Details for Patent: 8,541,451

Which drugs does patent 8,541,451 protect, and when does it expire?

Patent 8,541,451 protects YUPELRI and is included in one NDA.

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

Summary for Patent: 8,541,451

Title:	Crystalline freebase forms of a biphenyl compound
Abstract:	The invention provides two crystalline freebase forms of biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)piper- idin-4-yl ester. The invention also provides pharmaceutical compositions comprising the crystalline freebase or prepared using the crystalline freebases; processes and intermediates for preparing the crystalline freebases; and methods of using the crystalline freebases to treat a pulmonary disorder.
Inventor(s):	Woollam; Grahame (Horsham, GB)
Assignee:	Theravance, Inc. (South San Francisco, CA)
Application Number:	12/835,964
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,541,451
Patent Claim Types: see list of patent claims	Composition; Compound; Process;

Understanding the Scope and Claims of United States Patent 8,541,451

Introduction

United States Patent 8,541,451, titled "Crystalline freebase forms of a biphenyl compound," is a patent that has significant implications in the pharmaceutical industry, particularly in the development and production of specific drug compounds. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Patent Overview

The patent, assigned to Theravance Biopharma R&D IP, LLC, pertains to crystalline freebase forms of a biphenyl compound, specifically biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl)[1][5].

Scope of the Patent

The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:

Claims

• The patent includes multiple claims that cover different crystalline freebase forms of the biphenyl compound.
• These claims specify the structural and chemical characteristics of the crystalline forms, ensuring that any similar compounds developed by others would infringe on these claims if they fall within the described parameters[1][5].

Crystalline Forms

• The patent describes two distinct crystalline freebase forms of the biphenyl compound, each with its own unique physical and chemical properties.
• These forms are crucial for the stability, efficacy, and bioavailability of the drug, making them significant in pharmaceutical development[1].

Patent Claims Analysis

Independent Claims

• Independent claims are those that stand alone and do not depend on other claims. In this patent, the independent claims define the core aspects of the crystalline freebase forms, including their chemical structure and physical characteristics.
• These claims are critical because they set the boundaries of what is considered an infringement of the patent[3].

Dependent Claims

• Dependent claims build upon the independent claims and provide additional specificity. They often detail specific embodiments or variations of the invention.
• In the context of this patent, dependent claims might cover different methods of preparing the crystalline forms or specific uses of these forms in pharmaceutical applications[3].

Patent Landscape

Litigation and Settlements

• The patent has been involved in several litigation cases, particularly in the context of Abbreviated New Drug Applications (ANDAs) filed by generic drug manufacturers.
• For example, Theravance Biopharma R&D IP, LLC has been involved in lawsuits against companies like Accord Healthcare and Lupin, where the courts have ruled on the infringement and licensing of the patents-in-suit. These settlements often include provisions that prevent generic manufacturers from infringing the patents until their expiration, while also allowing the FDA to grant final approval to the ANDA applications[2].

Expiration and Licensing

• The patent's expiration date is crucial for understanding when generic versions of the drug can be legally produced.
• Licensing agreements are also a significant part of the patent landscape, as they allow other companies to use the patented technology in exchange for royalties or other considerations. These agreements can be part of settlement terms in litigation cases[2].

Valuation and Economic Impact

Patent Value

• The value of a patent like US 8,541,451 can be substantial, given its impact on the pharmaceutical industry. The value can be determined using methods such as the cost approach, income approach, and market approach.
• For instance, the income approach would consider the future benefits provided by the patent, such as royalties and licensing fees, over its lifetime. The market approach would look at what similar patents have sold for in the past[4].

Economic Impact

• Patents like this one can significantly influence the market by protecting innovative drugs and allowing the patent holder to recoup investment in research and development.
• The economic impact extends to the healthcare sector, where the availability of generic versions of the drug can be delayed due to patent protection, affecting drug prices and accessibility[4].

Metrics for Measuring Patent Scope

Claim Length and Count

• Research has shown that the scope of a patent can be measured using metrics such as independent claim length and count.
• Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process. This suggests that the patent office tends to narrow the scope of patent claims during the examination process[3].

Industry Expert Insights

Patent Quality and Innovation

• Industry experts often debate the quality of patents and their impact on innovation. Patents with clear and specific claims, like US 8,541,451, are generally seen as promoting innovation by providing clear boundaries and incentives for further research[3].

Illustrative Statistics

• The patent has been part of several high-profile litigation cases, with significant financial implications. For example, settlements involving this patent have included provisions that prevent infringement until the patent's expiration, highlighting the patent's economic value.
• The patent's involvement in ANDA litigation underscores its importance in the pharmaceutical industry, where patent protection can delay the entry of generic drugs into the market[2].

Key Takeaways

• Specific Claims: The patent includes detailed claims that specify the crystalline freebase forms of the biphenyl compound, protecting its unique structural and chemical characteristics.
• Litigation and Settlements: The patent has been involved in several litigation cases, particularly in the context of ANDA applications, with settlements that prevent infringement until the patent's expiration.
• Economic Impact: The patent significantly influences the pharmaceutical market by protecting innovative drugs and affecting the availability and pricing of generic versions.
• Metrics for Scope: The scope of the patent can be measured using metrics such as independent claim length and count, which indicate a narrower scope and higher probability of grant.
• Industry Insights: The patent's clear and specific claims promote innovation by providing clear boundaries and incentives for further research.

FAQs

1. What is the main subject of United States Patent 8,541,451?

   • The main subject is the crystalline freebase forms of a biphenyl compound, specifically biphenyl-2-ylcarbamic acid 1-(2-{[4-(4-carbamoylpiperidin-1-ylmethyl)benzoyl]methylamino}ethyl).

2. What are the key claims of the patent?

   • The key claims define the structural and chemical characteristics of the crystalline freebase forms of the biphenyl compound.

3. How has the patent been involved in litigation?

   • The patent has been involved in several ANDA litigation cases, where generic drug manufacturers have sought to produce generic versions of the drug protected by this patent.

4. What is the economic impact of this patent?

   • The patent protects innovative drugs, allowing the patent holder to recoup investment in research and development, and affects the availability and pricing of generic versions of the drug.

5. How is the scope of the patent measured?

   • The scope can be measured using metrics such as independent claim length and count, which indicate a narrower scope and higher probability of grant.

Sources

1. US8541451B2 - Crystalline freebase forms of a biphenyl compound - Google Patents
2. ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan
3. Patent Claims and Patent Scope - Hoover Institution
4. The value of a patent - Perpetual Motion Patents

Drugs Protected by US Patent 8,541,451

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes				Y

International Family Members for US Patent 8,541,451

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010273514
Brazil	112012000890
Canada	2765621
Canada	2989129