United States Patent 8,536,206: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,536,206, hereafter referred to as the '206 Patent, is a critical component of AstraZeneca's intellectual property portfolio, particularly in the context of the pharmaceutical product DALIRESP® (roflumilast). This patent is part of a family of patents that protect novel processes for the preparation of high-purity roflumilast, a drug used in the treatment of chronic obstructive pulmonary disease (COPD) and other airway disorders.
Background of the Patent
The '206 Patent, issued on July 12, 2012, is titled "Novel processes for the preparation of high-purity roflumilast"[4].
- It is one of the patents in a series that includes U.S. Patent Nos. 8,604,064 and 8,618,142, collectively known as the Patents-at-Issue[1][2].
Scope of the Patent
Claim Coverage
The '206 Patent contains 29 claims, all of which are focused on methods for the preparation of high-purity roflumilast. These claims are divided into several categories:
- Process Claims: These claims describe specific methods for synthesizing roflumilast, including steps such as crystallization, purification, and formulation[4].
- Product Claims: These claims cover the pharmaceutical compositions and dosage forms of roflumilast produced through the patented processes[1].
Claim Construction
The interpretation of the term "roflumilast" within the patent is crucial. The plaintiffs argue that "roflumilast" should be construed as a product of the processes disclosed in the patent specifications. However, defendants initially argued that the term should be given its plain and ordinary meaning, although they later aligned with the plaintiffs' construction[1].
Key Claims and Their Significance
Claim 1
Claim 1 is a representative claim that sets the tone for the rest of the patent:
- It describes a process for preparing high-purity roflumilast involving specific steps of synthesis and purification[4].
Claim Scope and Concepts
The claims in the '206 Patent are categorized based on scope concepts, which help in understanding the patent landscape. These concepts include:
- Synthesis Methods: Detailed steps for synthesizing roflumilast.
- Purification Techniques: Methods for achieving high purity of the drug.
- Pharmaceutical Compositions: Formulations and dosage forms of roflumilast[3].
Patent Landscape and Analytics
Patent Analytics Tools
To understand the full scope and coverage of the '206 Patent, patent analytics tools are essential. These tools help in:
- Tracking Patents by Claims and Scope Concepts: Categorizing patents by claims and overarching scope concepts to filter, search, and analyze large numbers of patent claims concurrently[3].
- Claim Charts: Generating interactive claim charts to review patent coverage with technical experts, identifying gaps in current coverage and future design opportunities[3].
Gaps and Opportunities
Using patent analytics, companies can identify:
- High-Value Claims: Claims that are currently valuable to the company.
- Medium-Value Claims: Claims indicating potential future directions.
- Low-Value Claims: Claims that may not be worth maintaining[3].
Litigation and Enforcement
The '206 Patent has been involved in several litigation cases, particularly against generic drug manufacturers seeking to market their own versions of roflumilast.
AstraZeneca vs. Aurobindo Pharma
In one notable case, AstraZeneca sued Aurobindo Pharma Limited and its subsidiary for patent infringement related to their Abbreviated New Drug Application (ANDA) for a generic version of DALIRESP®. The lawsuit sought to prevent the FDA from approving the generic version until the expiration of the '206, '064, and '142 Patents[2].
Claim Construction Disputes
The litigation also involved disputes over the construction of the term "roflumilast." The court's interpretation of this term was crucial in determining the scope of the patent and whether the generic versions infringed upon it[1].
Jurisdiction and Venue
The jurisdiction and venue for these litigation cases are often determined by the defendants' business activities and contacts within the United States. For instance, in the case against Aurobindo Pharma, the court had personal jurisdiction over the defendants due to their systematic contacts with the State of New Jersey[2].
Conclusion
The United States Patent 8,536,206 is a pivotal patent in AstraZeneca's portfolio, protecting novel processes for the preparation of high-purity roflumilast. Understanding the scope, claims, and patent landscape of this patent is crucial for both the patent holder and potential infringers.
Key Takeaways
- Novel Processes: The patent covers novel methods for synthesizing and purifying roflumilast.
- Claim Construction: The term "roflumilast" is interpreted in the context of the patented processes.
- Patent Analytics: Tools like claim charts and scope concepts help in analyzing and managing the patent landscape.
- Litigation: The patent has been involved in several infringement cases against generic drug manufacturers.
- Jurisdiction: Personal jurisdiction is often determined by the defendants' business activities within specific states.
FAQs
Q: What is the main subject of the United States Patent 8,536,206?
A: The main subject is novel processes for the preparation of high-purity roflumilast.
Q: How many claims are included in the '206 Patent?
A: The patent includes 29 claims.
Q: What is the significance of claim construction in the '206 Patent?
A: Claim construction, particularly of the term "roflumilast," is crucial in determining the scope of the patent and potential infringement.
Q: How do patent analytics tools help in managing the '206 Patent?
A: These tools help in categorizing claims, identifying gaps in coverage, and highlighting future design opportunities.
Q: What is the basis for jurisdiction in litigation cases involving the '206 Patent?
A: Jurisdiction is often based on the defendants' systematic business contacts within specific states, such as New Jersey.
Sources
- In re Certain Consol. Roflumilast Cases, Civ. Action No. - Casetext
- John E. Flaherty Ravin P. Patel MCCARTER & ENGLISH LLP Four ... - Insight.RPXCorp
- Patent Analytics | Intellectual Property Law - SLWIP
- United States Patent - googleapis.com - PatentImages.Storage.Googleapis.com
