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]: ##STR00001## wherein R.sup.1 is lower alkyl, hydroxy(lower)alkyl or halo(lower)alkyl, and R.sup.2 is hydrogen or amino protecting group, or R.sup.1 and R.sup.2 are bonded together and form lower alkylene or lower alkenylene; R.sup.3 is hydrogen or lower alkyl; R.sup.4 is ##STR00002## R.sup.5 is carboxy or protected carboxy; and R.sup.6 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):	Ohki; Hidenori (Osaka, JP), Okuda; Shinya (Osaka, JP), Yamanaka; Toshio (Osaka, JP), Ohgaki; Masaru (Osaka, JP), Toda; Ayako (Osaka, JP), Kawabata; Kohji (Osaka, JP), Inoue; Satoshi (Takata-gun, JP), Misumi; Keiji (Takata-gun, JP), Itoh; Kenji (Takata-gun, JP), Satoh; Kenji (Takata-gun, JP)
Assignee:	Astellas Pharma Inc. (Tokyo, JP) Wakunaga Pharmaceutical Co., Ltd (Osaka, JP)
Application Number:	10/695,895
Patent Claim Types: see list of patent claims	Compound; Process; Composition; Use;

United States Patent 7,129,232: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 7,129,232, titled "Cephem compounds," is a significant patent in the pharmaceutical industry, particularly in the development of cephalosporin antibiotics. This patent, issued on October 31, 2006, to inventors including Hidenori Ohki, Shinya Okuda, and others, has been the subject of various legal and regulatory proceedings. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.

Inventors and Assignees

The patent was invented by a team of researchers including Hidenori Ohki, Shinya Okuda, Toshio Yamanaka, Masaru Ohgaki, Ayako Toda, Kohji Kawabata, Satoshi Inoue, Keiji Misumi, Kenji Itoh, and Kenji Satoh. The patent is owned by Astellas and Wakunaga Pharmaceutical Co., Ltd., through assignments recorded with the USPTO[1].

Patent Scope and Claims

The patent describes a class of cephem compounds, which are a type of cephalosporin antibiotic. These compounds are defined by specific chemical structures, where R1 and R2 are specified as lower alkyl, hydroxy(lower)alkyl, or halo(lower)alkyl, and hydrogen, respectively[4].

Chemical Structure

The patent details the chemical formula and structure of these cephem compounds, which are crucial for their antibacterial properties. The specificity of these structures is key to the patent's claims, as it defines the scope of protection for the inventors' work[4].

Claims

The patent includes multiple claims that define the invention. These claims are critical as they demarcate the boundaries of the patent owner’s rights. The claims must be specific enough to capture the essence of the invention but broad enough to provide meaningful protection. However, as discussed later, the breadth of these claims can be a point of contention in patent litigation[3].

Regulatory Approval and Patent Term Extension

The product covered by this patent received regulatory approval under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 355(b)) on December 19, 2014. Following this approval, the patent holders applied for a patent term extension under 35 USC 156, which allows for the extension of a patent term to compensate for the time spent in regulatory review[1][5].

Patent Term Extension Application

The application for patent term extension included detailed information about the regulatory review period and the dates of commercial marketing approval. The USPTO applies several statutory limitations to determine the actual period of patent extension, and in this case, the applicants sought 1,302 days of patent term extension[5].

Patent Term and Expiration

The original patent term was set to expire on October 30, 2023, based on the 20-year term from the filing date of October 30, 2003. However, due to patent term adjustments under 35 USC 154(b), the patent received an additional 357 days, extending its expiration to October 21, 2024[1].

Patent Landscape in the Pharmaceutical Industry

The pharmaceutical industry, particularly the segment dealing with antibiotics and biologics, is heavily reliant on robust and predictable patent protection. However, recent jurisprudence, especially from the Federal Circuit, has made it challenging to obtain and maintain broad patent claims, particularly genus claims[3].

Genus Claims and Enablement

Genus claims, which cover a class of compounds rather than specific embodiments, are common in pharmaceutical patents. However, the Federal Circuit's rigid application of Section 112(a) of the patent statute has made it difficult for innovators to claim the full scope of their inventions. This has led to a situation where innovators are caught between claiming too broadly and risking invalidation or claiming too narrowly and allowing competitors to design around the claims[3].

Impact on Pharmaceutical and Biotechnology Industries

The current patent landscape has significant implications for the pharmaceutical and biotechnology industries. The inability to secure broad and meaningful patent protection can hinder innovation and investment in these fields. The market for therapeutic antibodies, for example, is projected to reach $300 billion by 2025, but the lack of robust patent protection could stifle growth in this area[3].

Litigation and Regulatory Challenges

Patent litigation and regulatory challenges are common in the pharmaceutical industry. The number of patent cases, including those related to infringement, validity, and enforceability, has seen a steady increase. The rise in filings with the Patent Trial and Appeal Board (PTAB) and the Court of Appeals for the Federal Circuit (CAFC) reflects the complexity and contentious nature of patent disputes in this sector[2].

PTAB and CAFC Cases

The PTAB has seen a significant rise in inter partes reviews and post-grant reviews, which are mechanisms for challenging the validity of patents. The CAFC, which hears appeals from the PTAB and district courts, has also seen an increase in patent cases, indicating the ongoing legal battles over patent rights in the pharmaceutical industry[2].

Generic Competition and Market Impact

The approval of generic drugs has significantly impacted the pharmaceutical market. Generic drugs now account for 89% of prescriptions dispensed in the U.S. but only 26% of total medicine spending. This shift has led to increased filings and approvals of Abbreviated New Drug Applications (ANDAs) by the FDA, further complicating the patent landscape for brand-name drugs[2].

Key Takeaways

• Patent Scope and Claims: The patent covers specific cephem compounds with defined chemical structures.
• Regulatory Approval: The product received FDA approval under section 505(b) of the Federal Food, Drug, and Cosmetic Act.
• Patent Term Extension: The patent term was extended due to regulatory review periods.
• Patent Landscape: The pharmaceutical industry faces challenges in securing broad patent claims due to recent jurisprudence.
• Litigation and Regulatory Challenges: The industry is marked by frequent patent litigation and regulatory challenges.

FAQs

What is the main subject of United States Patent 7,129,232?

The main subject of United States Patent 7,129,232 is a class of cephem compounds, which are a type of cephalosporin antibiotic.

Who are the inventors and assignees of this patent?

The inventors include Hidenori Ohki, Shinya Okuda, Toshio Yamanaka, and others. The patent is assigned to Astellas and Wakunaga Pharmaceutical Co., Ltd.

What is the significance of genus claims in pharmaceutical patents?

Genus claims are crucial in pharmaceutical patents as they allow for the protection of a class of compounds rather than specific embodiments. However, recent jurisprudence has made it challenging to secure broad genus claims.

How has the patent term of US 7,129,232 been extended?

The patent term was extended under 35 USC 156 to compensate for the time spent in regulatory review, adding 357 days to the original expiration date.

What are the implications of the current patent landscape for the pharmaceutical industry?

The current patent landscape, with its strict application of Section 112(a), hinders innovation and investment in the pharmaceutical and biotechnology industries by making it difficult to secure broad and meaningful patent protection.

Cited Sources

1. United States Patent and Trademark Office - Application for Patent Term Extension[1].
2. Seyfarth Shaw LLP - The BioLoquitur Bulletin[2].
3. DigitalCommons@NYLS - Eviscerating Patent Scope[3].
4. Google Patents - Cephem compounds[4].
5. Federal Register - Patent Term Restoration Application for ZERBAXA[5].

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
European Patent Office	1556389		122015000113	Germany