Company: BIVIW
Filing Date: 2025-08-08
Form Type: 424B5
Source: 0001520138-25-000247
Chunk: 50

Company: BIOVIE INC.
Filing Date: 2025-08-08
Form: 424B5
Chunk 50
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 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.S. Supreme Court has ruled on several patent cases in recent years, 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