Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 146

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 146
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 enforce patents that it might obtain in the future.

Similarly, changes in patent law and regulations in other countries
or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces
patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we have licensed or that we may obtain
in the future. For example, the complexity and uncertainty of European patent laws have also increased in recent years. In Europe,
in June 2023, a new unitary patent system was introduced, which will significantly impact European patents, including those granted
before the introduction of the system. Under the unitary patent system, after a European patent is granted, the patent proprietor can
request unitary effect, thereby getting a European patent with unitary Effect, or a Unitary Patent. Each Unitary Patent is subject to
the jurisdiction of the Unitary Patent Court, or the UPC. As the UPC is a new court system, there is no precedent for the court,
increasing the uncertainty of any litigation. Patents granted before the implementation of the UPC will have the option of opting out
of the jurisdiction of the UPC and remaining as national patents in the UPC countries. Patents that remain under the jurisdiction of the
UPC may be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in
all countries who are signatories to the UPC. We cannot predict with certainty the long-term effects of the new unitary patent
system.

74

We cannot predict future changes in the interpretation of patent laws
or changes to patent laws that might be enacted into law by United States and non-U.S. legislative bodies. Those changes
may materially affect our patents or patent applications and our ability to obtain additional patent protection in the future.

The validity, scope and enforceability of any patents listed
in the Orange Book that cover our product candidates or patents that cover our biologic product candidates can be challenged by third
parties.

If one of our product candidates is approved by the FDA and if a third
party files an application under Section 505(b)(2) or an abbreviated new drug application (“ANDA”) under
Section 505(j) for a generic product containing any of our product candidates, and relies in whole or in part on studies conducted
by or for us, the third party will be required to certify to the FDA that either: (1) there