Details for Patent: 5,562,925

Summary for Patent: 5,562,925

Title:	Anti-tumor method
Abstract:	Malignant tumors in animals are treated by parenterally administering to an affected animal a solution containing a complex compound of platinum in an amount effective to cause regression of the tumor.
Inventor(s):	Rosenberg; Barnett (Holt, MI), Vancamp; Loretta (East Lansing, MI), Krigas; Thomas (Okemos, MI)
Assignee:	Research Corporation Tech. Inc. (Tucson, AZ)
Application Number:	08/252,668
Patent Claim Types: see list of patent claims	Composition; Formulation;

United States Patent 5,562,925: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 5,562,925, hereafter referred to as the '925 patent, is a significant patent in the pharmaceutical industry, particularly related to the treatment of malignant tumors. This analysis will delve into the scope and claims of the patent, as well as the broader patent landscape in which it resides.

Background and Context

The '925 patent, titled "Anti-tumor method," was issued to Bristol-Myers Squibb (BMS) and pertains to a method for treating malignant tumors using a complex compound of platinum, specifically cisplatin (Platinol-AQ)[4][5].

Scope and Claims of the '925 Patent

Claims Overview

The '925 patent includes claims that describe a method for parenterally administering a solution containing a complex compound of platinum to treat malignant tumors in animals. These claims are specific to the use of cisplatin and its administration method[5].

Key Claim Elements

• The patent claims cover the use of cisplatin in treating malignant tumors.
• The method involves parenteral administration, which includes intravenous, intramuscular, or subcutaneous injection.
• The claims are limited to the specific formulation and dosage of cisplatin used in the treatment.

Patent Landscape Analysis

Defining Scope and Keywords

To analyze the patent landscape surrounding the '925 patent, one must define the relevant technology field and keywords. In this case, the focus is on anti-tumor treatments, platinum-based compounds, and specifically cisplatin[3].

Search and Organize Patents

Using patent databases, one can retrieve patents related to anti-tumor treatments and platinum-based compounds. These patents can be organized by factors such as filing date, assignee, and technology subcategories. For instance, patents filed by BMS and other pharmaceutical companies related to cisplatin would be of particular interest[3].

Identify Trends and Key Players

The analysis reveals that BMS was a key player in the development of cisplatin-based treatments. Trends in patent filings show a significant focus on improving the efficacy and safety of platinum-based anti-tumor drugs. Other key players include generic drug manufacturers that have filed Abbreviated New Drug Applications (ANDAs) for cisplatin products[1][4].

Analyze Citations and Evolution

Studying how patents reference each other helps in understanding the impact and development of the technology. The '925 patent has been cited in various subsequent patents related to anti-tumor treatments, indicating its influence on the field. Additionally, the evolution of patent claims and litigation around the '925 patent highlights the competitive and legal landscape[3].

Regulatory and Legal Considerations

Orange Book Listings

The '925 patent was listed in the FDA's Orange Book, which is a publication that identifies patents claiming a given drug product. This listing is crucial as it can trigger a 30-month stay on the approval of generic versions of the drug, pending patent litigation[1][4].

Paragraph IV Certifications

Generic drug applicants must file a Paragraph IV certification with their ANDA, stating that the listed patent is invalid, unenforceable, or not infringed. This certification can lead to patent infringement lawsuits, as seen in the case of BMS versus various ANDA applicants[1][4].

Litigation and Its Impact

Litigation surrounding the '925 patent has been significant. BMS filed patent infringement lawsuits against several ANDA applicants, which were later found to be objectively baseless. This litigation delayed the entry of generic cisplatin products into the market, affecting consumer access to affordable treatments[1].

Economic and Competitive Impact

Delay in Generic Entry

The wrongful listing of the '925 patent in the Orange Book and the subsequent baseless lawsuits delayed the entry of generic cisplatin products. This delay resulted in substantial economic harm to consumers, who were deprived of lower prices and other benefits of competition[1].

180-Day Exclusivity

The first ANDA applicant to file a Paragraph IV certification for a listed patent is eligible for 180-day exclusivity. However, this exclusivity cannot extend beyond the expiration of the patent. The '925 patent's litigation history highlights the complexities and potential disputes over exclusivity periods[4].

Expert Insights and Statistics

Industry Expert Views

Industry experts and legal practitioners have weighed in on the complexities of patent litigation and the need for clearer regulations. For example, the Administrative Conference of the United States (ACUS) has studied the feasibility of a small claims patent court to address such issues[2].

Statistical Impact

The delay in generic entry due to patent litigation can have significant statistical implications. For instance, a study might show that the average delay in generic entry due to such litigation is several years, resulting in billions of dollars in additional healthcare costs.

Case Study: BMS vs. Generic Manufacturers

Misrepresentation and Wrongful Listing

BMS was found to have provided false and misleading information to the FDA to obtain an Orange Book listing for the '925 patent. This wrongful listing triggered a 30-month stay, delaying generic entry and causing economic harm to consumers[1].

Court Decisions

The U.S. District Court for the Southern District of New York granted summary judgment in favor of generic manufacturers, finding that their ANDAs did not infringe the '925 patent and that BMS's proposed construction of the patent claim would render it invalid[1].

Key Takeaways

• The '925 patent is specific to the use of cisplatin in treating malignant tumors.
• The patent was wrongly listed in the Orange Book, leading to baseless lawsuits and delayed generic entry.
• Patent landscape analysis is crucial for understanding the competitive and legal environment surrounding a patent.
• Regulatory and legal considerations, such as Orange Book listings and Paragraph IV certifications, play a significant role in the approval and marketing of generic drugs.
• The economic impact of delayed generic entry can be substantial, affecting consumer access to affordable treatments.

FAQs

What is the '925 patent, and what does it cover?

The '925 patent covers a method for treating malignant tumors using a complex compound of platinum, specifically cisplatin.

Why was the '925 patent listed in the Orange Book?

The '925 patent was listed in the Orange Book as part of the FDA's process for identifying patents that claim a given drug product. However, it was later found that BMS provided false and misleading information to obtain this listing.

What was the impact of the wrongful listing of the '925 patent?

The wrongful listing triggered a 30-month stay, delaying the approval of generic cisplatin products and causing substantial economic harm to consumers.

How does Paragraph IV certification affect generic drug approval?

A Paragraph IV certification is filed by generic drug applicants stating that the listed patent is invalid, unenforceable, or not infringed. This can lead to patent infringement lawsuits and delays in generic drug approval.

What is the significance of 180-day exclusivity in the context of generic drugs?

The first ANDA applicant to file a Paragraph IV certification for a listed patent is eligible for 180-day exclusivity, which cannot extend beyond the expiration of the patent. This exclusivity period is crucial for generic manufacturers as it provides a market advantage.

Cited Sources:

1. Exhibit 12 - Regulations.gov
2. U.S. Patent Small Claims Court - ACUS
3. How to Do Patent Landscape Analysis - Goldstein Patent Law
4. EXHIBIT K - Regulations.gov
5. US5562925A - Anti-tumor method - Google Patents

Drugs Protected by US Patent 5,562,925

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