Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 171

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 171
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 are met. The length of the patent
term extension is related to the length of time the drug is under regulatory review while the patent is in force. The Drug Price Competition
and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the expiration date set for the patent.
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 each regulatory review period may be granted an extension and only those claims reading on the approved drug may be extended.
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. Thus, in the future, if and when our product candidates receive approval
by the FDA or foreign regulatory authorities, we expect to apply for patent term extensions on issued patents covering those products,
depending upon the length of the clinical trials for each drug and other factors. The expiration dates of our patents and patent applications
referred to above are without regard to potential patent term extension or other market exclusivity that may be available to us.

In addition to patents, we
may rely, in some circumstances, on trade secrets to protect our technology and maintain our competitive position. However, trade secrets
can be difficult to protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements with
our employees, corporate and scientific collaborators, consultants, scientific advisors, contractors and other third parties. We also
seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and
physical and electronic security of our information technology systems.

Government Regulations

Government authorities in
the United States, at the federal, state and local level, and in other countries and jurisdictions, including the European Union and the
United Kingdom, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval,
packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting,
and import and export of pharmaceutical products. The processes for obtaining regulatory approvals in the United States and in foreign
countries and jurisdictions, along with subsequent compliance with applicable statutes and regulations and other regulatory authorities,
require the expenditure of substantial time and financial resources. As we have disclosed herein, we are seeking to license our product
candidates and other formulations to licensing partners. While many of the rules and regulations set