Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 47

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 47
---

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, faster and potentially more potent tribunal for challenging patents
could increase the likelihood that our own patents will be challenged, thereby increasing the uncertainties and costs of maintaining
and enforcing them.

We may be unable to enforce our intellectual property rights throughout the world.

The laws of some foreign
countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered
significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. This could make it difficult
for us to stop infringement of our foreign patents, if obtained, or the misappropriation of our other intellectual property rights. For
example, some foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition,
some countries limit the enforceability of patents against third parties, including government agencies or government contractors. In
these countries, patents may provide limited