Company: RGNT
Filing Date: 2025-05-05
Form Type: F-1/A
Source: 0001213900-25-039589
Chunk: 52

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-05-05
Form: F-1/A
Chunk 52
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 and 2036. While we have attempted
to develop a patent portfolio that includes pending patent applications covering subsequent improvements in our products and processes,
we cannot be sure if these patent applications will result in any issued patents. Accordingly, we are not currently able to assess to
what extent the expiration of the basic patents will expose us to competition. If we are not able to implement subsequent sufficient patents
to protect our products, technologies and their uses, we may not be able to stop a competitor from marketing products that are the same
as or similar to our product candidates, which would have a material adverse effect on our business.

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Changes in U.S. patent laws may limit our ability to obtain, defend and/or enforce our patents.

Patent reform legislation
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 America Invents Act, or the Leahy-Smith Act, includes a number of significant changes to U.S. patent law.
These include provisions that affect the way patent applications are prosecuted and also affect patent litigation. 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 to file provisions, which became effective on March 16, 2013. The first to file
provisions limit the rights of an inventor to patent an invention if not the first to file an application for patenting that invention,
even if such invention was the first invention. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the
operation of our business.

However, the Leahy-Smith Act
and its implementation could increase the uncertainties and costs surrounding the enforcement and defense of our issued patents. For example,
the Leahy-Smith Act provides that an administrative tribunal known as the Patent Trial and Appeals Board, or the PTAB, provides a venue
for challenging the validity of patents at a cost that is much lower than district court litigation and on timelines that are much faster.
Although it is not clear what, if any, long-term impact the PTAB proceedings will have on the operation of our business, the initial results
of patent challenge proceedings before the PTAB since its inception in 2013 have resulted in the invalidation of many U.S. patent claims.
The availability of the PTAB as a lower-cost,