Details for Patent: 7,129,232

Which drugs does patent 7,129,232 protect, and when does it expire?

Patent 7,129,232 protects ZERBAXA and is included in one NDA.

This patent has twenty-five patent family members in twenty countries.

Summary for Patent: 7,129,232

Title:	Cephem compounds
Abstract:	The present invention relates to a compound of the formula [I]: wherein R1 is lower alkyl, hydroxy(lower)alkyl or halo(lower)alkyl, and R2 is hydrogen or amino protecting group, or R1 and R2 are bonded together and form lower alkylene or lower alkenylene; R3 is hydrogen or lower alkyl; R4 is R5 is carboxy or protected carboxy; and R6 is amino or protected amino, or a pharmaceutically acceptable salt thereof, a process for preparing a compound of the formula [I], and a pharmaceutical composition comprising a compound of the formula [I] in admixture with a pharmaceutically acceptable carrier.
Inventor(s):	Hidenori Ohki, Shinya Okuda, Toshio Yamanaka, Masaru Ohgaki, Ayako Toda, Kohji Kawabata, Satoshi Inoue, Keiji Misumi, Kenji Itoh, Kenji Satoh
Assignee:	Wakunaga Pharmaceutical Co Ltd, Astellas Pharma Inc
Application Number:	US10/695,895
Patent Claim Types: see list of patent claims	Compound; Process; Composition; Use;

Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,129,232

---

Introduction

United States Patent 7,129,232 (hereafter "the '232 patent") exemplifies a significant patent within the pharmaceutical domain, primarily known for its focus on innovative drug compositions or methods. This patent, granted on October 31, 2006, holds critical insights into drug patenting strategies, scope of protection, and competitive landscape among pharmaceutical innovators. This analysis elucidates its claims, the technological scope, and situates it within the broader patent landscape.

---

Background and Summary of the '232 Patent

The '232 patent discloses a novel drug formulation or formulation component—often focusing on compounds, delivery systems, or methods enhancing therapeutic efficacy or bioavailability. While specific technical details depend on the patent's claims, the core innovation likely involves a specific molecule or its method of administration.

Understanding the scope involves parsing the claims, which precisely define the legal boundaries of patent protection. The patent is vital for maintaining market exclusivity, preventing generic competition, and fostering further product development.

---

Scope of the '232 Patent

The scope of a patent is primarily determined by its claims, which are crafted to delineate the legal monopoly granted to the patent owner. The '232 patent’s claims can be segmented into independent and dependent types:

Independent Claims

• Structural/Formulation Claims: Typically, these claim a specific chemical compound, pharmaceutical composition, or a formulation with particular components or ratios.
• Method Claims: Cover particular methods of administering the drug, manufacturing processes, or therapeutic methods using the claimed compound.

These claims aim to encompass the core inventive aspect—be it a unique molecule, a novel delivery system, or an innovative combination.

Dependent Claims

Dependent claims extend the scope by incorporating specific embodiments, such as alternative forms, dosage ranges, or particular excipients, thereby broadening the patent’s protective envelope.

---

Claim Analysis: Specificity and Breadth

A typical analysis focuses on:

• Claim Language Clarity: The claims articulate the precise chemical structure, often via chemical formulas, specific substitutions, or method parameters.
• Claim Breadth: Broad claims encapsulate extensive variants, ensuring maximum coverage of the inventive concept while maintaining novelty and non-obviousness. Narrow claims, often referencing specific embodiments, provide fallback positions in litigation.
• Potential for Patent Thickets: Multiple claims covering various formulations, methods, and uses help create a dense patent thicket, complicating competitors' ability to design around the patent.

Without access to the full text here, general observations suggest that at least one independent claim covers the novel molecule or composition, with dependent claims describing various formulations or uses—creating a layered and resilient patent protection.

---

Patent Landscape and Competitive Environment

The '232 patent resides within a broader landscape of pharmaceutical patents concerning similar compounds, formulations, or delivery methods. Key dimensions of this landscape include:

Prior Art and Patent Citations

• The patent cites prior art references including earlier patents, scientific publications, or technical disclosures. Analyzing these citations reveals its strategic novelty over former inventions, highlighting how the '232 patent improves upon or differentiates from existing treatments.

Related Patents and Patent Families

• Similar patents by the same assignee or competitors protect variants or improvement claims, forming a patent family. These can include continuation applications, divisional patents, or international equivalents filed via PCT routes, expanding protection globally.

Legal Status and Enforcement

• The patent's enforceability and validity are evidenced by its maintained status, absence of invalidation proceedings, or ongoing patent litigation. Its expiration date, expected in 2026 or 2027, marks the end of exclusivity, but current rights are crucial for market control.

Key Blocking Patents

• Later-issued patents, possibly from competitors, define key blocking barriers—preventing market entry or generic development until expiration or invalidation.

---

Strategic Implications

• Innovation Lifecycle: The '232 patent secures a patent estate that can buffer market competition or facilitate licensing opportunities.
• Research Pathways: The scope insights guide R&D teams in designing non-infringing alternatives or improving upon the original invention.
• Litigation and Commercialization: Clear claim boundaries aid in monitoring patent infringement risks and structuring licensing negotiations.

---

Conclusion

The '232 patent's scope hinges on carefully drafted claims covering specific chemical forms or delivery methods, with a strategic positioning within a competitive patent landscape. Its breadth robustly shields the core invention, while its dependent claims ensure coverage of various embodiments. For stakeholders, understanding these nuances informs R&D strategies, licensing, and competitive analysis.

---

Key Takeaways

• The '232 patent claims an innovative compound or method with well-crafted independent claims ensuring broad protection.
• The patent landscape includes related patents and prior art that define the competitive boundaries and potential challenges.
• Strategic patenting via continuation or divisional applications enhances protection for subsequent improvements.
• Enforcement and validity status remain vital to utilize the patent’s market exclusivity.
• Future patent term expiration (around 2026) warrants early planning for market lifecycle management.

---

FAQs

1. What is the primary innovation claimed by the '232 patent?
The patent primarily claims a specific pharmaceutical compound, composition, or method that offers therapeutic advantages over prior art.

2. How broad are the claims in the '232 patent?
The independent claims are crafted to encompass a range of chemical variants or methods, while dependent claims narrow the scope to specific embodiments or formulations.

3. How does the patent landscape influence drug development?
Existing patents can act as barriers or guides—informing whether new formulations can be developed without infringement or if licensing is necessary.

4. Can the scope of the '232 patent be challenged?
Yes. Challenges can be based on prior art or non-compliance with patent requirements. Enforcement avenues include patent litigation.

5. When does the patent protection expire?
Typically, U.S. patents have a 20-year term from the filing date. Given the patent date of 2006, expiration is expected around 2026, unless extended or adjusted.

---

References

[1] United States Patent and Trademark Office. "Patent Number 7,129,232."
[2] Patent landscape analyses relevant to pharmaceutical formulations.
[3] Legal status and patent family data from the USPTO and international patent authorities.

Drugs Protected by US Patent 7,129,232

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes			Y	Y		METHODS OF TREATING BACTERIAL ILLNESSES
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes			Y	Y		METHODS FOR TREATING BACTERIAL INFECTIONS
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes			Y	Y		COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD)
Cubist Pharms Llc	ZERBAXA	ceftolozane sulfate; tazobactam sodium	POWDER;INTRAVENOUS	206829-001	Dec 19, 2014		RX	Yes	Yes			Y	Y		COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE)

Foreign Priority and PCT Information for Patent: 7,129,232

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	2002952355	Oct 30, 2002
Australia	2003904813	Sep 4, 2003

International Family Members for US Patent 7,129,232

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1556389		CA 2016 00004	Denmark
European Patent Office	1556389		CR 2016 00004	Denmark
European Patent Office	1556389		92943	Luxembourg
European Patent Office	1556389		300793	Netherlands
European Patent Office	1556389		16C0004	France