Understanding the Scope and Claims of United States Patent 6,177,074
Introduction
United States Patent 6,177,074, titled "Polyethylene glycol modified interferon therapy," is a significant patent in the field of biologic drugs, particularly for the treatment of viral infections such as hepatitis C. This article delves into the details of the patent's scope, claims, and the broader patent landscape surrounding it.
Patent Overview
The patent, filed by Schering Corporation (now part of Merck & Co.), was granted on January 23, 2001. It describes a method for treating patients suspected of having hepatitis C infection using a polyethylene glycol (PEG) modified interferon alpha conjugate in combination with ribavirin[1][2].
Inventors and Assignee
The inventors listed on the patent are Paul Glue, David L. Cutler, and Melton B. Affrime, all affiliated with Schering Corporation at the time of the patent application[1][2].
Patent Claims
The patent includes several claims that outline the specific methods and dosages for the treatment:
- Claim 1: A method for treating a patient suspected of having hepatitis C infection by administering a conjugate comprising PEG and interferon alpha-2b in combination with ribavirin. The dosage of the conjugate ranges from 0.5 μg/kg to 2.0 μg/kg, administered once or twice per week in single or divided doses[1][2].
- Claim 2: The method of claim 1 where the conjugate is administered in an amount of 0.5 μg/kg twice per week.
- Claim 3: The method of claim 1 where the conjugate is administered in an amount of 2.0 μg/kg once per week.
- Claim 4: The method of claim 1 where the conjugate is administered in an amount of 0.5, 1.0, or 1.5 μg/kg once per week[1][2].
Patent Scope
The scope of the patent is focused on the therapeutic use of PEGylated interferon alpha-2b in combination with ribavirin for treating viral infections, specifically chronic hepatitis C. This modification improves the pharmacokinetics of interferon, allowing for less frequent dosing and potentially better patient compliance.
International Patent Landscape
The patent has been filed and granted in several countries, including the United States, South Africa, and through the World Intellectual Property Organization (WIPO). Each country has its own estimated expiration date for the patent, which can vary based on local patent laws and any extensions or adjustments made during the patent's lifetime[1][2].
Expiration Dates
The expiration dates for the patent vary by country:
- United States: The primary patents related to this technology have already expired or are nearing expiration, opening the door for biosimilars.
- Other Countries: Expiration dates can be accessed through subscription-based services that track patent expirations globally[1][2].
Impact on Biologic Drugs
This patent has been pivotal in the development of biologic drugs for treating hepatitis C. The use of PEGylated interferon has become a standard treatment approach, enhancing the efficacy and convenience of interferon therapy. As the patent expires, it allows for the development and approval of biosimilars, which can provide more affordable treatment options for patients.
Biosimilars and Generic Competition
With the expiration of the patent, biosimilar versions of PEGylated interferon alpha-2b can enter the market. Biosimilars are biologic products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved biologic drug. This competition can drive down costs and increase access to treatment for patients with hepatitis C[1].
Legal and Regulatory Framework
The USPTO and other international patent offices play crucial roles in managing the patent landscape. Tools like the Global Dossier and Common Citation Document (CCD) help in tracking and analyzing patent families and citations across different jurisdictions, facilitating a more integrated global patent system[4].
Conclusion
United States Patent 6,177,074 has been a cornerstone in the treatment of hepatitis C, leveraging the benefits of PEGylated interferon alpha-2b. As the patent expires, it opens up opportunities for biosimilars to enter the market, potentially reducing costs and increasing treatment accessibility. Understanding the scope and claims of this patent is essential for both pharmaceutical companies and healthcare providers navigating the evolving landscape of biologic drugs.
Key Takeaways
- Patent Title: Polyethylene glycol modified interferon therapy
- Inventors: Paul Glue, David L. Cutler, Melton B. Affrime
- Assignee: Schering Corporation (now Merck & Co.)
- Claims: Focus on methods and dosages for treating hepatitis C using PEGylated interferon alpha-2b and ribavirin
- International Filings: Filed in multiple countries with varying expiration dates
- Impact: Pivotal in biologic drug development for hepatitis C treatment
- Biosimilars: Expiration allows for biosimilar competition, potentially reducing treatment costs
FAQs
Q1: What is the main focus of United States Patent 6,177,074?
The main focus of the patent is on a method for treating hepatitis C infection using a polyethylene glycol (PEG) modified interferon alpha conjugate in combination with ribavirin.
Q2: Who are the inventors listed on the patent?
The inventors are Paul Glue, David L. Cutler, and Melton B. Affrime.
Q3: What are the key claims of the patent?
The claims outline specific methods and dosages for administering PEGylated interferon alpha-2b in combination with ribavirin for treating hepatitis C.
Q4: How does the PEG modification improve the treatment?
The PEG modification improves the pharmacokinetics of interferon, allowing for less frequent dosing and potentially better patient compliance.
Q5: What happens as the patent expires?
As the patent expires, it opens up opportunities for biosimilar versions of the drug to enter the market, potentially reducing treatment costs and increasing accessibility.
Sources
- Drug Patent Watch: Summary for Patent: 6,177,074.
- Drug Patent Watch: When do biologic drug patents expire and when will biosimilars be available?
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for patents.
