United States Patent 5,569,652: A Detailed Analysis
Overview of the Patent
United States Patent 5,569,652, titled "Dihydrospirorenone as an antiandrogen," was granted for the use of a specific compound in the production of pharmaceutical agents. This patent is particularly notable for its association with the drug Yasmin, a popular oral contraceptive.
Scope of the Patent
Invention Description
The patent describes the use of dihydrospirorenone, a compound with antiandrogenic properties, for the treatment of hormonal conditions. This compound is integral to the formulation of Yasmin, which combines dihydrospirorenone (drospirenone) with ethinyl estradiol to achieve both contraceptive and antiandrogenic effects[4].
Claims
The patent claims cover methods and compositions involving the use of dihydrospirorenone. Specifically, it claims methods for simultaneously achieving a gestagenic effect and an antiandrogenic effect, which are crucial for the therapeutic profile of Yasmin[2].
Patent Landscape Analysis
Defining Scope and Keywords
To analyze the patent landscape around U.S. Patent 5,569,652, one must define the scope of the analysis to include keywords related to dihydrospirorenone, antiandrogenic compounds, and hormonal contraceptives. This involves searching patent databases using these keywords to identify relevant patents.
Search and Organize Patents
Using patent databases, one can retrieve patents related to dihydrospirorenone and similar compounds. These patents should be organized by factors such as filing date, assignee, and technology subcategories. For instance, patents assigned to Bayer, the original holder of the '652 patent, would be of particular interest[3].
Identify Trends and Key Players
The analysis reveals that Bayer is a significant player in the field of hormonal contraceptives, with a substantial portfolio of patents related to Yasmin and its active ingredients. Other key players may include generic manufacturers like Watson and Sandoz, which have been involved in litigation related to this patent[1].
Analyze Citations and Evolution
Studying the citations and references within the patent filings can provide insights into the technological evolution and impact of the '652 patent. For example, the patent's influence can be gauged by how often it is cited in subsequent patent applications related to hormonal contraceptives and antiandrogenic compounds[3].
Legal and Regulatory Context
Hatch-Waxman Act
The '652 patent is listed in the FDA's Orange Book, which is a critical component of the Hatch-Waxman Act. This act requires pioneer drug manufacturers to notify the FDA of all patents that claim the drug for which the New Drug Application (NDA) was submitted. Generic manufacturers must then certify their position regarding these patents when filing an Abbreviated New Drug Application (ANDA)[1].
Paragraph IV Certifications
When a generic manufacturer files an ANDA, they must make a certification addressing each patent listed in the Orange Book. For the '652 patent, a generic manufacturer would need to certify that the patent is invalid, not infringed, or will not be infringed by the manufacture, use, or sale of the generic drug. This certification can trigger a patent infringement lawsuit by the patent holder within 45 days[1].
Litigation History
Infringement Cases
The '652 patent has been at the center of several infringement cases, particularly involving generic manufacturers seeking to market generic versions of Yasmin. For instance, Bayer filed lawsuits against Watson and Sandoz in the Southern District of New York alleging infringement of this patent. These cases highlight the patent's significance and the efforts of the patent holder to protect its intellectual property[1].
Impact on the Pharmaceutical Industry
Generic Competition
The '652 patent's expiration or successful challenges by generic manufacturers can significantly impact the market for Yasmin. Generic versions of Yasmin, once approved, can reduce the market share of the branded product, affecting Bayer's revenue and market dominance[2].
Innovation and R&D
The patent landscape analysis around the '652 patent also reveals trends in innovation within the pharmaceutical industry. It highlights areas of ongoing research and development in hormonal contraceptives and antiandrogenic compounds, which can guide future R&D strategies for companies in this field[3].
Key Takeaways
- Patent Scope: The '652 patent covers methods and compositions involving dihydrospirorenone, a key component of Yasmin.
- Legal Context: The patent is governed by the Hatch-Waxman Act, which requires certifications from generic manufacturers and allows for infringement lawsuits.
- Litigation: The patent has been involved in several infringement cases, particularly against generic manufacturers.
- Industry Impact: The patent's status affects the market for Yasmin and guides R&D strategies in the pharmaceutical industry.
FAQs
What is the main claim of U.S. Patent 5,569,652?
The main claim of U.S. Patent 5,569,652 involves methods for simultaneously achieving a gestagenic effect and an antiandrogenic effect using dihydrospirorenone.
How does the Hatch-Waxman Act relate to this patent?
The Hatch-Waxman Act requires the patent to be listed in the FDA's Orange Book and mandates that generic manufacturers certify their position regarding this patent when filing an ANDA.
What is the significance of Paragraph IV certifications in relation to this patent?
Paragraph IV certifications allow generic manufacturers to challenge the validity or infringement of the '652 patent, which can trigger a patent infringement lawsuit by the patent holder.
Who are the key players in the patent landscape around this patent?
Key players include Bayer, the original patent holder, and generic manufacturers like Watson and Sandoz, which have been involved in litigation related to this patent.
How does the expiration or challenge of this patent affect the pharmaceutical industry?
The expiration or successful challenge of the '652 patent can lead to the entry of generic versions of Yasmin, potentially reducing Bayer's market share and revenue, and influencing future R&D strategies in the industry.
Sources
- UNITED STATES DISTRICT COURT - Sandoz in the Southern District of New York for infringement of U.S. Patent No. 5,569,652.
- Federal Circuit Clears Way For Generic Yasmin - Foley & Lardner LLP.
- How to Do Patent Landscape Analysis - Goldstein Patent Law.
- US5569652A - Dihydrospirorenone as an antiandrogen - Google Patents.
- FDA Approved Use Prevents Hatch-Waxman Patent Infringement Claim - Westlaw.
