Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 48

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 48
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, but the life of a patent, and the protection it affords, is limited. Even if patents
directed to our drug candidates are obtained, once the patent life has expired for a drug candidate, we may be open to competition from
competitive medications, including generic versions. Given the amount of time required for the development, testing and regulatory review
of new drug candidates, patents directed towards such drug candidates might expire before or shortly after such drug candidates are commercialized.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing
drug candidates similar or identical to ours for a meaningful amount of time, or at all.

Depending upon the timing, duration and conditions
of any FDA marketing approval of our drug candidates, one or more of our owned or licensed U.S. patents may be eligible for limited patent
term extension under the Hatch-Waxman Act, and similar legislation in the EU and certain other countries. The Hatch-Waxman Act permits
a patent term extension of up to five years for a patent covering an approved product as compensation for effective patent term lost during
product development and the FDA regulatory review process. However, we may not receive an extension if we fail to exercise due diligence
during the testing phase or regulatory review process, fail to apply within applicable deadlines, fail to apply prior to expiration of
relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the length of the extension could be less than we request.
Only one patent per approved product can be extended, the extension cannot extend the total patent term beyond 14 years from approval
and only those claims for the approved drug, a method for using it or a method for manufacturing it may be extended. If we are unable
to obtain patent term extension or the term of any such extension is less than we request, the period during which we can enforce our
patent rights for the applicable drug candidate will be shortened and our competitors may obtain approval to market competing products
sooner. As a result, our revenue from applicable products could be reduced. Further, if this occurs, our competitors may take advantage
of our investment in development and trials by referencing our clinical and nonclinical data and launch their product earlier than might
otherwise be the case, and our competitive position, business, financial condition, results of operations and prospects could be materially
harmed.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, maintaining, defending and
enforcing patents