Details for Patent: 10,449,159

Which drugs does patent 10,449,159 protect, and when does it expire?

Patent 10,449,159 protects ADHANSIA XR and is included in one NDA.

This patent has thirty-three patent family members in seventeen countries.

Summary for Patent: 10,449,159

Title:	Methods and compositions particularly for treatment of attention deficit disorder
Abstract:	There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.
Inventor(s):	Vargas Rincon; Ricardo Alberto (Mississauga, CA), Reiz; Joseph (Markham, CA)
Assignee:	Purdue Pharma L.P. (Stamford, CT)
Application Number:	16/282,876
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Understanding the Scope and Claims of United States Patent 10,449,159

Introduction

United States Patent 10,449,159, titled "Methods and compositions particularly for treatment of attention deficit disorder," is a significant patent that addresses innovative approaches to treating attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). This analysis delves into the patent's scope, claims, and the broader patent landscape it operates within.

Patent Overview

The patent, assigned to a pharmaceutical company, focuses on novel methods and compositions for the treatment of ADD and ADHD. The primary innovation involves a coated bead formulation that enhances the delivery and efficacy of methylphenidate, a commonly used medication for these conditions[1].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific inventions and innovations protected under the patent.

Claim Structure

The patent includes multiple claims, each detailing a different aspect of the invention. These claims can be categorized into:

• Independent Claims: These are the broadest claims that define the core invention. For example, Claim 1 might describe the overall composition and method of treatment.
• Dependent Claims: These claims build upon the independent claims, providing more specific details or variations of the invention. For instance, a dependent claim might specify the exact dosage or formulation of the coated beads[1].

Key Components

• Coated Beads: The patent describes a unique formulation where methylphenidate is encapsulated in coated beads. This design allows for a rapid onset of action and controlled release, enhancing patient compliance and efficacy.
• Pharmaceutically Acceptable Salts: The patent also covers various pharmaceutically acceptable salts of methylphenidate, which can be used in the formulation to improve stability and bioavailability[1].

Claim Analysis

Independent Claim Length and Count

Research suggests that the length and count of independent claims can be indicative of patent scope. Patents with narrower, more focused claims tend to have a higher probability of grant and shorter examination processes. In the case of US 10,449,159, the independent claims are carefully crafted to define the novel aspects of the coated bead formulation and its method of use, which likely contributed to its successful grant[3].

Claim Amendments

During the patent examination process, claim amendments can significantly impact the patent's scope. For instance, in cases like Hyatt v. PTO, significant claim amendments can lead to restriction requirements if the amended claims shift to different inventions. However, in the case of US 10,449,159, any amendments would have been carefully managed to ensure the claims remained focused on the core invention[2].

Patent Landscape

Historical Context

The patent landscape has evolved significantly over the years, particularly with changes in patent term durations. The Uruguay Round Agreements Act (URAA) changed the patent term from 17 years from the grant date to 20 years from the effective filing date. This change aimed to promote timely disclosure of innovations and reduce the practice of delaying patent prosecution through continuing applications[2].

Current Trends

The current patent landscape is characterized by a focus on patent quality and scope. There is ongoing debate about the breadth of patents and their impact on innovation. Metrics such as independent claim length and count are used to measure patent scope, and narrower claims are generally associated with higher grant probabilities and shorter examination times[3].

Legal and Policy Considerations

Small Claims Patent Court

There is an ongoing discussion about the feasibility of a small claims patent court in the U.S., which could impact the enforcement and litigation landscape for patents like US 10,449,159. Such a court would aim to provide a more streamlined and cost-effective process for resolving patent disputes, particularly for smaller entities[5].

International Patent Cooperation

The patent landscape is also influenced by international cooperation. Databases like PATENTSCOPE and the Cooperative Patent Classification (CPC) system facilitate global patent searching and classification, making it easier for inventors and companies to navigate the international patent landscape[4].

Practical Implications

Innovation and Competition

The grant of US 10,449,159 encourages innovation in the pharmaceutical sector by providing a protected market space for the novel formulation. This can drive competition among pharmaceutical companies to develop more effective treatments for ADD and ADHD.

Patient Benefits

The rapid onset of action and controlled release of methylphenidate from the coated beads can significantly improve patient outcomes. This formulation may enhance compliance and reduce side effects, making it a valuable advancement in the treatment of these conditions.

Key Takeaways

• Novel Formulation: The patent introduces a unique coated bead formulation of methylphenidate with a rapid onset of action.
• Claim Structure: The patent includes carefully crafted independent and dependent claims to define the scope of the invention.
• Patent Landscape: The patent operates within a landscape influenced by changes in patent term durations and ongoing debates about patent quality and scope.
• Legal Considerations: The enforcement and litigation of this patent could be impacted by potential changes in the U.S. patent court system.
• Practical Implications: The patent has significant implications for innovation, competition, and patient benefits in the pharmaceutical sector.

FAQs

1. What is the main innovation of US Patent 10,449,159?

   • The main innovation is a coated bead formulation of methylphenidate that allows for a rapid onset of action and controlled release.

2. How do claim amendments affect the patent examination process?

   • Claim amendments can shift the focus of the claims, potentially leading to restriction requirements if the amended claims cover different inventions.

3. What is the significance of the URAA in the patent landscape?

   • The URAA changed the patent term from 17 years from the grant date to 20 years from the effective filing date, promoting timely disclosure of innovations.

4. How does the current debate on patent quality impact patents like US 10,449,159?

   • The debate focuses on the breadth and clarity of patents, with narrower claims generally associated with higher grant probabilities and shorter examination times.

5. What is the potential impact of a small claims patent court on patent enforcement?

   • A small claims patent court could provide a more streamlined and cost-effective process for resolving patent disputes, particularly beneficial for smaller entities.

Sources

1. US10449159B2 - Methods and compositions particularly for treatment of attention deficit disorder - Google Patents
2. Hyatt v. United States Patent and Trademark Office - CAFC
3. Patent Claims and Patent Scope - SSRN
4. Research and Course Guides: Patent Searching, Advanced - Clemson University
5. U.S. Patent Small Claims Court - ACUS

Drugs Protected by US Patent 10,449,159

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-001	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No						METHOD OF TREATING ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

International Family Members for US Patent 10,449,159

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	103981
Australia	2015337779
Australia	2020227021
Australia	2020227022
Brazil	112017008993
Canada	2902911