So, due to the recent supreme court case, who owns the patent on the mutation?
If the drug company creates a process for advancing this gene, will the people they gleaned the gene mutation from own the mutation or does the drug company? Or nobody?
I think they got the patent on the testing procedure, not the gene, but I could be wrong.
If the drug company creates a process for advancing this gene, will the people they gleaned the gene mutation from own the mutation or does the drug company? Or nobody?
The drugs being tested here are not genes and do not alter genes. They are monoclonal antibodies.
If I am to guess at their mechanism, I would say that they bind to the normal form of the enzyme that is defective in these women. Their gene defect causes a defect in an enzyme involved in the formation of LDL. The monoclonal antibodies attach to this same enzyme in normal people, deactivating it. They won't be able to make LDL without it. I think people receiving this treatment will need constant monitoring to ensure that their LDL levels remain within the normal range.
I think the recent Supreme Court case is going to put a halt into development of diagnostics based on genetic mutations. It costs too much to push medical devices through FDA approval to make it worthwhile to base a diagnostic kit on an unpatentable marker.