United States Patent 9,060,992: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,060,992, titled "Treatment of Short Bowel Syndrome Patients with Colon-in-Continuity," is a significant patent in the pharmaceutical industry, particularly in the treatment of Short Bowel Syndrome (SBS). This patent is part of a larger family of patents related to the use of GLP-2 receptor agonists, such as teduglutide. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background
The patent 9,060,992 is assigned to Shire-NPS Pharmaceuticals, Inc., now a part of Takeda Pharmaceuticals. It is one of several patents in the GLP-2 SBS patent family, which includes multiple U.S. and foreign counterparts[4].
Scope of the Patent
The patent 9,060,992 specifically covers methods for treating patients with Short Bowel Syndrome (SBS) who have a colon-in-continuity. The treatment involves the use of GLP-2 receptor agonists, such as teduglutide, which is the active ingredient in GATTEX, a product marketed by Takeda[4].
Claims
The patent claims are directed towards specific methods of treatment rather than the composition of matter itself. The claims outline the dosing regimens, patient populations, and the specific conditions under which the GLP-2 receptor agonists are effective. These claims are critical in defining the intellectual property rights of the patent holder and in distinguishing the invention from prior art[3].
Patent Claims and Their Significance
The claims in the 9,060,992 patent are detailed and specific, ensuring that the patent holder has a clear monopoly over the described methods of treatment. Here are some key aspects:
- Method of Use Claims: These claims specify how the GLP-2 receptor agonists are to be used in treating SBS patients. This includes the dosage, administration schedule, and patient selection criteria[4].
- Patient Population: The patent claims are limited to patients with SBS who have a colon-in-continuity, which is a specific subset of SBS patients. This narrowing helps in avoiding infringement by generic manufacturers who might target different patient populations[4].
Patent Landscape
The patent landscape surrounding 9,060,992 is complex and involves multiple related patents.
Family of Patents
The 9,060,992 patent is part of a larger family of patents known as the GLP-2 SBS patents. This family includes several U.S. patents such as 7,847,061, 9,545,434, and numerous continuations and divisionals. These patents collectively cover various aspects of treating SBS with GLP-2 receptor agonists[4].
Orange Book Listings
The patents in this family were listed in the FDA's Orange Book, which is a critical database for tracking patents related to approved drugs. However, there have been significant changes in the Orange Book listings for GATTEX. Initially, twenty patents were listed, but following delisting requests and Inter Partes Review (IPR) proceedings, only a few patents, including the 7,056,886 patent, remain listed[2].
Inter Partes Review (IPR)
The 7,056,886 patent, which is closely related to the 9,060,992 patent, underwent an IPR process. The Federal Circuit affirmed the cancellation of method-of-use claims, significantly narrowing the scope of the patent. This decision had implications for the broader patent family, as it reduced the number of enforceable claims[2].
Litigation and Disputes
The 9,060,992 patent has been involved in several legal disputes, particularly regarding patent infringement and ownership.
- Patent Infringement Suits: Shire-NPS Pharmaceuticals has filed suits against generic manufacturers, such as Par Pharmaceuticals, alleging infringement of the GLP-2 SBS patents. These suits aim to block the entry of generic versions of teduglutide into the market[1][4].
- Ownership Disputes: There have been disputes over the ownership and licensing of the GLP-2 SBS patents. Shire-NPS has been accused of misrepresenting the inventors and ownership of the inventions claimed in these patents[4].
Impact on Generic Entry
The extensive patent family and the strategic listing of these patents in the Orange Book have been used to delay the entry of generic competitors into the market. However, the delisting of several patents and the narrowing of claims through IPR have opened up opportunities for generic manufacturers to challenge these patents and potentially enter the market sooner[2].
Key Takeaways
- Specific Method of Use Claims: The 9,060,992 patent claims are specific to methods of treating SBS patients with GLP-2 receptor agonists.
- Complex Patent Landscape: The patent is part of a large family of related patents, many of which have undergone significant changes due to delisting and IPR.
- Litigation and Ownership Disputes: The patent has been involved in several legal disputes, including infringement suits and ownership challenges.
- Impact on Generic Entry: The patent landscape has been used to delay generic entry, but recent changes have created opportunities for generic manufacturers.
FAQs
What is the main subject of United States Patent 9,060,992?
The main subject of United States Patent 9,060,992 is the treatment of Short Bowel Syndrome (SBS) patients with colon-in-continuity using GLP-2 receptor agonists.
Which company holds the 9,060,992 patent?
The 9,060,992 patent is held by Shire-NPS Pharmaceuticals, Inc., now a part of Takeda Pharmaceuticals.
What is the significance of the Orange Book listings for GATTEX?
The Orange Book listings for GATTEX include several patents related to the treatment, but many have been delisted or are subject to delisting requests, which affects the exclusivity period and generic entry.
How has Inter Partes Review (IPR) impacted the patent?
IPR has resulted in the cancellation of method-of-use claims in related patents, narrowing their scope and reducing the number of enforceable claims.
What are the ongoing disputes related to the 9,060,992 patent?
There are ongoing disputes over patent infringement and ownership, with Shire-NPS accused of misrepresenting the inventors and ownership of the inventions claimed in these patents.
Sources
- PharmaCompass: "Gattex (Teduglutide) - Shire-NPS Pharmaceuticals, Inc. v. AmbioPharm, Inc. and Par Pharmaceutical, Inc."
- Orange Book Insights: "Orange Book Vol. 42/Supp. 6 News: Watch out for the breadth of your use codes"
- DigitalCommons@NYLS: "Eviscerating Patent Scope"
- Unified Patents Portal: "Case 1:21-cv-11602-FDS Document 1 Filed 09/29/21 Page 1 of 92"
- Unified Patents Portal: "US-9060992-B2 - Treatment of Short Bowel Syndrome Patients with Colon-in-Continuity"
