Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 212

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 212
---
 patent
term extension, or if the term of any such extension is less than our request, the period during which we can enforce our patent rights
for that product will be in effect shortened, and our competitors may obtain approval to market competing diagnostic tests or products
sooner. The resulting reduction of years of revenue from applicable diagnostic tests or products could be substantial.

We
enjoy only limited geographical protection with respect to certain patents, and we may not be able to protect our intellectual property
rights throughout the world.

Filing,
prosecuting, and defending patents covering our diagnostic tests and therapeutic product candidates in all countries throughout the world
would be prohibitively expensive, and even in countries where we have sought protection for our intellectual property, such protection
can be less extensive than it is in the U.S. The requirements for patentability may differ in certain countries, particularly developing
countries, and the breadth of patent claims allowed can be inconsistent. In addition, the laws of some foreign countries do not protect
intellectual property rights to the same extent as federal and state laws in the U.S. In-licensing patents covering our diagnostic tests
and therapeutic product candidates in all countries throughout the world may similarly be prohibitively expensive, if such opportunities
are available at all. And in-licensing or filing, prosecuting, and defending patents even in only those jurisdictions in which we develop
or commercialize our diagnostic tests and therapeutic product candidates may be prohibitively expensive or impractical. Competitors may
use our and our licensors’ technologies in jurisdictions where we have not obtained patent protection or licensed patents to develop
their own diagnostic tests and therapeutic products and further may export otherwise infringing products to territories where we and
our licensors have patent protection, but where enforcement is not as strong as that in the U.S. or Europe. These diagnostic tests and
products may compete with our diagnostic tests and therapeutic product candidates, and our or our licensors’ patents or other intellectual
property rights may not be effective or sufficient to prevent them from competing.

 41 

The
laws of some jurisdictions do not protect intellectual property rights to the same extent as the laws or regulations in the U.S. and
Europe, and many companies have encountered significant difficulties in protecting and defending proprietary rights in such jurisdictions.
Moreover, the legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents,
trade secrets, or other forms of intellectual property, particularly those relating to biotechnology tests and products, which could
make it difficult for