Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for major markets including the United States, Europe, Japan and China.
Cell-based technology and product candidates
The patents that we have obtained, and continue to apply for, cover MLC technologies and product candidates derived from these technologies, irrespective of the tissue source, including bone marrow, adipose, placenta, umbilical cord and dental pulp.
These patents cover, among other technology areas, a variety of MLCs, including Mesenchymal Precursor Cells (MPCs) and Mesenchymal Stem Cells (MSCs), and the use of MLCs for expansion of hematopoietic stem cells (HSCs). Among the indication-specific issued or pending patents covering product candidates derived from our MLCs are those which provide commercial support for our Tier 1 product candidates - chronic heart failure, chronic low back pain due to disc degeneration, acute graft versus host disease, and chronic inflammation conditions including biologic refractory rheumatoid arthritis, and diabetic nephropathy .
We also have issued and pending patents covering all of our Tier 2 and pipeline indications, including rheumatoid arthritis, type 2 diabetes and its complications, inflammatory bowel disease (e.g. Crohn’s disease), neurologic diseases, and orthopedic disorders.
In addition, in many major jurisdictions we may be able to extend commercial exclusivity period for our product candidates, which include, but are not limited to the exclusive right to reference our data, orphan drug exclusivity and patent term extensions.
Manufacturing
Our patent portfolio also includes issued and pending coverage of proprietary manufacturing processes that are being used with our current two-dimensional (2D) manufacturing platform as well as the three-dimensional (3D) bioreactor manufacturing processes currently under development. These cell manufacturing patents cover isolation, expansion, purification, scale up, culture conditions, aggregates minimization, cryopreservation, release testing and potency assays.