United States Patent 5,900,424: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 5,900,424, hereafter referred to as the '424 patent, is a significant patent in the pharmaceutical industry, particularly related to the antacid medication omeprazole magnesium. This patent is held by AstraZeneca AB and its affiliates, and it plays a crucial role in the protection of their intellectual property related to the popular antacid Prilosec.
Background and Context
The '424 patent is part of a broader patent family that includes several other patents related to omeprazole and its various formulations. These patents are listed in the FDA's Orange Book, which is a comprehensive list of approved drugs and their associated patents[4].
Claims and Scope
Independent Claims
The '424 patent includes several independent claims that define the scope of the invention. The most critical claim is Independent Claim 1, which specifies that the omeprazole magnesium must exhibit at least 70% crystallinity in its structure as revealed by x-ray powder diffraction. This crystallinity requirement is a key distinguishing feature of the patented invention[4].
Claim Construction
The claim construction of the '424 patent has been the subject of several legal proceedings. The court has interpreted the claim language to ensure that any competing product must meet the specified crystallinity requirement to avoid infringement. For instance, if a competing product's omeprazole magnesium does not show more than 70% crystallinity, it does not infringe the patent[4].
Patent Landscape
Related Patents
The '424 patent is part of a larger patent family that includes other significant patents such as U.S. Patent No. 5,690,960 (the '960 patent) and U.S. Patent No. 5,714,504 (the '504 patent). These patents cover various aspects of omeprazole formulations, including the over-the-counter version of Prilosec distributed by Proctor & Gamble under license from AstraZeneca[4].
Expiration and Exclusivity
The '960 patent expired on November 25, 2014, and the '504 patent expired on February 3, 2015. The pediatric exclusivity periods associated with these patents also expired in 2015. However, the '424 patent remains in force, continuing to protect AstraZeneca's intellectual property related to omeprazole magnesium[5].
Litigation and Legal Proceedings
The '424 patent has been involved in several patent infringement cases. For example, in the case of AstraZeneca AB v. Dr. Reddy's Laboratories, Ltd., AstraZeneca alleged that Dr. Reddy's Laboratories' product infringed the claims of the '424 patent among others. The court's interpretation of the claim language was crucial in determining whether the competing product infringed the patent[4].
Claim Validity and Infringement
In various legal proceedings, the validity and infringement of the '424 patent have been challenged. For instance, in the case against Mylan Pharmaceuticals, Mylan filed counterclaims asserting invalidity and non-infringement of several patents, including the '424 patent. However, the court ultimately ruled on the validity and infringement of these patents based on the claim construction and evidence presented[2].
Impact on the Pharmaceutical Industry
The '424 patent and its associated patents have significant implications for the pharmaceutical industry. They protect the intellectual property of AstraZeneca, allowing the company to maintain market exclusivity for its omeprazole magnesium products. This exclusivity can impact the entry of generic competitors into the market, affecting the availability and pricing of antacid medications.
Metrics for Patent Scope
The scope of the '424 patent can be analyzed using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For instance, narrower claims, as seen in the '424 patent with its specific crystallinity requirement, are often associated with higher patent quality and a lower likelihood of litigation[3].
Conclusion
The United States Patent 5,900,424 is a critical component of AstraZeneca's intellectual property portfolio related to omeprazole magnesium. The patent's claims, particularly the requirement for 70% crystallinity, have been subject to detailed legal scrutiny. Understanding the scope and claims of this patent is essential for navigating the complex patent landscape in the pharmaceutical industry.
Key Takeaways
- The '424 patent protects omeprazole magnesium with a specific crystallinity requirement.
- The patent is part of a broader patent family including the '960 and '504 patents.
- The patent has been involved in several infringement cases and has been subject to claim construction and validity challenges.
- The scope of the patent can be analyzed using metrics such as independent claim length and count.
- The patent's exclusivity impacts the entry of generic competitors into the market.
Frequently Asked Questions (FAQs)
What is the main claim of the '424 patent?
The main claim of the '424 patent specifies that the omeprazole magnesium must exhibit at least 70% crystallinity in its structure as revealed by x-ray powder diffraction.
Which other patents are related to the '424 patent?
The '424 patent is related to other patents such as U.S. Patent No. 5,690,960 (the '960 patent) and U.S. Patent No. 5,714,504 (the '504 patent), which cover various aspects of omeprazole formulations.
What is the current status of the '424 patent?
The '424 patent remains in force, continuing to protect AstraZeneca's intellectual property related to omeprazole magnesium.
How has the '424 patent been involved in litigation?
The '424 patent has been involved in several patent infringement cases, including cases against Dr. Reddy's Laboratories and Mylan Pharmaceuticals, where the validity and infringement of the patent were challenged.
What impact does the '424 patent have on the pharmaceutical industry?
The '424 patent protects AstraZeneca's market exclusivity for omeprazole magnesium products, affecting the entry of generic competitors and the pricing of antacid medications.
Cited Sources:
- Astrazeneca AB, Akeiebolaget : CIVIL ACTION NO. 14-803 - USCOURTS-njd-3_15-cv-01057
- UNITED STATES DISTRICT COURT DISTRICT OF NEW JERSEY - Finnegan
- Patent Claims and Patent Scope - Hoover Institution
- AstraZeneca AB v. Dr. Reddy's Laboratories, Ltd. - Casetext
- Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg - FDA Access Data
