Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 205

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 205
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 therapeutic products and technology. In addition, we may need the cooperation of any such co-owners of our patents in order
to enforce such patents against third parties, and such cooperation may not be provided to us. Furthermore, our owned and in-licensed
patents may be subject to a reservation of rights by one or more third parties. Any of the foregoing could have a material adverse effect
on our competitive position, business, financial conditions, results of operations, and prospects.

Our
competitive position depends on protection of our intellectual property.

Development
and protection of our intellectual property are critical to our business. If we do not adequately protect our intellectual property,
or if competitors develop technologies incorporating the same or similar technologies that already are in the public domain, those competitors
may be able to develop similar technologies to our own. Our success depends in part on our ability to obtain patent protection for our
diagnostic tests, therapeutic products, or processes in the U.S. and other countries, protect trade secrets, and prevent others from
infringing on our proprietary rights.

Since
patent applications in the U.S. are maintained in secrecy for at least portions of their pendency periods (published on U.S. patent issuance
or, if earlier, 18 months from earliest filing date for most applications) and since other publication of discoveries in the scientific
or patent literature often lags behind actual discoveries, we cannot be certain that we are or will be the first to make the inventions
to be covered by our patent applications. The patent position of biopharmaceutical and biotechnology firms generally is highly uncertain
and involves complex legal and factual questions. The U.S. Patent and Trademark Office has not established a consistent policy regarding
the breadth of claims that it will allow in biotechnology patents.

The
patent applications we file, including applications that will follow the filing of provisional patents, may not issue as patents or the
claims of any issued patents may not afford meaningful protection for our technologies, tests, or products. In addition, patents issued
to us or to any future licensors may be challenged and subsequently narrowed, invalidated, or circumvented. Patent litigation is widespread
in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine
the scope and validity of third-party proprietary rights, and we may not have the required resources to pursue such litigation or to
protect our patent rights.

Although
we have executed assignment of invention agreements with current scientific and technical employees and