United States Patent 9,408,837: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,408,837, issued to Kitov Pharmaceuticals, is a significant patent in the pharmaceutical industry, particularly in the realm of drug development for treating osteoarthritis and hypertension. This patent, titled "Ameliorating Drug-Induced Elevations In Blood Pressure By Adjunctive Use Of Antihypertensive Drugs," provides long-term exclusivity for Kitov's lead drug candidate, KIT-302.
Background of the Patent
The patent was issued on August 9, 2016, by the United States Patent and Trademark Office (USPTO) and is expected to have a term that can extend to May 22, 2029[4][5].
Scope of the Patent
The patent covers a novel approach to treating pain caused by osteoarthritis while simultaneously addressing hypertension, a common side effect of certain stand-alone drugs used for osteoarthritis pain. KIT-302 is a combination of two U.S. FDA-approved drugs: celecoxib (the active ingredient in Pfizer's Celebrex) for pain treatment and amlodipine besylate for hypertension management[4][5].
Claims of the Patent
The patent includes claims that define the specific combination and method of using these drugs to achieve the desired therapeutic effect. Here are some key aspects of the claims:
- Combination Therapy: The patent claims a method of treating osteoarthritis pain and hypertension using a combination of celecoxib and amlodipine besylate.
- Dosage and Administration: The claims specify the dosages and administration methods for the combination therapy.
- Therapeutic Benefits: The patent highlights the therapeutic benefits of this combination, including the reduction of blood pressure elevations induced by certain drugs used for osteoarthritis pain[5].
Patent Landscape
Competitive Environment
The issuance of this patent places Kitov Pharmaceuticals in a strong competitive position within the pharmaceutical industry. By securing long-term exclusivity for KIT-302, Kitov can differentiate its product from other treatments for osteoarthritis and hypertension, potentially capturing a significant market share.
Regulatory Implications
The patent is crucial for Kitov's regulatory strategy, as it supports the company's plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The exclusivity provided by the patent will be essential in protecting Kitov's investment in the development and commercialization of KIT-302[4][5].
Intellectual Property Protection
Patent Term and Exclusivity
The patent term, which can extend to May 22, 2029, provides Kitov with a significant period of exclusivity. This exclusivity is critical for recouping the substantial investments made in research, development, and clinical trials[4].
Additional Claims and Inventions
Kitov Pharmaceuticals is also pursuing additional claims related to the inventions described in the U.S. Patent #9,408,837. This strategy aims to further broaden the scope of protection and ensure comprehensive coverage of their innovative approach[5].
Economic and Market Impact
Market Potential
The combination therapy covered by this patent addresses a significant medical need, as osteoarthritis and hypertension are common conditions that often co-exist. The market potential for KIT-302 is substantial, given the large patient population and the lack of similar combination therapies on the market.
Financial Implications
Securing this patent can have positive financial implications for Kitov Pharmaceuticals. The exclusivity period allows the company to generate revenue without immediate competition, which can be crucial for the financial sustainability and growth of the company.
Legal and Regulatory Considerations
Compliance with FDA Regulations
The patent supports Kitov's compliance with FDA regulations by providing a clear and protected method for the combination therapy. This is essential for the approval and commercialization of KIT-302.
Potential Litigation and Disputes
As with any significant patent, there is a potential for litigation or disputes over infringement or validity. Kitov must be prepared to defend its patent rights to maintain its competitive advantage.
Industry Expert Insights
Industry experts often highlight the importance of strong patent protection in the pharmaceutical sector. For example, "Patent protection is crucial for pharmaceutical companies to recoup their investments in research and development and to ensure they can bring innovative treatments to market without immediate competition"[4].
Statistics and Data
- Patent Scope Measurements: Studies like those conducted by the USPTO on patent scope measurements highlight the importance of detailed claims and the impact on patent scope. The Patent Claims Research Dataset provides insights into how claims are structured and their implications on patent protection[3].
Conclusion
United States Patent 9,408,837 is a pivotal asset for Kitov Pharmaceuticals, offering long-term exclusivity for its innovative combination therapy, KIT-302. The patent's scope and claims are carefully crafted to protect the company's intellectual property and support its regulatory and commercial strategies.
Key Takeaways
- Combination Therapy: The patent covers a unique combination of celecoxib and amlodipine besylate for treating osteoarthritis pain and hypertension.
- Exclusivity Period: The patent term extends to May 22, 2029, providing significant exclusivity.
- Regulatory Support: The patent supports Kitov's NDA submission to the FDA.
- Market Potential: The therapy addresses a significant medical need with substantial market potential.
- Financial Implications: Exclusivity can generate significant revenue for Kitov Pharmaceuticals.
FAQs
What is the main focus of United States Patent 9,408,837?
The main focus of this patent is the combination therapy of celecoxib and amlodipine besylate for treating osteoarthritis pain and hypertension.
Who is the patent holder?
The patent is held by Kitov Pharmaceuticals.
What is the expected patent term?
The patent term can extend to May 22, 2029.
How does this patent support Kitov's regulatory strategy?
The patent supports Kitov's plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
What are the potential financial implications of this patent for Kitov Pharmaceuticals?
The exclusivity provided by the patent can generate significant revenue for Kitov Pharmaceuticals by allowing the company to commercialize KIT-302 without immediate competition.
Cited Sources
- UNITED STATES SECURITIES AND EXCHANGE COMMISSION - Annual Report Archive[1]
- APPLE INC. v. WI-LAN INC. - Court of Appeals for the Federal Circuit[2]
- Patent Claims Research Dataset - USPTO[3]
- Kitov Pharmaceuticals Announces Issuance of US Patent - Marketscreener[4]
- Kitov Announces Issuance of U.S. Patent - PR Newswire[5]
