United States Patent 5,648,497: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,648,497, hereafter referred to as the '497 patent, is a significant intellectual property asset that has been involved in several legal and regulatory proceedings. This patent, owned by AbbVie Inc., pertains to pharmaceutical formulations and has been a focal point in patent infringement disputes. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Ownership
The '497 patent was duly and legally issued by the U.S. Patent and Trademark Office (USPTO) on July 15, 1997. AbbVie Inc. is the owner of this patent by assignment and has the right to sue for infringement thereof[2][5].
Scope and Claims
The '497 patent is listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (“Orange Book”) for a specific New Drug Application (NDA) number. This indicates that the patent covers a drug or formulation that has been approved by the FDA. The claims of the '497 patent are crucial as they define the scope of the invention and what is protected under the patent.
Claim Structure
Patent claims are the heart of any patent, as they delineate the boundaries of the invention. For the '497 patent, the claims would typically include a combination of independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. Understanding the claim structure is essential for determining the scope of protection and potential infringement[3].
Reexamination Proceedings
The '497 patent has been subject to reexamination proceedings at the USPTO. Reexamination is a process where the USPTO reevaluates the patentability of an issued patent based on new prior art or other grounds. This process can result in the patent being upheld, modified, or even revoked. The fact that the '497 patent has undergone reexamination indicates that its validity and scope have been scrutinized and potentially adjusted[2][5].
Patent Landscape
The patent landscape surrounding the '497 patent involves several key aspects:
International Patent Family
The '497 patent may be part of an international patent family, where similar patents are filed in multiple jurisdictions. Tools like the Global Dossier and the Common Citation Document (CCD) can help in identifying related applications and prior art cited by different patent offices. This is crucial for understanding the global reach and potential challenges to the patent[4].
Related Patents and Litigation
The '497 patent is often mentioned alongside other patents owned by AbbVie, such as the '359, '752, '157, and '403 patents. These patents collectively form a protective barrier around AbbVie's pharmaceutical products, particularly generic versions of ritonavir tablets. Litigation involving these patents, such as the cases against Roxane Laboratories, highlights the importance of these patents in protecting AbbVie's market position[2][5].
Regulatory Environment
The '497 patent operates within a complex regulatory environment, particularly under the Federal Food, Drug, and Cosmetic Act. Generic drug manufacturers, like Roxane, must navigate this landscape by filing Abbreviated New Drug Applications (ANDAs) and addressing patent certifications. The interactions between patent law and regulatory approvals are critical in this context[5].
Search and Analysis Tools
To analyze the '497 patent and its landscape, several tools and databases are available:
USPTO Databases
The USPTO provides various databases and tools, such as the Patent Public Search, Global Dossier, and the Patent Examination Data System (PEDS). These resources allow for detailed searches, access to file histories, and analysis of patent claims and citations[4].
International Databases
Databases like PATENTSCOPE from WIPO, esp@cenet from the European Patent Office, and others from international intellectual property offices, provide access to global patent information. These resources are essential for a comprehensive analysis of the patent's international scope and potential challenges[4].
Impact on Market and Industry
The '497 patent, along with other related patents, significantly impacts the pharmaceutical market. It protects AbbVie's proprietary formulations, preventing generic competition until the patent expires. This protection allows AbbVie to maintain market exclusivity and pricing power, which is critical for the company's revenue and profitability.
Generic Competition
Generic drug manufacturers often challenge these patents through ANDA filings and patent infringement litigation. The outcome of these challenges can significantly affect the market dynamics, as the entry of generic drugs can reduce prices and increase competition[2][5].
Key Takeaways
- Ownership and Scope: The '497 patent is owned by AbbVie Inc. and covers specific pharmaceutical formulations.
- Claims and Reexamination: The patent's claims define its scope, and it has undergone reexamination proceedings.
- Patent Landscape: The patent is part of a broader landscape involving related patents and international filings.
- Regulatory Environment: The patent interacts closely with FDA regulations and ANDA filings.
- Tools and Analysis: Various USPTO and international databases are available for detailed analysis.
- Market Impact: The patent protects AbbVie's market exclusivity and pricing power, affecting generic competition.
FAQs
Q: What is the significance of the '497 patent in the pharmaceutical industry?
A: The '497 patent is significant as it protects AbbVie's proprietary pharmaceutical formulations, preventing generic competition and maintaining market exclusivity.
Q: How does the reexamination process affect the '497 patent?
A: The reexamination process can result in the patent being upheld, modified, or revoked, which can impact its validity and scope.
Q: What tools are available for searching and analyzing the '497 patent?
A: Tools like the USPTO's Patent Public Search, Global Dossier, and international databases such as PATENTSCOPE and esp@cenet are available.
Q: How does the '497 patent interact with FDA regulations?
A: The patent interacts with FDA regulations through ANDA filings and patent certifications, which generic drug manufacturers must address.
Q: What is the impact of the '497 patent on generic drug manufacturers?
A: The patent prevents generic drug manufacturers from entering the market until it expires, thereby maintaining AbbVie's market exclusivity and pricing power.
Sources
- Clemson University Library Guides: Advanced Patent Searching.
- Rpxcorp Insight: Litigation Documents - AbbVie vs. Roxane Laboratories.
- USPTO: Patent Claims Research Dataset.
- USPTO: Search for Patents.
- Rpxcorp Insight: Litigation Documents - AbbVie vs. Roxane Laboratories.
