Details for Patent: 8,062,667

Which drugs does patent 8,062,667 protect, and when does it expire?

Patent 8,062,667 protects QUILLIVANT XR, DYANAVEL XR, KARBINAL ER, ONYDA XR, and TUZISTRA XR, and is included in five NDAs.

This patent has twenty-one patent family members in fourteen countries.

Summary for Patent: 8,062,667

Title:	Modified release formulations containing drug-ion exchange resin complexes
Abstract:	A coated drug-ion exchange resin complex comprising a core composed of a drug complexed with a pharmaceutically acceptable ion-exchange resin is provided. The drug-ion exchange resin complex is in admixture with a release retardant. The coating is a polyvinyl acetate polymer and a plasticizer. Methods of making and products containing this coated complex are described.
Inventor(s):	Mehta; Ketan (Cranbury, NJ), Tu; Yu-Hsing (West Windsor, NJ)
Assignee:	Tris Pharma, Inc. (Monmouth Junction, NJ)
Application Number:	11/724,966
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,062,667
Patent Claim Types: see list of patent claims	Composition; Process; Formulation;

United States Patent 8,062,667: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,062,667, titled "Modified release formulations containing drug-ion exchange resin complexes," is a significant patent in the pharmaceutical field, particularly in the development of extended-release drug formulations. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background and Inventors

The patent was issued on November 22, 2011, to Tris Pharma, Inc., and names inventors such as Ketan Mehta, Yu-Hsing Tu, and Ashok Perumal. It is part of a series of patents related to orally effective methylphenidate extended-release formulations[2].

Scope of the Patent

The patent focuses on modified release formulations that utilize drug-ion exchange resin complexes to delay the release of ionic drugs. This technology is crucial for creating extended-release formulations that maintain therapeutic drug levels over an extended period.

Key Components

• Drug-Ion Exchange Resin Complexes: The patent describes the use of ion-exchange resins to form complexes with ionic drugs. This complex delays the drug release, allowing for a controlled and extended release profile[4].
• Formulation Methods: The patent outlines various methods for preparing these formulations, including the use of coating agents, polymers, and other ingredients to achieve the desired release characteristics[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention.

Independent Claims

• Claim 1 describes the aqueous suspension composition containing an ionic drug and an ion-exchange resin.
• Claim 6, which was a subject of litigation, specifies the aqueous suspension composition further comprising an orally ingestible drug[2].

Dependent Claims

• Various dependent claims elaborate on the specific components, such as the type of ion-exchange resin, the drug concentration, and the preparation methods[4].

Patent Landscape and Related Patents

The patent 8,062,667 is part of a larger portfolio of patents held by Tris Pharma, Inc., related to extended-release methylphenidate formulations.

Related Patents

• U.S. Patent Nos. 8,287,903, 8,465,765, 8,563,033, 8,778,390, 8,956,649, and 9,040,083: These patents also pertain to orally effective methylphenidate extended-release powder and aqueous suspension products. They share similar inventors and are listed in the FDA's "Orange Book" for Quillivant XR[1][2].

Litigation and Validity

The patent was involved in significant litigation, particularly in the case of Tris Pharma, Inc. v. Actavis Labs. FL, Inc.

Infringement and Validity

• Actavis Laboratories FL, Inc. filed an Abbreviated New Drug Application (ANDA) for a generic version of Quillivant XR, which led to patent infringement claims by Tris Pharma, Inc.
• The court ruled that the asserted claims of the patents-in-suit, including the '667 patent, were invalid due to obviousness under 35 U.S.C. § 103[2].

Impact on Generic Drug Approval

The litigation outcome had a direct impact on the approval of generic versions of Quillivant XR.

Generic Drug Exclusivity

• Actavis Laboratories FL, Inc. was eligible for 180 days of generic drug exclusivity due to being the first ANDA applicant with a paragraph IV certification[1].

Patent Scope and Quality

The debate around patent scope and quality is relevant to this patent.

Metrics for Patent Scope

• Research suggests that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The examination process tends to narrow the scope of patent claims in terms of both claim length and claim count[3].

Conclusion

The United States Patent 8,062,667 is a critical component in the development of extended-release drug formulations, particularly for methylphenidate. Despite its significance, the patent faced challenges in litigation, leading to the invalidation of its claims due to obviousness.

Key Takeaways

• The patent describes the use of drug-ion exchange resin complexes for extended-release formulations.
• It was part of a broader portfolio of patents related to methylphenidate extended-release products.
• Litigation led to the invalidation of the patent's claims due to obviousness.
• The outcome impacted the approval of generic versions of Quillivant XR.

Frequently Asked Questions (FAQs)

What is the main technology described in U.S. Patent 8,062,667?

The main technology involves the use of drug-ion exchange resin complexes to create extended-release formulations of ionic drugs.

Who are the inventors of U.S. Patent 8,062,667?

The inventors are Ketan Mehta, Yu-Hsing Tu, and Ashok Perumal.

What was the outcome of the litigation involving this patent?

The court ruled that the asserted claims of the patent were invalid due to obviousness under 35 U.S.C. § 103.

How did the litigation affect the approval of generic drugs?

The litigation outcome allowed Actavis Laboratories FL, Inc. to be eligible for 180 days of generic drug exclusivity for their version of Quillivant XR.

What are the implications of narrower patent claims on the examination process?

Narrower claims at publication are associated with a higher probability of grant and a shorter examination process, indicating better patent quality and clarity.

Sources:

1. FDA Approval Letter for ANDA 206049 - FDA.
2. Tris Pharma, Inc. v. Actavis Labs. FL, Inc. - Casetext.
3. Patent Claims and Patent Scope - Hoover Institution.
4. US8062667B2 - Modified release formulations containing drug-ion exchange resin complexes - Google Patents.

Drugs Protected by US Patent 8,062,667

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nextwave	QUILLIVANT XR	methylphenidate hydrochloride	FOR SUSPENSION, EXTENDED RELEASE;ORAL	202100-001	Sep 27, 2012	AB	RX	Yes	Yes	8,062,667		Y
Tris Pharma Inc	DYANAVEL XR	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	SUSPENSION, EXTENDED RELEASE;ORAL	208147-001	Oct 19, 2015		RX	Yes	Yes	8,062,667		Y
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes	8,062,667		Y
Tris Pharma Inc	ONYDA XR	clonidine hydrochloride	SUSPENSION, EXTENDED RELEASE;ORAL	217645-001	May 24, 2024		RX	Yes	Yes	8,062,667		Y
Tris Pharma Inc	TUZISTRA XR	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	207768-001	Apr 30, 2015		DISCN	Yes	No	8,062,667		Y

International Family Members for US Patent 8,062,667

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E536867
Australia	2007227569
Brazil	PI0709606
Canada	2645855
China	101400343
China	102488652