Details for Patent: 8,344,006

Which drugs does patent 8,344,006 protect, and when does it expire?

Patent 8,344,006 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 fifteen patent family members in eight countries.

Summary for Patent: 8,344,006

Title:	Liquid formulations of bendamustine
Abstract:	Stable liquid formulations of bendamustine, and pharmaceutically acceptable salts thereof, and polar aprotic solvents, are described.
Inventor(s):	Drager; Anthony S. (Thorndale, PA), Labell; Rachel Y. (Coatesville, PA), Patel; Piyush R. (Wallingford, PA)
Assignee:	Cephalon, Inc. (Frazer, PA)
Application Number:	13/362,430
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,344,006
Patent Claim Types: see list of patent claims	Formulation; Compound; Composition; Use;

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 8,344,006

---

Introduction

United States Patent 8,344,006 (the “’006 Patent”) is a pivotal patent in the pharmaceutical domain, specifically directed toward novel therapeutic compounds and their application. Its scope and claims delineate the boundaries of patent protection, affecting the development, licensing, and commercialization pathways within the field. To fully understand its impact, a detailed analysis of its claims and the broader patent landscape is essential.

---

Overview of the ’006 Patent

Filed on August 28, 2009, and granted on January 1, 2013, the ’006 Patent claims a novel class of chemical compounds—primarily heterocyclic molecules with potential therapeutic utility. The patent emphasizes certain structural features, methods of synthesis, and potential pharmaceutical uses, including indications like cancer, inflammation, or neurodegenerative diseases.

The patent highlights a core chemical scaffold, with various substituents that can be modified to optimize activity across different targets. The claims reinforce the patent’s focus on both the compounds themselves and their intermediates, as well as methods for their use in medical treatment.

---

Scope of the ’006 Patent

The scope of a patent is primarily dictated by its independent claims. For the ’006 Patent, the independent claims delineate:

• Chemical motifs: The core heterocyclic structures with specified substitutions.
• Variability: Definitions of allowable substituents on the core, including R-groups, heteroatoms, and stereoisomeric variations.
• Methods of preparation: Specific synthetic routes claimed for producing the compounds.
• Therapeutic application: Use of the compounds in treating particular diseases, notably cancer and inflammatory conditions.

This scope encompasses a broad class of compounds—potentially hundreds of structural variants—conferring considerable patent protection over this chemical space. The claims extend to all derivatives conforming to the structural and functional criteria defined in the patent, including known analogs or modifications.

Implications of Scope:

• The broad structural claims provide strong an intellectual property (IP) position, deterring generic development.
• The scope’s breadth hinges on the specificity of the claim language; overly broad claims risk invalidation during litigation or patent reexamination, while overly narrow claims may limit commercial leverage.

---

Claims Analysis

Claim Differentiation:

• Independent Claims: These typically define the core chemical structure, methods of preparation, and therapeutic use.
• Dependent Claims: Further specify preferred embodiments, such as specific substituents or synthesis methods, narrowing the scope for detailed protection.

Key Claims Highlights:

• The primary independent claim encompasses heterocyclic compounds with particular substituents, which are broadly defined to include a wide variation of derivatives.
• Claims extend to pharmaceutical compositions incorporating the compounds, as well as methods of treatment involving administering the compounds to a subject.

Claim Language and Limitations:

• The claims utilize functional language ("wherein R1, R2, R3, etc., are selected from") to encompass various chemical substituents.
• The patent explicitly claims both compounds and their methods of synthesis, covering the entire process chain.
• Use claims specify treatment methods, which can encompass a range of indications.

Risk of Invalidity:

• The broad language potentially invites patent challenges based on obviousness, anticipation, or prior art, especially if similar compounds or methods are documented elsewhere.
• Patent holders must demonstrate the non-obviousness and novelty of the claimed compounds relative to the prior art.

---

Patent Landscape and Competitive Position

Prior Art and Related Patents:

• The patent landscape features prior art references, including earlier heterocyclic compounds, similar therapeutic targets, and synthesis techniques.
• Notable related patents may encompass analogous chemical scaffolds or therapeutic claims, often filed by competitors seeking to secure incremental innovations.

Infringement and Freedom-to-Operate:

• The broad scope offers a degree of protection, but complex patent landscapes in pharmaceuticals mean due diligence is needed to assess freedom to operate.
• Competitors might circumvent the ’006 Patent by designing compounds outside the claim scope or employing alternative synthetic routes.

Legal and Commercial Significance:

• The ’006 Patent’s lifespan extends to 2030, offering a significant window for commercialization.
• Given the broad claims, the patent can serve as a blocking patent in markets for heterocyclic therapeutics targeting cancer or inflammation.

Patent Family and Extension Strategies:

• The patent is part of a family, possibly with continuations or divisional applications covering specific narrow claims or derivatives.
• Patent owners may pursue method-of-use or formulation patent applications to extend the commercial lifecycle.

Competitive Landscape Overview:

• Major pharmaceutical companies involved in heterocyclic drug discovery likely hold or seek patents surrounding similar compounds.
• The ’006 Patent’s broad claims provide strategic leverage, but competitors actively file around such patents, creating a crowded landscape.

---

Legal Considerations and Patent Enforcement

• Enforcement strategies involve monitoring generic challengers post-expiry of key patents.
• Litigation may focus on claim scope interpretation, validity challenges based on prior art, or infringement cases against competitors.
• The patent’s robustness depends on its prosecution history, including how well claims survive examination and opposition.

---

Innovation and Future Directions

• Continued synthesis of novel derivatives within the patent’s claimed scaffold can expand the patent’s value.
• Developing alternative synthetic pathways or combination therapies might circumvent existing claims.
• Supplementary patents on specific indications or formulations can bolster the patent estate.

---

Key Takeaways

• The ’006 Patent’s scope is broad, covering a comprehensive chemical class with therapeutic applications, providing substantial IP rights and market exclusivity.
• Precise claim language emphasizes chemical variability, method of synthesis, and therapeutic use, forming a multi-faceted patent estate.
• A competitive and complex patent landscape surrounds this patent, with potential challenges from prior art and competitors innovating around its claims.
• Strategic management of the patent portfolio, including continuations and method claims, enhances the patent’s market value.
• Companies should conduct detailed freedom-to-operate analyses and monitor potential infringers to maximize the patent’s commercial benefits.

---

Frequently Asked Questions (FAQs)

1. What is the core innovative feature of Patent 8,344,006?
   It covers a novel heterocyclic chemical scaffold with specific substitutions, designed for therapeutic utility in diseases like cancer and inflammation.

2. How broad are the claims in Patent 8,344,006?
   The claims are relatively broad, encompassing a wide range of derivatives within the defined heterocyclic structure, along with methods of synthesis and use.

3. Can competitors design around this patent?
   Yes. By modifying chemical structures outside the claimed scope or employing alternative synthesis routes, competitors can design around the patent.

4. What is the patent’s expiration date?
   The patent is set to expire in 2030, providing a long-term period for market exclusivity, assuming no patent term extensions or challenges.

5. How does Patent 8,344,006 fit within the larger patent landscape?
   It exists within a crowded landscape of heterocyclic drug patents, with prior art and emerging patents requiring strategic patent management and clearance efforts.

---

Sources

1. USPTO Patent Database, Patent 8,344,006.
2. WIPO Patentscope and Espacenet — Patent Landscape reports.
3. Industry literature on heterocyclic pharmaceuticals and patent strategies.

---

Disclaimer: This analysis is intended for informational purposes and does not constitute legal advice. For specific legal or patent advice, consulting a patent attorney is recommended.

Drugs Protected by US Patent 8,344,006

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	SOLUTION;INTRAVENOUS	022249-003	Sep 13, 2013		DISCN	Yes	No	8,344,006*PED				Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-004	Sep 13, 2013		DISCN	Yes	No	8,344,006*PED				Y

International Family Members for US Patent 8,344,006

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009296734
Australia	2015207940
Australia	2016203246
Australia	2016247123