Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 58

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 58
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 one of our diagnostic tests or therapeutic product candidates, the defendant could counterclaim
that the patent covering our diagnostic tests or therapeutic product candidate, as applicable, is invalid and/or unenforceable. In patent
litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds
upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative
bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, inter partes review,
post grant review, and equivalent proceedings in foreign jurisdictions (i.e., opposition proceedings). Such proceedings could result 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