Details for Patent: 6,852,689

Summary for Patent: 6,852,689

Title:	Methods for administration of antibiotics
Abstract:	The invention provides methods for administering a therapeutically effective amount of daptomycin while minimizing skeletal muscle toxicity. The methods provide daptomycin administration at a dosing interval of 24 hours or greater. This long dosing interval minimizes skeletal muscle toxicity and allows for higher peak concentrations of daptomycin, which is related to daptomycin's efficacy. The invention also provides methods of administering lipopeptide antibiotics other than daptomycin while minimizing skeletal muscle toxicity by administering a therapeutically effective amount of the lipopeptide antibiotic at a dosage interval that does not result in muscle toxicity. The invention also provides methods of administering quinupristin/dalfopristin while minimizing skeletal muscle toxicity by administering a therapeutically effective amount of quinupristin/dalfopristin at a dosage interval that dos not result in muscle toxicity.
Inventor(s):	Oleson, Jr.; Frederick B. (Concord, MA), Tally; Francis P. (Lincoln, MA)
Assignee:	Cubist Pharmaceuticals, Inc. (Lexington, MA)
Application Number:	10/082,544
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,852,689
Patent Claim Types: see list of patent claims	Use;

United States Patent 6,852,689: A Detailed Analysis

Introduction

The United States Patent 6,852,689, hereafter referred to as the '689 patent, is one of the key patents involved in the litigation between Cubist Pharmaceuticals, Inc. and Hospira, Inc. This patent is part of a series of follow-on patents related to the antibiotic daptomycin, originally developed by Eli Lilly & Co. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of Daptomycin and Cubist Pharmaceuticals

Daptomycin, marketed under the brand name Cubicin, is a potent antibiotic used to treat bacterial infections. The original patent for daptomycin expired in 2002, but Cubist Pharmaceuticals obtained several follow-on patents, including the '689 patent, to extend their intellectual property protection[2][5].

Scope and Claims of the '689 Patent

The '689 patent is titled "Methods for Administration of Antibiotics" and specifically pertains to dosage regimens for administering daptomycin. The claims of this patent focus on the methods of administering daptomycin in a way that minimizes skeletal muscle toxicity, a significant side effect associated with this antibiotic[2][5].

Key Claims

• The patent claims involve administering daptomycin less frequently, typically in more concentrated doses, to reduce skeletal muscle toxicity while maintaining its antibiotic efficacy.
• These claims are based on the understanding that daptomycin's effectiveness is concentration-dependent, and thus, less frequent but more concentrated doses can enhance its antibiotic effect while reducing side effects[2].

Litigation and Validity Challenges

The '689 patent was challenged by Hospira, Inc. in their attempt to manufacture and sell a generic version of daptomycin. During the litigation, Hospira argued that the '689 patent was invalid due to obviousness.

Obviousness Findings

• The district court found that the '689 patent was invalid as obvious. This decision was based on prior art, specifically an article by James Woodworth, which reported that daptomycin would be effective at lower doses. Although the article did not explicitly address reducing skeletal muscle toxicity, the court determined that minimizing this toxicity was an inherent consequence of the disclosed dosage regimens[2][5].

Federal Circuit's Ruling

• The Federal Circuit upheld the district court's finding that the '689 patent was invalid due to obviousness. The court reasoned that those skilled in the art would have known that less-frequent, more-concentrated doses of daptomycin would enhance its antibiotic effect and reduce skeletal muscle toxicity, making the claimed methods obvious[2].

Patent Landscape Analysis

To understand the broader context of the '689 patent, a patent landscape analysis is essential.

Defining Scope and Keywords

• The analysis begins by defining the technology field, in this case, antibiotic compounds and methods of administration. Relevant keywords include "daptomycin," "dosage regimens," "skeletal muscle toxicity," and "antibiotic administration"[3].

Searching and Organizing Patents

• Using patent databases, relevant patents are identified and organized based on factors such as filing date, assignee, and technology subcategories. This helps in creating a comprehensive map of the patent landscape[3].

Identifying Trends and Key Players

• The analysis reveals trends in patent filings and identifies key players in the field. In this case, Cubist Pharmaceuticals and Eli Lilly & Co. are significant players due to their extensive work on daptomycin and related patents[3].

Analyzing Citations and Evolution

• Studying how patents reference each other provides insights into their impact and development. The '689 patent, for instance, was influenced by earlier work on daptomycin, including the original patent and other follow-on patents[3].

Competitive Landscape and Legal Vulnerabilities

The patent landscape analysis also helps in evaluating the competitive landscape and potential legal vulnerabilities.

Competitive Landscape

• The analysis shows that the market for daptomycin is highly competitive, with multiple generic manufacturers seeking to enter the market. The invalidation of the '689 patent reduces Cubist's protection and opens the market to generic competition[2][5].

Legal Vulnerabilities

• The invalidation of the '689 patent due to obviousness highlights a legal vulnerability for Cubist. This decision sets a precedent that similar dosage regimen patents may also be challenged on obviousness grounds[2].

Conclusion on the '689 Patent

The '689 patent, while initially significant for Cubist's intellectual property strategy, was ultimately found invalid due to obviousness. This outcome underscores the importance of thorough patent landscape analysis and the need for innovative and non-obvious claims in patent applications.

Key Takeaways

• The '689 patent pertains to dosage regimens for daptomycin aimed at reducing skeletal muscle toxicity.
• The patent was found invalid due to obviousness based on prior art.
• Patent landscape analysis is crucial for understanding the competitive and legal context of such patents.
• The invalidation of this patent highlights the challenges in maintaining intellectual property protection for follow-on patents.

FAQs

What is the main focus of the '689 patent?

The '689 patent focuses on methods for administering daptomycin to minimize skeletal muscle toxicity while maintaining its antibiotic efficacy.

Why was the '689 patent found invalid?

The '689 patent was found invalid due to obviousness, as the claimed methods were deemed to be inherently disclosed by prior art, specifically an article by James Woodworth.

What is the impact of the '689 patent's invalidation on Cubist Pharmaceuticals?

The invalidation of the '689 patent reduces Cubist's intellectual property protection for daptomycin, opening the market to generic competition.

How does patent landscape analysis help in understanding the '689 patent?

Patent landscape analysis helps in identifying trends, key players, and legal vulnerabilities, providing a comprehensive view of the competitive and legal context surrounding the '689 patent.

What are the implications of the Federal Circuit's ruling on the '689 patent?

The Federal Circuit's ruling sets a precedent that similar dosage regimen patents may be challenged on obviousness grounds, highlighting the need for innovative and non-obvious claims in future patent applications.

Cited Sources

1. United States Court of Appeals for the Federal Circuit - CUBIST PHARMACEUTICALS, INC. v. HOSPIRA, INC.[1]
2. Robins Kaplan LLP - Cubist Pharms., Inc. v. Hospira, Inc.[2]
3. Goldstein Patent Law - How to Do Patent Landscape Analysis[3]
4. United States Patent and Trademark Office - Search for patents[4]
5. Robins Kaplan LLP - Cubist Pharms., Inc. v. Hospira, Inc.[5]

Drugs Protected by US Patent 6,852,689

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 6,852,689

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1115417		91254	Luxembourg
European Patent Office	1115417		CA 2006 00018	Denmark
European Patent Office	1115417		300232	Netherlands
European Patent Office	1115417		06C0022	France
European Patent Office	1115417		SPC 018/2006	Ireland