Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 43

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 43
---
 agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent
protection. Further, we may not be aware of all third-party intellectual property rights potentially relating to our drug candidates.
Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United
States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot
know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we
were the first to file for patent protection of such inventions.

The patent position of pharmaceutical companies
generally is highly uncertain, involves complex legal, technological and factual questions and has, in recent years, been the subject
of much debate and litigation throughout the world. In addition, the laws of foreign countries may not protect our rights to the same
extent as the laws of the United States, or vice versa. The standards that the United States Patent and Trademark Office (the “USPTO”)
(and foreign countries) use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform,
worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. Accordingly,
we do not know the degree of future protection for our proprietary rights or the breadth of claims that will be allowed in any patents
issued to us or to others. The issuance, scope, validity, enforceability, and commercial value of our patent rights are highly uncertain.
The subject matter claimed in a patent application can be significantly reduced or eliminated before the patent issues, if at all, and
its scope can be reinterpreted or narrowed after issuance. Therefore, our pending and future patent applications may not result in patents
being issued in relevant jurisdictions that protect our drug candidates, in whole or in part, or that effectively prevent others from
commercializing competitive drug candidates, and even if our patent applications issue as patents in relevant jurisdictions, they may
not issue in a form that will provide us with any meaningful protection for our drug candidates or technology, prevent competitors from
competing with us or otherwise provide us with any competitive advantage. Additionally, our competitors may be able to circumvent our
patents by challenging their validity or by developing similar or alternative drug candidates or technologies in a non-infringing manner.

The issuance of a patent is not conclusive as
to its inventorship, scope,