Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 385

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 385
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 do not file a patent infringement lawsuit within the
required 45-day period, the third party’s ANDA will not be subject to the 30-month stay of FDA approval.

Moreover, a third party may challenge the current patents, or patents
that may issue in the future, within our portfolio, which could result in the invalidation of some or all of the patents that might otherwise
be eligible for listing in the Orange Book for one of our products. If a third party successfully challenges all of the patents that might
otherwise be eligible for listing in the Orange Book for one of our products before an ANDA or 505(b)(2) NDA is filed we will be
unable to obtain a 30-month stay of FDA approval of a 505(b)(2) or ANDA.

For biologics, the BPCIA provides a mechanism for one or more third
parties to seek FDA approval to manufacture or sell a biosimilar or interchangeable versions of brand name biological product candidates.
Due to the large size and complexity of biological product candidates, as compared to small molecules, a biosimilar must be “highly
similar” to the reference product with “no clinically meaningful differences between the two.” The BPCIA does not require
reference product sponsors to list patents in the FDA’s Orange Book and does not include an automatic 30-month stay of
FDA approval upon the timely filing of a lawsuit. The BPCIA, however, does require a formal pre-litigation process which includes
the exchange of information between a biosimilar applicant and a reference biologic sponsor that includes the identification of relevant
patents and each parties’ basis for infringement and invalidity. After the exchange of this information, we may then initiate a
lawsuit within 30 days to defend the patents identified in the exchange. If the biosimilar applicant successfully challenges the
asserted patent claims, it could result in the invalidation of, or render unenforceable, some or all of the relevant patent claims or
result in a finding of non-infringement.

If we are unsuccessful in enforcing our patents against generics or
biosimilars, our products could face competition prior to the expiration of the patents which cover such products, which could have a
material adverse effect on our business, financial condition, results of operations and prospects. Furthermore, any such litigation or
other proceedings to enforce or defend intellectual property rights are often very complex in nature, may be very