United States Patent 6,248,741: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 6,248,741, hereafter referred to as the '741 Patent, is a significant intellectual property asset held by Allergan, Inc. This patent pertains to a method of using brimonidine for neuroprotective purposes, specifically in the treatment of glaucoma and other ocular conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Context
The '741 Patent was granted in 2001 as part of Allergan's efforts to develop and protect new uses for brimonidine, a drug initially known for its intraocular pressure (IOP) reducing properties. The patent is a continuation of earlier patent applications and is listed in the FDA's "Orange Book," which provides notice to generic drug manufacturers of patents that cover approved new drugs[2][4].
Claims of the '741 Patent
The '741 Patent claims a method of using brimonidine as a neuroprotective agent to treat glaucoma and other ocular neural injuries. The claims are narrowly defined to cover this specific use, distinguishing it from other uses of brimonidine, such as reducing IOP.
Claim 1: Method of Use
Claim 1 of the '741 Patent specifically outlines the method of using brimonidine to protect the optic nerve and treat glaucoma. This claim is crucial as it defines the scope of protection for the patented method[2][4].
Claim Limitations
During the prosecution of the patent, Allergan had to limit its claims to avoid rejection for obviousness. Initially, claims for using brimonidine to reduce IOP were rejected, leading Allergan to focus on the neuroprotective aspects of the drug[2].
Patent Landscape and Related Patents
The '741 Patent is part of a family of patents related to brimonidine, including the '415 Patent (U.S. Patent No. 6,194,415). These patents collectively form a robust intellectual property portfolio for Allergan.
Global Dossier and Patent Family
Using tools like the Global Dossier provided by the USPTO, one can view the patent family for the '741 Patent, including related applications filed at participating IP Offices. This helps in understanding the global scope and citations related to these patents[1].
Common Citation Document (CCD)
The CCD application consolidates prior art citations from participating IP Offices, providing a single point of access to citation data for the '741 Patent and its family members. This is particularly useful for analyzing the patent's validity and scope[1].
Litigation and Infringement Claims
The '741 Patent has been at the center of several legal disputes, particularly with generic drug manufacturers seeking to market their own versions of brimonidine.
Allergan v. Alcon Laboratories
In the case of Allergan, Inc. v. Alcon Laboratories, Inc., Allergan contended that Alcon's filing of an Abbreviated New Drug Application (ANDA) with a Paragraph IV Certification constituted an act of infringement under Section 271(e)(2)(A) of the patent laws. However, the court ruled that Alcon's proposed generic drug, labeled for IOP reduction and not neuroprotection, did not infringe the '741 Patent[2][4].
Infringement and Inducement Claims
Allergan argued that Alcon's actions would induce infringement by doctors prescribing the generic drug for neuroprotective purposes. However, the court found that Alcon's filing of the ANDA was insufficient to support a claim of induced infringement[2][4].
Regulatory Framework and FDA Approval
The '741 Patent is subject to the regulatory framework governing generic drug approvals. The Hatch-Waxman Act allows generic drug manufacturers to file ANDAs, which can lead to earlier market entry if the pioneer drug's patent is challenged or expires.
ANDA Process and Certifications
Under the ANDA process, generic manufacturers must certify the status of the pioneer drug's patent. If a Paragraph IV Certification is filed, the patent owner has 45 days to sue for infringement. This process allows generic drugs to come to market quickly while also enabling challenges to the validity of the pioneer drug's patent[2][4].
Patent Analytics and Claim Coverage
To effectively manage and analyze the '741 Patent, companies can use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities.
Claim Coverage Matrix
A Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to the '741 Patent. This matrix helps in understanding the scope of protection and identifying any gaps or opportunities[3].
Claim Charts and Scope Concepts
Interactive claim charts generated by tools like ClaimScape® can be used to review patent coverage with technical experts. These charts categorize claims by scope concepts, making it easier to determine if a particular scope concept is applicable to a target product or method[3].
Key Takeaways
- Specific Use Claims: The '741 Patent claims a specific method of using brimonidine for neuroprotection, distinguishing it from other uses.
- Litigation History: The patent has been involved in significant litigation regarding infringement claims by generic drug manufacturers.
- Regulatory Compliance: The patent is subject to the Hatch-Waxman Act and the ANDA process, which governs generic drug approvals.
- Patent Analytics: Effective management of the patent involves using analytics tools to categorize claims and identify coverage gaps.
Frequently Asked Questions (FAQs)
1. What is the primary claim of the '741 Patent?
The primary claim of the '741 Patent is a method of using brimonidine as a neuroprotective agent to treat glaucoma and other ocular neural injuries.
2. How did the '741 Patent come into existence?
The '741 Patent was granted in 2001 as a continuation of earlier patent applications, after Allergan limited its claims to avoid rejection for obviousness.
3. What is the significance of the '741 Patent in the context of generic drug approvals?
The '741 Patent is significant because it affects the timing and approval process of generic versions of brimonidine, particularly through the ANDA process and Paragraph IV Certifications.
4. How does the Global Dossier help in analyzing the '741 Patent?
The Global Dossier provides access to the file histories of related applications from participating IP Offices, allowing users to view the patent family and citations related to the '741 Patent.
5. What tools can be used to analyze the claim coverage of the '741 Patent?
Tools like Claim Coverage Matrix and Claim Charts generated by ClaimScape® software can be used to analyze the claim coverage and identify gaps or opportunities in the patent landscape.
Cited Sources:
- USPTO - Search for patents https://www.uspto.gov/patents/search
- Allergan, Inc. v. Alcon Laboratories, Inc. https://casetext.com/case/allergan-inc-v-alcon-laboratories-inc-3
- Patent Analytics | Intellectual Property Law https://www.slwip.com/services/patent-analytics/
- Alcon Laboratories Inc. v. Allergan, Inc. https://case-law.vlex.com/vid/alcon-laboratories-inc-v-886140923
