Details for Patent: 10,512,613

Which drugs does patent 10,512,613 protect, and when does it expire?

Patent 10,512,613 protects ADHANSIA XR and is included in one NDA.

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

Summary for Patent: 10,512,613

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:	16/399,580
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

United States Patent 10,512,613: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 10,512,613, titled "Methods and compositions particularly for treatment of attention deficit disorder," is a significant patent in the pharmaceutical sector. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Publication Number and Authority

The patent number is US10512613B2, and it was granted by the United States Patent and Trademark Office (USPTO)[5].

Invention Description

The patent describes methods and compositions for the treatment of attention deficit disorder (ADD), specifically highlighting a coated bead and pharmaceutical composition that offers a rapid onset of action. This invention is particularly advantageous due to its quick efficacy, which is a critical factor in the treatment of ADD.

Scope of the Patent

Claims Analysis

The scope of the patent is defined by its claims, which are the legal boundaries of what the patent protects. For US10512613B2, the claims include specific formulations and methods for preparing the coated beads and pharmaceutical compositions. These claims are crucial as they determine what constitutes infringement and what does not[5].

Independent Claim Length and Count

Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process compared to broader claims[3].

Claims Structure

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. This structure helps in defining the precise scope of the invention and ensures that the patent protection is both broad and specific enough to cover the innovative aspects of the treatment method[5].

Prior Art and Citations

Prior Art Keywords

The patent lists prior art keywords such as "methylphenidate," "weight," "bead," "amount," and "granule." These keywords indicate the existing knowledge in the field and help in understanding how the current invention differs from or builds upon previous work[5].

Citation Data

The Common Citation Document (CCD) application, which consolidates prior art cited by participating IP offices, can be useful in understanding the global citation landscape for this patent. This tool helps in visualizing the search results for the same invention produced by several offices on a single page[1].

Patent Landscape

Global Patent Trends

The patent landscape for pharmaceutical treatments, particularly for ADD, is dynamic and globally interconnected. The USPTO, along with other international intellectual property offices, plays a crucial role in this landscape. For instance, the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO) provide searchable databases that can help in identifying similar or related patents globally[1].

Technology Areas and Trends

The USPTO classifies patents into various technology areas, and the data shows that patents related to pharmaceuticals and medical treatments are a significant part of the overall patent landscape. The increase in electrical engineering and information and communication technologies (ICT) patents also reflects the broader technological trends that can influence pharmaceutical innovations[4].

Patent Assignment and Ownership

Patent Assignment Search

The patent assignment search tool provided by the USPTO allows users to search for patent assignments and changes in ownership. This is crucial for understanding the current ownership and any potential licensing or collaboration opportunities related to the patent[1].

Public Access and Search Tools

Patent Public Search

Tools like the Patent Public Search application and the Global Dossier service provide enhanced access to prior art and related patent applications. These resources are essential for conducting thorough patent searches and ensuring that the invention is novel and non-obvious[1].

Public Search Facility and PTRCs

The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) offer additional resources for public users to access patent and trademark information. Trained staff at these facilities can assist in navigating the complex patent search process[1].

Statistical Context

USPTO Patent Activity

In 2018, the USPTO awarded 309,000 utility patents, with a significant portion related to pharmaceutical and medical treatments. This data highlights the active and innovative environment in which this patent was granted[4].

Expert Insights

Patent Quality and Scope

Industry experts often debate the quality and scope of patents, particularly in the context of patent breadth and clarity. Research indicates that narrower claims, like those in US10512613B2, are associated with higher grant probabilities and shorter examination processes, which can be indicative of better patent quality[3].

Key Takeaways

• Patent Scope and Claims: The patent's scope is defined by its claims, which are critical for determining what is protected and what constitutes infringement.
• Global Patent Landscape: The patent is part of a broader global landscape, with tools like the Global Dossier and CCD application providing insights into related international patents.
• Public Access: Resources such as the Patent Public Search and Public Search Facility are essential for conducting thorough patent searches.
• Statistical Context: The patent is part of a vibrant innovation ecosystem, as evidenced by USPTO patent activity statistics.
• Expert Insights: Narrower claims are often associated with better patent quality and a smoother examination process.

FAQs

What is the main invention described in US10512613B2?

The main invention described in US10512613B2 is a method and composition for the treatment of attention deficit disorder, specifically a coated bead and pharmaceutical composition with a rapid onset of action.

How can I search for related patents globally?

You can use tools like the Global Dossier, CCD application, and searchable databases provided by international intellectual property offices such as the EPO, JPO, and WIPO to search for related patents globally[1].

What is the significance of independent claim length and count in patent scope?

Independent claim length and count are metrics that can measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process, indicating better patent quality[3].

Where can I find more information about patent assignments and ownership changes?

You can use the Patent Assignment Search tool provided by the USPTO to search for patent assignments and changes in ownership[1].

What resources are available for public users to access patent information?

Public users can access patent information through the USPTO Public Search Facility, Patent and Trademark Resource Centers (PTRCs), and online tools like the Patent Public Search application[1].

Cited Sources

1. USPTO - Search for patents.
2. U.S. Patent and Trademark Office (USPTO) | USAGov.
3. Patent Claims and Patent Scope - Search eLibrary :: SSRN.
4. Invention: U.S. and Comparative Global Trends.
5. Methods and compositions particularly for treatment of attention deficit disorder - Google Patents.

Drugs Protected by US Patent 10,512,613

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)

Foreign Priority and PCT Information for Patent: 10,512,613

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Canada	2902911	Aug 27, 2015

International Family Members for US Patent 10,512,613

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