Details for Patent: 7,863,249

Which drugs does patent 7,863,249 protect, and when does it expire?

Patent 7,863,249 protects DIFICID and is included in two NDAs.

Protection for DIFICID has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has one hundred and twenty-seven patent family members in twenty-nine countries.

Summary for Patent: 7,863,249

Title:	Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Abstract:	The invention relates to novel forms of compounds displaying broad spectrum antibiotic activity, especially crystalline polymorphic forms and amorphous forms of such compounds, compositions comprising such crystalline polymorphic forms and amorphous forms of such compounds, processes for manufacture and use thereof. The compounds and compositions of the invention are useful in the pharmaceutical industry, for example, in the treatment or prevention of diseases or disorders associated with the use of antibiotics, chemotherapies, or antiviral therapies, including, but not limited to, colitis, for example, pseudo-membranous colitis; antibiotic associated diarrhea; and infections due to Clostridium difficile ("C. difficile"), Clostridium perfringens ("C. perfringens"), Staphylococcus species, for example, methicillin-resistant Staphylococcus, or Enterococcus including Vancomycin-resistant enterococci.
Inventor(s):	Chiu; Yu-Hung (San Diego, CA), Che; Tessie Mary (San Diego, CA), Romero; Alex (San Diego, CA), Ichikawa; Yoshi (San Diego, CA), Shue; Youe-Kong (Carlsbad, CA)
Assignee:	Optimer Pharmaceuticals, Inc. (San Diego, CA)
Application Number:	12/101,552
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,863,249
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 7,863,249

Introduction

The United States Patent 7,863,249, titled "Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof," is a significant patent in the pharmaceutical industry, particularly in the realm of antibiotic development. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it inhabits.

Patent Overview

Patent Number and Title

• The patent number is US7863249B2, and its title is "Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof."

Publication and Priority Dates

• The patent was published on January 4, 2011, with a priority date of June 30, 2006[4].

Scope of the Patent

Subject Matter

• This patent pertains to novel forms of macrolide compounds, which are known for their broad-spectrum antibiotic activity. Specifically, it covers crystalline polymorphic forms and amorphous forms of these compounds[1][4].

Applications

• The macrolide polymorphs described in the patent are intended for use in pharmaceutical compositions. These compositions can be used to treat various bacterial infections, leveraging the unique properties of the polymorphic forms for enhanced efficacy and stability[1].

Claims of the Patent

Independent and Dependent Claims

• The patent includes both independent and dependent claims. Independent claims define the broad scope of the invention, while dependent claims narrow down the scope by adding specific limitations or features.
  • For example, independent claims might cover the general composition of the macrolide polymorphs, while dependent claims could specify particular crystalline forms or methods of manufacture[1].

Claim Types

• The patent includes claims related to:
  • The macrolide compounds themselves, including their chemical structure and polymorphic forms.
  • Pharmaceutical compositions comprising these compounds.
  • Methods of manufacturing these compounds and compositions.
  • Methods of use, including therapeutic applications[1].

Patent Landscape

Related Patents

• The patent landscape surrounding US7863249B2 includes several related patents that cover various aspects of macrolide compounds and their applications.
  • Patents such as US7378508 and US7906489 also pertain to macrolide compounds and their pharmaceutical uses, often with overlapping but distinct claims[5].

Patent Expiration Dates

• The patent US7863249B2 is set to expire on July 31, 2027. This expiration date is crucial for understanding when generic versions of the drug could potentially enter the market[5].

Litigation and Enforcement

Patent Infringement Cases

• The patent has been involved in several patent infringement cases, particularly in the context of Abbreviated New Drug Applications (ANDAs) filed with the FDA.
  • For instance, Merck and Cubist Pharmaceuticals have filed lawsuits against Actavis Labs, FL, alleging patent infringement related to the submission of ANDA No. 208443, which sought approval for a generic version of a drug covered by this and other related patents[2].

Impact on Pharmaceutical Industry

Innovation and Competition

• Patents like US7863249B2 play a critical role in driving innovation in the pharmaceutical industry by providing exclusive rights to the inventors, allowing them to recoup their investment in research and development.
  • However, they also create barriers to entry for generic manufacturers, which can delay the availability of cheaper alternatives and impact public health[3].

Metrics for Patent Scope

Independent Claim Length and Count

• The scope of a patent can be measured using metrics such as independent claim length and the total number of independent claims.
  • Research has shown that narrower claims, as indicated by shorter independent claim lengths and fewer independent claims, are associated with a higher probability of patent grant and a shorter examination process[3].

Key Takeaways

• Patent Scope: The patent covers novel macrolide polymorphs, their compositions, and methods of use and manufacture.
• Claims: Include independent and dependent claims related to the compounds, compositions, and methods.
• Patent Landscape: Part of a broader landscape including related patents with overlapping claims.
• Expiration Date: Set to expire on July 31, 2027.
• Litigation: Involved in patent infringement cases related to ANDA submissions.
• Industry Impact: Drives innovation but can create barriers to generic competition.

FAQs

1. What is the main subject matter of US Patent 7,863,249?

   • The main subject matter is novel forms of macrolide compounds, specifically crystalline polymorphic forms and amorphous forms, and their use in pharmaceutical compositions.

2. What are the key claims of this patent?

   • The key claims include the macrolide compounds themselves, pharmaceutical compositions comprising these compounds, methods of manufacturing, and methods of use.

3. When is the patent set to expire?

   • The patent is set to expire on July 31, 2027.

4. Has this patent been involved in any litigation?

   • Yes, it has been involved in patent infringement cases related to ANDA submissions to the FDA.

5. How does this patent impact the pharmaceutical industry?

   • It drives innovation by providing exclusive rights but can delay the entry of generic alternatives, impacting competition and public health.

Sources

1. US7863249B2 - Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof - Google Patents.
2. MERCK SHARP & DOHME CORP., CUBIST PHARMACEUTICAL - Insight.RPXcorp.
3. Patent Claims and Patent Scope - Hoover Institution.
4. US7863249B2 - Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof - Google Patents.
5. Generic Dificid Availability - Drugs.com.

Drugs Protected by US Patent 7,863,249

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cubist Pharms Llc	DIFICID	fidaxomicin	FOR SUSPENSION;ORAL	213138-001	Jan 24, 2020		RX	Yes	Yes	7,863,249*PED				Y
Cubist Pharms Llc	DIFICID	fidaxomicin	TABLET;ORAL	201699-001	May 27, 2011		RX	Yes	Yes	7,863,249*PED				Y

International Family Members for US Patent 7,863,249

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1539977		C300727	Netherlands
European Patent Office	1539977		CA 2015 00020	Denmark
European Patent Office	1539977		92684	Luxembourg
European Patent Office	1539977		15C0028	France
European Patent Office	1539977		300727	Netherlands
European Patent Office	1539977		CR 2015 00020	Denmark