United States Patent 5,010,090: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,010,090, hereafter referred to as the '090 patent, is a significant intellectual property asset that has been involved in various legal and commercial activities. This article provides a comprehensive analysis of the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
The '090 patent is associated with pharmaceutical inventions, specifically related to the drug Gabitril® (tiagabine hydrochloride), which is used for the treatment of epilepsy. The patent was listed on the FDA’s Orange Book, indicating its importance in protecting the intellectual property related to this drug[2].
Scope of the Patent
The scope of the '090 patent encompasses the composition, method of manufacture, and use of tiagabine hydrochloride. This includes the chemical structure, synthesis methods, and the therapeutic applications of the drug. The patent's scope is critical in defining what is protected under the patent laws of the United States, particularly under 35 U.S.C. § 271(a) and (e)[2].
Claims of the Patent
The claims of a patent are its most crucial part, as they define the invention and the rights granted to the patent holder. For the '090 patent, the claims would typically include:
- Composition claims: These would describe the specific chemical composition of tiagabine hydrochloride.
- Method claims: These would cover the processes for synthesizing and manufacturing the drug.
- Use claims: These would specify the therapeutic uses of tiagabine hydrochloride, such as its application in treating epilepsy.
Understanding these claims is essential for determining what constitutes infringement and for assessing the patent's validity[3].
Patent Infringement and Litigation
The '090 patent has been involved in significant litigation, particularly in cases where generic drug manufacturers sought to enter the market. For instance, Sun Pharmaceutical Industries and Caraco Pharmaceutical Laboratories were accused of patent infringement for their attempts to market tiagabine hydrochloride tablets before the expiration of the '090 patent. This litigation highlights the importance of the patent in protecting the intellectual property rights of the original patent holder[2].
Patent Expiration and Generic Entry
The '090 patent expired on September 30, 2011, allowing generic manufacturers to enter the market. However, any attempts to market, offer for sale, or sell the generic version before the patent's expiration would constitute infringement. This scenario underscores the critical role of patent expiration dates in the pharmaceutical industry[2].
Patent Landscape Analysis
Analyzing the patent landscape around the '090 patent involves several key aspects:
Global Dossier and International Patent Family
Using tools like the Global Dossier, one can track the patent family for the '090 patent, including related applications filed at participating IP Offices. This helps in understanding the global protection and citation data associated with the patent[1].
Claim Coverage Matrix
A Claim Coverage Matrix can be used to determine which patents and claims are actively protecting the intellectual property related to tiagabine hydrochloride. This matrix helps in identifying gaps or opportunities in the patent coverage, which is crucial for strategic planning and future development[3].
Patent Analytics
Patent analytics tools, such as those provided by Schwegman, can categorize patents by claims and scope concepts. This approach enables a comprehensive analysis of the patent landscape, helping to identify whether a particular scope concept is applicable to a target product or method. Interactive claim charts generated by such tools can be reviewed by technical experts to determine coverage gaps and future design opportunities[3].
Public Search and Resource Centers
For detailed analysis, one can utilize resources such as the USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs). These facilities provide access to patent and trademark information, including the ability to browse through issued patents and access file histories of related applications[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application can be used to consolidate prior art cited by all participating offices for the family members of the '090 patent. This tool is particularly useful in visualizing search results from multiple offices on a single page, facilitating a more integrated analysis of the patent landscape[1].
Probability of Patent Allowance
Understanding the probability of patent allowance can provide insights into the broader patent landscape. Studies based on USPTO internal databases show trends in allowance rates, which can help in assessing the likelihood of similar patents being granted in the future. For instance, the family allowance rate, which includes the outcomes of continuation applications, can indicate the overall success rate of related patent applications[4].
Key Takeaways
- Scope and Claims: The '090 patent protects the composition, manufacture, and use of tiagabine hydrochloride, with specific claims defining the invention.
- Litigation and Infringement: The patent has been involved in significant litigation, highlighting its importance in protecting intellectual property.
- Patent Expiration: The expiration of the '090 patent allowed generic manufacturers to enter the market.
- Patent Landscape Analysis: Tools like Global Dossier, Claim Coverage Matrix, and patent analytics are essential for a comprehensive analysis of the patent landscape.
- Public Resources: Utilizing USPTO facilities and PTRCs can provide detailed information on patent and trademark data.
FAQs
What is the significance of the '090 patent in the pharmaceutical industry?
The '090 patent is significant because it protects the intellectual property related to tiagabine hydrochloride, a drug used for treating epilepsy. Its expiration allowed generic manufacturers to enter the market.
How can one analyze the patent landscape around the '090 patent?
One can use tools like the Global Dossier, Claim Coverage Matrix, and patent analytics to analyze the patent landscape. These tools help in identifying related applications, gaps in coverage, and future design opportunities.
What are the key claims of the '090 patent?
The key claims include composition claims, method claims, and use claims related to tiagabine hydrochloride.
What is the role of the Common Citation Document (CCD) in patent analysis?
The CCD consolidates prior art cited by all participating offices for the family members of a patent, facilitating a more integrated analysis of the patent landscape.
How does patent expiration impact the market entry of generic drugs?
Patent expiration allows generic manufacturers to market, offer for sale, or sell their versions of the drug, as seen with the '090 patent's expiration allowing generic tiagabine hydrochloride tablets to enter the market.
Sources
- USPTO - Search for patents - USPTO
- LITE DEPALMA GREENBERG, LLC - [PDF] LITE DEPALMA GREENBERG, LLC Allyn Z. Lite Michael E. Patunas ...
- SLWIP - Patent Analytics | Intellectual Property Law
- Yale Journal of Law & Technology - [PDF] What Is the Probability of Receiving a US Patent?
