Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2505

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2505
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 candidates can be commercialized, any related patent may expire or remain in force for
only a short period following commercialization, thereby limiting the protection such patent would afford the respective product and
any competitive advantage such patent may provide.

37

The
term of individual patents depends upon the date of filing of the patent application, the date of patent issuance and the legal term
of patents in the countries in which they are obtained. In most countries, including the United States, the patent term is 20 years from
the earliest filing date of a non-provisional patent application. In the United States, a patent’s term may be lengthened by patent
term adjustment, which compensates a patentee for administrative delays by the USPTO in examining and granting a patent, or may be shortened
if a patent is terminally disclaimed over an earlier expiring patent.

The
term of a patent claiming a new drug product may also be eligible for a limited patent term extension when FDA approval is granted, provided
statutory and regulatory requirements are met. The restoration period granted on a patent covering a product is typically one-half the
time between the effective date of a clinical investigation involving human beings is begun and the submission date of an application,
plus the time between the submission date of an application and the ultimate approval date. The restoration period cannot be longer than
five years and the total patent term, including the restoration period, must not exceed 14 years following FDA approval. Only one patent
applicable to an approved product is eligible for the extension, and only those claims covering the approved product, a method for using
it, or a method for manufacturing it may be extended. Additionally, the application for the extension must be submitted prior to the
expiration of the patent in question. A patent that covers multiple products for which approval is sought can only be extended in connection
with one of the approvals. The United States Patent and Trademark Office reviews and approves the application for any patent term extension
or restoration in consultation with the FDA. In the future, if our product candidates receive approval by the FDA, we expect to apply
for patent term extensions on any issued patents covering those products, depending upon the length of the clinical studies for each
product and other factors.

There
can be no assurance that our pending provisional or PCT patent applications will issue or that we will benefit from any patent term extension
or favorable adjustments to the terms of any patents we may own or in-license in the future. In addition, the actual