Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 373

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 373
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Patent terms and their scope may be inadequate to protect our
competitive position on current and future product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all
maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing
date. In certain instances, the patent term may be adjusted to add additional days to compensate for delays incurred by the USPTO
in issuing the patent. Also, the patent term may be extended for a period of time to compensate for at least a portion of the time a product
candidate was undergoing FDA regulatory review. However, the life of a patent, and the protection it affords, is limited. Even if patents
covering product candidates are obtained, once the patent life has expired, we may be open to competition from competitive product candidates,
including generics or biosimilars. Given the amount of time required 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