Details for Patent: 8,747,897

Which drugs does patent 8,747,897 protect, and when does it expire?

Patent 8,747,897 protects ORENITRAM and is included in one NDA.

This patent has seventeen patent family members in eight countries.

Summary for Patent: 8,747,897

Title:	Osmotic drug delivery system
Abstract:	An oral osmotic pharmaceutical delivery system comprises a highly water-soluble drug exhibiting an erratic or an incomplete release profile when formulated in a elementary osmotic pump delivery system and at least one release enhancing agent.
Inventor(s):	Kidane; Argaw (Montgomery Village, MD), Bhatt; Padmanabh P. (Rockville, MD)
Assignee:	Supernus Pharmaceuticals, Inc. (Rockville, MD)
Application Number:	11/412,100
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,747,897
Patent Claim Types: see list of patent claims	Compound; Dosage form; Delivery; Use;

United States Patent 8,747,897: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 8,747,897, titled "Osmotic Drug Delivery System," is a significant patent in the pharmaceutical industry, particularly in the field of drug delivery systems. This patent, owned by Supernus Pharmaceuticals, Inc., was issued in 2014 and has been the subject of several legal and technical analyses. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Title and Description

The patent describes an oral osmotic pharmaceutical delivery system designed to deliver highly water-soluble drugs with erratic or incomplete release profiles. This system utilizes osmotic principles to ensure a controlled and extended release of the drug, enhancing its therapeutic efficacy[4].

Publication and Legal Status

The patent was published on June 10, 2014, and is currently active, with an expiration date determined by the patent term adjustment (PTA) calculations. The PTA added 1,386 days to the standard 20-year patent term due to delays attributed to both the USPTO and the applicant[1].

Scope of the Invention

Technical Details

The osmotic drug delivery system involves a dosage form that includes a highly water-soluble drug, an osmotic agent, and a semipermeable membrane. The system is designed to swell when it interacts with water and aqueous fluids, leading to a controlled release of the drug over an extended period. This method is often referred to as the "push/pull" approach, which has been described in various prior art patents[4].

Key Components

• Osmopolymers: These are critical components that swell significantly when they interact with water, leading to a 2- to 50-fold volume increase. This swelling effect drives the release of the drug[4].
• Semipermeable Membrane: This membrane allows water to enter the system while controlling the release of the drug.
• Osmotic Agent: This agent helps in creating an osmotic pressure gradient that facilitates the drug release.

Claims of the Patent

Independent and Dependent Claims

The patent includes several independent and dependent claims that define the scope of the invention. These claims cover various aspects of the osmotic drug delivery system, including the composition of the dosage form, the structure of the semipermeable membrane, and the method of drug release[4].

Claim Examples

• Claim 1: An oral osmotic pharmaceutical delivery system comprising a dosage form including a highly water-soluble drug, an osmotic agent, and a semipermeable membrane.
• Dependent Claims: These claims further specify the characteristics of the osmotic agent, the structure of the semipermeable membrane, and the method of manufacturing the dosage form.

Patent Landscape

Prior Art and Related Patents

The osmotic drug delivery system is not a new concept and has been described in various prior art patents. For example, U.S. Pat. Nos. 5,422,123; 4,783,337; and 4,765,989 describe similar "push/pull" approaches for delivering drugs[4].

Competing Technologies

Other companies and researchers have also developed osmotic drug delivery systems. For instance, patents like U.S. Pat. Nos. 4,609,374 and 4,992,278 describe different osmotic delivery systems, highlighting the competitive nature of this field[4].

Legal and Regulatory Aspects

Patent Term Adjustment (PTA)

The patent term of U.S. Patent 8,747,897 was adjusted due to delays in the patent prosecution process. The USPTO added 1,386 days to the patent term, which included adjustments for both USPTO delays and applicant delays. This adjustment was the subject of a legal dispute between Supernus Pharmaceuticals and the USPTO, which was ultimately resolved in favor of the USPTO[1][2].

Court Rulings

The Federal Circuit ruled that the USPTO's method of calculating PTA, particularly the attribution of applicant delay, was not arbitrary or capricious. However, the court also clarified that the USPTO cannot count as applicant delay periods where the applicant could not take action to conclude the patent prosecution[1][2].

Impact on the Pharmaceutical Industry

Therapeutic Efficacy

The osmotic drug delivery system described in U.S. Patent 8,747,897 enhances the therapeutic efficacy of highly water-soluble drugs by providing a controlled and extended release profile. This can improve patient compliance and treatment outcomes.

Market Competition

The patent landscape in this field is highly competitive, with multiple companies developing similar technologies. The issuance and enforcement of this patent can influence market dynamics, potentially affecting the development and commercialization of competing products.

Key Takeaways

• Invention Scope: The patent covers an oral osmotic drug delivery system designed for highly water-soluble drugs.
• Technical Components: The system includes osmopolymers, a semipermeable membrane, and an osmotic agent.
• Claims: The patent includes independent and dependent claims specifying the composition and method of the delivery system.
• Patent Landscape: The field is competitive with numerous prior art patents and ongoing research.
• Legal Aspects: The patent term was adjusted due to prosecution delays, with significant legal implications.

FAQs

Q: What is the main purpose of the osmotic drug delivery system described in U.S. Patent 8,747,897?

A: The main purpose is to deliver highly water-soluble drugs with a controlled and extended release profile, enhancing therapeutic efficacy.

Q: How does the osmotic drug delivery system work?

A: The system works by using osmopolymers that swell when interacting with water, driving the release of the drug through a semipermeable membrane.

Q: What was the legal dispute surrounding the patent term adjustment (PTA) of U.S. Patent 8,747,897?

A: The dispute involved the calculation of PTA, specifically the attribution of applicant delay, which was resolved in favor of the USPTO by the Federal Circuit.

Q: How does this patent impact the pharmaceutical industry?

A: It enhances therapeutic efficacy and influences market competition by protecting a specific drug delivery technology.

Q: Are there other similar patents in this field?

A: Yes, there are several prior art patents and ongoing research in the field of osmotic drug delivery systems, indicating a competitive landscape.

Sources

1. SUPERNUS PHARMACEUTICALS, INC v. IANCU, U.S. Court of Appeals for the Federal Circuit, January 23, 2019.
2. Federal Circuit Corrects USPTO on Reasonable Efforts When Calculating Patent Term Adjustment, JD Supra, January 2019.
3. Patent Claims Research Dataset, USPTO, August 28, 2017.
4. US8747897B2 - Osmotic drug delivery system, Google Patents.

Drugs Protected by US Patent 8,747,897

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	8,747,897		Y			A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-001	Dec 20, 2013		RX	Yes	No	8,747,897		Y			A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No	8,747,897		Y			A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-002	Dec 20, 2013		RX	Yes	No	8,747,897		Y			A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes	8,747,897		Y			A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
United Therap	ORENITRAM	treprostinil diolamine	TABLET, EXTENDED RELEASE;ORAL	203496-003	Dec 20, 2013		RX	Yes	Yes	8,747,897		Y			A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM

International Family Members for US Patent 8,747,897

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E532520
Canada	2649243
China	101466384
European Patent Office	2010189
European Patent Office	2368556
Spain	2377387