Understanding the Scope and Claims of United States Patent 7,220,742
Introduction
United States Patent 7,220,742 is a significant patent in the pharmaceutical industry, particularly related to the drug Stiolto Respimat, which is used for the treatment of chronic obstructive pulmonary disease (COPD). This analysis will delve into the details of the patent's scope, claims, and the broader patent landscape surrounding it.
Patent Overview
Patent 7,220,742 was issued to Boehringer Ingelheim International GmbH and is part of a series of patents protecting various aspects of the drug Stiolto Respimat. This patent covers specific formulations and methods related to the drug's composition and delivery mechanism.
Patent Claims
The claims of a patent are crucial as they define the scope of the invention and what is protected by the patent. Here are some key aspects of the claims in Patent 7,220,742:
Independent Claims
Independent claims are the broadest claims in a patent and define the overall scope of the invention. For Patent 7,220,742, these claims typically include:
- The composition of the drug, including the active ingredients and their proportions.
- The method of administration, such as the use of an inhaler or specific delivery mechanisms.
- Any unique formulations or combinations of ingredients that distinguish the drug from others[2].
Dependent Claims
Dependent claims are narrower and build upon the independent claims. They often specify particular embodiments or variations of the invention. For example:
- Specific concentrations of the active ingredients.
- Particular methods of manufacturing the drug.
- Additional components or excipients in the formulation[2].
Patent Scope
The scope of a patent is determined by the language of its claims. Here are some metrics and considerations that define the scope of Patent 7,220,742:
Claim Length and Count
Research suggests that the length and count of independent claims can be indicative of the patent's scope. Narrower claims with fewer words and fewer claims overall tend to have a more focused scope, which can lead to a higher probability of grant and a shorter examination process[3].
Breadth of Patent Classes
The breadth of patent classes to which the patent belongs can also indicate its scope. Patents that span multiple classes may have a broader scope, covering a wider range of inventions[3].
Patent Expiration Dates
The expiration date of a patent is critical for understanding when generic competition can enter the market. For Patent 7,220,742, the expiration date is May 12, 2025. This date marks the end of the exclusive rights granted to the patent holder, after which generic versions of the drug can be developed and marketed[2].
Patent Landscape
The patent landscape surrounding Patent 7,220,742 includes several other related patents that protect different aspects of Stiolto Respimat:
Related Patents
Other patents related to Stiolto Respimat include:
- Patent 7,284,474: Expiring on August 26, 2024.
- Patent 7,396,341: Expiring on October 10, 2026.
- Patent 7,727,984: Expiring on January 19, 2027.
These patents cover various components, such as the atomizer and method of atomizing fluid, and other specific formulations and delivery mechanisms[2].
Patent Term Extensions
Patent term extensions can be sought under certain conditions, such as delays in the FDA approval process. For example, the patent term for U.S. Patent No. 7,727,984 was extended due to Patent Term Adjustment (PTA) and terminal disclaimers, but these did not significantly alter the expiration date in this case[4].
Impact on Generic Competition
The expiration of Patent 7,220,742 and related patents will have a significant impact on generic competition:
Generic Entry
Once the patent expires, generic manufacturers can file Abbreviated New Drug Applications (ANDAs) with the FDA to market generic versions of Stiolto Respimat. The Reference Listed Drug (RLD) for these generics will be the original branded version, ensuring bioequivalence[2].
Market Dynamics
The entry of generic competitors can significantly alter market dynamics, often leading to reduced prices and increased competition. This can benefit consumers but may also impact the revenue of the original patent holder.
Litigation and Enforcement
Patent litigation is a common aspect of the pharmaceutical industry, especially as patents near expiration. The filings with the Patent Trial and Appeal Board (PTAB) and the Court of Appeals for the Federal Circuit (CAFC) have seen significant increases in recent years, reflecting the importance of patent disputes in this sector[1].
Conclusion
Understanding the scope and claims of United States Patent 7,220,742 is crucial for both the patent holder and potential generic competitors. The patent's expiration date, related patents, and the broader patent landscape all play critical roles in determining the timing and nature of generic entry into the market.
Key Takeaways
- Patent 7,220,742 expires on May 12, 2025, marking the end of exclusive rights for the patent holder.
- The patent covers specific formulations and delivery mechanisms for Stiolto Respimat.
- Related patents protect other aspects of the drug, with varying expiration dates.
- Generic competition is expected to increase following the patent's expiration.
- Patent litigation and enforcement are significant factors in the pharmaceutical industry.
FAQs
Q: What is the primary drug protected by Patent 7,220,742?
A: The primary drug protected by Patent 7,220,742 is Stiolto Respimat, used for the treatment of chronic obstructive pulmonary disease (COPD).
Q: When does Patent 7,220,742 expire?
A: Patent 7,220,742 expires on May 12, 2025.
Q: What happens after the patent expires?
A: After the patent expires, generic manufacturers can develop and market generic versions of Stiolto Respimat.
Q: How do related patents affect the market?
A: Related patents can extend the period of exclusivity for different aspects of the drug, delaying full generic competition.
Q: What role does the FDA play in generic entry?
A: The FDA ensures that generic versions are bioequivalent to the Reference Listed Drug (RLD) through the Abbreviated New Drug Application (ANDA) process.
Sources
- The BioLoquitur Bulletin - Seyfarth Shaw LLP
- Generic Stiolto Respimat Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- Application for Patent Term Extension U.S. Patent 7,727,984 - Regulations.gov
