Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 181

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 181
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, current, or future collaboration
partners’ patents, may initiate legal proceedings against us in which the third party challenges the validity, enforceability, or
scope of our patent(s).

In administrative and court actions, grounds for
a patent validity challenge may include alleged failures to meet any of several statutory requirements, including novelty, nonobviousness
(or inventive step), clarity, adequate written description and enablement of the claimed invention. Grounds for unenforceability assertions
include allegations that someone associated with the filing or prosecution of the patent withheld material information from the Examiner
during prosecution in the USPTO or made a misleading statement during prosecution in the USPTO, the EPO or elsewhere. Third parties also
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