Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 55

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 55
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 a diagnostic test or
therapeutic product expire, our business may become subject to competition from competitive diagnostics or therapeutics. Given the amount
of time required for the development, testing, and regulatory review and approval of new diagnostic test or therapeutic product candidates,
patents protecting such candidates may expire before or shortly after such candidates are commercialized. As a result, our owned and licensed
patent portfolio may not provide us with sufficient rights to exclude others from commercializing diagnostic tests and therapeutic products
similar or identical to ours.

| 25 |

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If we or a licensee initiate legal proceedings against
a third party to enforce a patent covering 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