Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 191

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 191
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). If a drug or drug
product designated as an orphan product ultimately receives marketing approval for an indication broader than what was designated in its
orphan product application, it may not be entitled to exclusivity.

Patent Term Restoration and Extension

The term of a United States
patent that covers a drug, biological product or medical device approved pursuant to a PMA may also be eligible for patent term extension
when FDA approval is granted, provided that certain statutory and regulatory requirements are met. The length of the patent term extension
is related to the length of time the product is under regulatory review while the patent is in force. The Hatch-Waxman Act permits a patent
term extension of up to five years beyond the expiration date set for the patent. However, patent extension cannot extend the remaining
term of a patent beyond a total of 14 years from the date of product approval. Only one patent applicable to an approved drug may be granted
an extension, and the extension must be applied for prior to expiration of the patent. The United States Patent and Trade Office reviews
and approves the application for any patent term extension or restoration in consultation with the FDA. Similar provisions are available
in Europe and certain other foreign jurisdictions to extend the term of a patent that covers an approved drug, provided that statutory
and regulatory requirements are met.

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Regulation Outside the United States

In order to market any product
outside of the United States, a company must also comply with numerous and varying regulatory requirements of other countries and jurisdictions
regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization, commercial sales and
distribution of drug products. Whether or not it obtains FDA approval for a product, the company would need to obtain the necessary approvals
by the comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product in those countries
or jurisdictions. The approval process ultimately varies between countries and jurisdictions and can involve additional product testing
and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions might differ from
and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not ensure regulatory
approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively impact the
regulatory process in others.

Regulation and Marketing Authorization in the European Union

The process governing approval of medicinal products
in the European Union follows essentially the same lines as in the United States and, likewise, generally involves