Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 327

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 327
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 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. 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