Details for Patent: 9,974,752

Which drugs does patent 9,974,752 protect, and when does it expire?

Patent 9,974,752 protects ADHANSIA XR and is included in one NDA.

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

Summary for Patent: 9,974,752

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 (Pickering, Ontario, CA)
Application Number:	14/928,276
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

United States Patent 9,974,752: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 9,974,752, titled "Methods and compositions particularly for treatment of attention deficit disorder," is a significant patent in the pharmaceutical sector. This patent, issued to address treatments for attention deficit disorder (ADD), involves innovative methods and compositions that enhance the delivery and efficacy of central nervous system stimulants.

Patent Overview

Publication Number and Authority

The patent number is US9,974,752B2, issued by the United States Patent and Trademark Office (USPTO)[4].

Background and Purpose

The patent describes methods and compositions for treating attention deficit disorder, focusing on the development of oral solid pharmaceutical compositions. These compositions are designed to provide both immediate and delayed release of active pharmaceutical ingredients, such as methylphenidate, a common central nervous system stimulant.

Scope of the Patent

Claims

The patent includes several claims that define the scope of the invention. Here are some key claims:

• Claim 1: Describes an oral solid pharmaceutical composition comprising coated beads. Each bead has a granule coated with a layer containing the active pharmaceutical ingredient, designed for immediate or delayed release[4].
• Claim 2: Specifies the composition where the first plurality of coated beads provides immediate release, and the second plurality provides delayed release until the beads reach the distal intestine[4].
• Claim 3: Details the coating layers and the amount of active ingredient in each bead, ensuring controlled release under specific conditions[4].

Technical Details

The patent delves into the technical aspects of the composition, including:

• Immediate Release Beads: These beads are coated with a layer containing the active pharmaceutical ingredient, ensuring rapid release upon administration.
• Delayed Release Beads: These beads have an additional layer that delays the release of the active ingredient until the beads reach the distal intestine, providing a sustained therapeutic effect[4].

Claims Analysis

Claim Structure

The claims are structured to cover various aspects of the invention, including the composition, the method of preparation, and the method of use. This ensures broad protection for the inventors while allowing for flexibility in implementation.

Dependency Between Claims

The claims are interdependent, with some claims building upon others to provide a comprehensive description of the invention. For example, Claim 2 depends on Claim 1, adding additional specificity to the composition[4].

Patent Landscape

Prior Art

The patent cites several prior art references, including international patent publications and other related patents. This indicates that the inventors have considered existing technologies and have innovated beyond them to create a unique solution[4].

Global Patent Family

The patent is part of a global patent family, with corresponding applications and grants in other jurisdictions. This is evident from the international patent publication numbers mentioned in the patent document[4].

Economic and Market Impact

Market Need

The treatment of attention deficit disorder is a significant market need, and this patent addresses it by providing innovative compositions that enhance the efficacy and convenience of existing treatments.

Competitive Advantage

The unique composition and release mechanism described in the patent provide a competitive advantage over existing treatments. This can lead to market dominance and increased revenue for the patent holders.

Legal and Regulatory Considerations

Inventorship

The patent must list the true and only inventors, as required by US patent law. Incorrect or deceptive inventorship can lead to the patent being unenforceable, as seen in cases like Frank’s Casing Crew v. PMR Technologies[5].

Enforcement

The patent holders must ensure that the patent is enforced correctly to prevent infringement. This includes monitoring for unauthorized use and taking legal action when necessary.

Search and Research Tools

For researchers and patent professionals, tools like the USPTO's Global Dossier and Common Citation Document (CCD) can be invaluable in understanding the patent landscape and prior art related to this patent. The Global Dossier provides access to file histories and related applications from participating IP offices, while the CCD consolidates citation data from multiple offices[1].

Key Takeaways

• Innovative Composition: The patent describes a unique oral solid pharmaceutical composition with immediate and delayed release mechanisms.
• Broad Claims: The claims cover various aspects of the invention, ensuring comprehensive protection.
• Global Impact: The patent is part of a global patent family, addressing a significant market need in the treatment of attention deficit disorder.
• Legal Considerations: Correct inventorship and enforcement are crucial for maintaining the validity and enforceability of the patent.

FAQs

Q: What is the main focus of United States Patent 9,974,752?

A: The main focus is on methods and compositions for treating attention deficit disorder using oral solid pharmaceutical compositions with controlled release mechanisms.

Q: How does the patent ensure controlled release of the active pharmaceutical ingredient?

A: The patent describes beads with multiple layers, where some beads provide immediate release and others provide delayed release until they reach the distal intestine.

Q: What are the legal implications of incorrect inventorship in a patent?

A: Incorrect or deceptive inventorship can render the patent unenforceable, as seen in cases where the court found patents invalid due to fraudulent intent in naming inventors.

Q: How can researchers access related patent information and prior art?

A: Tools like the USPTO's Global Dossier and Common Citation Document (CCD) provide access to related applications and consolidated citation data.

Q: What is the economic impact of this patent?

A: The patent can provide a competitive advantage in the market for attention deficit disorder treatments, potentially leading to increased revenue and market dominance for the patent holders.

Sources

1. USPTO - Search for patents: https://www.uspto.gov/patents/search
2. USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
4. Google Patents - US9974752B2: https://patents.google.com/patent/US9974752B2/en
5. Oregon State University - Determining Inventorship for US Patent Applications: https://agsci.oregonstate.edu/sites/agsci/files/main/research/vrc_release_inventorship-gattari.pdf

Drugs Protected by US Patent 9,974,752

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	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-002	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-003	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-005	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-006	Feb 27, 2019		DISCN	Yes	No	9,974,752		Y

Foreign Priority and PCT Information for Patent: 9,974,752

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

International Family Members for US Patent 9,974,752

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