Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 81

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 81
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 be adversely affected.

Patent
terms may be inadequate to protect our competitive position on our diagnostic tests or therapeutic product candidates for an adequate
amount of time.

The
term of any individual patent depends on applicable law in the country where the patent is granted. In the U.S., provided all maintenance
fees are timely paid, a patent generally has a term of 20 years from its application filing date or earliest claimed non-provisional
filing date. Extensions may be available under certain circumstances, but the life of a patent and, correspondingly, the protection it
affords is limited. Even if we or our licensors obtain patents covering our diagnostic tests and therapeutic product candidates, when
the terms of all patents covering 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.

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