United States Patent 7,411,070: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,411,070, titled "Form of S-omeprazole," is a significant patent in the pharmaceutical industry, particularly related to the drug esomeprazole, which is the S-enantiomer of omeprazole. This patent, held by AstraZeneca, has been a focal point in various legal and pharmaceutical discussions.
Background of the Patent
The patent was issued on August 12, 2008, and is a divisional application related to U.S. Patent No. 6,369,085 ('085 Patent)[2].
- The '070 Patent is part of a larger family of patents that have protected AstraZeneca's Nexium® products since their initial FDA approval in 2001.
Scope of the Patent
Novel Form of S-Omeprazole
The patent specifically relates to a novel form of the magnesium salt of the S-enantiomer of omeprazole trihydrate, known as S-omeprazole. This form is crucial for the therapeutic efficacy and stability of the drug[1][2][4].
Processes and Pharmaceutical Compositions
The patent also covers processes for preparing this form of the magnesium salt of S-omeprazole and pharmaceutical compositions containing it. This includes intermediates used in the preparation process[1][4].
Claims of the Patent
Key Claim Terms
The primary claim term is "[t]he magnesium salt of S-omeprazole trihydrate." This term is central to all claims in both the '085 and '070 Patents. The claims include various limitations and specifications related to the preparation and composition of this magnesium salt[2].
Claim Construction
The claim construction proceedings for this patent were extensive, involving joint hearings for multiple cases against different defendants. The court had to construe the claim terms to determine infringement by generic drug manufacturers[2].
Patent Landscape
Patent Family
The '070 Patent is part of the '085 Patent Family, which includes several patents that have protected Nexium® products over the years. This family also includes patents like U.S. Patent No. 5,714,504 ('504 Patent), which has since expired[2].
Expiration and Terminal Disclaimer
The '070 Patent was subject to a terminal disclaimer, ensuring that its expiration date aligned with that of the '085 Patent, which was May 25, 2018[2].
Litigation and Challenges
The Nexium® product line has faced numerous challenges from generic drug manufacturers seeking FDA approval. AstraZeneca has engaged in extensive litigation to protect its patents, including cases against Andrx Labs, LLC, and Perrigo[2].
Impact on Generic Drug Manufacturers
Generic drug manufacturers have had to navigate the complex patent landscape to avoid infringement. For example, AstraZeneca alleged infringement of claims 1-4 and 12 of the '085 Patent against Andrx and Perrigo, highlighting the stringent protection of these patents[2].
Pharmaceutical Significance
Therapeutic Use
The magnesium salt of S-omeprazole trihydrate is used in the treatment of various gastrointestinal conditions, such as gastroesophageal reflux disease (GERD) and peptic ulcers. The stability and efficacy of this form are critical for its therapeutic use[1][4].
FDA Approval and Regulatory Aspects
The FDA has reviewed and approved various formulations of esomeprazole, including delayed-release capsules. The regulatory approval process involves ensuring that generic versions do not infringe on existing patents[5].
Patent Analytics and Claim Coverage
Claim Coverage Matrix
To manage the complex patent landscape, companies like AstraZeneca use patent analytics tools, such as Claim Coverage Matrix, to track patents by claims and scope concepts. This helps in identifying gaps or opportunities in their intellectual property protection[3].
Interactive Claim Charts
Tools like ClaimScape® software generate interactive claim charts that help technical experts determine whether a particular scope concept is applicable to a target product or method. This aids in identifying areas where claim coverage is lacking and highlights future design opportunities[3].
Key Takeaways
- Novel Form of S-Omeprazole: The patent covers a novel form of the magnesium salt of S-omeprazole trihydrate.
- Processes and Compositions: It includes processes for preparing this form and pharmaceutical compositions containing it.
- Claim Construction: Extensive claim construction proceedings were necessary to determine infringement.
- Patent Landscape: Part of the '085 Patent Family, with significant litigation history.
- Impact on Generics: Generic manufacturers must carefully navigate this patent landscape to avoid infringement.
- Therapeutic Significance: Critical for the treatment of gastrointestinal conditions.
- Regulatory Aspects: FDA approval and regulatory compliance are crucial.
FAQs
What is the primary claim term of U.S. Patent 7,411,070?
The primary claim term is "[t]he magnesium salt of S-omeprazole trihydrate."
What is the significance of the terminal disclaimer in the '070 Patent?
The terminal disclaimer ensures that the '070 Patent expires on the same date as the '085 Patent, which was May 25, 2018.
How has the patent landscape affected generic drug manufacturers?
Generic manufacturers have faced extensive litigation and must carefully navigate the patent claims to avoid infringement.
What is the therapeutic use of the magnesium salt of S-omeprazole trihydrate?
It is used in the treatment of various gastrointestinal conditions, such as GERD and peptic ulcers.
How do companies manage complex patent landscapes like that of the '070 Patent?
Companies use patent analytics tools, such as Claim Coverage Matrix and interactive claim charts, to track and analyze their patent claims.
What is the role of FDA approval in the context of this patent?
FDA approval involves ensuring that generic versions of esomeprazole do not infringe on existing patents and meet regulatory standards.
Sources
- US7411070B2 - Form of S-omeprazole - Google Patents
- Astrazeneca AB v. Andrx Labs, LLC - Casetext
- Patent Analytics | Intellectual Property Law - SLWIP
- Form of S-omeprazole - Patent US-7411070-B2 - PubChem
- Esomeprazole Magnesium Delayed-release Capsules USP, 20 mg - FDA
