Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 36

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 4
Chunk 36
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 if issued, have expected expiry dates of no earlier than 2040, not including any patent term extensions and/or patent term adjustments.
 
Three of our patent families are directed to compositions of matter of mebufotenin, including high purity mebufotenin, the aerosol generated for the administration of GH001, and an HBr salt. These patent families include patents issued in the U.S. and Europe.  The issued patents in these families, and the pending patent applications if issued, have expected expiry dates of no earlier than between 2040 and 2043, not including any patent term extensions and/or patent term adjustments.
 
At least 25 of our patent families are directed to various methods of use of mebufotenin, including use of mebufotenin to treat postpartum depression and bipolar disorder. The pending patent applications in these families, if issued, would have expected expiry dates of no earlier than 2043 or later, not including any patent term extensions and/or patent term adjustments.
 

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Three of our patent families are directed to our proprietary device. The pending patent applications in these families, if issued, would have expected expiry dates of no earlier than 2044 or later, not including any patent term extensions and/or patent term adjustments.
 
We also own design patent applications directed to our proprietary device, one of which has been granted in Europe and is expected to expire in 2049.
 
Two of our patent families are directed to manufacturing methods for the preparation of mebufotenin. These patent families include patents issued in at least Europe.  The issued patents in these families, and the pending patent applications if issued, have expected expiry dates of no earlier than 2040.
 
In total, we have over 250 patent applications pending globally, including in the United States, Australia, Brazil, Canada, China, Europe, Hong Kong, Israel, India, Japan, Korea, and Taiwan, as well as pending international applications under the Patent Cooperation Treaty, or PCT.
 
Government Regulation
 
Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, record keeping, 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