Details for Patent: 8,603,514

Which drugs does patent 8,603,514 protect, and when does it expire?

Patent 8,603,514 protects SUBOXONE, EXSERVAN, SYMPAZAN, and KYNMOBI, and is included in four NDAs.

This patent has one hundred and sixty-two patent family members in nineteen countries.

Summary for Patent: 8,603,514

Title:	Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Abstract:	The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.
Inventor(s):	Yang; Robert K. (Fushing, NY), Fuisz; Richard C. (McLean, VA), Myers; Garry L. (Kingsport, TN), Fuisz; Joseph M. (Washington, DC)
Assignee:	MonoSol RX, LLC (Warren, NJ)
Application Number:	11/775,484
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,603,514
Patent Claim Types: see list of patent claims	Composition; Delivery; Use;

United States Patent 8,603,514: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,603,514, hereafter referred to as the '514 Patent, is a crucial patent in the pharmaceutical industry, particularly related to Indivior's Suboxone film. This patent has been at the center of several high-profile litigation cases and has significant implications for the manufacture and distribution of buprenorphine and naloxone films used in the treatment of opioid dependence.

Background and Issuance

The '514 Patent was issued on December 11, 2013, to Reckitt Benckiser Pharmaceuticals Inc., now known as Indivior Inc.[2][5].

Patent Claims and Specifications

The '514 Patent covers specific methods and compositions related to the manufacture of films containing buprenorphine and naloxone. The claims are focused on the uniform distribution of the active ingredients within the film, ensuring consistent dosing and efficacy.

Uniformity Requirement

A key aspect of the '514 Patent is the requirement for "substantial uniformity" in the distribution of the active ingredients. This means that the film must have less than 10% variation from the desired amount of the active ingredients across different parts of the film[4].

Drying Process

The patent also specifies the drying process for the film, which is a critical step in maintaining the uniformity of the active ingredients. The specification and prosecution history indicate that while top-air drying can be used, it must be used in conjunction with other drying methods and not alone[4].

Litigation History

The '514 Patent has been involved in several significant litigation cases, primarily against generic drug manufacturers seeking to produce generic versions of Suboxone film.

Delaware Litigation

In 2016, the U.S. District Court for the District of Delaware ruled that Actavis and Par's ANDA (Abbreviated New Drug Application) products infringed the asserted claims of the '514 Patent. The court also found that the asserted claims of the '514 Patent were valid and enforceable[2].

Appeals and Inter Partes Review

Dr. Reddy's Laboratories (DRL) and other defendants appealed the district court's decisions, arguing that the '514 Patent claims were invalid as obvious. However, the Federal Circuit upheld the district court's rulings, finding that the claims were not invalid as obvious[5].

Parallel Inter Partes Review

In a parallel inter partes review proceeding, the Patent Trial and Appeal Board (PTAB) held certain claims of related patents, such as the '832 Patent, unpatentable as anticipated and obvious. However, this did not directly impact the validity of the '514 Patent[5].

Patent Expiration and Generic Challenges

The '514 Patent is set to expire on April 3, 2024. This expiration date has significant implications for the generic drug market, as it will allow other manufacturers to produce generic versions of Suboxone film without infringing on Indivior's patent rights[2][3].

Impact on Generic Manufacturers

Generic manufacturers like Dr. Reddy's Laboratories and Par Pharmaceutical have been involved in lengthy litigation to challenge the validity of the '514 Patent. These challenges are aimed at clearing the path for the launch of generic versions of Suboxone film, which could significantly reduce the cost of treatment for opioid dependence.

Manufacturing Process Adjustments

To avoid infringement, generic manufacturers have had to modify their film manufacturing processes. For example, Watson modified its process after the district court's infringement judgment, highlighting the complexities and challenges in navigating the patent landscape around Suboxone film[5].

Antitrust Implications

In addition to patent infringement litigation, Indivior has faced antitrust lawsuits from dozens of states alleging anticompetitive practices related to its Suboxone products. These lawsuits further complicate the legal and regulatory environment surrounding the '514 Patent[1].

Conclusion on Patent Landscape

The '514 Patent is a cornerstone in the intellectual property portfolio of Indivior, protecting its Suboxone film product. The patent's claims and specifications have been rigorously tested in court, and its expiration will mark a significant shift in the market dynamics for opioid dependence treatments.

Key Takeaways

• Patent Claims: The '514 Patent covers methods and compositions for uniform distribution of buprenorphine and naloxone in films.
• Litigation History: The patent has been involved in multiple litigation cases, with the Federal Circuit upholding its validity.
• Expiration Date: The patent is set to expire on April 3, 2024, opening the market for generic versions.
• Generic Challenges: Generic manufacturers have faced significant legal hurdles in challenging the patent.
• Antitrust Implications: Indivior has faced antitrust lawsuits related to its Suboxone products.

FAQs

What is the main subject of the '514 Patent?

The '514 Patent primarily covers the methods and compositions for the manufacture of films containing buprenorphine and naloxone, ensuring uniform distribution of the active ingredients.

When is the '514 Patent set to expire?

The '514 Patent is set to expire on April 3, 2024.

What were the outcomes of the litigation cases involving the '514 Patent?

The Federal Circuit upheld the validity of the '514 Patent in several appeals, finding that the claims were not invalid as obvious.

How have generic manufacturers responded to the '514 Patent?

Generic manufacturers have modified their manufacturing processes to avoid infringement and have challenged the patent's validity through litigation and inter partes review.

What are the antitrust implications related to the '514 Patent?

Indivior has faced antitrust lawsuits from dozens of states alleging anticompetitive practices related to its Suboxone products.

Sources

1. Indivior Inc. v. Dr. Reddy's Labs. S.A. - Casetext
2. Indivior Welcomes Court Ruling on ANDA Litigation - Indivior
3. Suboxone patent expiration - Pharsight
4. Reckitt.pdf - Morris James LLP
5. United States Court of Appeals for the Federal Circuit - GovInfo

Drugs Protected by US Patent 8,603,514

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	AB	RX	Yes	No	8,603,514		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	AB	RX	Yes	No	8,603,514		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	AB	RX	Yes	No	8,603,514		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-004	Aug 10, 2012	AB	RX	Yes	Yes	8,603,514		Y			TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
Aquestive	EXSERVAN	riluzole	FILM;ORAL	212640-001	Nov 22, 2019		DISCN	Yes	No	8,603,514		Y

International Family Members for US Patent 8,603,514

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	077803
Austria	536868
Austria	536869
Austria	553746
Australia	2002332118