Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 211

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 211
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 in revocation or amendment to our patents in such a way that
they no longer cover our diagnostic tests or therapeutic product candidates. The outcome following legal assertions of invalidity and
unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating
prior art, of which we, our patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on
a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our
diagnostic tests or therapeutic product candidates. Such a loss of patent protection could have a material adverse impact on our business.

If
we do not obtain patent term extension in the U.S. under the Hatch-Waxman Act and in foreign countries under similar legislation,
thereby potentially extending the term of marketing exclusivity for our diagnostic tests or therapeutic product candidates, our business
may be harmed.

In
the U.S., a patent that covers an FDA-approved 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