United States Patent 7,943,621: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,943,621, titled "Salts of Piperazine Compounds as D3 Dopamine Receptor Antagonists," is a significant patent in the pharmaceutical sector, particularly in the field of dopamine receptor modulation. This patent, assigned to Forest Laboratories, LLC (now part of Allergan), covers novel salts of piperazine compounds and their use in treating various conditions related to dopamine receptor modulation.
Patent Overview
Inventors and Assignees
The patent was invented by Laszlo Czibula, Ferenc Sebok, Istvan Levant, Gyorgy Domany, Eva Againe Csongor, and others, and is assigned to Forest Laboratories, LLC[4].
Patent Details
- Patent Number: US 7,943,621 B2
- Date of Patent: May 17, 2011
- International Classification: A61K 31/55, C07D 295/00
- U.S. Classification: 514/252.12, 544/393[4].
Claims and Scope
Independent Claims
The patent includes 17 claims, with the broadest claims defining the scope of the invention. These claims cover:
- Novel salts of trans 4-2-[4-(2,3-dichlorophenyl)-piperazine-1-yl-ethyl-N,N-dimethylcarbamoyl-cyclohexylamine], including monohydrochloride, dihydrochloride, monohydrobromide, maleate, and methane sulphonate salts.
- Processes for preparing these salts and their hydrates and/or solvates.
- Pharmaceutical compositions containing these salts and their use in treating or preventing conditions that require modulation of dopamine receptors[4].
Dependent Claims
Dependent claims serve as fallback positions, narrowing down the scope of the independent claims. These claims specify various aspects of the salts, such as their preparation methods, pharmaceutical compositions, and specific uses.
Scope Measurement
The breadth of a patent's scope can be measured by the length of its claims. Generally, longer claims imply more conditions that must be met for a patent to be violated, making the patent narrower. In this case, the patent's scope is defined by its broadest claims, which are relatively specific, indicating a balanced scope that is neither overly broad nor too narrow[3].
Patent Landscape
Related Patents and Applications
The patent 7,943,621 is part of a broader patent landscape related to dopamine receptor antagonists. Other patents, such as US 7,737,142, also filed by Forest Laboratories, LLC, cover similar compounds and uses, indicating a strategic approach to protecting intellectual property in this therapeutic area[5].
Litigation and Settlements
Patents like 7,943,621 are often involved in ANDA (Abbreviated New Drug Application) litigation, where generic manufacturers challenge the validity or enforceability of the patents. For example, Allergan USA, Inc. v. Sun Pharmaceutical Industries Ltd. involved disputes over the validity and infringement of patents related to Vraylar (cariprazine), which is covered by this patent. The settlement typically involves the generic manufacturer agreeing not to infringe the patent until its expiration or obtaining a license[1].
Technical Field and Applications
Dopamine Receptor Modulation
The patent pertains to the field of dopamine receptor antagonists, specifically targeting the D3 dopamine receptor. This receptor is implicated in various neurological and psychiatric conditions, making the compounds covered by this patent potentially valuable for treating conditions such as schizophrenia and bipolar disorder[4].
Pharmaceutical Compositions
The patent describes pharmaceutical compositions containing the novel salts and their hydrates and/or solvates. These compositions are designed for oral administration and are intended to provide therapeutic benefits by modulating dopamine receptor activity[4].
Regulatory Aspects
Patent Extension Applications
Forest Laboratories, LLC has filed for patent extension applications under 35 U.S.C. § 156 for patents including 7,943,621, which can extend the patent term to compensate for delays in the FDA approval process[5].
Industry Impact
Market Protection
The patent provides significant market protection for Vraylar (cariprazine), a drug used in the treatment of schizophrenia and bipolar disorder. This protection prevents generic manufacturers from producing and marketing similar drugs until the patent expires, ensuring a monopoly for the innovator company during the patent term[1].
Research and Development
The patent landscape around dopamine receptor antagonists encourages continued research and development in this therapeutic area. Companies are incentivized to innovate and file new patents to protect their intellectual property and maintain market share[3].
Expert Insights
Patent attorneys and industry experts emphasize the importance of broad yet specific claims in patents. As Thomas Kulaga notes, "Broad patents typically offer more protection against infringers than a narrow patent" because they are often harder to design around[3].
Key Takeaways
- Patent Scope: The patent's scope is defined by its broadest claims, which cover novel salts of piperazine compounds and their use in treating dopamine receptor-related conditions.
- Claims Structure: The patent includes 17 claims, with independent claims defining the broad scope and dependent claims narrowing it down.
- Patent Landscape: The patent is part of a larger landscape involving ANDA litigation and settlements, and it provides significant market protection for Vraylar.
- Technical Field: The patent pertains to dopamine receptor antagonists, specifically targeting the D3 dopamine receptor.
- Regulatory Aspects: The patent has been subject to extension applications to compensate for FDA approval delays.
FAQs
What is the main subject of United States Patent 7,943,621?
The main subject of United States Patent 7,943,621 is novel salts of piperazine compounds that act as D3 dopamine receptor antagonists.
Who are the inventors and assignees of the patent?
The inventors include Laszlo Czibula, Ferenc Sebok, Istvan Levant, and others, and the patent is assigned to Forest Laboratories, LLC.
What are the key claims of the patent?
The key claims cover the novel salts, their preparation methods, pharmaceutical compositions, and their use in treating or preventing conditions related to dopamine receptor modulation.
How does the patent impact the pharmaceutical market?
The patent provides market protection for Vraylar (cariprazine), preventing generic manufacturers from producing similar drugs until the patent expires.
What regulatory actions have been taken regarding this patent?
Forest Laboratories, LLC has filed for patent extension applications under 35 U.S.C. § 156 to extend the patent term due to FDA approval delays.
Cited Sources:
- Robins Kaplan LLP. ANDA Litigation Settlements | Hatch-Waxman - Robins Kaplan LLP.
- Regulations.gov. Patent Extension Application for VRAYLAR ... - Regulations.gov.
- Boston University Law. The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope.
- USPTO. United States Patent 7,943,621 B2.
- Regulations.gov. OCT 1011 - Regulations.gov.
