Understanding the Scope and Claims of United States Patent 8,889,191
Introduction
United States Patent 8,889,191, titled "Sustained-Release Formulations of Topiramate," is a crucial patent held by Supernus Pharmaceuticals, Inc. This patent is part of a broader portfolio related to the pharmaceutical product Trokendi XR®, a sustained-release formulation of topiramate. Here, we will delve into the details of the patent's scope, claims, and the surrounding patent landscape.
Patent Overview
The '191 patent was issued on November 18, 2014, to Supernus Pharmaceuticals, Inc., upon assignment from inventors Likan Liang, Hua Wang, Padmanabh P. Bhatt, and Michael L. Vieira[2][4].
Claim Construction
Claim construction is a critical aspect of patent law, as it determines the scope of protection afforded by the patent. For the '191 patent, the claim construction involves several key terms.
Definition of "Continuous"
One of the disputed terms is "continuous." During the prosecution of the '191 patent, the applicants clarified that "continuous" means "simply ‘without interruption,'” without defining the amount of drug release. This interpretation is supported by statements in the patent prosecution history, where it was noted that "[t]he term ‘continuous' does not define the amount of drug release, only the manner in which it is released (i.e., ‘continuously’)"[1].
Extrinsic Evidence
In addition to intrinsic evidence, extrinsic evidence such as dictionary definitions and expert reports can be used to support the proposed claim construction. For example, the expert report of Mansoor A. Khan, R.Ph., Ph.D., has been cited to support Supernus's proposed construction[1].
Scope of the Patent
The '191 patent covers sustained-release formulations of topiramate, which is a medication used for various neurological conditions, including epilepsy and migraines. The patent describes specific formulations and methods for achieving sustained release, which are critical for maintaining therapeutic efficacy over an extended period.
Embodiments and Examples
The patent specification includes several embodiments and examples of sustained-release formulations. These embodiments are detailed to provide a clear understanding of what the invention encompasses. However, the claims must be anchored to these embodiments to avoid issues of overbreadth and invalidation[3].
Patent Landscape
The '191 patent is part of a larger portfolio of patents related to Trokendi XR®. This portfolio includes several other patents, such as U.S. Patent Nos. 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,992,989, 9,549,940, 9,555,004, 9,622,983, and 10,314,790[2][4].
Litigation and Infringement
The '191 patent has been involved in several litigation cases where Supernus has alleged infringement by generic drug manufacturers. For instance, Supernus has sued companies like Dr. Reddy’s Laboratories, Inc. and Apotex, Inc. for filing Abbreviated New Drug Applications (ANDAs) that allegedly infringe on the patents in suit, including the '191 patent[2][4].
Importance of Claim Scope
The scope of the claims in the '191 patent is crucial for its validity and enforceability. A common misconception is that broader claims are always better, but this is not the case. Broader claims can be more difficult to get granted and are easier to invalidate due to issues such as the abstract idea exception and failure to meet the written description requirement[3].
Avoiding Overbreadth
To avoid these issues, patent drafters must ensure that the claims are not overly broad. The claims should be grounded in the specific embodiments described in the specification. This balance is essential for maintaining the strength and validity of the patent[3].
Industry Impact
The '191 patent and its associated portfolio have significant implications for the pharmaceutical industry. These patents protect Supernus's investment in research and development, allowing the company to maintain market exclusivity for Trokendi XR®. This exclusivity is critical for Supernus's business strategy and revenue generation[5].
Expert Insights
Industry experts emphasize the importance of precise claim construction and scope. For example, Letao Qin notes that "getting the claim scope right is arguably more important than getting a patent" because it directly affects the patent's validity and enforceability[3].
Statistical Significance
The impact of these patents can be seen in the financial reports of Supernus Pharmaceuticals. For instance, the company's revenue from Trokendi XR® is a significant portion of its total revenue, highlighting the importance of these patents in protecting their market share[5].
Conclusion
The '191 patent is a vital component of Supernus Pharmaceuticals' intellectual property portfolio, particularly in the context of Trokendi XR®. Understanding the scope and claims of this patent is essential for navigating the complex landscape of pharmaceutical patents.
Key Takeaways
- Claim Construction: The term "continuous" in the '191 patent means "without interruption" based on the patent prosecution history.
- Scope of the Patent: The patent covers specific sustained-release formulations of topiramate.
- Patent Landscape: The '191 patent is part of a larger portfolio related to Trokendi XR®.
- Litigation: The patent has been involved in several infringement cases against generic drug manufacturers.
- Importance of Claim Scope: Precise claim scope is crucial for the validity and enforceability of the patent.
- Industry Impact: The patent protects Supernus's market exclusivity and revenue generation.
FAQs
Q: What is the '191 patent related to?
A: The '191 patent is related to sustained-release formulations of topiramate, a medication used for neurological conditions.
Q: What does the term "continuous" mean in the context of the '191 patent?
A: The term "continuous" means "without interruption" as clarified during the patent prosecution.
Q: Why is precise claim scope important for the '191 patent?
A: Precise claim scope is important to avoid issues of overbreadth and to ensure the patent's validity and enforceability.
Q: Which companies have been sued by Supernus for allegedly infringing the '191 patent?
A: Supernus has sued companies like Dr. Reddy’s Laboratories, Inc. and Apotex, Inc. for alleged infringement.
Q: How does the '191 patent impact Supernus Pharmaceuticals' business?
A: The patent protects Supernus's market exclusivity and is crucial for their revenue generation from Trokendi XR®.
Sources
- Supernus Pharm. v. Ajanta Pharma., Civ. 21-6964 (GC)
- United States, Title 35, United States Code, involving United States Patent Nos. 8,298,576, etc.
- The Importance of Getting the Claim Scope Right in a US Patent Application
- UNITED STATES DISTRICT COURT EASTERN DISTRICT OF NEW JERSEY
- UNITED STATES SECURITIES AND EXCHANGE COMMISSION
