Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 328

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 328
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 compared to the evidentiary
standard in U.S. federal court necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding
sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first
presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures, e.g., an IPR, to invalidate
our patent claims that would not have been invalidated if first challenged by the third party in a district court action.

We may not have sufficient patent term or regulatory exclusivity
protections for our drug candidates to effectively protect our competitive position.

Patents have a limited term. In the United States
and most jurisdictions worldwide, the statutory expiration of a non-provisional patent is generally 20 years after it is first filed.
Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering
our technologies, drug candidates and associated uses are obtained, once the patent’s life has expired, including for failure to
pay maintenance fees or annuities, we may be open to competition from generic, biosimilar or biobetter medications.

Patent term extensions under the Hatch-Waxman
Act in the United States, and regulatory extensions in Japan and certain other countries, and under Supplementary Protection Certificates
in Europe, may be available to extend the patent or market or data exclusivity terms of our drug candidates depending on the timing and
duration of the regulatory review process relative to patent term. In addition, upon issuance of a United States patent, any patent term
may be adjusted based on specified delays during patent prosecution caused by the applicant(s) or the USPTO. Although we will likely
seek patent term extensions in the U.S. and in one or more international jurisdictions where available, we cannot provide any assurances
that any such patent term extensions will be granted and, if so, for how long. As a result, we may not be able to maintain exclusivity
for our drug candidates for an extended period after regulatory approval, if any, which would negatively impact our business, financial
condition, results of operations and prospects. If we do not have sufficient patent term or regulatory exclusivity to protect our drug
candidates, our business and results of operations will be adversely affected.

If we are unable to obtain and maintain patent protection for
any drug candidates, our competitors could develop and