United States Patent 6,933,395: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,933,395, assigned to Bayer Schering Pharma AG, is a significant patent in the pharmaceutical industry, particularly related to the production of drospirenone, a key component in several oral contraceptive drugs such as Yasmin and Yaz. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Context
The patent in question is part of a complex web of intellectual property disputes involving Bayer and generic drug manufacturers like Sandoz and Watson. These disputes often revolve around the Hatch-Waxman amendments, which allow generic manufacturers to seek expedited FDA approval by submitting an Abbreviated New Drug Application (ANDA) and a Paragraph IV certification, alleging non-infringement of the brand-name drug's patent[1].
Patent Overview
Filing and Status
The patent was filed on August 1, 2008, and is currently closed. It was litigated in the Nevada District Court, with Bayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals Inc. as the plaintiffs[2].
Invention Description
The patent describes a process for the production of drospirenone, a synthetic progestogen used in oral contraceptives. The invention involves specific chemical synthesis steps and conditions to produce drospirenone efficiently and with high purity[5].
Claims Analysis
Independent and Dependent Claims
The patent includes several independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding additional limitations.
- Independent Claims: These claims outline the core process steps for producing drospirenone, including specific chemical reactions and conditions.
- Dependent Claims: These claims build upon the independent claims by specifying additional details such as reaction temperatures, reagents, and purification methods.
Claim Scope and Coverage
The claims in this patent are designed to protect the specific process of producing drospirenone. This includes:
- The synthesis of intermediate compounds.
- The conditions under which the final product is formed.
- The purification steps to achieve high purity drospirenone.
Patent Landscape
Related Patents and Litigation
The patent is part of a larger patent portfolio related to Yasmin and Yaz. Other patents involved in the litigation include U.S. Patent No. 5,569,652, U.S. Patent No. 6,787,531, and U.S. Reissue Patents No. 37,564 and No. 37,838. These patents cover various aspects of the drugs, including their composition and additional processes[1].
Competitors and Generic Manufacturers
Generic manufacturers like Sandoz and Watson have been involved in litigation with Bayer over these patents. These companies have submitted ANDAs and Paragraph IV certifications, challenging the validity of Bayer's patents and seeking to market generic versions of Yasmin and Yaz[1].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To understand the full scope of protection provided by this patent, a Claim Coverage Matrix can be used. This matrix categorizes patents and claims by scope concepts, helping to identify gaps or opportunities in the patent landscape. For example, it can show which claims cover the technology intended to be protected and highlight areas where additional patent coverage might be needed[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review the patent coverage. These charts categorize claims by their scope concepts, indicating their value to the company:
- High-value claims that are crucial to current products.
- Medium-value claims that indicate potential future directions.
- Low-value claims that may not be worth maintaining[3].
Litigation and Procedural History
District Court Actions
The patent has been involved in multiple lawsuits in the Southern District of New York and the District of Nevada. For instance, on April 17, 2008, Bayer sued Watson and Sandoz in the Southern District of New York for patent infringement related to Yasmin, and on September 18, 2008, Bayer sued Sandoz and Watson in the same district for infringement related to Yaz[1].
Counterclaims and Consolidation
Sandoz and Watson have asserted various counterclaims involving multiple patents, including the `395 patent. The Nevada District Court consolidated the two Yaz actions, highlighting the overlapping issues between the New York and Nevada actions[1].
Doctrine of Obviousness-Type Double Patenting
This doctrine is relevant when considering the validity of patents in the same family. It prevents the extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent. This doctrine applies to all commonly-owned patents and is crucial in preventing multiple infringement suits by different assignees[4].
Key Takeaways
- Patent Scope: The patent covers a specific process for producing drospirenone, a key component in oral contraceptives.
- Claims Analysis: The patent includes independent and dependent claims that define the core process and additional details.
- Patent Landscape: The patent is part of a larger portfolio related to Yasmin and Yaz, with ongoing litigation involving generic manufacturers.
- Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for understanding and managing the patent landscape.
- Litigation: The patent has been involved in multiple lawsuits, highlighting the complexity of intellectual property disputes in the pharmaceutical industry.
FAQs
What is the main subject of United States Patent 6,933,395?
The main subject of this patent is a process for the production of drospirenone, a synthetic progestogen used in oral contraceptives.
Which companies are involved in the litigation related to this patent?
Bayer Schering Pharma AG, Bayer Healthcare Pharmaceuticals Inc., Sandoz, and Watson are involved in the litigation related to this patent.
What is the significance of the Hatch-Waxman amendments in this context?
The Hatch-Waxman amendments allow generic manufacturers to seek expedited FDA approval by submitting an ANDA and a Paragraph IV certification, which is central to the litigation involving this patent.
How does the doctrine of obviousness-type double patenting apply to this patent?
This doctrine prevents the extension of the right to exclude through claims in a later patent that are not patentably distinct from claims in a commonly owned earlier patent, which is relevant in the context of multiple patents held by Bayer.
What tools can be used to analyze the claim coverage of this patent?
Tools such as a Claim Coverage Matrix and interactive claim charts generated by software like ClaimScape® can be used to analyze the claim coverage and identify gaps or opportunities in the patent landscape.
Cited Sources
- BAYER SCHERA PHARMA AG v. SANDOZ, INC. - Casetext
- US-6933395-B1 - Unified Patents Portal
- Patent Analytics - Schwegman Lundberg & Woessner, P.A.
- IMMUNEX CORP. v. SANDOZ, INC. - CAFC
- United States Patent 6,933,395 B1 - USPTO
