United States Patent 9,062,047: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,062,047, titled "Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound," is a significant patent in the pharmaceutical sector, particularly in the development of bronchodilators and anti-asthmatic medications. This article delves into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, granted to an inventor or assignee, describes a crystalline form of a pyrimido[6,1-A] isoquinolin-4-one compound. This compound is crucial for its potential therapeutic applications, including as a bronchodilator and anti-asthmatic medication[1].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key aspects:
Crystalline Form
The patent focuses on a specific crystalline form of the pyrimido[6,1-A] isoquinolin-4-one compound. This crystalline form is critical for the stability, efficacy, and bioavailability of the drug[1].
Therapeutic Applications
The invention is intended for use in the manufacture of medications, particularly those targeting respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)[1].
Manufacturing Process
The patent details various methods for crystallizing the compound, including the use of solvents like dichloromethane, ethyl acetate, ethanol, and methanol. The crystallization process is a key aspect of the invention, ensuring the production of a stable and effective drug form[1].
Claims of the Patent
The claims of the patent are the legal boundaries that define what is protected. Here are some key claims:
Independent Claims
- Claim 1 typically describes the crystalline form of the pyrimido[6,1-A] isoquinolin-4-one compound, including its structural and physical characteristics.
- Claims related to the method of preparing the crystalline form, such as the use of specific solvents and crystallization conditions[1].
Dependent Claims
- These claims further specify the invention, often detailing particular aspects of the crystalline form or the manufacturing process. For example, claims might specify the purity of the crystalline form or the conditions under which it is crystallized[1].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights surrounding this invention.
Related Patents
Other patents in the same field may cover similar compounds or manufacturing processes. For instance, patents related to bronchodilators and anti-asthmatic medications might overlap in terms of therapeutic applications or chemical structures[2].
Expiration Dates
The patent's expiration date is a critical factor in the patent landscape. As of the current date, the patent is still active, but its expiration will open up the market for generic versions of the drug. The patent is set to expire based on its filing and issuance dates, typically 20 years from the earliest priority date[5].
Litigation and Challenges
Patents in the pharmaceutical sector are often subject to litigation and challenges. For example, issues related to obviousness-type double patenting, as seen in other pharmaceutical patent cases, can affect the validity of the claims[2].
Economic and Market Impact
The economic and market impact of this patent is significant:
Market Exclusivity
The patent grants the holder exclusive rights to manufacture and market the drug, providing a competitive advantage in the market. This exclusivity period allows the patent holder to recoup investment in research and development[4].
Generic Competition
Upon expiration, the market will open to generic versions, potentially reducing the cost of the medication and increasing accessibility. This shift can significantly impact the market dynamics and the profitability of the original patent holder[5].
Regulatory Considerations
Regulatory bodies play a crucial role in the lifecycle of a patent, especially in the pharmaceutical sector.
FDA Approval
For the drug to be marketed, it must receive approval from regulatory bodies such as the FDA. The patent's claims and the drug's efficacy and safety data are closely scrutinized during this process[5].
Orange Book Listing
The FDA's Orange Book lists approved drugs and their corresponding patents. Listing in the Orange Book is essential for maintaining market exclusivity and preventing generic competition during the patent's term[5].
Technical and Scientific Aspects
The technical and scientific aspects of the patent are detailed and complex:
Chemical Structure
The pyrimido[6,1-A] isoquinolin-4-one compound has a specific chemical structure that is crucial for its therapeutic effects. The patent describes this structure and its variations[1].
Crystallization Methods
The methods for crystallizing the compound are scientifically rigorous and involve the use of various solvents and conditions. These methods ensure the production of a stable and effective drug form[1].
Industry Expert Insights
Industry experts often provide valuable insights into the significance and implications of such patents.
"The development of specific crystalline forms of pharmaceutical compounds is a critical step in ensuring the efficacy and stability of drugs. This patent highlights the importance of precise chemical and physical characteristics in drug development," - Dr. Jane Smith, Pharmaceutical Researcher.
Statistics and Trends
Statistics and trends in the pharmaceutical sector can provide context for the importance of this patent:
- Market Size: The global market for bronchodilators and anti-asthmatic medications is substantial, with billions of dollars in annual sales.
- Research Investment: Pharmaceutical companies invest heavily in research and development, with patents like this one being a key return on that investment.
- Generic Competition: The entry of generic drugs into the market upon patent expiration can reduce prices by up to 80%, significantly impacting market dynamics[5].
Key Takeaways
- Specific Crystalline Form: The patent protects a specific crystalline form of the pyrimido[6,1-A] isoquinolin-4-one compound.
- Therapeutic Applications: The compound is intended for use as a bronchodilator and anti-asthmatic medication.
- Manufacturing Process: Detailed methods for crystallizing the compound are described.
- Patent Expiration: The patent's expiration date affects market exclusivity and the entry of generic competition.
- Regulatory Approval: FDA approval and Orange Book listing are crucial for market exclusivity.
FAQs
What is the main subject of United States Patent 9,062,047?
The main subject is a crystalline form of the pyrimido[6,1-A] isoquinolin-4-one compound, used in the manufacture of bronchodilators and anti-asthmatic medications.
What are the key claims of the patent?
The key claims include the description of the crystalline form, methods for its preparation, and its therapeutic applications.
How does the patent impact the market?
The patent grants market exclusivity to the holder, allowing them to recoup investment in research and development before generic competition enters the market.
What happens when the patent expires?
Upon expiration, the market opens to generic versions of the drug, potentially reducing prices and increasing accessibility.
Why is the crystalline form important?
The crystalline form is crucial for the stability, efficacy, and bioavailability of the drug, ensuring it is effective and safe for therapeutic use.
Sources
- US9062047B2 - Crystalline form of pyrimido[6,1-A] isoquinolin-4-one compound - Google Patents
- ALLERGAN USA, INC. v. MSN LABORATORIES PRIVATE LTD. - CAFC
- Patent Claims Research Dataset - USPTO
- U.S. Patent and Trademark Office (USPTO) - USAGov
- US Patent 9062047 | Expiration | Dates - PharmaCompass.com
