Details for Patent: 8,349,869

Which drugs does patent 8,349,869 protect, and when does it expire?

Patent 8,349,869 protects OLYSIO and is included in one NDA.

This patent has sixty-three patent family members in forty-one countries.

Summary for Patent: 8,349,869

Title:	Macrocylic inhibitors of hepatitis C virus
Abstract:	Inhibitors of HCV replication of formula (I) ##STR00001## and the N-oxides, salts, and stereoisomers, wherein each dashed line represents an optional double bond; X is N, CH and where X bears a double bond it is C; R.sup.1 is --OR.sup.7, --NH--SO.sub.2R.sup.8; R.sup.2 is hydrogen, and where X is C or CH, R.sup.2 may also be C.sub.1-6alkyl; R.sup.3 is hydrogen, C.sub.1-6alkyl, C.sub.1-6alkoxyC.sub.1-6alkyl, C.sub.3-7cycloalkyl; R.sup.4 is aryl or Het; n is 3, 4, 5, or 6; R.sup.5 is halo, C.sub.1-6alkyl, hydroxy, C.sub.1-6alkoxy, phenyl, or Het; R.sup.6 is C.sub.1-6alkoxy, or dimethylamino; R.sup.7 is hydrogen; aryl; Het; C.sub.3-7cycloalkyl optionally substituted with C.sub.1-6alkyl; or C.sub.1-6alkyl optionally substituted with C.sub.3-7cycloalkyl, aryl or with Het; R.sup.8 is aryl; Het; C.sub.3-7cycloalkyl optionally substituted with C.sub.1-6alkyl; or C.sub.1-6alkyl optionally substituted with C.sub.3-7cycloalkyl, aryl or with Het; aryl is phenyl optionally substituted with one, two or three substituents; Het is a 5 or 6 membered saturated, partially unsaturated or completely unsaturated heterocyclic ring containing 1 to 4 heteroatoms selected from nitrogen, oxygen and sulfur, and being optionally substituted with one, two or three substituents; pharmaceutical compositions containing compounds (I) and processes for preparing compounds (I). Bioavailable combinations of the inhibitors of HCV of formula (I) with ritonavir are also provided.
Inventor(s):	Simmen; Kenneth Alan (Tervuren, BE), De Kock; Herman Augustinus (Arendonk, BE), Raboisson; Pierre Jean-Marie Bernard (Sterrebeek, BE), Hu; Lili (Mechelen, BE), Tahri; Abdellah (Anderlecht, BE), Surleraux; Dominique Louis Nestor Ghislain (Braine-le-chateau, BE), Nilsson; Karl Magnus (Goteborg, SE), Samuelsson; Bengt Bertil (Skarholmen, SE), Rosenquist; .ANG.sa Annica Kristina (Huddinge, SE), Ivanov; Vladimir (Moscow, RU), Pelcman; Mikael (Alvsjo, SE), Belfrage; Anna Karin Gertrud Linea (Uppsala, SE), Johansson; Per-Ola Mikael (Huddinge, SE), Vendeville; Sandrine Marie Helene (Etterbeek, BE)
Assignee:	Tibotec Pharmaceuticals Ltd. (Eastgate, County Cork, IE) Medivir AB (Huddinge, SE)
Application Number:	13/412,997
Patent Claim Types: see list of patent claims	Compound; Composition; Use; Process;

United States Patent 8,349,869: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,349,869, issued on January 8, 2013, is a significant patent in the pharmaceutical sector, particularly in the treatment of hepatitis C. This patent is associated with the drug Olysio™ (simeprevir), a macrocyclic inhibitor of the hepatitis C virus (HCV) NS3/4A protease. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

Inventors and Assignees

The patent was invented by Kenneth Alan Simmen, Herman Augustinus De Kock, Pierre Jean-Marie Bernard Raboisson, and Lili Hu, among others. It is assigned to Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson[1].

Issue Date and Expiration

The patent was issued on January 8, 2013, and is set to expire on July 28, 2026. The expiration date is crucial as it marks the end of the exclusive rights granted to the patent holders[1].

Claims and Scope

Claim Structure

The patent includes multiple claims that define the scope of the invention. These claims are categorized into several types, including compound claims, method of use claims, and method of manufacture claims.

Compound Claims

Claims 1-4, 6, 8-11, 13-17, 22, 24, 25, and 27-30 describe specific compounds, including the macrocyclic inhibitor simeprevir. These claims detail the chemical structure of the compounds, including their stereochemistry and pharmaceutical acceptable salts or N-oxides[1].

Method of Use Claims

These claims outline the methods for using the compounds to treat HCV infections. For example, claims related to the administration of simeprevir in combination with other antiviral agents are included[1].

Method of Manufacture Claims

The patent also includes claims related to the synthesis of the compounds. These claims are essential for protecting the proprietary methods developed by the inventors to produce the drug[1].

Scope of Protection

The scope of protection is defined by the claims that read on the approved product, Olysio™ (simeprevir), as well as methods of using or manufacturing the product. This ensures that any infringement would be identified based on these specific claims[1].

Patent Landscape

Related Patents

The patent landscape for HCV treatments is complex, with multiple patents covering different aspects of HCV therapy. U.S. Patent 8,349,869 is part of a larger family of patents related to HCV protease inhibitors. Other patents in this family may cover different compounds, methods of use, or manufacturing processes[1].

Competitors and Litigation

In the pharmaceutical industry, patent litigation is common. Companies often challenge the validity of competitors' patents or defend their own patents against infringement claims. For instance, the case of AI Visualize, Inc. v. Nuance Communications, Inc., although unrelated to this specific patent, illustrates the complexities and challenges in patent litigation, particularly in determining patent eligibility under 35 U.S.C. § 101[2].

Patent Term Extension

The patent holders have sought and may have been granted a patent term extension under 35 U.S.C. § 156. This extension is typically granted when there are delays in the regulatory approval process, which can extend the patent term beyond its original expiration date. For U.S. Patent 8,349,869, the application for a patent term extension was submitted within the required sixty-day period following the first commercial marketing of the product[1].

Economic and Research Implications

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides valuable insights into patent claims, including those related to pharmaceuticals. This dataset can help researchers and analysts understand the trends and scope of patent claims over time, which is crucial for understanding the competitive landscape in the pharmaceutical industry[3].

Market Impact

Patents like U.S. Patent 8,349,869 have significant market impact. They protect innovative drugs like Olysio™, allowing the patent holders to recoup their investment in research and development. This protection also incentivizes further innovation in the field of HCV treatments.

Maintenance Fees and Reexamination

Maintenance Fees

To keep the patent in force, the patent holders must pay maintenance fees at four, eight, and twelve years after the grant date. The payment windows for these fees are specified, and failure to pay these fees can result in the patent lapsing[1].

Reexamination and Correction

No reexamination certificate or disclaimer has been issued for this patent. However, a request for a certificate of correction was filed, indicating that minor errors or clarifications may have been necessary[1].

Key Takeaways

• Patent Scope: The patent covers specific compounds, methods of use, and methods of manufacture related to the HCV protease inhibitor simeprevir.
• Claims Structure: The claims are detailed and specify the chemical structure, methods of use, and methods of manufacture.
• Patent Landscape: The patent is part of a broader landscape of HCV treatment patents and is subject to potential litigation and regulatory extensions.
• Economic Impact: The patent protects a significant innovation in HCV treatment, influencing market dynamics and encouraging further research.
• Maintenance and Reexamination: Regular maintenance fees are required, and any corrections or reexaminations are closely monitored.

FAQs

What is the main subject of U.S. Patent 8,349,869?

The main subject of U.S. Patent 8,349,869 is the macrocyclic inhibitor simeprevir, used in the treatment of hepatitis C virus (HCV) infections.

Who are the inventors of U.S. Patent 8,349,869?

The inventors include Kenneth Alan Simmen, Herman Augustinus De Kock, Pierre Jean-Marie Bernard Raboisson, and Lili Hu, among others.

What is the expiration date of U.S. Patent 8,349,869?

The patent is set to expire on July 28, 2026.

What types of claims are included in U.S. Patent 8,349,869?

The patent includes compound claims, method of use claims, and method of manufacture claims.

Can the patent term of U.S. Patent 8,349,869 be extended?

Yes, the patent holders have sought a patent term extension under 35 U.S.C. § 156 due to delays in regulatory approval.

Sources

1. U.S. Patent and Trademark Office, "Application for Patent Term Extension Under 35 U.S.C. § 156," January 17, 2014.
2. United States Court of Appeals for the Federal Circuit, "AI VISUALIZE, INC. v. NUANCE COMMUNICATIONS, INC.," April 4, 2024.
3. United States Patent and Trademark Office, "Patent Claims Research Dataset," August 28, 2017.

Drugs Protected by US Patent 8,349,869

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Janssen Prods	OLYSIO	simeprevir sodium	CAPSULE;ORAL	205123-001	Nov 22, 2013		DISCN	Yes	No	8,349,869		Y	Y		METHOD OF TREATING HEPATITIS C

International Family Members for US Patent 8,349,869

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1912999		CA 2014 00053	Denmark
European Patent Office	1912999		C300697	Netherlands
European Patent Office	1912999		PA2014036	Lithuania
European Patent Office	1912999		1490062-5	Sweden