United States Patent 11,103,494: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 11,103,494, titled "Methylphenidate extended release chewable tablet," is a significant patent in the pharmaceutical industry, particularly in the treatment of attention-deficit/hyperactivity disorder (ADHD). This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent describes an oral methylphenidate extended release tablet that can be scored and still retain its extended release profile. Methylphenidate is a commonly used medication for ADHD, and the development of an extended release formulation enhances patient compliance and therapeutic efficacy.
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific features and limitations of the invention. Here are some key aspects:
Claim Structure
The patent includes multiple claims, each detailing different aspects of the invention. For example:
- Independent Claims: These claims define the standalone invention, such as the composition and structure of the methylphenidate extended release tablet.
- Dependent Claims: These claims build upon the independent claims, adding additional features or limitations, such as the scoring feature that allows the tablet to be divided without compromising its extended release profile[5].
Claim Examples
- Claim 1: This claim might describe the basic composition of the methylphenidate extended release tablet, including the active ingredient, excipients, and the extended release mechanism.
- Claim 5: This could detail the scoring feature, specifying how the tablet is designed to be scored and the materials used to ensure the extended release profile is maintained[5].
Claims Analysis
Independent Claims
Independent claims are crucial as they define the core invention. For instance, Claim 1 might read:
- "An oral methylphenidate extended release tablet comprising methylphenidate, at least one extended release excipient, and at least one scoring line, wherein the tablet retains its extended release profile when scored along the scoring line."
Dependent Claims
Dependent claims add specificity and additional features to the independent claims. For example:
- "The tablet of Claim 1, wherein the extended release excipient is selected from the group consisting of hydroxypropyl methylcellulose, ethylcellulose, and polyvinyl acetate."
Patent Landscape
Related Patents
The patent landscape for methylphenidate extended release formulations is complex, with several related patents. For instance:
- US Patent 9,545,399: This patent, also owned by Tris Pharma, Inc., covers other aspects of methylphenidate extended release formulations, including different excipients and manufacturing processes[2].
Competitors and Litigation
The pharmaceutical industry is highly competitive, and patent litigation is common. Tris Pharma, Inc. has been involved in litigation with Teva Pharmaceuticals USA, Inc. regarding the infringement of several patents, including the '494 and '495 patents, which are related to the '494 patent in question[2].
Litigation and Enforcement
Infringement Allegations
Teva Pharmaceuticals USA, Inc. has been accused of infringing the '494 patent by seeking FDA approval for a generic version of QuilliChew ER®, a methylphenidate extended release chewable tablet. Tris Pharma, Inc. alleges that Teva's actions constitute infringement under 35 U.S.C. § 271(e)(2)[2].
Statutory Requirements
The litigation involves compliance with statutory requirements, such as the Paragraph IV certification under 21 U.S.C. § 355(j)(2)(B)(iv), which requires the generic drug applicant to certify that the patent in question is invalid or will not be infringed by the manufacture, use, or sale of the new drug[2].
Patent Term and Expiration
The '494 patent is set to expire on August 14, 2033. This expiration date is critical for both the patent holder and potential generic manufacturers, as it marks the end of the exclusive rights granted by the patent[2].
Obviousness-Type Double Patenting (ODP)
While not directly applicable to the '494 patent, the concept of ODP is relevant in the broader patent landscape. ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a previously granted patent. This is particularly important in cases where patents have been granted with different patent terms due to adjustments like Patent Term Adjustment (PTA)[1].
Global Dossier and International Implications
The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices. This can be useful for understanding the global patent family and any international implications or filings related to the '494 patent[4].
Public Search and Access
The USPTO Public Search Facility and online databases provide public access to patent information, including the full text of patents and related documentation. This facilitates research and analysis of patents like the '494 patent[4].
Economic and Research Implications
The Patent Claims Research Dataset by the USPTO provides detailed information on claims from U.S. patents, which can be used to analyze trends and scope measurements. This dataset can help in understanding the broader economic and research implications of patents like the '494 patent[3].
Key Takeaways
- Scope and Claims: The patent defines a methylphenidate extended release tablet with a scoring feature, ensuring the extended release profile is maintained.
- Patent Landscape: The patent is part of a complex landscape involving related patents and ongoing litigation.
- Litigation and Enforcement: The patent is subject to infringement allegations and statutory compliance requirements.
- Patent Term: The patent expires on August 14, 2033.
- Global and Public Access: The patent is part of a global dossier and accessible through public search facilities.
FAQs
What is the main invention described in US Patent 11,103,494?
The main invention is an oral methylphenidate extended release tablet that can be scored and still retain its extended release profile.
Who is the owner of US Patent 11,103,494?
The owner of the patent is Tris Pharma, Inc.
What is the significance of the scoring feature in the patent?
The scoring feature allows the tablet to be divided without compromising its extended release profile, enhancing patient compliance.
Is there ongoing litigation related to this patent?
Yes, Tris Pharma, Inc. is involved in litigation with Teva Pharmaceuticals USA, Inc. regarding infringement allegations.
When does the patent expire?
The patent is set to expire on August 14, 2033.
Sources:
- In re Cellect - United States Court of Appeals for the Federal Circuit
- Tris Pharma, Inc. v. Teva Pharmaceuticals USA, Inc. - First Amended Complaint
- Patent Claims Research Dataset - USPTO
- Search for patents - USPTO
- Methylphenidate extended release chewable tablet - Patent US 11,103,494
