Detailed Analysis of the Scope and Claims of United States Patent 9,951,080
Introduction
United States Patent 9,951,080, issued on April 24, 2018, is a significant patent held by AbbVie Inc., related to the pharmaceutical compound upadacitinib, marketed as RINVOQ®. This patent is part of a broader portfolio of patents protecting various aspects of upadacitinib, including its preparation, solid state forms, and pharmaceutical compositions.
Patent Overview
Inventors and Assignee
The patent was invented by Ayman Allian and assigned to AbbVie Inc.[2][4].
Patent Expiration Date
The patent is set to expire on October 17, 2036, aligning with the expiration dates of several other related patents held by AbbVie Inc.[2].
Scope of the Patent
Processes for Preparation
The patent primarily focuses on processes for preparing the compound (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, which is the active ingredient in RINVOQ®. These processes include various methods for synthesizing the compound and its solid state forms[2][4].
Solid State Forms
The patent also covers different solid state forms of the compound, which are crucial for the stability, bioavailability, and overall efficacy of the pharmaceutical product. Solid state forms can include polymorphs, solvates, and other crystalline forms that enhance the drug's performance[4].
Pharmaceutical Compositions
In addition to the synthesis and solid state forms, the patent describes pharmaceutical compositions that contain the compound. These compositions can be formulated for various routes of administration, such as oral, topical, or injectable forms, and may include excipients, stabilizers, and other additives to enhance the drug's delivery and efficacy[4].
Methods of Treatment
The patent includes claims related to methods of treating JAK-associated conditions, such as rheumatoid arthritis, using the compound. This encompasses the therapeutic use of upadacitinib in human subjects suffering from these conditions[4].
Claims Analysis
Claim Scope
The claims in the patent are carefully crafted to balance the need for broad protection with the specificity required to avoid invalidation. A common misconception is that broader claims are always better, but overly broad claims can be easier to invalidate due to issues such as the abstract idea exception or failure to meet the written description requirement[3].
Specific Embodiments
The claims are anchored to specific embodiments disclosed in the specification, ensuring that they are not overly broad. For example, the patent specifies particular methods of synthesis and solid state forms, which are supported by detailed descriptions and examples in the patent specification[3][4].
Prior Art Considerations
The patent application process involved a thorough review of prior art to ensure that the claims were novel and non-obvious. The technical field of pharmaceuticals, especially in the area of JAK inhibitors, is highly competitive and has seen numerous patent applications, making it crucial to differentiate the invention from existing prior art[3].
Patent Landscape
Related Patents
AbbVie Inc. holds a portfolio of patents related to upadacitinib, including patents for tricyclic compounds (e.g., Patent 8,962,629), other processes for preparation (e.g., Patent 9,963,459), and various solid state forms and pharmaceutical compositions. These patents collectively provide comprehensive protection for RINVOQ® until their expiration dates, primarily around October 17, 2036[2][5].
Patent Infringement Litigation
The extensive patent protection has led to litigation against generic manufacturers who have submitted Abbreviated New Drug Applications (ANDAs) to the FDA. Companies like Hetero, Aurobindo, Sandoz, Intas, and Sun Pharmaceutical Industries are involved in ongoing patent infringement cases related to their attempts to market generic versions of RINVOQ® before the expiration of AbbVie's patents[1].
Impact on Generic Availability
Current Status
As of the current date, there is no therapeutically equivalent generic version of RINVOQ® available in the United States due to the robust patent protection held by AbbVie Inc.[2].
Future Outlook
The expiration of the key patents in 2036 will likely open the market for generic versions of upadacitinib, provided that the generic manufacturers can successfully navigate the regulatory and legal landscape to obtain FDA approval and avoid further patent infringement litigation.
Key Takeaways
- Patent Scope: The patent covers specific processes for preparing upadacitinib, its solid state forms, and pharmaceutical compositions.
- Claim Analysis: The claims are balanced to avoid being overly broad and are anchored to specific embodiments in the specification.
- Patent Landscape: AbbVie Inc. holds a comprehensive portfolio of patents protecting RINVOQ®, with key patents expiring in 2036.
- Litigation: Ongoing patent infringement cases against generic manufacturers aim to protect AbbVie's market exclusivity.
- Generic Availability: No generic version of RINVOQ® is currently available, but this is expected to change after the patent expirations in 2036.
FAQs
What is the main subject of United States Patent 9,951,080?
The main subject of this patent is the processes for preparing the compound (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide, which is the active ingredient in RINVOQ®.
Who is the assignee of this patent?
The assignee of this patent is AbbVie Inc.
What is the expiration date of this patent?
The patent is set to expire on October 17, 2036.
Are there any generic versions of RINVOQ® available in the United States?
No, there are currently no therapeutically equivalent generic versions of RINVOQ® available in the United States.
Why are there ongoing patent infringement cases related to RINVOQ®?
These cases are due to generic manufacturers submitting ANDAs to the FDA before the expiration of AbbVie's patents, prompting AbbVie to file patent infringement lawsuits to protect its market exclusivity.
Sources
- United States District Court Document: "Civil Action for Patent Infringement" - Case 1:23-cv-01332-UNA[1].
- Drugs.com: "Generic Rinvoq Availability"[2].
- Rimon Law: "The Importance of Getting the Claim Scope Right in a US Patent Application"[3].
- Google Patents: "Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof"[4].
- Drugs.com: "Generic Rinvoq LQ Availability"[5].
