Details for Patent: 11,306,106

Which drugs does patent 11,306,106 protect, and when does it expire?

Patent 11,306,106 protects XOFLUZA and is included in two NDAs.

This patent has thirty-seven patent family members in twenty-three countries.

Summary for Patent: 11,306,106

Title:	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof
Abstract:	The present invention provides a pharmaceutical composition containing the following compound having antiviral action: ##STR00001## wherein each of the symbols is defined in the specification.
Inventor(s):	Kawai; Makoto (Osaka, JP)
Assignee:	Shionogi & Co., Ltd. (Osaka, JP)
Application Number:	16/937,877
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

United States Patent 11,306,106: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 11,306,106, hereafter referred to as the '106 Patent, is part of a series of patents related to the drug baloxavir marboxil, marketed under the brand name Xofluza. This patent is crucial in the context of pharmaceutical innovation, particularly in the treatment of influenza. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background on Baloxavir Marboxil

Baloxavir marboxil is an influenza virus polymerase acidic (PA) endonuclease inhibitor, indicated for the treatment of acute uncomplicated influenza. It was developed by Shionogi and is marketed by Genentech in the United States[4].

Patent Overview

The '106 Patent is one of several patents protecting baloxavir marboxil. Here are some key details:

Patent Number and Issue Date

• The patent number is 11,306,106, and it was issued on August 9, 2022[4].

Inventors and Assignees

• The inventors and assignees of this patent include researchers and entities associated with Shionogi and Genentech, reflecting the collaborative nature of pharmaceutical research[4].

Claims

The '106 Patent includes multiple claims that define the scope of the invention. These claims typically cover various aspects such as:

• The chemical composition of baloxavir marboxil.
• Methods of manufacture.
• Methods of use, including treatment protocols for influenza.
• Specific formulations and dosages.

For example, the patent might claim specific compounds, their synthesis methods, and their application in treating influenza, ensuring that any similar products or methods would infringe on these claims[2].

Scope of the Patent

The scope of the '106 Patent is defined by its claims, which are carefully crafted to protect the intellectual property related to baloxavir marboxil.

Chemical Composition

The patent likely includes detailed descriptions of the chemical structure of baloxavir marboxil and its derivatives, ensuring that any identical or very similar compounds would be covered under the patent[4].

Methods of Manufacture

Claims related to the synthesis and production processes of baloxavir marboxil are crucial. These methods are often proprietary and represent significant research and development investments[2].

Methods of Use

The patent covers the therapeutic use of baloxavir marboxil, including specific treatment protocols, dosages, and patient populations. This ensures that the drug's application in clinical settings is protected[4].

Patent Landscape

The '106 Patent is part of a larger patent landscape that includes several other patents related to baloxavir marboxil.

Related Patents

Other patents in this series include:

• US8927710
• US9815835
• US8987441
• US10392406
• US10633397
• US10759814
• US11261198
• US11925648

These patents collectively provide a robust protection framework for baloxavir marboxil, covering various aspects of the drug from its chemical composition to its clinical use[4][5].

Patent Expiration Dates

Understanding the expiration dates of these patents is crucial for both the patent holders and potential competitors. For instance:

• The '106 Patent is estimated to expire on August 9, 2037[4].

Litigation and Enforcement

Patents like the '106 Patent are often involved in litigation to protect against infringement. For example, Shionogi and Genentech have been involved in legal actions against generic manufacturers seeking to produce baloxavir marboxil before the patent expiration dates[2].

Impact on the Pharmaceutical Industry

The '106 Patent and its associated patents have significant implications for the pharmaceutical industry.

Innovation and Research

These patents incentivize innovation by protecting the intellectual property of pharmaceutical companies, allowing them to recoup their research and development investments[3].

Market Competition

The patent protection period limits competition from generic manufacturers, giving the original developers a monopoly on the market. This can impact pricing and accessibility of the drug[5].

Patient Access

While patent protection can limit immediate generic competition, it also ensures that the original developers have the financial incentive to continue researching and improving treatments, ultimately benefiting patients in the long term[4].

Key Takeaways

• Patent Scope: The '106 Patent covers the chemical composition, methods of manufacture, and therapeutic use of baloxavir marboxil.
• Patent Landscape: It is part of a series of patents protecting baloxavir marboxil, ensuring comprehensive protection.
• Expiration Dates: The patent is estimated to expire on August 9, 2037.
• Industry Impact: The patent influences innovation, market competition, and patient access to the drug.

FAQs

What is the primary use of baloxavir marboxil?

Baloxavir marboxil is primarily used for the treatment of acute uncomplicated influenza.

Who are the main assignees of the '106 Patent?

The main assignees include Shionogi and Genentech.

What is the estimated expiration date of the '106 Patent?

The estimated expiration date of the '106 Patent is August 9, 2037.

How does the '106 Patent impact the pharmaceutical industry?

The patent protects the intellectual property of the drug, incentivizing innovation and limiting competition from generic manufacturers during the protection period.

Are there any ongoing litigations related to the '106 Patent?

Yes, there have been legal actions against generic manufacturers to protect against infringement of the '106 Patent and related patents.

Sources

1. West Virginia University - Funds Analysis (Excel Sheet)
2. RPX Corporation - Case 1:23-cv-00161-UNA Document 1 Filed 02/13/23
3. USPTO - Supplementary Material - Inventing AI
4. DrugBank - Baloxavir marboxil: Uses, Interactions, Mechanism of Action
5. Pharsight - Xofluza patent expiration

Drugs Protected by US Patent 11,306,106

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes						METHOD FOR TREATING INFLUENZA
Genentech Inc	XOFLUZA	baloxavir marboxil	FOR SUSPENSION;ORAL	214410-001	Nov 23, 2020		RX	Yes	Yes						METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No						METHOD FOR TREATING INFLUENZA
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-001	Oct 24, 2018		DISCN	Yes	No						METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No						METHOD FOR TREATING INFLUENZA
Genentech Inc	XOFLUZA	baloxavir marboxil	TABLET;ORAL	210854-002	Oct 24, 2018		RX	Yes	No						METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA

Foreign Priority and PCT Information for Patent: 11,306,106

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	JP2016-157732	Aug 10, 2016

International Family Members for US Patent 11,306,106

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	109315
Australia	2017310774
Australia	2023202350
Brazil	112019001911
Canada	3033180
Chile	2019000325