Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 58

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 58
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 breadth of claims, if any, that may be allowed under any
of our patent applications, or the enforceability of any of our allowed patents. See “ Item 3. D. Risk Factors - We may not obtain
adequate protection for our products through our intellectual property.”

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Patents extend for varying periods according to the
date of patent filing or grant and the legal term of patents in the various countries where patent protection is obtained. The actual
protection afforded by a patent, which can vary from country to country, depends on the type of patent, the scope of its coverage and
the availability of legal remedies in the country. In the U. S., the patent term of a patent that covers an FDA-approved drug may also
be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during the FDA
regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent,
in which the patentee may file an application for yearly interim extensions within five years if the patent will expire and the FDA has
not yet approved the NDA. The length of the patent term extension is related to the length of time the drug is under regulatory review.
Patent extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval and only one
patent applicable to an approved drug may be extended.

Similar provisions are available in Europe and other
foreign jurisdictions to extend the term of a patent that covers an approved drug. In these jurisdictions, however, no interim extensions
exist and the marketing approval must be granted before the patent expires. In the future, we expect to apply for patent term extensions
on patents covering those products, outside the U. S. While we anticipate that any such applications for patent term extensions will likely
be granted, we cannot predict the precise length of time for which such patent terms would be extended in the U. S., Europe or other jurisdictions.
If we are not able to secure patent term extensions on patents covering our products for meaningful periods of additional time, we may
not achieve or sustain profitability, which would adversely affect our business.

In addition to patent protection, our products may
benefit from the market-exclusivity provisions contained in the orphan-drug regulations or the pediatric-exclusivity provisions or other
provisions of the FDA Act, such as a NCE exclusivity or new formulation exclusivity. Orphan drug