Company: BIVIW
Filing Date: 2025-07-22
Form Type: S-1/A
Source: 0001520138-25-000216
Chunk: 52

Company: BIOVIE INC.
Filing Date: 2025-07-22
Form: S-1/A
Chunk 52
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 damages or other remedies awarded, if any, may not be commercially meaningful.

Many foreign countries, including some EU countries,
India, Japan and China, have compulsory licensing laws under which a patent owner may be compelled under specified circumstances to grant
licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors.
In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party,
which could materially diminish the value of the applicable patents and limit our potential revenue opportunities. Accordingly, our efforts
to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we develop or license, which could adversely affect our business, financial condition, results of operations and prospects.

In 2012, the European Patent Package, or EU Patent
Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court
(“UPC”), for litigation involving European patents. Implementation of the EU Patent Package occurred in 2023. Under the UPC,
all European patents, including those issued prior to ratification of the European Patent Package, will by default automatically fall
under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and
allow for the possibility of a competitor to obtain pan-European injunctions. It will be several years before we will understand the scope
of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. Under the EU Patent Package
as currently proposed, we will have the right to opt our patents out of the UPC over the first seven years of the court’s existence,
but doing so may preclude us from realizing the benefits of the new unified court.

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Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates.

Obtaining and enforcing patents in the pharmaceutical
industry is inherently uncertain, due in part to ongoing changes in the patent laws. For example, in the United States, depending on decisions
by Congress, the federal courts, and the USPTO, the laws and regulations governing patents, and interpretation thereof, could change in
unpredictable ways that could weaken our and our collaborators’ or licensors’ ability to obtain new patents or to enforce
existing or future patents. For example, the U