Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 39

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 3
Chunk 39
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 may be issued with coverage significantly narrower than what we currently seek.

Our proprietary position for our product
candidates currently depends upon patents protecting the method of use, which may not prevent a competitor or other third party from using
the same product candidate for another use.

The primary patent based intellectual
property protection for our product candidates are patents granted on the method of use and formulation. We do not have patents or patent
applications covering our products as a composition of matter (i. e., compound claims) for all our product candidates.

Composition of matter patent
claims on the active pharmaceutical ingredient, or API, in pharmaceutical drug products are generally considered to be the favored form
of intellectual property protection for pharmaceutical products, as such patents provide protection without regard to any particular method
of use, manufacture or formulation of the API used. Method of use patent claims protect the use of a product for the specified method
and dosing. These types of patent claims do not prevent a competitor or other third party from making and marketing an identical API for
an indication that is outside the scope of the method claims or from developing a different dosing regimen. Moreover, even if competitors
or other third parties do not actively promote their product for our targeted indications or uses for which we may obtain patents, physicians
may recommend that patients use these products off-label, or patients may do so themselves. Although off-label use may infringe or contribute
to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute.

Because the patent positions of pharmaceutical
products are complex and uncertain, we cannot predict the scope and extent of patent protection of our issued patents for our product
candidates.

Our issued patents may not
ensure the protection of our intellectual property for a number of reasons, including without limitation the following:

  any issued patents may not be broad or strong enough to prevent competition from other drug products including identical or similar drug products;  
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  if issued patents expire, there would be no protections against competitors making generic equivalents;  

  there may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim;  
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  there may be other patents existing, now or in the future, in the patent landscape for Quilience and Nolazol, or any other product candidates