United States Patent 9,840,492: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,840,492, titled "Antifungal compounds and processes for making," is a significant patent in the pharmaceutical industry, particularly in the field of antifungal treatments. This patent is held by Mycovia Pharmaceuticals, Inc. and is crucial for understanding the intellectual property landscape surrounding the drug Vivjoa (oteseconazole).
Patent Overview
Issuance and Assignee
The patent was issued on December 12, 2017, and is assigned to Mycovia Pharmaceuticals, Inc.[5].
Inventors
The inventors listed on this patent include William J. Hoekstra, David Dale Wirth, Tracy Ehiwe, and Thierry Bonnaud[5].
Scope and Claims
Antifungal Compounds
The patent primarily deals with antifungal compounds, specifically polymorphic forms of oteseconazole (compound 1 or 1a) and processes for preparing these polymorphs. Oteseconazole is an azole antifungal designed to selectively inhibit fungal CYP51, which is essential for the treatment of severe vulvovaginal candidiasis[4].
Processes for Making
The patent describes new methodologies for preparing polymorphs of oteseconazole and its substituted derivatives. These processes are critical for ensuring the stability, efficacy, and bioavailability of the antifungal agent[5].
Metalloenzyme Inhibitor Compounds
Although the primary focus is on antifungal compounds, related patents in the same family also cover metalloenzyme inhibitor compounds. However, US Patent 9,840,492 specifically focuses on the antifungal aspects[5].
Patent Claims
Drug Substance Claim
The patent claims cover the drug substance itself, including the polymorphic forms of oteseconazole. This ensures that any use of these specific forms of the compound would infringe on the patent[4].
Drug Product Claim
In addition to the drug substance, the patent also claims the drug product, which includes formulations and compositions containing oteseconazole. This extends the protection to the final product that is marketed and used by patients[4].
Patent Expiration Date
The patent is set to expire on March 17, 2036. This date is significant because it marks the end of the exclusive rights granted to Mycovia Pharmaceuticals, Inc. to manufacture and market products using the claimed antifungal compounds and processes[5].
Patent Landscape
Related Patents
The patent landscape surrounding US Patent 9,840,492 includes several related patents that cover different aspects of the drug and its manufacturing processes. These include:
- US Patent 10,414,751: Also deals with polymorphic forms of oteseconazole and processes for preparing them, with an expiration date of March 17, 2036[5].
- US Patent 11,247,981: Covers metalloenzyme inhibitor compounds and has an expiration date of May 9, 2033[5].
- US Patent 8,236,962: Describes metalloenzyme modulating activity and has an expiration date of April 22, 2031[5].
Exclusivity Periods
In addition to patent protection, the FDA may grant exclusivity periods that run concurrently with or independently of patent terms. For Vivjoa, any exclusivity granted by the FDA would further limit the ability of other manufacturers to market generic versions of the drug[5].
Impact on the Pharmaceutical Industry
Market Dominance
The exclusive rights granted by this patent and related patents ensure that Mycovia Pharmaceuticals, Inc. maintains market dominance for the antifungal drug Vivjoa until the patents expire. This period allows the company to recoup its investment in research and development and to generate significant revenue without direct competition from generic versions[4].
Innovation and Research
The patent encourages innovation by protecting the intellectual property of the inventors. This protection incentivizes further research and development in the field of antifungal treatments, as companies can invest in new technologies and compounds knowing that their discoveries will be protected[3].
Regulatory Considerations
FDA Approval
The drug Vivjoa, protected by this patent, has undergone rigorous clinical trials and has been approved by the FDA. The regulatory review period, which includes the testing and application periods, is a critical factor in determining the patent term extension, if applicable[1].
Key Takeaways
- Patent Scope: US Patent 9,840,492 covers antifungal compounds, specifically polymorphic forms of oteseconazole, and processes for making these compounds.
- Expiration Date: The patent expires on March 17, 2036.
- Related Patents: Several related patents cover different aspects of the drug and its manufacturing processes.
- Market Impact: The patent ensures market dominance for Mycovia Pharmaceuticals, Inc. until its expiration.
- Innovation: The patent protection incentivizes further research and development in antifungal treatments.
FAQs
What is the main subject of US Patent 9,840,492?
The main subject of US Patent 9,840,492 is antifungal compounds, specifically polymorphic forms of oteseconazole, and processes for making these compounds.
Who is the assignee of this patent?
The assignee of this patent is Mycovia Pharmaceuticals, Inc.
When does the patent expire?
The patent is set to expire on March 17, 2036.
What other patents are related to this one?
Related patents include US Patent 10,414,751, US Patent 11,247,981, and US Patent 8,236,962, which cover different aspects of the drug and its manufacturing processes.
How does this patent impact the pharmaceutical industry?
This patent ensures market dominance for Mycovia Pharmaceuticals, Inc. until its expiration and incentivizes further research and development in antifungal treatments.
What is the significance of the FDA approval in relation to this patent?
The FDA approval is crucial as it validates the safety and efficacy of the drug, and the regulatory review period can affect the patent term extension, if applicable.
