Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 321

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 321
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 protected rights at the time of publication.

We could be required to incur significant expenses to obtain
our intellectual property rights, and we cannot ensure that we will obtain meaningful patent protection for our drug candidates.

The patent prosecution process is expensive and
time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in
a timely manner. In addition, it is also possible that we will fail to identify patentable aspects of further inventions made in the course
of our research, development or commercialization activities before they are publicly disclosed, making it in many cases too late to obtain
patent protection on them. Further, given the amount of time required for the development, testing and regulatory review of new drug candidates,
patents protecting such candidates might expire before or shortly after such candidates are commercialized. We expect to seek extensions
of patent terms where these are available in any countries where we are prosecuting patents. This includes in the United States under
the Drug Price Competition and Patent Term Restoration Act of 1984, which permits a patent term extension of up to five years beyond the
expiration of a patent that covers an approved product where the permission for the commercial marketing or use of the product is the
first permitted commercial marketing or use, and as long as the remaining term of the patent does not exceed 14 years from the product’s
approval date. However, the applicable authorities, including the FDA in the United States, and any comparable regulatory authority in
other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our
patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to take advantage of our investment
in development and clinical trials by referencing our clinical and preclinical data and launch their product earlier than might otherwise
be the case. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish
the value of our patents or narrow the scope of our patent protection. The laws of international countries may not protect our rights
to the same extent as the laws of the United States, and these international laws may also be subject to change. Publications of discoveries
in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions
are typically not published until 18 months after filing or in some cases not at all. Therefore, we cannot be certain that we or our past,
current