Details for Patent: 7,563,871

Which drugs does patent 7,563,871 protect, and when does it expire?

Patent 7,563,871 protects BYDUREON, BYDUREON PEN, and BYDUREON BCISE, and is included in two NDAs.

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

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

Summary for Patent: 7,563,871

Title:	Polymer-based sustained release device
Abstract:	This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions, for the sustained release of biologically active polypeptides. The sustained release compositions of this invention comprise a biocompatible polymer having dispersed therein, a biologically active polypeptide and a sugar.
Inventor(s):	Wright; Steven G. (Madeira, OH), Christensen; Troy (Mason, OH), Yeoh; Thean (Foxboro, MA), Rickey; Michael E. (Loveland, OH), Hotz; Joyce M. (Cincinnati, OH), Kumar; Rajesh (Marlborough, MA), Fineman; Mark (San Diego, CA), Smith; Christine (San Diego, CA), Ong; John (San Diego, CA), Lokensgard; David (San Diego, CA), Costantino; Henry R. (Woodinville, WA)
Assignee:	Alkermes, Inc. (Cambridge, MA) Amylin Pharmaceuticals, Inc. (San Diego, CA)
Application Number:	11/521,091
Patent Claim Types: see list of patent claims	Composition; Use;

Analyzing the Scope and Claims of United States Patent 7,563,871

Introduction

United States Patent 7,563,871, titled "Polymer-based sustained release device," is a significant patent in the field of pharmaceuticals and biotechnology. This patent, granted to inventors involved in the development of sustained release devices, is crucial for understanding the landscape of intellectual property in this domain.

Background

The patent in question pertains to compositions and methods for the sustained release of biologically active polypeptides. This technology is vital for the delivery of therapeutic agents over an extended period, enhancing the efficacy and convenience of treatments.

Patent Overview

Publication Details

• Publication Number: US7563871B2
• Filing Date: October 27, 2006
• Grant Date: July 21, 2009
• Status: Expired - Lifetime[4].

Claims and Scope

Independent Claims

The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition, the method of forming the composition, and the method of using the composition for sustained release.

• Claim 1: This claim describes a composition comprising a biologically active polypeptide and a polymer matrix, where the polypeptide is dispersed within the matrix.
• Claim 10: This claim outlines a method for forming the composition, involving the steps of mixing the polypeptide with the polymer and then shaping the mixture into a desired form[4].

Dependent Claims

Dependent claims further specify the details of the independent claims, such as the types of polymers used, the specific polypeptides, and the conditions under which the composition is formed.

• Claim 2: This claim specifies that the polymer matrix can be made from a biodegradable polymer.
• Claim 11: This claim details the method of using the composition, including the administration route and the therapeutic effect[4].

Technical Details

Composition

The patent describes a composition that includes a biologically active polypeptide, such as exendin, and a polymer matrix. The polymer can be biodegradable, ensuring the gradual release of the polypeptide over time.

Method of Formation

The method involves mixing the polypeptide with the polymer and then shaping the mixture into a desired form, such as a pellet or an implant. This process ensures uniform distribution of the polypeptide within the polymer matrix.

Method of Use

The composition is designed for the sustained release of the polypeptide, which can be administered via various routes, including subcutaneous or intramuscular injection. The therapeutic effect is achieved through the controlled release of the polypeptide over an extended period[4].

Patent Landscape

Prior Art and Related Patents

The patent landscape in this area is complex, with numerous patents related to sustained release compositions and methods. For example, other patents like WO-2003066585-A2 also describe sustained release compositions, highlighting the competitive and innovative nature of this field[5].

Terminal Disclaimers and Patent Thickets

In the broader context of pharmaceutical patents, the use of terminal disclaimers and the creation of patent thickets can significantly impact the landscape. Patent thickets, where multiple patents are filed to protect a single product, can make it challenging for generic or biosimilar manufacturers to enter the market. This is particularly relevant in the bio/pharma sector, where 75% of the remaining patents for a drug like IMBRUVICA were found to be terminally disclaimed, indicating a strategy to extend patent protection and delay generic entry[1].

Economic and Regulatory Implications

Cost and Litigation

Challenging patents in this field can be highly costly. For instance, generic or biosimilar applicants may budget millions of dollars to challenge patents in district court litigation, making the process both financially and legally complex[1].

USPTO Regulations

The USPTO has the authority to impose conditions on patent claims, including those related to terminal disclaimers. This regulatory framework is crucial for maintaining the integrity and quality of patents, ensuring that only valid and distinct claims are enforced[1].

Data and Statistics

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014. This dataset can be used to analyze trends in patent scope and claim dependency, offering insights into the evolving landscape of patent claims[3].

Industry Impact

Expert Insights

Industry experts emphasize the importance of patent strategy in the bio/pharma sector. For example, the use of patent thickets and terminal disclaimers can significantly delay the entry of generic or biosimilar products, affecting market competition and patient access to affordable treatments.

Statistics and Trends

In fiscal year 2024, 65% of inter partes and post-grant review petitions were instituted, indicating a high rate of challenges to patent validity. This highlights the ongoing battle between brand manufacturers and generic/biosimilar applicants in the patent landscape[1].

Key Takeaways

• Patent Scope and Claims: US Patent 7,563,871 covers specific compositions and methods for sustained release of biologically active polypeptides.
• Technical Details: The patent involves biodegradable polymers and precise methods for forming and using the compositions.
• Patent Landscape: The field is marked by patent thickets and terminal disclaimers, which can delay generic entry.
• Economic and Regulatory Implications: Challenging patents is costly, and USPTO regulations play a crucial role in maintaining patent quality.
• Industry Impact: The patent strategy significantly affects market competition and patient access to treatments.

FAQs

1. What is the main subject of US Patent 7,563,871?

   • The main subject is compositions and methods for the sustained release of biologically active polypeptides.

2. What is the status of US Patent 7,563,871?

   • The patent has expired.

3. How do terminal disclaimers impact the bio/pharma sector?

   • Terminal disclaimers can delay generic or biosimilar entry by creating patent thickets that make it costly and legally complex to challenge.

4. What is the significance of the USPTO's Patent Claims Research Dataset?

   • It provides detailed information on patent claims, helping to analyze trends in patent scope and claim dependency.

5. Why is patent strategy important in the bio/pharma sector?

   • It affects market competition, patient access to treatments, and the financial viability of generic or biosimilar manufacturers.

Citations

1. Letterhead DC Office - Regulations.gov

   • "Our patents reflect important innovative and inventive steps that the United States Patent and Trademark Office agreed merit protection."
   • [Source: Letterhead DC Office - Regulations.gov][1]

2. Polymer-based sustained release device - Patent US-7563871-B2

   • "This invention relates to compositions for the sustained release of biologically active polypeptides, and methods of forming and using said compositions."
   • [Source: Polymer-based sustained release device - Patent US-7563871-B2][4]

3. Patent Claims Research Dataset - USPTO

   • "The Patent Claims Research Dataset contain detailed information on claims from US patents granted between 1976 and 2014 and US patent applications published between 2001 and 2014."
   • [Source: Patent Claims Research Dataset - USPTO][3]

Drugs Protected by US Patent 7,563,871

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca Ab	BYDUREON	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-001	Jan 27, 2012		DISCN	Yes	No	7,563,871*PED				Y
Astrazeneca Ab	BYDUREON PEN	exenatide synthetic	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	022200-002	Feb 28, 2014		DISCN	Yes	No	7,563,871*PED				Y
Astrazeneca Ab	BYDUREON BCISE	exenatide synthetic	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	209210-001	Oct 20, 2017		RX	Yes	Yes	7,563,871*PED				Y

International Family Members for US Patent 7,563,871

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1734971		16/2012	Austria
European Patent Office	1734971		122012000028	Germany
European Patent Office	1734971		C300526	Netherlands
European Patent Office	1734971		CA 2012 00015	Denmark
European Patent Office	1734971		PA2012006	Lithuania
European Patent Office	1734971		91989	Luxembourg