Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 145

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 145
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 or would
be commercializing a potentially competitive product or service. In such a circumstance, such third party may be able to compete with
us or our subsidiaries or investment companies, which could have a material adverse effect on our competitive position, business, financial
condition, results of operations, and prospects.

Changes in U.S. patent law or the patent law of other countries
or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.

As is the case with other biopharmaceutical companies, the Company’s
success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical
industry involves both technological and legal complexity and is costly, time-consuming and inherently uncertain. For example, on
September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act
included a number of significant changes to U.S. patent law, including provisions that affect the way patent applications will be
prosecuted and that may also affect patent litigation. In particular, under the Leahy-Smith Act, the United States transitioned
in March 2013 to a “first to file” system in which the first inventor to file a patent application is typically entitled
to the patent. Third parties are allowed to submit prior art before the issuance of a patent by the USPTO, and may become involved in
post-grant proceedings, including opposition, derivation, reexamination, inter partes review or interference proceedings challenging
our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce
the scope or enforceability of, or invalidate, our patent rights, which could adversely affect the Company’s competitive position.

In addition, The U.S. Supreme Court has ruled on several patent
cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights
of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future,
this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the
U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that
would weaken the Company’s ability to obtain new patents or to