Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 52

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 52
---
 in the U.S. and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our diagnostic tests and therapeutic product candidates.

As is the case with other biopharmaceutical companies,
our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical
industry involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Changes in
either the patent laws or interpretation of the patent laws in the U.S. could increase the uncertainties and costs, and may diminish our
ability to protect our inventions, obtain, maintain, and enforce our intellectual property rights and, more generally, could affect the
value of our intellectual property or narrow the scope of our owned and licensed patents. Patent reform legislation in the U.S. and other
countries, including the Leahy-Smith America Invents Act (the “Leahy-Smith Act”), signed into law on September 16, 2011, could
increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued
patents. The Leahy-Smith Act included a number of significant changes to U.S. patent law. These include provisions that affect the way
patent applications are prosecuted, redefine prior art, and provide more efficient and cost-effective avenues for competitors to challenge
the validity of patents. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional
procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes
review, and derivation proceedings. Further, because of a lower evidentiary standard in these USPTO post-grant proceedings compared to
the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence
in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate
the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate
our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.
Thus, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent
applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business,