Company: NCEL
Filing Date: 2025-09-10
Form Type: 424B3
Source: 0001213900-25-086600
Chunk: 157

Company: NewcelX Ltd.
Filing Date: 2025-09-10
Form: 424B3
Chunk 157
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 position for its 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 its product candidates are patents granted on the method of use and formulation. NLS does not have patents or patent applications covering its products as a composition of matter (i.e., compound claims) for all its 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 its targeted indications or uses for which NLS may obtain patents, physicians may recommend that patients use these products off -label, or patients may do so themselves. Although off -labeluse 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. 46 Because the patent positions of pharmaceutical products are complex and uncertain, NLS cannot predict the scope and extent of patent protection of its issued patents for its product candidates. NLS’s issued patents may not ensure the protection of its 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; •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; •there may be other patents existing, now or in the future, in the patent landscape for Quilience and Nolazol, or any other product candidates that we seek to commercialize or develop, if any, that will affect NLS’s freedom to operate; •if NLS’s patents are challenged, a court could determine that they are not valid or enforceable; •a court could determine that a competitor’s technology or product does not infringe NLS’s patents; •