Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 184

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 184
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 commercial
markets.

●Ownership of our patents or patent applications may be challenged by third parties.

●The patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business.

Changes in patent law could diminish the value of patents in
general, thereby impairing our ability to protect our drug candidates and any future drug candidates.

As is the case with other biotechnology and pharmaceutical
companies, our success is heavily dependent on intellectual property rights, particularly patents. Obtaining and enforcing patents in
the biopharmaceutical industry involves technological and legal complexity, and obtaining and enforcing biopharmaceutical patents is costly,
time-consuming and inherently uncertain. The U.S. Supreme Court in recent years has issued rulings either narrowing the scope of patent
protection available in certain circumstances or weakening the rights of patent owners in certain situations or ruling that certain subject
matter is not eligible for patent protection. In addition to increasing uncertainty with regard to our ability to obtain patents in the
future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions
by Congress, the federal courts, the USPTO and equivalent bodies in non-U.S. jurisdictions, the laws and regulations governing patents
could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce existing patents and patents we may
obtain in the future.

Patent reform laws, such as the Leahy-Smith America
Invents Act (“Leahy-Smith Act”), as well as changes in how patent laws are interpreted, could increase the uncertainties
and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith
Act made a number of significant changes to U.S. patent law. These include provisions that affect the filing and prosecution strategies
associated with patent applications, including a change from a “first-to-invent” to a “first-inventor-to-file”
patent system, and a change allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures
to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review
and derivation proceedings. The USPTO has developed regulations and procedures to govern administration of the Leahy-Smith Act, and many
of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the “first-inventor-to-file”
provisions.