United States Patent 6,387,383: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,387,383, titled "Topical Low-Viscosity Gel Composition," is a significant patent in the pharmaceutical industry, particularly in the treatment of skin diseases and disorders. This patent, issued on May 14, 2002, is held by Dow Pharmaceutical Sciences, Inc. and exclusively licensed to Medicis Pharmaceutical Corporation. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignees
The '383 patent lists three inventors: Gordon J. Dow, Robert W. Lathrop, and Debra A. Dow. Dow Pharmaceutical Sciences, Inc. is the sole assignee of this patent, with Medicis Pharmaceutical Corporation holding the exclusive license[2].
Scope of the Patent
The '383 patent relates to a topical gel composition designed for the treatment of skin diseases and disorders, such as acne vulgaris. The invention encompasses both the composition itself and the methods of administering and preparing it. This includes a low-viscosity gel formulation that is more easily applied and absorbed by the skin, enhancing the efficacy of the treatment[2].
Claims of the Patent
The '383 patent contains fifty-nine claims, with three independent claims (claims 1, 18, and 37). These claims are crucial as they define the scope of the invention and what is protected under the patent.
- Claim 1: This claim is directed to the topical gel composition itself, specifying the ingredients and their proportions.
- Claims 18 and 37: These claims pertain to the methods of preparing and administering the gel composition, respectively[2].
Claim Construction and Interpretation
In patent litigation, the construction of claims is a critical step. The court must determine the ordinary and customary meaning of the claim terms as understood by a person of ordinary skill in the art at the time of the invention. This involves analyzing the claims within the context of the entire patent, including the specification and drawings[2].
Patent Litigation and Enforcement
The '383 patent has been involved in significant litigation, notably in the case of Medicis Pharm. Corp. v. Actavis Mid Atl. LLC. In this Hatch-Waxman action, Medicis and Dow Pharmaceutical Sciences alleged infringement by Actavis Mid Atlantic LLC. The case centered on the claim construction and the validity of the '383 patent. The defendants filed counterclaims for declaratory judgments of non-infringement and invalidity of the patent[2].
Orange Book Listing
The '383 patent, along with U.S. Reissue Patent No. 41,134, is listed in the FDA's Orange Book, which covers Medicis's Ziana® gel. This listing is significant as it indicates that these patents are considered to protect the intellectual property related to Ziana®, a gel containing clindamycin phosphate and tretinoin used to treat skin diseases like acne vulgaris[2].
Patent Expiration and Intellectual Property Protection
The '383 patent expired on August 3, 2020. This expiration date marks the end of the exclusive rights granted to the patent holders, allowing generic versions of the gel composition to enter the market. Prior to its expiration, any other patents related to desonide gel, another topical treatment, had already expired according to Skin Medica's knowledge[1].
Patent Analytics and Landscape
Understanding the patent landscape is crucial for companies to protect their intellectual property and identify gaps or opportunities. Patent analytics tools, such as Claim Coverage Matrix and Claim Charts, help in categorizing patents by claims and scope concepts. These tools enable companies to filter, search, and analyze large numbers of patent claims efficiently, highlighting areas where claim coverage is lacking and identifying future design opportunities[3].
Impact on Pharmaceutical Industry
The '383 patent has had a significant impact on the pharmaceutical industry, particularly in the development and marketing of topical gel compositions for skin treatments. The exclusive rights granted by this patent allowed Medicis and Dow Pharmaceutical Sciences to dominate the market for a substantial period. Post-expiration, the entry of generic versions is expected to increase competition and potentially reduce costs for consumers.
Key Takeaways
- Invention Scope: The '383 patent covers a topical low-viscosity gel composition and methods for its preparation and administration.
- Claims: Fifty-nine claims, with three independent claims defining the scope of the invention.
- Litigation: Involved in significant Hatch-Waxman litigation against Actavis Mid Atlantic LLC.
- Orange Book Listing: Listed to protect Medicis's Ziana® gel.
- Patent Expiration: Expired on August 3, 2020.
- Patent Analytics: Important for understanding and managing the patent landscape.
FAQs
Q: Who are the inventors of the '383 patent?
A: The inventors are Gordon J. Dow, Robert W. Lathrop, and Debra A. Dow.
Q: What is the primary use of the gel composition described in the '383 patent?
A: The gel composition is used for the treatment of skin diseases and disorders, such as acne vulgaris.
Q: Which companies are involved in the exclusive licensing of the '383 patent?
A: Dow Pharmaceutical Sciences, Inc. is the assignee, and Medicis Pharmaceutical Corporation holds the exclusive license.
Q: What is the significance of the '383 patent being listed in the Orange Book?
A: It indicates that the patent protects the intellectual property related to Medicis's Ziana® gel.
Q: When did the '383 patent expire?
A: The '383 patent expired on August 3, 2020.
Cited Sources
- FDA Center for Drug Evaluation and Research, "Administrative Information and Product Labeling," August 3, 2000.
- Casetext, "Medicis Pharm. Corp. v. Actavis Mid Atl. LLC," June 12, 2012.
- Schwegman, Lundberg & Woessner, P.A., "Patent Analytics," accessed December 20, 2024.
