Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 135

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 135
---
 the eventual outcome is favorable to us. Any of the foregoing could have a material adverse effect on our business,
financial condition, results of operations and prospects.

69

Even if they are unchallenged, our owned and licensed patents and pending
patent applications, if issued, may not provide us with any meaningful protection or prevent competitors from designing around our patent
claims to circumvent our owned or licensed patents by developing similar or alternative technologies or therapeutics in a non-infringing manner.
For example, a third party may develop a competitive product that provides benefits similar to one or more of our product candidates but
that falls outside the scope of our patent protection. Moreover, patents have a limited lifespan. In the United States, the natural
expiration of a patent is generally 20 years after it is filed. Various extensions may be available; however the life of a patent,
and the protection it affords, is limited. Without patent protection for our current or future product candidates, it may be open to competition
from generic versions of such product candidates. Given the amount of time required for the development, testing and regulatory review
of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.
As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing
product candidates similar or identical to our own and, which could have a material adverse effect on our business, financial condition,
results of operations and prospects.

Patent terms and their scope may be inadequate to protect our
competitive position on current and future product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all
maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional filing
date. In certain instances, the patent term may be adjusted to add additional days to compensate for delays incurred by the USPTO
in issuing the patent. Also, the patent term may be extended for a period of time to compensate for at least a portion of the time a product
candidate was undergoing FDA regulatory review. However, the life of a patent, and the protection it affords, is limited. Even if patents
covering product candidates are obtained, once the patent life has expired, we may be open to competition from competitive product candidates,
including generics or biosimilars. Given the amount of time required