Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 136

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 136
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 for the development, testing and regulatory review of new product
candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

We do not currently and may not in the future own or license
any issued composition of matter patents covering certain of our product candidates, and we cannot be certain that any of our other issued
patents will provide adequate protection for such product candidates.

Composition-of-matter patents on the active pharmaceutical ingredient
(“API”) in prescription drug products are generally considered to be the strongest form of intellectual property protection
for drug products because those types of patents provide protection without regard to any particular method of use or manufacture or formulation
of the API used. While we generally seek composition of matter patents for our product candidates, such patents may not be available for
all of our product candidates.

Method-of-use patents protect the use of a product for the specified
method and formulation patents cover formulations of the API. These types of patents do not prevent a competitor or other third party
from developing or marketing an identical product for an indication that is outside the scope of the patented method or from developing
a different formulation that is outside the scope of the patented formulation. Moreover, with respect to method-of-use patents,
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 this type of infringement
is difficult to prevent or prosecute.

Our owned and licensed patents and pending patent applications, if
issued, may not adequately protect our intellectual property or prevent competitors or others from designing around our patent claims
to circumvent our owned or licensed patents by developing similar or alternative technologies or therapeutics in a non-infringing manner.
If the breadth or strength of protection provided by the patents and patent applications we own or license with respect to our product
candidates is not sufficient to impede such competition or is otherwise threatened, it could dissuade companies from collaborating with
us to develop, and threaten our ability to commercialize, our product candidates. Any of the foregoing could have a material adverse effect
on our business, financial condition, results of operations and prospects.

70

If we do not obtain protection under the Hatch-Wax