United States Patent 9,155,706: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,155,706, titled "Pharmaceutical Composition," is a significant patent in the pharmaceutical industry, particularly in the realm of cancer treatment. This patent, assigned to Novartis AG, revolves around a specific compound known as Compound A, which is an inhibitor of MEK activity. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Invention
The patent describes Compound A, specifically N-3-(3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl)phenyl)acetamide, as a potent inhibitor of MEK (Mitogen-Activated Protein Kinase Kinase) activity. MEK inhibitors are crucial in the treatment of various cancers, as they target the MAPK/ERK pathway, which is often dysregulated in cancer cells[1].
Scope of the Patent
The scope of the patent encompasses several key aspects:
Compound A and Its Solvates
The patent covers Compound A in its unsolvated form and various solvates, including dimethyl sulfoxide (DMSO) solvate. Other solvates mentioned include hydrate, acetic acid, ethanol, nitromethane, chlorobenzene, 1-pentanol, isopropyl alcohol, ethylene glycol, and 3-methyl-1-butanol[1].
Pharmaceutical Compositions
The patent describes pharmaceutical compositions containing Compound A, which can be formulated in various dosage forms such as tablets, capsules, and liquids. These compositions are designed for oral administration and are intended for the treatment of cancers where MEK inhibition is beneficial[1].
Method of Preparation
The patent details methods for preparing Compound A and its solvates, referencing international applications and other U.S. patent publications for comprehensive preparation procedures[1].
Claims of the Patent
The claims of the patent are critical in defining the scope of protection:
Independent Claims
- Claim 1 typically covers the compound itself, including its solvates and pharmaceutically acceptable salts.
- Claim 2 might cover specific pharmaceutical compositions containing Compound A.
- Claim 3 could cover methods of treating cancer using Compound A[1].
Dependent Claims
Dependent claims further narrow down the scope by specifying particular solvates, dosage forms, and methods of administration. These claims help in protecting the specific embodiments of the invention[1].
Patent Landscape
Understanding the patent landscape is essential for navigating the intellectual property rights surrounding Compound A and similar MEK inhibitors.
Related Patents
Other patents related to MEK inhibitors and their use in cancer treatment include:
- U.S. Patent No. 8,580,304
- U.S. Patent No. 9,271,941
- U.S. Patent No. 9,399,021
These patents collectively protect various aspects of MEK inhibitors, including their combination with other drugs and specific methods of treatment[2][4].
Patent Expiration Dates
The expiration dates of these patents are crucial for generic drug manufacturers:
- U.S. Patent No. 9,155,706: Expiration date is tied to maintenance fees and adjustments under 35 U.S.C. 154(b), with the latest maintenance fee paid in March 2023[4].
- Other related patents have expiration dates ranging from 2027 to 2034[4].
ANDA Litigation and Settlements
Abbreviated New Drug Application (ANDA) litigation often involves disputes over patent infringement. For example, Novugen’s ANDA for trametinib tablets, which is related to MEK inhibitors, has been a subject of patent infringement litigation[2].
Patent Analytics and Claim Coverage
To effectively manage the patent portfolio, companies use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities[3].
Claim Coverage Matrix
A Claim Coverage Matrix can show which patents and claims are actively protecting the intellectual property related to MEK inhibitors. This matrix helps in identifying where gaps or opportunities exist in the patent landscape[3].
Interactive Claim Charts
Interactive claim charts generated by software like ClaimScape® facilitate the review of patent coverage with technical experts. These charts help in determining whether a particular scope concept is applicable to a target product or method, ensuring that there are no gaps in current coverage[3].
Industry Impact and Future Directions
The patent landscape around MEK inhibitors is dynamic, with ongoing litigation and settlements shaping the market.
Generic Launches
The expiration of key patents will pave the way for generic launches, which can significantly impact the market dynamics. Generic manufacturers must ensure they do not infringe on existing patents until their expiration[4].
Research and Development
Continued research and development in MEK inhibitors will lead to new patents and claims, further complicating the patent landscape. Companies must stay vigilant and use patent analytics to navigate this complex environment[3].
Key Takeaways
- Compound A: The patent covers Compound A, an MEK inhibitor, in various solvates and pharmaceutical compositions.
- Scope and Claims: The patent's scope includes specific solvates, pharmaceutical compositions, and methods of preparation.
- Patent Landscape: The landscape involves multiple related patents with varying expiration dates and ongoing litigation.
- Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing the patent portfolio.
- Industry Impact: The expiration of patents and ongoing R&D will continue to shape the market for MEK inhibitors.
Frequently Asked Questions
Q: What is the primary compound covered by U.S. Patent 9,155,706?
A: The primary compound is Compound A, an MEK inhibitor known as N-3-(3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl)phenyl)acetamide.
Q: What are the common solvates of Compound A mentioned in the patent?
A: The patent mentions solvates such as dimethyl sulfoxide (DMSO), hydrate, acetic acid, ethanol, nitromethane, chlorobenzene, 1-pentanol, isopropyl alcohol, ethylene glycol, and 3-methyl-1-butanol.
Q: How do patent analytics tools help in managing the patent portfolio?
A: Patent analytics tools help by categorizing patents by claims and scope concepts, generating interactive claim charts, and identifying gaps or opportunities in the patent landscape.
Q: What is the significance of the expiration dates of related patents?
A: The expiration dates determine when generic versions of the drug can be launched without infringing on existing patents, significantly impacting market dynamics.
Q: What is the role of ANDA litigation in the context of MEK inhibitors?
A: ANDA litigation involves disputes over patent infringement and can result in settlements that allow generic manufacturers to enter the market once the patents expire.
Cited Sources
- United States Patent and Trademark Office, "Pharmaceutical Composition," U.S. Patent No. 9,155,706 B2, October 13, 2015.
- Insight.RPXcorp.com, "Case 1:23-cv-01449-UNA Document 1 Filed 12/20/23 Page 1 of 31," December 20, 2023.
- SLWIP.com, "Patent Analytics | Intellectual Property Law."
- Pharsight.Greyb.com, "Mekinist patent expiration - Pharsight."
