Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 134

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 134
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 art and provided more efficient
and cost-effective avenues for competitors to challenge the validity of patents. The Leahy-Smith Act and its implementation
could increase the uncertainties and costs surrounding the prosecution of our patent applications, our ability to obtain future patents,
and the enforcement or defense of our issued patents, all of which could harm our business, financial condition, results of operations
and prospects.

The issuance of a patent is not conclusive as to its inventorship,
scope, validity or enforceability, and our owned and licensed patents may be challenged in the courts or patent offices in the United States
and abroad.

Any patents that we have or may be issued provide us some protections
but the patent issuance may be challenged on multiple grounds. We may in the future be subject to third-party pre-issuance submissions
of prior art to the USPTO or its equivalents and we or our licensors have in the past, and may in the future, become involved in opposition,
derivation, reexamination, inter partes review, post-grant review or interference proceedings in the U.S. or
in other jurisdictions challenging our patent rights or the patent rights of others. A third party may also claim that our owned or licensed
patent rights are invalid or unenforceable in a litigation.

The outcome following legal assertions of invalidity and unenforceability
is unpredictable. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate,
our patent rights, allow third parties to commercialize our technology or product candidates and compete directly with us, without payment
to us, result in our inability to manufacture or commercialize product candidates without infringing third-party patent rights or
result in our breach of agreements pursuant to which we license such rights to our collaborators or licensees. In addition, if the breadth
or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating
with us to license, develop or commercialize current or future product candidates. Such challenges may result in loss of exclusivity
or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others
from using or commercializing similar or identical technology and product candidates, or limit the duration of the patent protection
of our technology and product candidates. Such challenges also may result in substantial cost and require significant time from our scientists
and management, even if