Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 370

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 370
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 encounter delays in regulatory approvals, the period of time during which
we could market a product candidate under patent protection could be reduced. If any of our patents are challenged, invalidated, circumvented
by third parties or otherwise limited or expire prior to the commercialization of our product candidates, and if we do not own or have
exclusive rights to other enforceable patents protecting our product candidates or other technologies, competitors and other third parties
could market product candidates and use processes that are substantially similar to, or superior to, ours and our business would suffer.

68

If the patent applications we hold or have in-licensed with
respect to our product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide
meaningful exclusivity for our product candidates or any future product candidate, it could dissuade companies from collaborating with
us to develop product candidates, and threaten our ability to commercialize, future drugs. Any such outcome could have a materially adverse
effect on our business.

The patent position of biotechnology and pharmaceutical companies generally
is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. The
standards that the U.S. Patent and Trademark Office (the “USPTO”) and its counterparts in other countries use to grant
patents are not always applied predictably or uniformly. In addition, the laws of countries other than the United States may not
protect our rights to the same extent as the laws of the United States, and many companies have encountered significant problems
in protecting and defending such rights in such jurisdictions. For example, European patent law restricts the patentability of methods
of treatment of the human body more than United States law does.

Other parties have developed technologies that may be related or competitive
to our own technologies and such parties may have filed or may file patent applications, or may have received or may receive patents,
claiming inventions that may overlap or conflict with those claimed in our own or licensed patent applications or issued patents. Furthermore,
publications of discoveries in scientific literature often lag behind the actual discoveries, and patent applications in the United States
and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, we cannot
know with certainty whether we or our licensors were the first to make the inventions claimed in our owned or licensed patents or pending
patent applications, or that we or our licensors