Analyzing the Scope and Claims of United States Patent 8,852,636
Introduction
United States Patent 8,852,636, issued on October 7, 2014, is one of the patents received by Pozen, Inc., and later acquired by Horizon Pharma plc. This patent is part of a series of patents related to the drug VIMOVO, a combination of esomeprazole and naproxen used for the treatment of certain gastrointestinal conditions. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Background of the Patent
The patent in question, U.S. Patent 8,852,636, is titled "Pharmaceutical Compositions for the Coordinated Delivery of Naproxen and Esomeprazole" and is assigned to Horizon Pharma plc. This patent is significant as it protects the formulation and delivery method of VIMOVO, a drug that combines the anti-inflammatory effects of naproxen with the acid-reducing properties of esomeprazole[2].
Scope of the Patent
The scope of U.S. Patent 8,852,636 encompasses the specific formulation and delivery system of VIMOVO. Here are the key aspects:
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include a combination of naproxen and esomeprazole. These compositions are designed to provide coordinated delivery of both active ingredients, ensuring that the naproxen is released in a manner that minimizes gastrointestinal irritation, while the esomeprazole reduces stomach acid to protect the stomach lining[2].
Delivery System
The patent details a unique delivery system that involves a delayed-release formulation for esomeprazole and an immediate-release formulation for naproxen. This dual-release mechanism ensures that the esomeprazole starts acting after a delay, providing a protective environment for the stomach, while the naproxen is released immediately to start its anti-inflammatory action[2].
Claims of the Patent
The claims of U.S. Patent 8,852,636 are crucial as they define the boundaries of what is protected under the patent. Here are some key claims:
Independent Claims
- The patent includes independent claims that describe the pharmaceutical composition comprising naproxen and esomeprazole in specific formulations.
- These claims specify the delayed-release and immediate-release characteristics of the esomeprazole and naproxen, respectively[2].
Dependent Claims
- Dependent claims further detail the specific ratios of naproxen to esomeprazole, the types of excipients used, and the manufacturing processes involved.
- These claims also cover various aspects of the delivery system, including the coating materials and the release profiles of the active ingredients[2].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding VIMOVO.
Related Patents
- U.S. Patent 8,852,636 is part of a family of patents related to VIMOVO. Other patents, such as U.S. Patent 8,858,996 and U.S. Patent 8,865,190, also cover different aspects of the drug, including its process of preparation and additional formulations[2].
Listing in the Orange Book
- The patents related to VIMOVO, including U.S. Patent 8,852,636, are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This listing is crucial for protecting the drug from generic competition and ensuring that any generic versions must demonstrate bioequivalence and comply with the patented formulations[2].
International Patent Considerations
While U.S. Patent 8,852,636 is specific to the United States, it is important to consider the global patent landscape.
Global Dossier
- The Global Dossier service provided by the USPTO allows users to view the patent family for a specific application, including related applications filed at participating IP Offices. This service can help in understanding the global reach of similar patents[1].
International Patent Offices
- Searching databases from other international intellectual property offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and the World Intellectual Property Organization (WIPO), can provide insights into whether similar patents exist or are pending in other countries[1].
Economic and Strategic Impact
The economic and strategic impact of U.S. Patent 8,852,636 is significant.
Market Protection
- The patent provides market protection for VIMOVO, allowing Horizon Pharma plc to maintain exclusivity and prevent generic competition until the patent expires. This protection is crucial for the company's revenue and market share[2].
Innovation and Research
- The patent also encourages innovation and research by providing a financial incentive for companies to invest in the development of new drugs and formulations. The exclusive rights granted by the patent allow companies to recoup their investment in research and development[4].
Legal and Regulatory Framework
The legal and regulatory framework surrounding U.S. Patent 8,852,636 is governed by the America Invents Act (AIA).
First-Inventor-to-File System
- The AIA introduced a first-inventor-to-file system, which gives priority to the first person to file a patent application for an invention, rather than the first person to invent it. This system aligns the U.S. patent system with international standards and reduces the complexity of priority disputes[5].
Key Takeaways
- Patent Scope and Claims: U.S. Patent 8,852,636 covers the specific formulation and delivery system of VIMOVO, including the delayed-release and immediate-release characteristics of esomeprazole and naproxen.
- Patent Landscape: The patent is part of a family of patents related to VIMOVO and is listed in the FDA’s Orange Book.
- International Considerations: Global Dossier and international patent offices provide insights into the global reach of similar patents.
- Economic and Strategic Impact: The patent protects market exclusivity and encourages innovation and research.
- Legal and Regulatory Framework: The patent is governed by the first-inventor-to-file system under the AIA.
FAQs
Q: What is the main subject of U.S. Patent 8,852,636?
A: The main subject is the pharmaceutical composition and delivery system for the combination of naproxen and esomeprazole, known as VIMOVO.
Q: How does the delivery system of VIMOVO work?
A: The delivery system involves a delayed-release formulation for esomeprazole and an immediate-release formulation for naproxen.
Q: Why is U.S. Patent 8,852,636 listed in the Orange Book?
A: It is listed to protect the drug from generic competition and ensure that any generic versions comply with the patented formulations.
Q: What is the significance of the Global Dossier service in relation to this patent?
A: The Global Dossier service allows users to view related applications filed at participating IP Offices, providing insights into the global reach of similar patents.
Q: How does the America Invents Act (AIA) affect the priority of U.S. Patent 8,852,636?
A: The AIA introduces a first-inventor-to-file system, giving priority to the first person to file a patent application for an invention.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Biospace - Pozen, Inc. Announces Receipt Of Three Patents: https://www.biospace.com/pozen-inc-announces-receipt-of-three-patents-from-b-the-united-states-patent-and-trademark-office-b
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- U.S. Department of Commerce - U.S. Patent and Trademark Office: https://www.commerce.gov/bureaus-and-offices/uspto
- CAFC - SNIPR TECHNOLOGIES LIMITED v. ROCKEFELLER UNIVERSITY: https://cafc.uscourts.gov/opinions-orders/22-1260.OPINION.7-14-2023_2157777.pdf
