Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 324

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 324
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may raise similar claims before administrative bodies in the USPTO or the EPO, even outside the context of litigation. The outcome following
legal assertions of invalidity or unenforceability are unpredictable. With respect to patent claim validity, for example, we cannot be
certain that there is no invalidating prior art, of which we or the patent examiner was unaware during prosecution. Further, we cannot
be certain that all of the potentially relevant art relating to our patents and patent applications has been brought to the attention
of every patent office. If a defendant or other patent challenger were to prevail on a legal assertion of invalidity or unenforceability,
we could lose at least part, and perhaps all, of the patent protection on our drug candidates, compositions and associated uses.

73

In addition, the complexity and uncertainty of
European patent laws have increased in recent years. In Europe, a new unitary patent system was launched on June 1, 2023, which significantly
impacted European patents, including those granted before the introduction of such a system. Under the unitary patent system, European
applications now have the option, upon grant of a patent, of becoming a Unitary Patent which are subject to the jurisdiction of the Unitary
Patent Court (“UPC”). As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of
any litigation. Patents granted before the implementation of the UPC have the option of opting out of the jurisdiction of the UPC and
remaining as national patents in the UPC countries. Patents that remain under the jurisdiction of the UPC will be potentially vulnerable
to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the
UPC. We cannot predict with certainty the long-term effects of any potential changes.

The patent protection and patent prosecution for some of our
drug candidates may in the future be dependent on third parties.

While we normally seek to gain the right to fully
prosecute the patent applications relating to our drug candidates, there may be times when certain patents or patent applications relating
to our drug candidates, their compositions, uses or their manufacture may be controlled by our current or future collaboration partners
or licensors. If any of our current or future collaboration partners fail to appropriately or broadly prosecute patent applications or
maintain patent protection of claims covering any of our drug candidates, their compositions, uses or their manufacture, our ability to
develop and commercialize