Understanding the Scope and Claims of United States Patent 10,414,751
Introduction
United States Patent 10,414,751, 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 assigned to Mycovia Pharmaceuticals, Inc., and it plays a crucial role in the development and protection of Vivjoa, an antifungal drug.
Patent Overview
Issuance and Inventors
The patent was issued on September 17, 2019, to inventors William J. Hoekstra, David Dale Wirth, Tracy Ehiwe, and Thierry Bonnaud[1][4].
Patent Expiration
The patent is set to expire on March 17, 2036, which is a critical date for understanding the timeline of exclusivity and potential generic competition[1][5].
Scope of the Patent
Antifungal Compounds
The patent focuses on polymorphic forms of specific antifungal compounds, identified as compound 1 or 1a. These compounds are designed to inhibit lanosterol demethylase (CYP51), an enzyme crucial in the biosynthesis of ergosterol, a key component of fungal cell membranes[4].
Processes for Preparation
The patent details various processes for preparing these polymorphic forms, including methods for crystallization using specific solvents and co-solvents such as ethyl acetate, isopropyl acetate, ethanol, and others. The process may involve repeating enantio-enrichment and purification steps to achieve the desired level of purity[4].
Pharmaceutical Compositions
The invention includes pharmaceutical compositions comprising these antifungal compounds and pharmaceutically acceptable carriers. These compositions are designed for the treatment of metalloenzyme-related disorders or diseases, particularly those involving fungal infections[4].
Claims of the Patent
Compound and Polymorph Claims
The patent claims cover the antifungal compounds themselves, including their polymorphic forms, hydrates, solvates, complexes, and prodrugs. These claims are specific to the chemical structures and their therapeutic applications[4].
Method Claims
The patent also includes method claims for modulating metalloenzyme activity and treating subjects suffering from or susceptible to metalloenzyme-related disorders. These methods involve administering effective amounts of the compounds or pharmaceutical compositions to achieve the desired therapeutic effect[4].
Patent Landscape and Exclusivity
Related Patents
In addition to Patent 10,414,751, Mycovia Pharmaceuticals holds other patents related to Vivjoa, including Patent 11,247,981 and Patent 8,236,962. These patents collectively protect various aspects of the drug, including its composition and methods of use[1][5].
Exclusivity
The FDA has granted exclusivity to Vivjoa, which includes New Chemical Entity (NCE) exclusivity until April 26, 2027, and Generating Antibiotic Incentives Now (GAIN) exclusivity until April 26, 2032. These exclusivities run concurrently with the patent protection, further extending the period during which generic versions cannot be approved[1].
Impact on Generic Competition
Listing Patents in the Orange Book
The brand-name manufacturer's decision to list patents in the FDA's Orange Book can significantly delay the approval of generic versions. If a patent is listed and claims the drug or its method of use, the FDA will withhold approval of a generic application for up to 30 months, unless the generic manufacturer can successfully challenge the patent[2].
Challenges to Patent Listings
Recent legal developments, such as the Orange Book Transparency Act (OBTA), aim to prevent branded manufacturers from improperly listing patents to block generic competition. This act requires that listed patents must claim the drug or its method of use directly, rather than just being potentially infringed by the generic product[2].
Challenges in Pharmaceutical Patent Landscape
Enablement and Written Description
The pharmaceutical industry faces challenges due to the strict application of enablement and written description requirements under 35 U.S.C. ยง 112. These requirements can make it difficult for innovators to claim the full scope of their inventions without risking invalidation of their patents. This has led to uncertainty and reduced the effectiveness of patent protection in the biopharmaceutical sector[3].
Key Takeaways
- Patent Scope: The patent covers specific antifungal compounds, their polymorphic forms, and processes for their preparation.
- Exclusivity: Vivjoa enjoys both patent protection and FDA-granted exclusivities, extending its market exclusivity period.
- Impact on Generics: The listing of patents in the Orange Book and the challenges to these listings can significantly affect the timing of generic competition.
- Industry Challenges: Strict patent disclosure laws and the interpretation of enablement and written description requirements pose significant challenges to pharmaceutical innovators.
FAQs
Q: What is the main subject of United States Patent 10,414,751?
A: The patent focuses on antifungal compounds, specifically polymorphic forms of compound 1 or 1a, and processes for their preparation.
Q: Who are the inventors of this patent?
A: The inventors are William J. Hoekstra, David Dale Wirth, Tracy Ehiwe, and Thierry Bonnaud.
Q: When is the patent set to expire?
A: The patent is set to expire on March 17, 2036.
Q: What is the significance of the FDA's Orange Book in relation to this patent?
A: The Orange Book listing can delay the approval of generic versions of the drug by up to 30 months if the listed patents claim the drug or its method of use.
Q: How do recent legal developments affect the patent landscape for pharmaceuticals?
A: Recent developments, such as the Orange Book Transparency Act, aim to prevent improper patent listings and ensure that only relevant patents are used to block generic competition.
Sources
- Generic Vivjoa Availability - Drugs.com
- Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal - CAFC
- Eviscerating Patent Scope - UIC Review of Intellectual Property Law
- US10414751B2 - Antifungal compounds and processes for making - Google Patents
- Vivjoa patent expiration - Pharsight
