Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 56

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 56
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drug or biologic may be eligible for a term extension designed to restore the period of the patent term that is lost during the premarket
regulatory review process conducted by the FDA. Depending upon the timing, duration, and conditions of FDA marketing authorization of
our diagnostic tests or therapeutic product candidates, one or more of our U.S. patents may be eligible for limited patent term extension
under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), which permits a patent
term extension of up to five years for a patent covering an approved diagnostic test or therapeutic product as compensation for effective
patent term lost during diagnostic test or therapeutic product development and the FDA regulatory review process. A patent term extension
cannot extend the remaining term of a patent beyond a total of 14 years from the date of diagnostic test or therapeutic product approval,
and only claims covering such approved diagnostic test or drug product, a method for using it, or a method for manufacturing it may be
extended. In Europe, our diagnostic test or therapeutic product candidates may be eligible for term extensions based on similar legislation.
In either jurisdiction, however, we may not receive an extension if we fail to apply within applicable deadlines, fail to apply prior
to expiration of relevant patents, or otherwise fail to satisfy applicable requirements. Even if we are granted such an extension, the
duration of such extension may be less than our request. If we are unable to obtain a patent term extension, or if the term of any such
extension is less than our request, the period during which we can enforce our patent rights for that product will be in effect shortened,
and our competitors may obtain approval to market competing diagnostic tests or products sooner. The resulting reduction of years of revenue
from applicable diagnostic tests or products could be substantial.

We enjoy only limited geographical protection with respect to certain patents, and we may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, and defending patents covering
our diagnostic tests and therapeutic product candidates in all countries throughout the world would be prohibitively expensive, and even
in countries where we have sought protection for our intellectual property, such protection can be less extensive than it is in the U.S.
The requirements for patentability may differ in certain countries, particularly developing countries, and the breadth of patent claims
allowed can be inconsistent. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent
as federal and state laws in the U.S.