Details for Patent: 9,855,278

Which drugs does patent 9,855,278 protect, and when does it expire?

Patent 9,855,278 protects OXTELLAR XR and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 9,855,278

Title:	Modified release preparations containing oxcarbazepine and derivatives thereof
Abstract:	Controlled-release preparations of oxcarbazepine and derivatives thereof for once-a-day administration are disclosed. The inventive compositions comprise solubility- and/or release enhancing agents to provide tailored drug release profiles, preferably sigmoidal release profiles. Methods of treatment comprising the inventive compositions are also disclosed.
Inventor(s):	Bhatt; Padmanabh P. (Rockville, MD), Kidane; Argaw (Montgomery Village, MD), Edwards; Kevin (Lovettsville, VA)
Assignee:	Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:	15/166,816
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,855,278
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 9,855,278

Introduction

The United States Patent 9,855,278, hereafter referred to as the '278 patent, is one of the patents held by Supernus Pharmaceuticals, Inc., and is crucial in the context of pharmaceutical formulations, particularly for extended-release oxcarbazepine tablets. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The '278 patent is part of a series of patents that describe formulations for extended-release oxcarbazepine tablets, used in the treatment of partial seizures in adults and children. Oxcarbazepine is an antiepileptic drug, and the formulations covered by these patents are designed to provide a controlled release of the active ingredient over a prolonged period[5].

Claims of the '278 Patent

The claims of the '278 patent are central to understanding its scope and the protection it offers. Here are some key aspects:

Independent Claims

• The independent claims typically define the broadest scope of the invention. For the '278 patent, these claims would outline the essential components and characteristics of the extended-release oxcarbazepine formulation, such as the specific matrix composition, the release profile, and any other critical features[5].

Dependent Claims

• Dependent claims build upon the independent claims and provide more specific details or variations of the invention. These claims might include specific ratios of ingredients, manufacturing processes, or other detailed aspects of the formulation.

Patent Landscape Analysis

To fully comprehend the '278 patent, it is essential to analyze the broader patent landscape.

Competitors and Market Developments

• Patent landscape analysis reveals competitors and market developments such as mergers and acquisitions, in/out-licensing, and litigation activities. For instance, Supernus Pharmaceuticals has been involved in several patent infringement cases against generic drug manufacturers like Apotex and RiconPharma, indicating a competitive and legally active environment[1][5].

Patent Trends and Expiry Dates

• Understanding patent trends and expiry dates is crucial for strategic planning. The '278 patent, along with other related patents, has specific expiry dates that can impact market strategies. For example, the agreement between Supernus and Apotex allows Apotex to market a generic version of Oxtellar XR starting September 1, 2024, or earlier under certain circumstances[2].

Legal Status and Litigation

• The legal status of the '278 patent, including any litigation or opposition activities, is vital. Supernus has filed complaints against several generic drug manufacturers alleging patent infringement, which highlights the ongoing legal battles to protect the patent's validity and enforceability[1][5].

Claim Construction and Infringement

In patent infringement cases, claim construction is a critical step.

Claim Construction

• The court determines the meaning of the claims in the patent, a process known as claim construction. This involves analyzing the written documents, primarily the patent itself, and sometimes requiring factual determinations to assist in understanding the written words[5].

Infringement Analysis

• After claim construction, the court compares the claims to the allegedly infringing product. For the '278 patent, this would involve determining whether the generic formulations submitted by companies like Apotex or RiconPharma infringe on the protected claims[5].

Recent Developments and Agreements

Recent agreements and developments have significant implications for the '278 patent.

Settlement with Apotex

• Supernus Pharmaceuticals and Apotex have agreed to dismiss all claims and counterclaims in their ongoing patent litigation. As part of this agreement, Supernus granted Apotex a license to market a generic version of Oxtellar XR, which is covered by the '278 patent, starting September 1, 2024, or earlier under certain circumstances[2].

Strategic Implications

Understanding the scope and claims of the '278 patent has several strategic implications:

Market Entry and Competition

• The expiry dates and licensing agreements impact when and how generic competitors can enter the market. This information is crucial for both the patent holder and potential competitors in planning their market strategies[2].

Litigation and Enforcement

• The ongoing litigation and the detailed statements required for non-infringement contentions highlight the importance of robust legal strategies to protect the patent's validity and enforceability[1].

Innovation and R&D

• The patent landscape analysis can also guide research and development efforts by identifying gaps in current technologies and potential areas for innovation that do not infringe existing patents[3].

Key Takeaways

• Patent Scope and Claims: The '278 patent covers specific formulations for extended-release oxcarbazepine tablets, with claims that define the essential components and characteristics.
• Patent Landscape: The broader landscape includes competitors, market developments, and legal activities that impact the patent's validity and enforceability.
• Claim Construction and Infringement: These are critical steps in patent infringement cases, involving detailed analysis of the patent claims and comparison with allegedly infringing products.
• Recent Developments: Agreements like the one with Apotex affect market entry and competition, highlighting the importance of strategic planning and legal enforcement.

FAQs

1. What is the primary use of the '278 patent?

   • The '278 patent is used for the formulation of extended-release oxcarbazepine tablets, which are antiepileptic drugs used to treat partial seizures in adults and children.

2. Who are the key competitors in the patent landscape for the '278 patent?

   • Key competitors include generic drug manufacturers like Apotex and RiconPharma, which have been involved in patent infringement cases with Supernus Pharmaceuticals.

3. What is the significance of the agreement between Supernus and Apotex?

   • The agreement allows Apotex to market a generic version of Oxtellar XR starting September 1, 2024, or earlier under certain circumstances, and involves the dismissal of all claims and counterclaims in their ongoing patent litigation.

4. How does claim construction impact patent infringement cases?

   • Claim construction involves determining the meaning of the claims in the patent, which is a critical step before comparing the claims to the allegedly infringing product.

5. What tools are available for analyzing the patent landscape?

   • Tools such as patent landscape analysis reports, the USPTO Public Search Facility, and services like the Global Dossier can be used to analyze the patent landscape and gain valuable insights into competitors and market developments[3][4].

Sources

1. Case 3:22-cv-00322 Document 1 Filed 01/24/22 Page 8 of 40 PageID: 8 – 9 –
2. Form 8-K for Supernus Pharmaceuticals INC filed 06/23/2023
3. Navigating Technological Domains with Patent Landscape Analysis
4. Search for patents - USPTO
5. Supernus Pharm. v. RiconPharma - Casetext

Drugs Protected by US Patent 9,855,278

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-001	Oct 19, 2012	AB	RX	Yes	No			Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-002	Oct 19, 2012	AB	RX	Yes	No			Y
Supernus Pharms	OXTELLAR XR	oxcarbazepine	TABLET, EXTENDED RELEASE;ORAL	202810-003	Oct 19, 2012	AB	RX	Yes	Yes			Y

International Family Members for US Patent 9,855,278

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007242984
Austria	E496623
Canada	2597740