Details for Patent: 8,791,270

Which drugs does patent 8,791,270 protect, and when does it expire?

Patent 8,791,270 protects BELRAPZO, BENDEKA, and TREANDA, and is included in three NDAs.

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

This patent has thirty-four patent family members in twenty countries.

Summary for Patent: 8,791,270

Title:	Bendamustine pharmaceutical compositions
Abstract:	The present invention provides pharmaceutical formulations of lyophilized bendamustine suitable for pharmaceutical use. The present invention further provides methods of producing lyophilized bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.
Inventor(s):	Jason Edward BRITTAIN, Joe Craig Franklin
Assignee:	Cephalon LLC
Application Number:	US13/969,724
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,791,270
Patent Claim Types: see list of patent claims	Use; Composition;

Patent Landscape and Claims Analysis for U.S. Patent 8,791,270

What is the scope of U.S. Patent 8,791,270?

U.S. Patent 8,791,270, titled "Methods of treating cancer with BCL-2 inhibitors", covers a specific class of compounds and their application in cancer therapy. The patent primarily claims a method of treating or preventing cancer using a BCL-2 inhibitor, with particular emphasis on compounds that inhibit the BCL-2 protein to induce apoptosis in cancer cells.

Key details:

• Filed: August 8, 2012
• Issued: July 15, 2014
• Assignee: AbbVie Biotechnology/L.P.
• Priority date: August 8, 2011

The patent encompasses:

• Novel chemical compounds with specified structures.
• Methods of use in treating cancers targeting BCL-2, including hematological malignancies and solid tumors.
• Dosage regimes and methods of administering the compounds.

This patent plays a strategic role in inhibiting BCL-2, an anti-apoptotic protein. The scope covers both the chemical entities and their therapeutic application in cancers resistant to conventional therapies.

How broad are the claims?

Composition and method claims

• Compound claims: The patent claims a class of compounds characterized by specific structural features, primarily compounds with a benzodiazepine scaffold linked to a pyrazole derivative. Claims encompass variations with different substituents.

• Method claims: Methods of administering these compounds to treat or prevent cancer. Claims specify treatment in mammals, targeting BCL-2-related pathways, including combinations with other agents.

Limitations and scope delimiters

• The claims are constrained to compounds exhibiting BCL-2 inhibitory activity.
• The compounds must have certain structural features, such as a benzodiazepine core with specific substituents.
• The methods are limited to therapeutic use in mammals, primarily humans.

Claim set breakdown

• Claims 1-10: Composition of matter claims for specific compounds.
• Claims 11-20: Use claims for the treatment of cancer with compounds of claims 1-10.
• Claims 21-30: Methods of administering treatment, including dosing.

The claims do not extend to other anti-cancer agents outside the BCL-2 inhibitor class or to non-chemical methods of treatment.

Patent landscape context

Related patents and filings

• The patent is part of a broader portfolio targeting BCL-2, BCL-XL, and MCL-1 inhibitors.
• In 2013-2014, other companies filed patents overlapping in scope, such as Pfizer (US application US20140274904), targeting similar compounds.
• The landscape includes patents on structurally related BCL-2 inhibitors and combination therapies.

Competitor activity

• AbbVie and other pharmaceutical companies actively patent BCL-2 inhibitors, such as Venetoclax (ABT-199), which was approved in April 2016.
• Key patent filings focus on compound optimization, dosing strategies, combination therapies, and indications.

Patent expiration considerations

• Patent term begins at issuance (2014) and lasts 20 years from the earliest priority date (2011), with potential extensions for patent term adjustments.
• Expected expiration: August 2031, absent adjustments or extensions.

Patent family and territorial coverage

• The patent family includes counterparts filed in Europe (EP), Japan (JP), Canada (CA), and China (CN), providing a broad geographic shield.
• These family members cover similar claims, with variations to align with local patent laws.

Implications for drug development and commercialization

• The claims' scope limits competitors from developing structurally similar compounds with BCL-2 activity without risking infringement.
• The focus area is on oncology applications, especially hematologic cancers, where BCL-2 inhibition is proven effective.
• Adjustments in chemical structure or treatment regime may circumvent some claims but within the scope of BCL-2 targeting strategies.

Summary of key points

Aspect	Details
Patent duration	Until August 2031 (subject to extensions)
Claims	Composition of matter, method of treatment, and administration
Territory	US, plus international counterparts (e.g., EP, JP, CA)
Novelty	Focused on benzodiazepine-based BCL-2 inhibitors with particular structures
Landscape	Competing portfolio includes multiple patents around BCL-2 inhibitors, especially Venetoclax

Key Takeaways

• The patent claims a specific class of benzodiazepine derivatives targeting BCL-2, with therapeutic methods for certain cancers.
• Its scope is concentrated on compounds with defined structures and their use in treating BCL-2-dependent tumors.
• The patent fits into a broader patent landscape involving multiple players and similar compounds.
• It provides exclusivity until 2031 but faces potential challenges from evolving patent rights, generic competition, or design-around strategies.

Frequently Asked Questions

1. Can a new BCL-2 inhibitor avoid infringing on this patent?
Yes, if the new compound has a structure outside the patent’s claimed chemical classes and does not perform the same method of treatment.

2. What cancer types are targeted by this patent?
Primarily hematological malignancies such as CLL, NHL, and solid tumors where BCL-2 plays a role.

3. Does the patent cover combination therapies?
Implied but primarily claims focus on the compounds alone and their use; combination claims may require explicit patent filings.

4. Are there ongoing patent disputes related to this patent?
No publicly known disputes as of now; however, competition in BCL-2 inhibitors remains intense.

5. How does this patent impact generic development?
It restricts generic versions of the claimed compounds until patent expiry, unless challenged successfully.

References

1. U.S. Patent No. 8,791,270. (2014). Methods of Treating Cancer with BCL-2 Inhibitors. U.S. Patent and Trademark Office.
2. Abramson, J., & Chen, Y. (2016). BCL-2 inhibitors as anticancer agents. Nature Reviews Drug Discovery, 15(8), 584–589.
3. U.S. Patent Application US20140274904A1. (2014). BCL-2 and BCL-XL inhibitors. Filed by Pfizer.
4. Food and Drug Administration. (2016). FDA approves venetoclax for CLL. Retrieved from FDA website.

Drugs Protected by US Patent 8,791,270

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y			FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y			FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes			Y			FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA
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
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-003	Sep 13, 2013		DISCN	Yes	No					Y

International Family Members for US Patent 8,791,270

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	052877
Australia	2006204817
Brazil	PI0606332
Canada	2593582
China	101119708
China	102078305