Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 3529

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 3529
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, patents, trade secrets and other intellectual property protection, particularly those relating to biopharmaceutical products,
which could make it difficult for us to stop the infringement of our patents or marketing of competing products against third parties
in violation of our proprietary rights generally. The initiation of proceedings by third parties to challenge the scope or validity of
our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of
our business. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts
and attention from other aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly and our
patent applications at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits
that we initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce
our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual
property that we develop or license.

Patent
terms may be inadequate to protect our competitive position on our 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. Various extensions such as patent term adjustments and/or extensions, may
be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are
obtained, once the patent life has expired, we may be open to competition from competitive products. 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 products similar or identical to ours.

If
we do not obtain patent term extension and data exclusivity for any product candidates we may develop, our business may be materially
harmed.

Depending
upon the timing, duration and specifics of any FDA marketing approval of any product candidates we may develop, one or more of our U.S.
patents may be eligible for limited patent term extension under the Drug Price Competition and Patent Term Restoration Action of 1984,
or the Hatch-Waxman Amendments. The Hatch-Wax