Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 185

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 185
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 The Leahy-Smith Act and its implementation may increase the uncertainties and costs surrounding the prosecution of our patent
applications and the enforcement or defense of our issued patents, all of which could harm our business, financial condition and results
of operations.

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The Leahy-Smith Act also provides a process known
as IPR, which has been used by many third parties to challenge and invalidate patents. The IPR process is not limited to patents filed
after the Leahy-Smith Act was enacted and would therefore be available to a third party seeking to invalidate any of our U.S. patents,
even those issued or filed before March 16, 2013. Because of a lower evidentiary standard in USPTO proceedings 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.