Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2100

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2100
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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 protection afforded
by a patent varies on a product-by-product basis, from country-to-country, and depends upon many factors, including the type of patent,
the scope of its coverage, the availability of regulatory-related extensions, the availability of legal remedies in a particular country
and the validity and enforceability of the patent. Patent term may be inadequate to protect our competitive position on our products
for an adequate amount of time.

As
of December 31, 2024, we exclusively license 16 allowed or issued patents and 36 pending patent applications. The issued patents and
pending patent applications have nominal expiration dates ranging from 2032 to 2041, without accounting for any available patent term
adjustments or extensions. We have further exclusively sublicensed our rights and obligations under our licenses