United States Patent 6,645,988: A Detailed Analysis
Introduction
The United States Patent 6,645,988, often referred to as the '988 patent, is a significant patent in the pharmaceutical domain, particularly related to proton pump inhibitors (PPIs). This patent is part of a series of patents associated with the formulation and use of omeprazole, a well-known PPI.
Background and Invention
The '988 patent, along with other related patents (e.g., '346, '885, '882, and '772), was invented by Dr. Jeffrey Phillips and assigned to the University of Missouri. These patents cover various formulations of omeprazole, which is marketed under the brand name Zegerid by Santarus, Inc.[5].
Claims and Scope
The '988 patent specifically deals with substituted benzimidazole dosage forms and methods of using them. Here are some key aspects of the claims:
Dosage Forms
The patent describes liquid and solid dosage forms of substituted benzimidazoles, which are proton pump inhibitors. These dosage forms are designed to improve the stability and bioavailability of the active ingredient, omeprazole[1].
Formulation Details
The patent includes detailed descriptions of the formulation process, including the use of buffers and other excipients to enhance the stability of omeprazole. It also covers various physical forms such as pills, tablets, and discs, characterized by specific shapes, structures, or sizes[1].
Method of Use
The patent outlines the methods for using these dosage forms, including the administration routes and dosages. This is crucial for ensuring the effective treatment of conditions such as gastroesophageal reflux disease (GERD) and other acid-related disorders[1].
Patent Landscape Analysis
To understand the broader context of the '988 patent, a patent landscape analysis is essential.
Related Patents
The '988 patent is part of a chain of continuations and continuations-in-part that trace back to an earlier patent, the '737 patent. This chain includes other significant patents such as the '346, '885, '882, and '772 patents, all of which are related to omeprazole formulations[2][5].
Legal Status and Expiry Dates
The '988 patent has expired, as indicated by its legal status. Understanding the expiry dates of patents is crucial for determining the timeline for generic entry and for strategic business decisions[3].
Litigation and Infringement
The '988 patent was involved in significant litigation between Santarus, Inc. and Par Pharmaceutical, Inc. Par filed an Abbreviated New Drug Application (ANDA) to market a generic version of Zegerid, leading to infringement claims by Santarus. The court found that Par’s ANDA products infringed the Phillips patents, but some claims were invalidated due to obviousness and lack of written description[2][5].
Infringement and Validity
The validity of the '988 patent was challenged in court.
Infringement
The Delaware Court found that Par’s ANDA products infringed the claims of the '988 patent, among others. However, Par did not challenge the finding of infringement on appeal[2].
Validity Challenges
The district court held that some claims of the '988 patent were invalid due to obviousness over prior art. However, the Federal Circuit later reversed some of these findings, affirming the validity of certain claims while invalidating others[5].
Impact of Court Rulings
The court rulings had significant implications for the patent landscape.
Written Description Requirement
The Federal Circuit introduced a new requirement for the written description in claims, which has important consequences for patent content and prosecution. This ruling was controversial, with Judge Pauline Newman dissenting and arguing that it would taint many properly granted patents[5].
Obviousness Over Prior Art
The court also held that most of the claims in suit were invalid on the ground of obviousness over references that explicitly taught away from the inventions in the Phillips patents. Judge Newman criticized this ruling, stating it was contrary to statute, precedent, and common sense[5].
Competitive Landscape
Understanding the competitive landscape is crucial for businesses operating in the pharmaceutical sector.
Market Developments
Patent landscape analysis reveals market developments such as mergers and acquisitions, in/out-licensing, and litigation activities. These insights help in minimizing business risks and capitalizing on opportunities[3].
Generic Entry
The expiry of the '988 patent and related patents opens the market to generic versions of omeprazole. This can significantly impact the market share of branded products like Zegerid[3].
Conclusion and Key Takeaways
- Patent Scope: The '988 patent covers specific dosage forms and methods of use for omeprazole, a proton pump inhibitor.
- Legal Status: The patent has expired, affecting its enforceability and the market for generic versions.
- Litigation: The patent was involved in significant litigation, with findings of infringement and validity challenges.
- Court Rulings: The Federal Circuit's rulings introduced new requirements for written description and obviousness, impacting patent prosecution.
- Competitive Landscape: Understanding the patent landscape is crucial for navigating market developments and strategic business decisions.
FAQs
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What is the main subject of the '988 patent?
The '988 patent primarily deals with substituted benzimidazole dosage forms and methods of using them, specifically related to omeprazole.
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Who are the inventors and assignees of the '988 patent?
The inventors are Dr. Jeffrey Phillips, and the patent is assigned to the University of Missouri.
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What was the outcome of the litigation between Santarus and Par Pharmaceutical?
The court found infringement by Par’s ANDA products, but some claims were invalidated due to obviousness and lack of written description.
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What is the current legal status of the '988 patent?
The '988 patent has expired.
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How does the expiry of the '988 patent affect the market?
The expiry allows for the entry of generic versions of omeprazole, potentially impacting the market share of branded products like Zegerid.
Cited Sources
- US6645988B2 - Substituted benzimidazole dosage forms and method of using same - Google Patents
- Santarus, Inc. v. Par Pharmaceutical, Inc. (Fed. Cir. 2012) - JD Supra
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
- Search for patents - USPTO
- Federal Circuit Revives Some Santarus Generic Zegerid Patent Claims v Par - Mandour Law
