Details for Patent: 7,847,061

Which drugs does patent 7,847,061 protect, and when does it expire?

Patent 7,847,061 protects GATTEX KIT and is included in one NDA.

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

This patent has eight patent family members in seven countries.

Summary for Patent: 7,847,061

Title:	Treatment of short bowel syndrome patients with colon-in-continuity
Abstract:	Intestinal absorption is enhanced in short bowel syndrome patients presenting with colon-in-continuity by treatment with a GLP-2 receptor agonist, such as teduglutide.
Inventor(s):	Sanguinetti; Elizabeth Lemaire (Salt Lake City, UT), Marriott; Thomas B. (Sandy, UT), Lopansri; Jennifer (Salt Lake City, UT), Blosch; Consuelo Maria (Mercer Island, WA)
Assignee:	NPS Pharmaceuticals, Inc. (Bedminster, NJ)
Application Number:	11/262,980
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,847,061
Patent Claim Types: see list of patent claims	Use;

United States Patent 7,847,061: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 7,847,061, hereafter referred to as the '061 Patent, is a significant patent in the field of pharmaceuticals, particularly for the treatment of Short Bowel Syndrome (SBS). This patent is part of a larger portfolio of patents related to GLP-2 receptor agonists, specifically teduglutide, marketed as GATTEX. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background

The '061 Patent was issued on December 7, 2010, from the '980 Application, and it is one of the earliest patents in the series of GLP-2 SBS Patents filed by Shire-NPS (now part of Takeda USA)[1][2].

Scope of the Patent

The '061 Patent claims methods for treating patients with Short Bowel Syndrome (SBS) using GLP-2 receptor agonists. Specifically, it covers the administration of teduglutide to treat adult patients with SBS, particularly those with colon-in-continuity. This scope is crucial as it addresses a specific and critical medical condition where patients require intravenous nutritional support[4].

Claims of the Patent

The patent includes multiple claims that define the method of treatment, the dosage regimen, and the specific patient population. Here are some key aspects of the claims:

• Method of Treatment: The patent claims a method of treating SBS by administering a GLP-2 receptor agonist, such as teduglutide, to patients with colon-in-continuity.
• Dosage Regimen: The claims specify the dosage and administration schedule for the treatment.
• Patient Population: The patent is limited to adult patients with SBS, emphasizing the specific demographic it aims to treat[1].

Inventors and Ownership

The '061 Patent, along with other GLP-2 SBS Patents, has a complex ownership history. Drs. Mortensen and Jeppesen, who conducted the original research at Rigshospitalet, are the inventors of the inventions claimed in these patents. However, Shire-NPS did not disclose this to the inventors or the hospital and instead filed and prosecuted the patent applications without their knowledge[1].

Patent Landscape

The '061 Patent is part of a larger family of patents related to GLP-2 receptor agonists. Here are some key points about the patent landscape:

• Related Patents: The GLP-2 SBS Patents include numerous other U.S. and foreign patents, such as U.S. Patent Nos. 9,060,992; 9,545,434; 9,981,014; and others, all claiming priority to the original '233 Application[1][2].
• Orange Book Listings: These patents were listed in the Orange Book with respect to the New Drug Application (NDA) for GATTEX. However, many of these patents have since been disclaimed or delisted, leaving only the '061 and '992 patents listed as of 2023[2].
• Patent Term: The '061 Patent, along with other related patents, is set to expire in 2026, marking the end of the exclusive period for Shire-NPS (Takeda USA) to market GATTEX under these patents[4].

Patent Scope Metrics

The scope of the '061 Patent can be analyzed using metrics such as independent claim length and independent claim count, as discussed in the Hoover Institution paper on patent scope. These metrics help in understanding the breadth and clarity of the patent claims:

• Independent Claim Length: This metric measures the number of words in the shortest independent claim, which can indicate the complexity and specificity of the claim.
• Independent Claim Count: This metric counts the total number of independent claims, which can reflect the breadth of the patent's coverage[3].

Litigation and Disputes

The '061 Patent has been involved in several legal disputes, particularly regarding the ownership and disclosure of the inventions. Rigshospitalet and the inventors, Drs. Mortensen and Jeppesen, have alleged that Shire-NPS concealed the filing and prosecution of these patents, leading to significant legal battles[1].

Impact on Innovation

The '061 Patent and related patents have significant implications for innovation in the pharmaceutical industry. The broad scope of these patents can influence the development of similar treatments and the licensing costs associated with them. However, the disclaiming and delisting of many related patents may reduce these barriers and open up opportunities for generic or biosimilar products[2][3].

Conclusion

The United States Patent 7,847,061 is a pivotal patent in the treatment of Short Bowel Syndrome using GLP-2 receptor agonists. Its scope and claims are specific to the method of treatment and patient population, and it is part of a complex patent landscape involving multiple related patents. The ownership disputes and litigation surrounding this patent highlight the importance of transparency and ethical practices in patent filing and prosecution.

Key Takeaways

• The '061 Patent covers methods for treating SBS with GLP-2 receptor agonists.
• It is part of a larger family of GLP-2 SBS Patents with complex ownership issues.
• The patent is set to expire in 2026.
• The scope and claims can be analyzed using metrics like independent claim length and count.
• The patent has been involved in significant legal disputes.

FAQs

Q: What is the primary use of the '061 Patent? A: The primary use of the '061 Patent is for the treatment of Short Bowel Syndrome (SBS) using GLP-2 receptor agonists, specifically teduglutide.

Q: Who are the inventors of the '061 Patent? A: The inventors are Drs. Mortensen and Jeppesen, who conducted the original research at Rigshospitalet.

Q: What is the current status of the '061 Patent in the Orange Book? A: As of 2023, the '061 Patent remains listed in the Orange Book along with the '992 patent, while many other related patents have been disclaimed or delisted.

Q: When is the '061 Patent set to expire? A: The '061 Patent is set to expire in 2026.

Q: How can the scope of the '061 Patent be measured? A: The scope can be measured using metrics such as independent claim length and independent claim count.

Sources

1. Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 1 of 92
2. Case 1:24-cv-01366-UNA Document 1 Filed 12/13/24 Page 1 of 28
3. Patent Claims and Patent Scope - Hoover Institution
4. Teduglutide: Uses, Interactions, Mechanism of Action - DrugBank

Drugs Protected by US Patent 7,847,061

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Takeda Pharms Usa	GATTEX KIT	teduglutide	POWDER;SUBCUTANEOUS	203441-001	Dec 21, 2012		RX	Yes	Yes	7,847,061*PED				Y

International Family Members for US Patent 7,847,061

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2585482
Denmark	1809318
European Patent Office	1809318
Spain	2427150
Hong Kong	1107026