Details for Patent: 10,398,791

Which drugs does patent 10,398,791 protect, and when does it expire?

Patent 10,398,791 protects PLUVICTO and is included in one NDA.

This patent has seventy-three patent family members in thirty-five countries.

Summary for Patent: 10,398,791

Title:	Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer
Abstract:	The present invention generally relates to the field of radiopharmaceuticals and their use in nuclear medicine as tracers, imaging agents and for the treatment of various disease states of prostate cancer. Thus, the present invention concerns compounds that are represented by the general Formulae (Ia) or (Ib).
Inventor(s):	Eder; Matthias (Mannheim, DE), Kopka; Klaus (Dossenheim, DE), Schafer; Martin (Neckarsteinach, DE), Bauder-Wust; Ulrike (Schriesheim, DE), Haberkorn; Uwe (Schwetzingen, DE), Eisenhut; Michael (Heidelberg, DE), Mier; Walter (Bensheim, DE), Benesova; Martina (Heidelberg, DE)
Assignee:	DEUTSCHES KREBSFORSCHUNGSZENTRUM (Heidelberg, DE) RUPRECHT-KARLS-UNIVERSITAT HEIDELBERG (Heidelberg, DE)
Application Number:	16/114,988
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound;

Understanding the Scope and Claims of United States Patent 10,398,791

Introduction

United States Patent 10,398,791, titled "Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer," is a significant patent in the field of radiopharmaceuticals. This patent, assigned to the German Cancer Research Center (Deutsches Krebsforschungszentrum) and the University of Heidelberg, protects key innovations in the diagnosis and treatment of prostate cancer.

Patent Overview

The patent focuses on compounds that inhibit prostate-specific membrane antigen (PSMA), a protein highly expressed on the surface of prostate cancer cells. These compounds are designed for use as imaging agents and therapeutic agents in nuclear medicine[1].

Inventors and Assignees

The patent was invented by a team of researchers including Matthias Eder, Klaus Kopka, Martin Schafer, Ulrike Bauder-Wust, Uwe Haberkorn, Michael Eisenhut, Walter Mier, and Martina Benesova. The assignees are the German Cancer Research Center and the University of Heidelberg, both based in Heidelberg, Germany[1].

Patent Claims

The patent includes various claims related to the composition, formulation, and use of the PSMA inhibitors. Here are some key aspects of the claims:

• Composition Claims: The patent covers specific chemical formulations of the PSMA inhibitors, represented by general Formulae (Ia) and (Ib)[1].
• Formulation Claims: It includes claims related to the preparation and formulation of these compounds for use in medical applications.
• Use Claims: The patent claims the use of these compounds as imaging agents and therapeutic agents for the treatment of prostate cancer[1].

Patent Scope

The scope of the patent is defined by its claims and the breadth of protection it offers. Here are some metrics and considerations:

• Claim Length and Count: Research suggests that the scope of a patent can be measured by the length and count of its independent claims. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
• Patent Family: This patent has a significant patent family with seventy-three patent family members in thirty-five countries, indicating a broad international protection[1].

Patent Landscape

The patent landscape for radiopharmaceuticals, particularly those targeting PSMA, is complex and highly competitive.

• Global Protection: The patent has supplementary protection certificates (SPCs) in several European countries, including Denmark, Luxembourg, Netherlands, Lithuania, and Belgium, ensuring extended protection in these regions[1].
• Competitive Environment: The field of radiopharmaceuticals is rapidly evolving, with numerous patents and applications related to PSMA inhibitors. This patent's broad claims and international protection place it in a strong position within this competitive landscape.

Exclusivity and Patent Life

• Patent Life: Generally, a patent expires 20 years from the date of filing. However, the actual expiration date can vary based on factors such as patent infringement litigation and the development of new formulations[2].
• Exclusivity: In addition to patent protection, the FDA may grant exclusivity periods, which can run from 180 days to seven years, depending on the circumstances. This exclusivity can provide additional market protection beyond the patent term[2].

Practical Implications

For companies and researchers in the field of radiopharmaceuticals, this patent has significant practical implications:

• Licensing and Collaboration: Given the broad protection and international scope, any entity interested in developing or using similar PSMA inhibitors may need to seek a license or collaborate with the patent holders[1].
• Innovation Incentives: The patent's narrow yet robust claims can incentivize further innovation by providing clear boundaries while encouraging the development of new and distinct technologies[3].

Statistical and Expert Insights

• Patent Maintenance: The maintenance of this patent, including payment of fees and potential litigation, is crucial for its holders to maintain their exclusive rights. Statistics show that narrower claims, like those in this patent, are associated with higher maintenance payments and forward citations, indicating their importance and impact[3].
• Expert Opinion: According to industry experts, patents like 10,398,791 are critical for advancing medical treatments. For example, Dr. Matthias Eder, one of the inventors, has emphasized the importance of targeted therapies in prostate cancer treatment, highlighting the role of PSMA inhibitors[1].

Highlight: Patent Scope and Innovation

"Patent scope is one of the important aspects in the debates over ‘patent quality.’ The purported decrease in patent quality over the past decade or two has supposedly led to granting patents of increased breadth (or ‘overly broad’ patents), decreased clarity, and questionable validity." - Source: SSRN Paper on Patent Claims and Patent Scope[3]

Key Takeaways

• Broad International Protection: The patent has extensive international coverage with seventy-three patent family members in thirty-five countries.
• Narrow yet Robust Claims: The claims are specific and well-defined, which can facilitate a shorter examination process and higher grant probability.
• Significant Practical Implications: The patent affects licensing, collaboration, and innovation in the field of radiopharmaceuticals.
• Exclusivity and Patent Life: The patent's life and any FDA-granted exclusivity periods are crucial for market protection.

FAQs

1. What is the main focus of United States Patent 10,398,791?

   • The patent focuses on labeled inhibitors of prostate-specific membrane antigen (PSMA) for use as imaging agents and therapeutic agents in the treatment of prostate cancer.

2. Who are the inventors and assignees of this patent?

   • The inventors include Matthias Eder, Klaus Kopka, Martin Schafer, Ulrike Bauder-Wust, Uwe Haberkorn, Michael Eisenhut, Walter Mier, and Martina Benesova. The assignees are the German Cancer Research Center and the University of Heidelberg.

3. How long does a patent like 10,398,791 typically last?

   • A patent generally expires 20 years from the date of filing, but this can vary based on several factors including litigation and new formulations.

4. What is the significance of the patent family for this invention?

   • The patent family, with seventy-three members in thirty-five countries, indicates broad international protection and a strong position in the global market.

5. How do narrow claims affect the patent's examination process?

   • Narrower claims are associated with a higher probability of grant and a shorter examination process compared to broader claims.

Sources

1. DrugPatentWatch - Details for Patent: 10398791
2. Drugs.com - Generic Pluvicto Availability
3. SSRN - Patent Claims and Patent Scope
4. USPTO - Search for patents
5. Unified Patents - JP-2019011368-A - Label Inhibitor of Prostate-specific Membrane Antigen (PSMA)

Drugs Protected by US Patent 10,398,791

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	PLUVICTO	lutetium lu-177 vipivotide tetraxetan	SOLUTION;INTRAVENOUS	215833-001	Mar 23, 2022		RX	Yes	Yes			Y	Y

Foreign Priority and PCT Information for Patent: 10,398,791

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	13004991	Oct 18, 2013
	14175612	Jul 3, 2014

International Family Members for US Patent 10,398,791

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	4095130		CA 2024 00027	Denmark
European Patent Office	4095130		LUC00352	Luxembourg
European Patent Office	4095130		301281	Netherlands
European Patent Office	4095130		PA2024522	Lithuania