Details for Patent: 8,835,452

Which drugs does patent 8,835,452 protect, and when does it expire?

Patent 8,835,452 protects XIFAXAN and is included in one NDA.

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

Summary for Patent: 8,835,452

Title:	Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Abstract:	Crystalline polymorphous forms of rifaximin (INN) antibiotic named rifaximin .alpha. and rifaximin .beta., and a poorly crystalline form named rifaximin .gamma., useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.
Inventor(s):	Viscomi; Giuseppe Claudio (Bologna, IT), Campana; Manuela (Bologna, IT), Braga; Dario (Bologna, IT), Confortini; Donatella (Bologna, IT), Cannata; Vincenzo (Bologna, IT), Righi; Paolo (Bologna, IT), Rosini; Goffredo (Bologna, IT)
Assignee:	Alfa Wassermann S.p.A. (IT)
Application Number:	13/680,967
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,835,452
Patent Claim Types: see list of patent claims	Composition; Dosage form;

Understanding the Scope and Claims of United States Patent 8,835,452

Introduction

United States Patent 8,835,452 is a significant patent that has been involved in various legal and commercial transactions. To understand its importance, it is crucial to delve into its scope, claims, and the broader patent landscape it operates within.

Patent Overview

The patent in question, U.S. Patent No. 8,835,452, is part of a series of patents related to pharmaceutical formulations and methods. Here is a brief overview:

Title and Classification

• Title: The title of the patent is not explicitly provided in the sources, but it is related to pharmaceutical formulations, likely involving specific active ingredients and their manufacturing processes.
• Classification: The patent falls under classifications such as A61K 9/0053, A61K 31/437, and others related to medicinal preparations and their production methods[4].

Scope of the Patent

The scope of a patent is defined by its claims, which outline the specific inventions or innovations protected by the patent.

Claim Structure

• The patent includes multiple claims that define the invention. These claims can be independent or dependent, with independent claims standing alone and dependent claims referring back to one or more previous claims[3].
• For example, the patent might include claims related to the composition of the pharmaceutical formulation, the method of manufacturing, and any specific processes or ingredients used.

Claim Examples

While the exact claims of U.S. Patent No. 8,835,452 are not detailed in the sources, similar patents in the pharmaceutical sector often include claims such as:

• "A pharmaceutical composition comprising [specific active ingredient], [specific excipient], and [specific manufacturing process]."
• "A method for producing a pharmaceutical formulation, comprising the steps of [step 1], [step 2], and [step 3]."

Patent Claims and Litigation

The patent has been involved in litigation, which highlights its significance and the disputes surrounding its claims.

Litigation Context

• The patent is mentioned in a lawsuit involving Salix Pharmaceuticals, Inc., where the plaintiffs alleged infringement of several patents, including U.S. Patent No. 8,835,452. The lawsuit pertains to the commercial manufacture, use, offer for sale, sale, and/or importation of a generic product that allegedly infringes on the patent claims[5].

Infringement Claims

• The litigation documents indicate that the defendants were accused of infringing one or more claims of the ’452 patent by submitting an Abbreviated New Drug Application (ANDA) to the FDA for approval to manufacture and sell a generic version of the drug. This suggests that the patent's claims are critical in protecting the proprietary rights of the original drug formulation[5].

Patent Landscape

Understanding the broader patent landscape is essential to grasp the value and strategic importance of U.S. Patent No. 8,835,452.

Patent Valuation

• Patents in the pharmaceutical sector can be highly valuable. For instance, the sale of patent portfolios involving similar types of patents has resulted in significant financial transactions. For example, the consortium including Apple, BlackBerry, Ericsson, Microsoft, and Sony paid $4.5 billion for 6,000 patent documents from Nortel, which translates to $750,000 per patent document[1].

Patent Scope Metrics

• The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims, which are crucial in determining the patent's quality and potential for litigation[3].

Strategic Importance

The strategic importance of U.S. Patent No. 8,835,452 can be understood from several perspectives:

Market Exclusivity

• Patents like U.S. Patent No. 8,835,452 provide market exclusivity, allowing the patent holder to prevent others from making, using, or selling the invention without permission. This exclusivity is particularly valuable in the pharmaceutical industry, where it can protect significant investments in research and development[5].

Licensing and Litigation

• The patent's involvement in litigation highlights its strategic value. Companies often engage in patent litigation to protect their intellectual property and prevent infringement. The ability to enforce patent claims can be a powerful tool in maintaining market share and revenue[5].

Conclusion

U.S. Patent No. 8,835,452 is a significant patent within the pharmaceutical industry, with its scope and claims defining a specific invention related to pharmaceutical formulations. Its involvement in litigation underscores its strategic importance and the value it holds for its owners.

Key Takeaways

• Patent Scope: Defined by its claims, which outline the specific invention protected.
• Litigation: The patent has been involved in litigation related to infringement claims.
• Strategic Importance: Provides market exclusivity and is valuable in protecting intellectual property.
• Valuation: Patents in this sector can be highly valuable, as seen in significant financial transactions involving similar patents.
• Metrics: Independent claim length and count can measure the patent's scope and quality.

FAQs

1. What is the general classification of U.S. Patent No. 8,835,452?

   • The patent falls under classifications such as A61K 9/0053 and A61K 31/437, related to medicinal preparations and their production methods.

2. Why is U.S. Patent No. 8,835,452 involved in litigation?

   • The patent is involved in litigation due to allegations of infringement by a generic drug manufacturer.

3. How is the scope of a patent measured?

   • The scope can be measured using metrics such as independent claim length and independent claim count.

4. What is the strategic importance of U.S. Patent No. 8,835,452?

   • It provides market exclusivity and protects significant investments in research and development.

5. How valuable can patents in the pharmaceutical sector be?

   • Patents in this sector can be highly valuable, with transactions involving millions or even billions of dollars.

Sources

1. Perpetual Motion Patents - The value of a patent
2. RPX Corporation - Case 1:20-cv-00430-RGA Document 59 Filed 11/13/20
3. Hoover Institution - Patent Claims and Patent Scope
4. Google APIs - United States Patent - googleapis.com
5. RPX Corporation - in the united states district court for the district of delaware salix ...

Drugs Protected by US Patent 8,835,452

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004		RX	Yes	Yes	8,835,452		Y	Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	8,835,452		Y	Y

Foreign Priority and PCT Information for Patent: 8,835,452

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Italy	MI2003A002144	Nov 7, 2003

International Family Members for US Patent 8,835,452

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	043547
Argentina	081991
Argentina	081992
Austria	361927
Austria	421965