Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 137

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 137
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man Amendments
by extending the patent term, our business may be harmed.

Our commercial success will largely depend on our ability to obtain
and maintain patent and other intellectual property in the United States and other countries with respect to our proprietary technology,
product candidates and our target indications. Given the amount of time required for the development, testing and regulatory review of
new product candidates, patents protecting our product candidates might expire before or shortly after such candidate begins to be commercialized.
We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting
patents.

Depending upon the timing, duration and specifics of FDA marketing
approval of product candidates, one or more of our U.S. patents may be eligible for a limited patent term extension (“PTE”)
under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments. The
Hatch-Waxman Amendments permit a patent restoration term of up to five years beyond the normal expiration of the patent as compensation
for patent term lost during development and the FDA regulatory review process, which is limited to the approved indication (and potentially
additional indications approved during the period of extension) covered by the patent. This extension cannot extend the remaining term
of a patent beyond a total of 14 years from the date of product approval and is limited to only one patent that covers the approved
product, the approved use of the product, or a method of manufacturing the product. However, the applicable authorities, including the
FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may refuse to grant extensions
to our patents, or may grant more limited extensions than we request. We may not be granted an extension because of, for example, failing
to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable
requirements. Moreover, the applicable time-period or the scope of patent protection afforded could be less than we request. Even
if we are able to obtain an extension, the patent term may still expire before or shortly after we receive FDA marketing approval.

If we are unable to extend the expiration date of our existing patents
or obtain new patents with longer expiry dates, our competitors may be able to take advantage of our investment in development and clinical
trials by referencing our clinical and pre-clinical data