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Last Updated: December 25, 2024

Details for Patent: 6,165,513


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Summary for Patent: 6,165,513
Title: Film-coated tablet for improved upper gastrointestinal tract safety
Abstract:A novel oral dosage to be delivered to the stomach comprising a safe and effective amount of an active ingredient selected from the group consisting of emepronium bromidebromide, doxycycline, and other tetracyclines/antibiotics, iron preparations, quinidine, nonsteroidal anti-inflammatory drugs, alprenolol, ascorbic acid, captopril, theophylline, zidovoudine (AZT), bisphosphonates and mixtures thereof and pharmaceutically-acceptable excipients, wherein said oral dosage form is a generally oval form and film coated to facilitate rapid esophageal transit and avoid irritation in the mouth, buccal cavity, pharynx, and esophagus.
Inventor(s): Dansereau; Richard John (Mason, OH), Bekker; Petrus Jakobus (Cincinnati, OH)
Assignee: The Procter & Gamble Co. (Cincinnati, OH)
Application Number:09/095,322
Patent Claim Types:
see list of patent claims
Dosage form; Delivery; Composition;
Patent landscape, scope, and claims:

United States Patent 6,165,513: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 6,165,513, hereafter referred to as the '513 patent, is a significant patent in the pharmaceutical sector, particularly involving the treatment of osteoporosis. This analysis will delve into the scope and claims of the patent, as well as the broader patent landscape in which it resides.

Background of the Patent

The '513 patent, titled "Method for treating osteoporosis," was granted to a pharmaceutical company and involves a method for the treatment of osteoporosis using bisphosphonates. The patent is part of a series of patents related to the treatment of bone diseases and has been the subject of several legal disputes and claim construction analyses[1].

Claim Scope and Construction

The claim scope of the '513 patent is crucial for understanding its protection and enforcement. Here are some key aspects of the claim construction:

Claim Language

The claims in the '513 patent describe a method for treating osteoporosis, which includes the administration of bisphosphonates. The language is specific about the treatment process, emphasizing the monthly administration of the drug[1].

Claim Construction Analysis

In a significant court case, the claim construction of the '513 patent was analyzed in detail. The court construed key terms such as "treating or inhibiting" and "a subject in need of such treatment." For instance, "treating or inhibiting" was defined as "taking measures to counteract, prevent, retard, or interfere with the progression of a disease or disorder." Similarly, "a subject in need of such treatment" was defined as "a patient who has osteoporosis or has experienced bone loss or is otherwise at risk of developing osteoporosis"[1].

Prosecution History

The prosecution history of the patent also played a significant role in claim construction. The court considered the specification and the prosecution history to correct drafting errors and ensure that the claims were consistent with the intended invention. For example, the court corrected a drafting error to ensure that the claim language aligned with the specification and prosecution history[1].

Importance of Claim Scope

The scope of the claims in a patent application is critical for several reasons:

Broad vs. Narrow Claims

While broader claims may offer broader protection, they are more difficult to get granted and easier to invalidate. A common misconception is that broader claims are always better, but this is not the case. Broader claims can run afoul of the abstract idea exception and fail to meet the written description requirement[3].

Anchoring to Embodiments

Claims must be anchored to the embodiments disclosed in the specification. Overly broad claims that go beyond the specific details disclosed can lead to invalidation. The '513 patent's claims were carefully constructed to align with the specific treatment method described in the specification[3].

Patent Landscape

The patent landscape surrounding the '513 patent is complex and involves multiple stakeholders and related patents.

Related Patents

The '513 patent is part of a larger family of patents related to osteoporosis treatment. Other patents, such as U.S. Patent Nos. 7,192,938 and 7,718,634, also deal with similar treatments and have been subject to claim construction analyses and legal disputes[1].

International Patent Search

To understand the global patent landscape, it is essential to conduct searches in international patent databases. Resources such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide access to international patent applications and granted patents. This helps in identifying prior art and ensuring that the claims do not infringe on existing patents globally[4].

Public Search Facilities

The United States Patent and Trademark Office (USPTO) offers various tools and facilities for patent searching, including the Patent Public Search tool, Global Dossier, and Patent and Trademark Resource Centers (PTRCs). These resources are invaluable for conducting thorough searches and understanding the patent landscape[4].

Legal Disputes and Enforcement

The '513 patent has been involved in several legal disputes, including infringement claims and counterclaims of non-infringement, invalidity, and unenforceability.

Claim Construction Hearings

A Markman hearing was held to construct the claims of the '513 patent, which is a critical step in patent litigation. The court's construction of the claims can significantly impact the outcome of infringement and validity disputes[1].

Counterclaims and Defenses

Defendants in these cases often assert counterclaims of non-infringement, invalidity, and unenforceability. The success of these counterclaims can depend on the claim construction and the strength of the patent's specification and prosecution history[1].

Industry Impact

The '513 patent and similar patents in the osteoporosis treatment field have significant implications for the pharmaceutical industry.

Market Domination

Patents like the '513 patent can provide a competitive edge in the market by excluding others from using similar methods for treating osteoporosis. This can lead to market domination and significant revenue for the patent holder[3].

Innovation and Research

The existence of these patents can also drive innovation by encouraging research into new and improved methods for treating osteoporosis. Companies may invest in research and development to find alternative treatments that do not infringe on existing patents[3].

Key Takeaways

  • Claim Construction: The scope and construction of claims are critical for patent enforcement and validity.
  • Prosecution History: The prosecution history and specification are essential for ensuring that claims align with the intended invention.
  • Patent Landscape: Understanding the global patent landscape is crucial for identifying prior art and avoiding infringement.
  • Legal Disputes: Claim construction hearings and counterclaims are common in patent litigation and can significantly impact the outcome.
  • Industry Impact: Patents in the pharmaceutical sector can drive innovation and market competition.

FAQs

What is the main subject of U.S. Patent 6,165,513?

The main subject of U.S. Patent 6,165,513 is a method for treating osteoporosis using bisphosphonates.

How are the claims in the '513 patent constructed?

The claims in the '513 patent are constructed to describe a specific method for treating osteoporosis, including the monthly administration of bisphosphonates, and are anchored to the embodiments disclosed in the specification.

Why is claim construction important in patent litigation?

Claim construction is crucial because it defines the scope of protection and can significantly impact the outcome of infringement and validity disputes.

What resources are available for conducting international patent searches?

Resources such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide access to international patent applications and granted patents.

How can overly broad claims affect a patent's validity?

Overly broad claims can lead to invalidation due to the abstract idea exception and failure to meet the written description requirement.

Sources

  1. IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ... - U.S. District Court for the District of Delaware[1].
  2. US-D813372-S1 - Pharmaceutical tablet | Unified Patents - Unified Patents[2].
  3. The Importance of Getting the Claim Scope Right in a US Patent ... - Rimon Law[3].
  4. Search for patents - USPTO - United States Patent and Trademark Office[4].
  5. Court Report - Patent Docs - Patent Docs[5].

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Drugs Protected by US Patent 6,165,513

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

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