939
Chile	2009000742