Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 384

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 384
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 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 is no patent information listed in the
FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) with respect to our
NDA for the applicable approved product candidate; (2) the patents listed in the Orange Book have expired; (3) the listed patents
have not expired, but will expire on a particular date and approval is sought after patent expiration; or (4) the listed patents
are invalid or will not be infringed by the manufacture, use or sale of the third party’s generic product. A certification under
21 CFR § 314.94(a)(12)(i)(A)(4) that the new product will not infringe the Orange Book-listed patents for the applicable
approved product candidate, or that such patents are invalid, is called a paragraph IV certification. If the third party submits
a paragraph IV certification to the FDA, a notice of the paragraph IV certification must also be sent to us once the third party’s
ANDA is accepted for filing by the FDA. We may then initiate a lawsuit to defend the patents identified in the notice. The filing
of a patent infringement lawsuit within 45 days of receipt of the notice automatically prevents the FDA from approving the third
party’s ANDA until the earliest of 30 months or the date on which the patent expires, the lawsuit is settled, or the court
reaches a decision in the infringement lawsuit in favor of the third party. If we