United States Patent 6,469,030: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,469,030, titled "Methods for the treatment and prevention of ileus," is a significant patent in the pharmaceutical industry, particularly in the realm of gastrointestinal health. This patent, issued to Adolor Corporation (now part of Cubist Pharmaceuticals), outlines methods for treating and preventing ileus, a condition characterized by the temporary halt of the normal contractions of the bowel muscles.
Background of the Patent
The patent was granted on October 22, 2002, and it has been a subject of interest in various legal and pharmaceutical contexts. Ileus, the condition targeted by this patent, can be postoperative, paralytic, or mechanical, and the methods described aim to alleviate or prevent these conditions using specific pharmaceutical agents.
Scope of the Patent
The scope of the patent is defined by its claims, which are the legally binding descriptions of the invention. Here are some key aspects:
Claims Overview
The patent includes multiple claims that describe the methods of treating and preventing ileus. These claims are divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims further specify or limit the independent claims[3].
Key Claims
- Claims 20, 31, 49, and 53 are particularly notable as they have been involved in litigation. These claims specify the administration of peripheral mu opioid receptor antagonists to treat or prevent ileus[2][5].
Chemical Compounds
The patent describes the use of specific chemical compounds, including peripheral mu opioid receptor antagonists. These compounds are designed to selectively target opioid receptors in the gastrointestinal tract without affecting the central nervous system[1].
Patent Landscape and Litigation
The patent landscape surrounding US 6,469,030 is complex and has been the subject of several legal disputes.
Litigation Involvement
- The patent has been involved in several ANDA (Abbreviated New Drug Application) litigation cases. For example, in the case of Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., the patent was cited along with another patent (8,946,262) in a dispute over the generic version of Entereg (alvimopan capsules), which is used to treat postoperative ileus[2][5].
REMS Patents and Generic Approval
The patent is also linked to the discussion around REMS (Risk Evaluation and Mitigation Strategies) patents. REMS programs are regulatory requirements that can delay generic drug approvals. The listing of REMS-related patents, such as this one, in the Orange Book can create barriers for generic manufacturers, leading to potential infringement claims and delays in market entry[5].
Patent Scope Metrics
The scope of the patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics are indicators of patent breadth and clarity. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation and Generic Entry
The breadth and validity of patents like US 6,469,030 can significantly impact innovation and generic entry in the pharmaceutical market. Broader patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. The specific claims and scope of this patent have been scrutinized to ensure they do not overly broaden the patent's reach and stifle competition[3][5].
Regulatory and Legal Scrutiny
The patent has faced regulatory and legal scrutiny, particularly regarding its listing in the Orange Book and its impact on generic drug approvals. There have been proposals to delist REMS patents from the Orange Book and to subject them to more rigorous scrutiny in courts and at the U.S. Patent and Trademark Office (PTO)[5].
Expert Opinions and Statistics
Industry experts and legal scholars have weighed in on the implications of such patents. For instance, Michael A. Carrier and Brenna Sooy suggest that REMS patents, including those like US 6,469,030, should be subject to more stringent review to prevent them from blocking generic entry unnecessarily[5].
Statistics
- According to some studies, narrower claims at publication are associated with a higher probability of grant and a shorter examination process. For example, a study found that patents with shorter independent claims had a 20% higher grant rate compared to those with longer claims[3].
Conclusion and Key Takeaways
- Patent Scope and Claims: The patent outlines specific methods for treating and preventing ileus using peripheral mu opioid receptor antagonists.
- Litigation and Regulatory Impact: The patent has been involved in several ANDA litigation cases and is linked to REMS patents, which can delay generic drug approvals.
- Metrics and Analysis: The scope of the patent can be measured using independent claim length and count, indicating its breadth and clarity.
- Impact on Innovation: The patent's breadth and validity can affect innovation and generic entry, with broader patents potentially increasing costs and diminishing incentives.
- Regulatory Scrutiny: There are ongoing discussions and proposals to subject REMS patents to more rigorous scrutiny to prevent unnecessary barriers to generic entry.
Key Takeaways
- The patent describes methods for treating and preventing ileus using specific pharmaceutical agents.
- It has been involved in significant litigation related to generic drug approvals.
- The scope and claims of the patent are critical in determining its impact on innovation and competition.
- Regulatory scrutiny and proposals aim to ensure that such patents do not overly restrict generic entry.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 6,469,030?
The main subject of this patent is the methods for the treatment and prevention of ileus, a condition characterized by the temporary halt of the normal contractions of the bowel muscles.
What are the key claims of this patent?
The key claims include the administration of peripheral mu opioid receptor antagonists to treat or prevent ileus, specifically claims 20, 31, 49, and 53.
How has this patent been involved in litigation?
This patent has been involved in several ANDA litigation cases, particularly in disputes over generic versions of drugs like Entereg (alvimopan capsules).
What is the impact of REMS patents like US 6,469,030 on generic drug approvals?
REMS patents can delay generic drug approvals by creating barriers such as infringement claims and regulatory requirements that must be met before a generic version can be approved.
How can the scope of this patent be measured?
The scope can be measured using metrics such as independent claim length and independent claim count, which indicate the patent's breadth and clarity.
Cited Sources:
- US6469030B2 - Methods for the treatment and prevention of ileus - Google Patents
- ANDA Litigation Settlements | Robins Kaplan LLP Law Firm
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- EXHIBIT 1 - Regulations.gov
- FIVE SOLUTIONS TO THE REMS PATENT PROBLEM - Boston University Law Review
