Patents

A HAMLET patent portfolio has been established, with a number of issued patents, world-wide. Intellectual property rights include patents covering the manufacturing and use of HAMLET and substances derived from HAMLET ‘’second generation drug candidates’’. Patents have been granted in the US, Europe, Asia and Australia. Among the latest patent and patent applications are patents and applications that protect the production and use of recombinantly produced HAMLET, applications that protect the next generation HAMLET substances (peptide drugs), and applications for protection of use of HAMLET for prophylactic purposes.

HAMLET / BAMLET is protected by five patent families

This patent family protects the production of a particularly advantageous recombinant version of HAMLET named all-ALA. This type of recombinant HAMLET is relatively simple to produce. The patent has been linked to the compound’s potential overall effect on cancer especially on bladder cancer and glioblastoma. The application also mentions the possibility of using parts of the protein (two peptides). The patent has been granted in the United States, Japan and in seven European countries. The application is still being processed in Australia, Canada and in India. The patents that are approved are valid until January 8, 2030.

As the availability of human alpha-lactalbumin is limited, production of recombinant HAMLET is not only a prerequisite for producing large amounts of drug substance but also a necessary step to perform Phase II clinical trials. The patent applications regarding the production and use of recombinant HAMLET was submitted in 2010.

This patent family protects variant of HAMLET with production advantages and describes peptides that could be the base for the second-generation product. The peptides could have significant advantages over HAMLET itself. The application also includes a description and claims relating to some of the mechanisms of action. Patents are granted in the US and the application evaluated by the EPO for a European patent. The patents that are granted are valid until November 24, 2031.

Two additional patent applications have been filed relating to the possibility of using HAMLET and related proteins for prophylaxis purposes. The first application covers a new and important discovery regarding use of HAMLET and all its possible variants for preventive treatment, which may open the market for preventive treatment of healthy individuals, especially those who are genetically predestined to become ill. The second application concerns the more simple production of a therapeutic entity that could be made available for the large so-called neutraceutical market. The applications were submitted in August 2013, and thus any patents will be valid until August 2033.

This patent family protects the use of HAMLET for treatment of papillomas. The patent has been granted in the United States, Australia and in eight European countries. The patents are valid until May 8, 2023.

This patent family protects an essential production step for production of HAMLET and thus also the products produced in the process. All of the patents in the patent family are granted and valid in the United States and eight European countries. The patents are currently valid to November 23, 2018.

Hamlet Pharma intends to pursue an active patent application strategy and with increased resources Hamlet Pharma will have the opportunity to further strengthen the protection around the existing technology and the next generation HAMLET. The Company’s patent applications are handled by the UK based Patent FIrm C.P. Greaves & Co.