Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 186

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 186
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 required patent information has not been filed by the original applicant; |

| II. | the listed patent has expired; |

| III. | the listed patent has not expired, but will expire on a particular date and approval is sought after patent 
 expiration; or                                                                                              |

| IV. | the listed patent is invalid, unenforceable or will not be infringed by manufacture, use or sale of the 
 new product.                                                                                            |

If a Paragraph I or II certification
is filed, the FDA may make approval of the application effective immediately upon completion of its review. If a Paragraph III certification
is filed, the approval may be made effective on the patent expiration date specified in the application, although a tentative approval
may be issued before that time. If an application contains a Paragraph IV certification, a series of events will be triggered, the outcome
of which will determine the effective date of approval of the ANDA or 505(b)(2) application.

| 93 |

A certification that the new
product will not infringe the already approved product’s listed patents or that such patents are invalid or unenforceable is called
a Paragraph IV certification. If the follow-on applicant has provided a Paragraph IV certification to the FDA, the applicant must also
send notice of the Paragraph IV certification to the NDA and patent holders once the follow-on application in question has been accepted
for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph
IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of a Paragraph IV certification automatically
prevents the FDA from approving the ANDA or 505(b)(2) NDA until the earlier of 30 months after the receipt of the Paragraph IV notice,
expiration of the patent or a decision in the infringement case that is favorable to the ANDA or 505(b)(2) applicant. Alternatively, if
the listed patent holder does not file a patent infringement lawsuit within the required 45-day period, the follow-on applicant’s
ANDA or 505(b)(2) NDA will not be subject to the 30-month stay.

Reference Product Exclusivity for Biological Products

In March 2010, the Patient
Protection and Affordable Care Act, or ACA, was enacted in the United States and included the Biologics Price Competition and Innovation
Act of 2009, or the BPCIA. The BPCIA amended the PHSA to create an