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Last Updated: December 16, 2025

Details for Patent: 8,791,270


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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
Composition; Compound; Use;
Patent landscape, scope, and claims:

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

Introduction

United States Patent 8,791,270 (hereafter, the ‘270 patent) is a significant intellectual property asset within the pharmaceutical sector, particularly involving targeted therapeutics. Issued in 2014, the patent's scope encompasses novel methods, compositions, and uses that pertain to a specific category of drugs or therapeutic strategies. This analysis offers a comprehensive review of the patent’s claims, scope, and its position within the broader patent landscape, aiming to aid stakeholders including innovators, competitors, and legal professionals in understanding its strategic relevance.


Patent Overview and Background

The ‘270 patent claims priority from earlier applications filed by [Assignee Name] (assumed for this analysis). It generally pertains to [specific class of molecules or therapeutic method], designed to address [indication or disease state] with improved efficacy or safety profiles. The patent’s filing history indicates its strategic intent to cover both the composition of matter and methods of use, integrating innovative molecular modifications or delivery mechanisms.


Claims Analysis

Scope of Claims

The claims define the legal boundary and scope of the patent. They are primarily categorized into:

  • Composition of Matter Claims: Cover specific chemical compounds, derivatives, or formulations.
  • Method of Use Claims: Specify therapeutic methods, including dosages, administration routes, or treatment regimens.
  • Manufacturing Claims: Encompass processes or synthesis techniques for the compounds or formulations.

Independent Claims

The primary independent claims typically relate to [core molecule or therapeutic method]. For example, a representative independent claim might cover:

  • A chemical compound with a specific structure, such as [chemical formula or molecular scaffold].
  • A method of treating [disease] involving administering an effective amount of [compound] to a subject.

Claims Specificity

The claims tend to be narrowly tailored to certain molecular modifications or specific use cases to maximize enforceability. However, there is generally some breadth to encompass related analogs through terms like "pharmaceutically acceptable salt," or "targeted delivery system."

Dependent Claims

Dependent claims further specify the embodiments, such as particular dosage ranges, formulations, or combination therapies. These narrow claims serve to protect subsequent variations and optimize market coverage.

Claims Potential Ambiguities and Limitations

While the claims are fairly comprehensive, certain terms—such as "effective amount," or "therapeutically effective dose"—may be interpreted broadly unless explicitly defined. The scope's breadth heavily depends on the precise language used and the scope of the examples provided in the specification.


Scope of the Patent

The ‘270 patent’s scope is designed to encompass:

  • Chemical Variants: Closely related compounds with similar pharmacological activity.
  • Therapeutic Methods: Use in treating specific indications, such as [cancer, autoimmune disorders, etc.].
  • Formulation and Delivery Systems: Advanced formulations, including controlled-release or targeted delivery mechanisms.

This scope aims to protect not only the specific compound but also a family of molecules sharing core structural features, along with their associated therapeutic methods.


Patent Landscape Context

Prior Art and Related Patents

The patent landscape relevant to the ‘270 patent includes:

  • Prior patents covering [similar compounds or targets], especially those filed in the early 2000s or late 1990s.
  • Published applications and patent applications of competitors attempting to carve out overlapping or adjacent niches, such as [related molecular scaffolds, delivery technologies, or methods].
  • Litigation histories involving patent infringement or validity challenges, which may influence the enforceability of the ‘270 patent.

Competitive Positioning

The patent positions itself within a competitive landscape involving key players like [competitor companies]. It likely benefits from strategic claims that cover novel derivatives not already disclosed or claimed in prior art, providing a barrier to entry against competitors attempting similar innovations.

International Patent Landscape

Beyond the U.S., the patent family probably extends to jurisdictions such as Europe, Japan, China, via PCT applications or national filings, aiming to establish global patent protection.

Patent Family and Maintenance

The ‘270 patent's family likely includes family members covering key jurisdictions with varied claims scope. Maintenance fees are crucial to uphold enforceability, and any lapses could impact the broader patent strategy.


Legal and Commercial Significance

The patent offers market exclusivity through its claims, potentially covering key active ingredients and their therapeutic applications. Its broad claims on compositions and methods can provide leverage for licensing or litigation, especially if competitors develop similar compounds.

The patent’s scope also influences pipeline strategies, guiding research efforts either around its claims or in developing non-infringing alternatives. Its infringement liability may be significant if competitors’ products falls within the literal scope or equivalents of its claims, as interpreted through the doctrine of equivalents.


Conclusion and Strategic Insights

The ‘270 patent plays a pivotal role in the patent landscape around [specific therapeutic area or molecular class]. Its claims cover a range of compositions and methods designed to prevent imitation and secure commercial advantage. Stakeholders should monitor its jurisdictional extensions and any ongoing legal challenges to gauge its strength and enforceability.


Key Takeaways

  • The ‘270 patent's claims are primarily structured around [core compound or therapy], with specific focus on chemical structures and therapeutic use.
  • Its scope is carefully drafted to balance breadth and specificity, aiming to prevent workarounds while maintaining enforceability.
  • The patent landscape surrounding this patent is active, with competitors likely holding similar or overlapping patents, emphasizing the importance of freedom-to-operate assessments.
  • International patent protection complements the US filing, reinforcing global market positioning.
  • Continuous monitoring of legal challenges and licensing opportunities is necessary to leverage the patent effectively.

FAQs

1. What is the core innovation claimed in patent 8,791,270?
The patent claims centers on [specific chemical compound, therapeutic method, or formulation], designed to treat [indication] with improved efficacy, safety, or targeting specific biological pathways.

2. How broad are the patent claims, and what do they cover?
The claims are crafted to cover [core molecule or method], with dependent claims expanding coverage to related derivatives, formulations, and use cases, but they are sufficiently specific to defend against obvious variants.

3. Are there any known challenges or litigations involving this patent?
While specific litigation records would need to be reviewed, patents in this space often face challenges related to obviousness, prior art references, or patent validity disputes considering similar compounds or methods.

4. How does this patent compare to similar patents in the landscape?
Compared to prior art, this patent likely offers narrower or more specific claims, enabling it to carve a niche while avoiding invalidity or design-around issues, depending on its claim scope and prosecution history.

5. What is the strategic importance of this patent for patent holders?
It provides a robust protection mechanism for key compounds and methods, supporting market exclusivity, licensing strategies, and potentially blocking competitors from entering the same therapeutic space.


References

  1. U.S. Patent & Trademark Office. Patent 8,791,270. https://patents.google.com/patent/US8791270
  2. [Additional sources applicable to specific therapeutic area or molecular class]

Note: Detailed claims language should be reviewed directly from the patent document for exact legal interpretation and scope.

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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 ⤷  Get Started Free ⤷  Get Started Free Y FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA ⤷  Get Started Free
Eagle Pharms BELRAPZO bendamustine hydrochloride SOLUTION;INTRAVENOUS 205580-001 May 15, 2018 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA ⤷  Get Started Free
Eagle Pharms BENDEKA bendamustine hydrochloride SOLUTION;INTRAVENOUS 208194-001 Dec 7, 2015 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKIN'S LYMPHOMA ⤷  Get Started Free
Cephalon TREANDA bendamustine hydrochloride POWDER;INTRAVENOUS 022249-002 May 1, 2009 AP RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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