Company: BIVIW
Filing Date: 2025-07-11
Form Type: S-1/A
Source: 0001520138-25-000205
Chunk: 53

Company: BIOVIE INC.
Filing Date: 2025-07-11
Form: S-1/A
Chunk 53
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, either narrowing the
scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Therefore,
there is increased uncertainty with regard to our and our collaborators’ or licensors’ ability to obtain patents in the future,
as well as uncertainty with respect to the value of patents once obtained.

Patent reform legislation could increase the uncertainties
and costs surrounding the prosecution of our and our collaborators’ or licensors’ patent applications and the enforcement
or defense of our or our collaborators’ or licensors’ issued patents. For example, assuming that other requirements for patentability
are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside
the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America
Invents Act (the “Leahy-Smith Act”), enacted in September 2011, the United States transitioned to a first inventor to file
system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled
to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. The Leahy-Smith Act also
includes a number of significant changes that affect the way patent applications are prosecuted and may also affect patent litigation.
These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge
the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation
proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive
changes to patent law associated with the Leahy-Smith Act, particularly the first inventor-to-file provisions. Accordingly, it is not
clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation
could increase the uncertainties and costs surrounding the prosecution of our or our licensors’ patent applications and the enforcement
or defense of our or our licensors’ issued patents. Similarly, statutory or judicial changes to the patent laws of other countries
may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents.
Any of the foregoing could harm our business, financial condition, results of operations and prospects.

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