Details for Patent: 9,089,607

Which drugs does patent 9,089,607 protect, and when does it expire?

Patent 9,089,607 protects RYTARY and is included in one NDA.

This patent has twenty-five patent family members in twelve countries.

Summary for Patent: 9,089,607

Title:	Controlled release formulations of levodopa and uses thereof
Abstract:	The current invention provides a controlled release oral solid formulation of levodopa comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid. Also provided by this invention is multiparticulate, controlled release oral solid formulations of levodopa comprising: i) a controlled release component comprising a mixture of levodopa, a decarboxylase inhibitor and a rate controlling excipient; ii) a carboxylic acid component; and iii) an immediate release component comprising a mixture of levodopa and a decarboxylase inhibitor.
Inventor(s):	Hsu; Ann (Los Altos Hills, CA), Kou; Jim H. (San Jose, CA), Alani; Laman Lynn (Fort Worth, TX)
Assignee:	Impax Laboratories, Inc. (Hayward, CA)
Application Number:	13/900,408
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,089,607
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Use;

United States Patent 9,089,607: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 9,089,607, titled "Controlled Release Formulations of Levodopa and Uses Thereof," is a significant patent in the pharmaceutical industry, particularly in the treatment of Parkinson's disease. This patent, issued on July 28, 2015, to inventors Ann Hsu, Jim H. Kou, and Laman Lynn Alani, and assigned to Impax, covers crucial formulations and methods related to levodopa, a key medication for managing Parkinson's symptoms.

Background and Context

Levodopa, combined with a decarboxylase inhibitor such as carbidopa, is a standard treatment for Parkinson's disease. The controlled release formulations described in this patent aim to improve the efficacy and patient compliance of levodopa therapy by providing a more stable and sustained release of the medication.

Patent Scope

The scope of U.S. Patent 9,089,607 is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key aspects of the patent scope:

Independent Claims

The patent includes several independent claims that define the core of the invention. For example:

• Claim 1: A controlled release oral solid formulation of levodopa, comprising levodopa, a decarboxylase inhibitor, and a carboxylic acid polymer[2].

Dependent Claims

Dependent claims further specify the details of the formulation, such as the types of decarboxylase inhibitors and carboxylic acid polymers used. For instance:

• Claim 7: The controlled release oral solid formulation of claim 1, wherein the decarboxylase inhibitor is carbidopa[2].

Claims Analysis

Claim Length and Count

Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].

Specificity and Clarity

The claims in U.S. Patent 9,089,607 are specific and clear, detailing the components and their roles in the controlled release formulation. This clarity is crucial for defining the boundaries of the invention and preventing potential infringement.

Patent Landscape

Related Patents

The inventors of U.S. Patent 9,089,607 have also been granted other related patents, such as U.S. Patent No. 8,557,283 and U.S. Patent No. 9,089,608, all of which cover various aspects of controlled release formulations of levodopa. These patents collectively form a robust intellectual property portfolio around this therapeutic area[1].

Expiration Dates

All these related patents, including U.S. Patent 9,089,607, are set to expire on December 26, 2028, as per the FDA Orange Book patent data. This expiration date is critical for understanding the timeline for generic or biosimilar entries into the market[1].

Litigation and Enforcement

Patent Infringement Actions

Impax, the assignee of U.S. Patent 9,089,607, has been involved in litigation to protect its intellectual property rights. For example, Impax has filed actions against Ascent for alleged infringement related to the filing of ANDA (Abbreviated New Drug Application) products that allegedly practice the claims of the ’607 patent[1].

Indirect Infringement

In addition to direct infringement claims, Impax also alleges indirect infringement, arguing that Ascent's products contribute to the direct infringement by others and are not suitable for substantial non-infringing use[1].

Search and Analysis Tools

USPTO Resources

For those interested in conducting a thorough search of patents related to U.S. Patent 9,089,607, the USPTO offers several tools:

• Patent Public Search: A web-based tool that provides enhanced access to prior art.
• Global Dossier: A service that allows users to view the file histories of related applications from participating IP Offices.
• Common Citation Document (CCD): A tool that consolidates prior art cited by multiple offices for the same invention[4].

Industry Impact

Innovation and Licensing

The issuance and enforcement of patents like U.S. Patent 9,089,607 can significantly impact innovation and licensing in the pharmaceutical industry. While these patents protect the intellectual property of innovators, they can also increase licensing and litigation costs, potentially diminishing incentives for further innovation[3].

Patient Compliance and Efficacy

The controlled release formulations described in this patent can improve patient compliance and the efficacy of levodopa therapy. This is particularly important for chronic conditions like Parkinson's disease, where consistent and reliable medication delivery is crucial for managing symptoms.

Key Takeaways

• Specific Claims: U.S. Patent 9,089,607 includes specific and clear claims that define the controlled release formulations of levodopa.
• Related Patents: The patent is part of a broader portfolio of related patents covering various aspects of levodopa formulations.
• Litigation: Impax has taken legal actions to protect its intellectual property rights against alleged infringement.
• Expiration Dates: The patent is set to expire on December 26, 2028.
• Industry Impact: The patent affects innovation, licensing, and patient compliance in the treatment of Parkinson's disease.

FAQs

Q: What is the main subject of U.S. Patent 9,089,607?

A: The main subject is controlled release formulations of levodopa and their uses, particularly in treating Parkinson's disease.

Q: Who are the inventors of U.S. Patent 9,089,607?

A: The inventors are Ann Hsu, Jim H. Kou, and Laman Lynn Alani.

Q: What is the expiration date of U.S. Patent 9,089,607?

A: The patent is set to expire on December 26, 2028.

Q: What tools can be used to search for related patents?

A: Tools such as the USPTO's Patent Public Search, Global Dossier, and Common Citation Document (CCD) can be used.

Q: How does this patent impact the pharmaceutical industry?

A: It protects intellectual property, influences licensing and litigation costs, and improves patient compliance and efficacy in levodopa therapy.

Sources

1. Case 2:24-cv-05299-KMW Document 1 Filed 04/18/24: U.S. Patent No. 8,557,283, U.S. Patent No. 9,089,607, and U.S. Patent No. 9,089,608.
2. United States Patent - googleapis.com: U.S. Patent No. 9,089,607.
3. Patent Claims and Patent Scope - SSRN: Metrics for measuring patent scope.
4. USPTO - Search for patents: Tools and resources for patent searching.

Drugs Protected by US Patent 9,089,607

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015		RX	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015		RX	Yes	No			Y			METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015		RX	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-002	Jan 7, 2015		RX	Yes	No			Y			METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No			Y			TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-003	Jan 7, 2015		RX	Yes	No			Y			METHOD OF PROVIDING A THERAPEUTICALLY EFFECTIVE AND STABLE MEDIAN BLOOD PLASMA LEVEL OF LEVODOPA
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-004	Jan 7, 2015		RX	Yes	Yes			Y			TREATMENT OF PARKINSON'S DISEASE, POST-ENCEPHALITIC PARKINSONISM, AND PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION OR MANGANESE INTOXICATION

International Family Members for US Patent 9,089,607

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008343787
Canada	2711014
China	101910113
European Patent Office	2234963
Spain	2804348
Israel	206756
Israel	248520