Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 48

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 48
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 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 or no benefit. Patent protection must ultimately be sought on a country-by-country basis, which
is an expensive and time-consuming process with uncertain outcomes. Accordingly, we may choose not to seek patent protection in certain
countries,