Details for Patent: 7,736,665

Which drugs does patent 7,736,665 protect, and when does it expire?

Patent 7,736,665 protects PROBUPHINE and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 7,736,665

Title:	Implantable polymeric device for sustained release of buprenorphine
Abstract:	The present invention provides compositions, methods, and kits for treatment of opiate addiction and pain. The invention provides a biocompatible nonerodible polymeric device which releases buprenorphine continuously with generally linear release kinetics for extended periods of time. Buprenorphine is released through pores that open to the surface of the polymeric matrix in which it is encapsulated. The device may be administered subcutaneously to an individual in need of continuous treatment with buprenorphine.
Inventor(s):	Patel; Rajesh A. (Redwood City, CA), Bucalo; Louis R. (Miami Beach, FL)
Assignee:	Titan Pharmaceuticals, Inc. (South San Francisco, CA)
Application Number:	10/453,377
Patent Claim Types: see list of patent claims	Use; Device;

United States Patent 7,736,665: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 7,736,665, titled "Implantable polymeric device for sustained release of buprenorphine," is a significant patent in the field of medical devices, particularly for the treatment of opioid addiction. This patent, assigned to Titan Pharmaceuticals, involves an innovative delivery mechanism for buprenorphine, a partial opioid agonist. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background and Invention

The patent describes an implantable polymeric device designed to provide sustained release of buprenorphine over a period of six months. This device consists of four rods implanted under the skin of a patient’s arm, each containing a biocompatible, nonerodible polymeric matrix that releases buprenorphine continuously[1][4].

Inventors and Assignment

The inventors of this patent are Rajesh Patel and Louis Bucalo, and the patent is assigned to Titan Pharmaceuticals. Notably, the invention was conceived in part during work supported by a grant from the National Institute of Mental Health (1R43 MH60037-01), which grants the U.S. government certain rights in the invention under the Bayh-Dole Act[1].

Patent Claims

The patent includes several claims that define the scope of the invention. Here are some key aspects:

Independent Claims

• The patent claims an implantable device comprising a biocompatible, nonerodible polymeric matrix that contains buprenorphine.
• The device is designed for the sustained release of buprenorphine over an extended period, specifically six months[4].

Dependent Claims

• These claims further specify the composition of the polymeric matrix, the method of implantation, and the dimensions of the rods.
• For example, the claims describe the use of specific polymers and the configuration of the rods to ensure consistent drug release[4].

Patent Scope

The scope of the patent is defined by its claims and the description provided in the patent document.

Claim Length and Count

Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and complexity. In this case, the patent has a focused set of claims that clearly define the invention, suggesting a well-defined scope[3].

Practical Application

The practical application of the invention is crucial, as it must be available to the public on reasonable terms to meet the requirements under 35 U.S.C. § 201(f). The device's ability to provide sustained release of buprenorphine for opioid addiction treatment fulfills this criterion[1].

Patent Landscape

Related Patents and Technologies

The patent landscape in the field of drug delivery systems, especially for opioid addiction treatment, is highly competitive. Other notable inventions include those by Joseph Fuisz, who has developed various drug delivery mechanisms, including thin-film drug delivery systems and dissolving tobacco film strips[2].

Federal Funding and Government Rights

The fact that this invention was partially funded by a federal grant gives the U.S. government significant rights, including a nontransferable, irrevocable, paid-up license to practice the invention. Additionally, the government retains "march-in" rights under 35 U.S.C. § 203, allowing it to force the rights holder to grant licenses if the invention is not made available to the public on reasonable terms[1].

Exclusivity and Patent Life

The sole patent listed in the FDA Orange Book for Probuphine, which is the commercial product based on this invention, is 7,736,665. This patent provided exclusivity until 2024. The expiration of this patent could open up opportunities for generic versions of the device, although the unique delivery mechanism may still be protected by other intellectual property rights[1].

Impact on Opioid Addiction Treatment

The invention has significant implications for the treatment of opioid addiction. By providing a continuous supply of buprenorphine over six months, it reduces the need for daily dosing and minimizes the risk of withdrawal symptoms. This can improve patient compliance and outcomes in opioid addiction treatment[1].

Economic and Regulatory Considerations

The economic impact of this patent is substantial, given the high cost of Probuphine and its importance in opioid addiction treatment. Regulatory bodies, including the FDA and the U.S. government, play a crucial role in ensuring that such inventions are made available to the public on reasonable terms. The government's rights under the Bayh-Dole Act can be leveraged to control pricing and ensure accessibility[1].

Conclusion

The United States Patent 7,736,665 represents a critical innovation in the treatment of opioid addiction. The patent's scope, defined by its claims, ensures a specific and practical application of the invention. The patent landscape, influenced by federal funding and government rights, highlights the complex interplay between intellectual property, public health, and regulatory oversight.

Key Takeaways

• Invention: The patent describes an implantable polymeric device for the sustained release of buprenorphine.
• Claims: The patent includes specific claims defining the device's composition and method of implantation.
• Scope: The scope is well-defined, with a focus on practical application.
• Federal Funding: The invention was partially funded by a federal grant, granting the U.S. government significant rights.
• Exclusivity: The patent provided exclusivity until 2024.
• Impact: The device significantly improves opioid addiction treatment by providing continuous buprenorphine release.

FAQs

1. What is the primary purpose of the United States Patent 7,736,665?

   • The primary purpose is to describe an implantable polymeric device for the sustained release of buprenorphine to treat opioid addiction.

2. Who are the inventors of this patent?

   • The inventors are Rajesh Patel and Louis Bucalo.

3. What is the significance of federal funding in this patent?

   • The federal funding grants the U.S. government certain rights, including a nontransferable, irrevocable, paid-up license and "march-in" rights.

4. How long does the device release buprenorphine?

   • The device releases buprenorphine continuously over a period of six months.

5. What are the implications of the patent's expiration?

   • The expiration of the patent could allow for the development of generic versions of the device, although other intellectual property rights may still apply.

Sources

1. KEI Online: US Federal rights in patents on Probuphine, to treat opioid addiction.
2. Wikipedia: Joseph Fuisz.
3. Hoover Institution: Patent Claims and Patent Scope.
4. Google Patents: Implantable polymeric device for sustained release of buprenorphine.

Drugs Protected by US Patent 7,736,665

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Reacx Pharms	PROBUPHINE	buprenorphine hydrochloride	IMPLANT;IMPLANTATION	204442-001	May 26, 2016		DISCN	Yes	No	7,736,665					FOR OPIOID DEPENDENCE

International Family Members for US Patent 7,736,665

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003240493
Australia	2008212011
Canada	2487577
Cyprus	1120510
Denmark	2561860
European Patent Office	1509182
European Patent Office	2561860