Detailed Analysis of the Scope and Claims of United States Patent 8,980,873
Introduction
United States Patent 8,980,873, titled "11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene citrate salt," is a significant patent in the pharmaceutical industry, particularly related to the drug Vonjo. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Brian Dymock, Cheng H. Lee, and Anthony D. William, and is assigned to CTI Biopharma Corp.[5].
Publication and Expiry Dates
The patent was issued on March 17, 2015, and is set to expire in March 2030, approximately 5 years from the current date[2][5].
Patent Scope
The patent covers specific salts of the compound 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene, particularly the citrate salt. This compound is part of a class of drugs used in the treatment of various cancers and other diseases such as acute myeloid leukemia, colon cancer, and myelofibrosis[4].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
- Chemical Structure: The patent describes the specific chemical structure of the citrate salt, including its molecular formula and structural configuration[4].
- Synthesis and Manufacturing: The claims cover the methods for synthesizing and manufacturing the citrate salt, including the use of specific solvents and reaction conditions[4].
- Pharmaceutical Uses: The patent claims the use of the citrate salt in pharmaceutical formulations for treating various diseases, highlighting its therapeutic applications[4].
Analytical Methods
The patent details various analytical methods used to characterize the citrate salt, such as differential scanning calorimetry, powder X-ray diffraction, and thermal gravimetric analysis. These methods are crucial for ensuring the purity and stability of the compound[4].
Patent Landscape
Related Patents
The drug Vonjo, which uses the compound covered by this patent, is protected by multiple patents. In addition to US8980873B2, there are patents such as US8153632 and US9573964, which cover other aspects of the drug, including oxygen-linked pyrimidine derivatives and different modes of administration[2].
Exclusivities and Patent Expiry
The FDA has granted exclusivities to Vonjo, which, along with the patent protection, delay the launch of generic versions. These exclusivities can run concurrently with the patent terms and can extend the period during which no generic or bioequivalent version can be marketed[2].
Legal Activities
Recent legal activities, such as transactions for FDA determination of regulatory review periods and payments of maintenance fees, indicate ongoing efforts to maintain and potentially extend the patent protection. These activities are crucial for tracking the latest developments in the patent process and understanding when generic versions might become available[2].
Impact on Innovation and Competition
The breadth and scope of the patent claims can influence innovation and competition in the pharmaceutical industry. Narrower claims, as seen in this patent, can provide clearer boundaries and reduce the likelihood of litigation, thereby encouraging further innovation. However, broader claims can sometimes lead to increased licensing and litigation costs, potentially stifling innovation[3].
Therapeutic Applications
The compound covered by this patent has significant therapeutic applications, particularly in oncology. The patent's focus on the citrate salt ensures that this specific formulation is protected, which is crucial for maintaining the efficacy and safety profile of the drug in clinical use[4].
Conclusion
United States Patent 8,980,873 is a critical patent in the pharmaceutical sector, protecting a specific citrate salt used in the drug Vonjo. The patent's scope, claims, and the surrounding patent landscape highlight its importance in ensuring exclusive rights for the patent holder until its expiry in March 2030. Understanding these aspects is vital for pharmaceutical companies, researchers, and regulatory bodies.
Key Takeaways
- Patent Scope: Covers the citrate salt of a specific compound used in cancer treatments.
- Claims: Include chemical structure, synthesis methods, and pharmaceutical uses.
- Analytical Methods: Detailed methods for characterizing the compound.
- Patent Landscape: Protected by multiple patents and FDA exclusivities.
- Expiry Date: March 2030.
- Impact on Innovation: Narrower claims can encourage innovation by reducing litigation costs.
FAQs
What is the main compound protected by US Patent 8,980,873?
The main compound protected is the citrate salt of 11-(2-pyrrolidin-1-yl-ethoxy)-14,19-dioxa-5,7,26-triaza-tetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2(26),3,5,8,10,12(27),16,21,23-decaene.
What diseases is the compound used to treat?
The compound is used to treat various cancers, including acute myeloid leukemia, colon cancer, and myelofibrosis.
When does the patent expire?
The patent is set to expire in March 2030.
Are there any FDA exclusivities granted to Vonjo?
Yes, the FDA has granted exclusivities to Vonjo, which run concurrently with the patent terms and delay the launch of generic versions.
What are the implications of the patent's scope on innovation?
The narrower claims in this patent can reduce litigation costs and encourage further innovation by providing clear boundaries.
Cited Sources
- US Patent 8,980,873B2 - Google Patents
- Vonjo patent expiration - Pharsight
- Patent Claims and Patent Scope - SSRN
- US Patent 8,980,873B2 - Google Patents
- Generic Vonjo Availability - Drugs.com
