Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 46

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 46
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 may be open to competition. In addition, although upon
issuance in the United States a patent’s term can be extended based on certain delays caused by the USPTO, this extension can be
reduced or eliminated based on certain delays caused by the patent applicant during patent prosecution. Given the amount of time required
for the development, testing and regulatory review of new products, patents protecting such products might expire before or shortly after
such products are commercialized. If we do not have sufficient patent terms to protect our products, technologies and their uses, our
business would be seriously harmed.

Our patent portfolio See
“Business—Intellectual Property—GelrinC”) has expiration dates between 2025 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