United States Patent 5,691,336: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,691,336, issued to Merck Sharp & Dohme Corp., is a significant patent in the pharmaceutical industry, particularly for the treatment of chemotherapy-induced nausea and vomiting (CINV). This patent covers the chemical compound fosaprepitant dimeglumine, commercially known as EMEND® for Injection. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Scope of the Patent
The '336 patent, issued on November 25, 1997, pertains to a new chemical compound, fosaprepitant dimeglumine. This compound is designed to prevent CINV, a common side effect of highly emetogenic chemotherapy used in cancer treatment. The patent specifically claims the compound's chemical structure and its application in an intravenous form to obstruct the Substance P-NK-1 receptor system, which is involved in the neurological pathway causing nausea and vomiting[1].
Claims of the Patent
The '336 patent includes several key claims that define the scope of the invention:
- Claim 16: This claim specifies the compound by its formal chemical name and structure, detailing it as "2-(R)-(1-(R)-(3,5-bis(trifluoromethyl)phenyl)ethoxy)-3-(S)-(4-fluoro)phenyl-4-(3-(1-phosphoryl-5-oxo-4H-1,2,4-triazolo)methylmorpholine, bis(N-methyl-D-glucamine)"[1].
- Claim 18: This claim describes the compound with a specific counterion, where "K+ is N-methyl-D-glucamine"[1].
- Claim 19: This claim further specifies the compound with additional structural details, though the exact text is not provided in the available sources[1].
These claims are critical as they define the exact chemical composition and structure of fosaprepitant dimeglumine, ensuring that any generic or similar compounds must differ significantly to avoid infringement.
Legal Standard for Obviousness
The validity of the '336 patent was challenged by Sandoz Inc. on the grounds of obviousness. The legal standard for determining obviousness under 35 U.S.C. § 103(a) involves a factual inquiry based on the Graham factors:
- The scope and content of the prior art.
- The level of ordinary skill in the art.
- The differences between the claimed invention and the prior art.
- Evidence of secondary factors, such as objective indicia of non-obviousness[1].
The burden of proof lies with the challenger, who must provide clear and convincing evidence to prove obviousness.
Patent Landscape Analysis
To understand the broader patent landscape surrounding the '336 patent, several key steps are involved:
Define Scope and Keywords
Identify the technology field and specific terms related to the patent. For fosaprepitant dimeglumine, this would include terms related to CINV treatment, Substance P-NK-1 receptor antagonists, and intravenous pharmaceuticals[3].
Search and Organize Patents
Use patent databases to retrieve relevant patents based on the chosen keywords. Organize these patents by factors such as filing date, assignee, and technology subcategories. This helps in creating a comprehensive map of the patent landscape, including visual aids like heat maps[3].
Identify Trends and Key Players
Recognize patterns in patent filings to pinpoint significant contributors in the field. For example, Merck Sharp & Dohme Corp. is a key player in the development of CINV treatments, as evidenced by the '336 patent[3].
Analyze Citations and Evolution
Study how patents reference each other to understand their impact and development. This analysis can reveal the influence of the '336 patent on subsequent innovations in CINV treatment and related pharmaceuticals[3].
Generate Insights for Decisions
Translate the analysis outcomes into practical guidance for strategic choices. This includes evaluating the competitive landscape and potential legal vulnerabilities. For instance, understanding the patent landscape can help in identifying potential infringement risks or opportunities for collaboration and licensing[3].
Global Patent Coverage
The '336 patent and related patents for fosaprepitant dimeglumine have extensive global coverage. Merck has secured patents in numerous countries, including the United States, Canada, Australia, China, and many European countries. This global coverage ensures broad protection for the invention across different markets[4].
Insights from Patent Landscape Analysis
A patent landscape analysis for the '336 patent provides several key insights:
- Technological Trends: The analysis reveals ongoing innovations in CINV treatment, highlighting the importance of Substance P-NK-1 receptor antagonists.
- Key Players: Merck Sharp & Dohme Corp. is identified as a significant player in this field, with a strong patent portfolio related to fosaprepitant dimeglumine.
- Legal Vulnerabilities: The analysis can identify potential legal vulnerabilities, such as challenges to the patent's validity based on obviousness, as seen in the case with Sandoz Inc.[3].
Impact on the Pharmaceutical Industry
The '336 patent has had a substantial impact on the pharmaceutical industry, particularly in the treatment of CINV. Fosaprepitant dimeglumine has become a standard treatment option, and its patent protection has allowed Merck to maintain market exclusivity. This has driven research and development in related areas, pushing the boundaries of pharmaceutical innovation.
"Patent landscape analysis offers insights into ongoing innovations by revealing information about patent filings within a specific technological domain, offering a present picture and a prediction about technological trends, key players, and new and exciting innovations."[3]
Key Takeaways
- The '336 patent covers the chemical compound fosaprepitant dimeglumine, used to prevent CINV.
- The patent includes specific claims defining the compound's chemical structure and application.
- The legal standard for obviousness involves a factual inquiry based on the Graham factors.
- Patent landscape analysis is crucial for understanding technological trends, key players, and legal vulnerabilities.
- The '336 patent has extensive global coverage, ensuring broad protection for the invention.
FAQs
What is the primary use of the compound covered by the '336 patent?
The primary use of the compound fosaprepitant dimeglumine is to prevent chemotherapy-induced nausea and vomiting (CINV).
Who is the assignee of the '336 patent?
The assignee of the '336 patent is Merck Sharp & Dohme Corp.
What are the key claims of the '336 patent?
The key claims include Claim 16, which specifies the compound's chemical structure, Claim 18, which details a specific counterion, and Claim 19, which provides additional structural details.
What is the legal standard for determining obviousness of a patent?
The legal standard involves a factual inquiry based on the Graham factors, including the scope and content of the prior art, the level of ordinary skill in the art, the differences between the claimed invention and the prior art, and evidence of secondary factors.
How does a patent landscape analysis help in understanding the '336 patent?
A patent landscape analysis helps in identifying technological trends, key players, and legal vulnerabilities, providing a comprehensive view of the patent's impact and position within the pharmaceutical industry.
Sources
- Merck Sharp & Dohme Corp. v. Sandoz Inc. - Casetext
- Case 3:12-cv-03324-PGS-LHG Document 1 Filed 06/01/12 Page 1 - Insight.RPXCorp
- How to Do Patent Landscape Analysis - Goldstein Patent Law
- Product patents - MSD - MSD
- Federal Register/Vol. 74, No. 191/Monday, October 5, 2009/Notices - GovInfo
