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Patent landscape, scope, and claims: |
United States Patent 6,551,620: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,551,620, titled "Pellet Formulation for the Treatment of the Intestinal Tract," is a significant patent in the pharmaceutical industry, particularly in the treatment of intestinal diseases such as ulcerative colitis. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
This patent was issued to Salix Pharmaceuticals, Inc. and Dr. Falk Pharma GmbH, and it pertains to a specific formulation of mesalamine, an anti-inflammatory drug used in the treatment of bowel diseases[2][5].
Scope of the Patent
The patent 6,551,620 describes an orally administrable pharmaceutical pellet formulation designed for the controlled release of mesalamine in the intestinal tract. This formulation is engineered to release the active ingredient at a specific pH, ensuring that the drug is delivered directly to the site of inflammation in the intestines.
Claims of the Patent
The patent includes several key claims that define the scope of the invention:
- Claim 1: The patent claims a pharmaceutical pellet formulation comprising mesalamine or a pharmaceutically acceptable salt thereof, and a controlled release coating that dissolves at a pH of 6 or higher[4].
- Claim 2: This claim specifies the composition of the pellet, including the type and amount of mesalamine, and the materials used for the controlled release coating[4].
- Claim 3: This claim details the method of preparing the pellet formulation, including the steps involved in coating the pellets to achieve the desired release profile[4].
Mechanism of Action
The mesalamine in the pellet formulation works locally in the intestinal mucosa to reduce inflammation. The exact mechanism is not fully understood, but it is believed to involve the inhibition of the production of arachidonic acid metabolites, which are pro-inflammatory substances[1].
Clinical Significance
This patent is clinically significant because it provides a formulation that ensures the delivery of mesalamine directly to the site of inflammation in the intestines, enhancing the efficacy of the treatment for conditions like ulcerative colitis. The controlled release profile helps in maintaining therapeutic drug levels over an extended period, which is crucial for managing chronic conditions.
Patent Landscape
The patent landscape surrounding 6,551,620 is complex and involves multiple patents related to mesalamine formulations and their use in treating bowel diseases.
- Related Patents: There are several other patents associated with the same product, such as U.S. Patent No. 8,865,688, which also pertains to compositions and methods for treating bowel diseases. These patents collectively form a robust intellectual property portfolio protecting the product[2].
- Litigation History: The patent has been involved in litigation, notably in the case of Salix Pharmaceuticals, Inc. and Dr. Falk Pharma GmbH vs. Mylan Pharmaceuticals, Inc. and Mylan, Inc. The court ultimately ruled in favor of the defendants, finding that Mylan had not infringed the asserted claims of the ‘688 Patent, which is related to the ‘620 Patent[2].
Patent Analytics and Claim Coverage
To fully understand the protection offered by this patent, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps or opportunities in the intellectual property landscape.
- Claim Coverage Matrix: This tool shows which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. It helps in filtering, searching, and analyzing large numbers of patent claims concurrently[3].
- Claim Charts: These charts, generated by software like ClaimScape®, facilitate the review of patent coverage with technical experts. They help in determining whether a particular scope concept is applicable to a target product or method, highlighting areas where claim coverage may be lacking[3].
Impact on Pharmaceutical Industry
The patent 6,551,620 has a significant impact on the pharmaceutical industry, particularly in the development and marketing of mesalamine formulations.
- Competition: The existence of this patent and related patents can delay the entry of generic versions of mesalamine into the market. For instance, Mylan’s attempt to gain FDA approval for a generic version was delayed due to patent infringement litigation[2].
- Innovation: The patent encourages innovation by protecting the intellectual property of the inventors, allowing them to recoup their investment in research and development.
Key Takeaways
- The United States Patent 6,551,620 protects a specific pellet formulation of mesalamine for treating intestinal diseases.
- The patent includes claims that define the composition, preparation, and release profile of the pellet formulation.
- The patent is part of a broader intellectual property portfolio related to mesalamine formulations.
- Patent analytics tools are crucial for understanding the scope and coverage of this patent.
- The patent has significant implications for the pharmaceutical industry, affecting competition and innovation.
FAQs
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What is the main claim of the United States Patent 6,551,620?
- The main claim is for a pharmaceutical pellet formulation comprising mesalamine or a pharmaceutically acceptable salt thereof, with a controlled release coating that dissolves at a pH of 6 or higher[4].
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How does the mesalamine in the pellet formulation work?
- The mesalamine works locally in the intestinal mucosa to reduce inflammation by inhibiting the production of arachidonic acid metabolites[1].
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What is the clinical significance of this patent?
- The patent provides a formulation that ensures the delivery of mesalamine directly to the site of inflammation in the intestines, enhancing the efficacy of the treatment for conditions like ulcerative colitis.
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Has this patent been involved in any litigation?
- Yes, it was involved in a litigation case between Salix Pharmaceuticals, Inc. and Dr. Falk Pharma GmbH vs. Mylan Pharmaceuticals, Inc. and Mylan, Inc.[2].
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How can patent analytics tools help in understanding this patent?
- Patent analytics tools can help in categorizing patents by claims and scope concepts, identifying gaps or opportunities in the intellectual property landscape, and facilitating the review of patent coverage with technical experts[3].
Cited Sources:
- APRISO® (mesalamine) extended-release capsules - FDA Label[1].
- UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT - Salix Pharmaceuticals, Inc. vs. Mylan Pharmaceuticals, Inc.[2].
- Patent Analytics - Schwegman, Lundberg & Woessner, P.A.[3].
- US6551620B2 - Pellet formulation for the treatment of the intestinal tract - Google Patents[4].
- Case 1:12-cv-01104-GMS Document 70 Filed 08/19/13 - Insight.RPXcorp.com[5].
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